Janice Eng, PhD, Robert Teasell, MD, William Miller, PhD, Dalton Wolfe, PhD, Andrea Townson, MD, Jo-Anne Aubut

, BA, Caroline Abramson, MA, Jane Hsieh, MSc, Sandra Connolly, BHScOT, and the SCIRE Research Team

Editors:
Janice J. Eng, PhD, BSc (PT/OT), Robert Teasell, MD, FRCPC, William C. Miller, PhD, OT, Dalton Wolfe, PhD, Andrea F. Townson, MD, FRCPC, Jo-Anne Aubut, BA, Caroline Abramson, MA, Jane Hsieh, MSc, Sandra Connolly, BHScOT(C), OTReg. (Ont.)

This review has been prepared based on the scientific and professional information available in 2005. The SCIRE information (print, CD or web site www.icord.org/scire) is provided for informational and educational purposes only. Please feel free to use this information, as seen fit, without alteration. If you have or suspect you have a health problem, you should consult your health care provider. The SCIRE editors, contributors and supporting partners shall not be liable for any damages, claims, liabilities, costs or obligations arising from the use or misuse of this material.

Table of Contents

Start Page Forward ....................................................................................................................i Acknowledgements ................................................................................................ii Executive Summary ................................................................................................iii Editors ......................................................................................................................ix Contributors ............................................................................................................x

End Page i ii viii ix xi

Chapter 1 Chapter 2 Chapter 3 Chapter 4 Chapter 5 Chapter 6 Chapter 7 Chapter 8 Chapter 9

Rehabilitation: From Bedside to Community Following Spinal Cord Injury (SCI) .................................................................... 1-1 Methods of the Systematic Reviews ................................................ 2-1 Rehabilitation Practice and Associated Outcomes Following Spinal Cord Injury ............................................................................. 3-1 Community Reintegration Following Spinal Cord Injury .................... 4-1 Upper Limb Rehabilitation Following Spinal Cord Injury ................... 5-1 Lower Limb Rehabilitation Following Spinal Cord Injury ................... 6-1 Cardiovascular Health and Exercise Following Spinal Cord Injury.... 7-1 Respiratory Management Following Spinal Cord Injury .................... 8-1 Bone Health Following Spinal Cord Injury ......................................... 9-1

1-11 2-11 3-44 4-37 5-58 6-34 7-28 8-30 9-18 10-19 11-40 12-17 13-77 14-32 15-25 16-17

Chapter 10 Depression Following Spinal Cord Injury .......................................... 10-1 Chapter 11 Sexual Health Following Spinal Cord Injury ...................................... 11-1 Chapter 12 Neurogenic Bowel Following Spinal Cord Injury ............................... 12-1 Chapter 13 Bladder Health and Function Following Spinal Cord Injury .............. 13-1 Chapter 14 Pain Following Spinal Cord Injury .................................................... 14-1 Chapter 15 Venous Thromboembolism Following Spinal Cord Injury ................. 15-1 Chapter 16 Orthostatic Hypotension Following Spinal Cord Injury ...................... 16-1

Table of Contents (Cont.)
Start Page Chapter 17 Autonomic Dysreflexia Following Spinal Cord Injury ......................... 17-1 Chapter 18 Heterotopic Ossification Following Spinal Cord ................................ 18-1 Chapter 19 Nutrition Issues Following Spinal Cord Injury .................................... 19-1 End Page 17-27 18-8 19-13

Chapter 20 Pressure Ulcers Following Spinal Cord Injury ................................... 20-1 20-26 Chapter 21 Spasticity Following Spinal Cord Injury ............................................. 21-1 21-56 Chapter 22 Outcome Measures .......................................................................... 22- 1 22-89

Eng JJ, Teasell RW, Miller WC, Wolfe DL, Townson AF, Aubut J, Abramson C, Hsieh JTC, Connolly S, editors. Spinal Cord Injury Rehabilitation Evidence. 2006: Vancouver. www.icord.org/scire

FORWARD Over the past few years, the volume of publications encompassing a broad definition of rehabilitation after spinal cord injury (SCI) has expanded exponentially. As in all rapidly expanding research fields, it is helpful, from time to time, to review what has been published and assess the quality of the data and conclusions of these reports. Thus was born the SCIRE project. This manual represents the first comprehensive synthesis of the published evidence on rehabilitation strategies and community-based programs designed to improve the functional outcomes and quality of life for people living with a SCI. It is primarily intended as a guide for professionals in the areas of SCI health care and community care. It should also prove useful to SCI researchers, public policy makers, and people with SCI and their families. The goal is to provide everyone with the necessary objective information to make better-informed decisions as to the strength and validity of current rehabilitation programs and emerging strategies, as well as to identify gaps in our knowledge and possible research priorities. A knowledge translation project as large as SCIRE requires clearly identified validation criteria and the coordinated efforts of a large number of individuals. The more than 40 invited reviewers from across Canada have long-standing expertise on the topics they reviewed. Drs. Janice Eng, Robert Teasell and William Miller provided the vision, framework and critical leadership for SCIRE and the ensuing team work between the Vancouver and London sites. Their tireless efforts ensured the timely release of this first version. Version 1 is just the beginning of SCIRE activities. In the years to come, we can anticipate revised versions of SCIRE, as new SCI research evidence comes to light and future best practices in SCI rehabilitation are validated. In addition, this compilation can form a basis for activities such as the development of clinical practice guidelines and identification of disparities between current practice and best practice. On behalf of ICORD, The Ontario Neurotrauma Foundation, and The Rick Hansen Foundation, we offer thanks and congratulations to everyone who contributed to the successful launch of SCIRE.

John D. Steeves John and Penny Ryan BC Leadership Professor Director of ICORD Vancouver, Canada

September 2006

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ACKNOWLEDGEMENTS This large-scale project represents the collaborations and tremendous efforts of so many dedicated people. We would like to thank the funding agencies that provided financial support – the Rick Hansen Man in Motion Foundation and the Ontario Neurotrauma Foundation. The SCIRE Advisory Committee met regularly to provide feedback on the process and translation methods for the SCIRE project and their input was invaluable. The SCIRE Advisory Committee members: Caroline Abramson, Research Coordinator, GF Strong Rehab Centre/University of BC Jo-Anne Aubut, Research Coordinator (Parkwood, London) Karen Anzai, Rehab Consultant, SCI Program, GF Strong Rehab Centre Sandra Connolly, OT, Spinal Cord Program (Parkwood, London) Armin Curt, MD, Research Chair, ICORD Chris Fraser, Reg. Dietician, SCI & ABI Programs, SCI consumer (Parkwood, London) Chris McBride, PhD, Managing Director, ICORD Dave Metcalf, Vocational Counselor, SCI consumer (GF Strong Rehab Centre) Kelly Moore, Educator, SCI Program, GF Strong Rehab Centre Steve Orenczuk, PsyD, SCI program (Parkwood, London) Andrea Townson, MD, FRCPC, GF Strong Rehab Centre, Co-PI, SCIRE Project Dalton Wolfe, PhD, SCI (Parkwood, London) Daryl Rock, Associate Director, Knowledge Exchange Canadian Council on Learning In addition to the editors and contributors already recognized, several individuals made significant contributions to assessing and extracting data from Vancouver: Jennifer Cumal, Nicole Elfring, Marcia Fukunaga, Chihya Hung, Emily Procter, and Jeff Tan and from London: Joan Conlon and Dr. Jeff Jutai. We are grateful to the GF Strong Rehab Centre (Vancouver Coastal Health), Parkwood Hospital (St. Joseph’s Health Care) and Lawson Health Research Institute which provided the space and infrastructure support for undertaking the project. We’d also like to recognize the support from ICORD, in particular, Cheryl Niamath for her graphic designs and endless patience, Dave Pataky for his web and CD development and Dr. John Steeves for his guidance. Lastly, we’d like to express our gratitude to the many SCI rehabilitation scientists and clinicians who spent endless hours putting the chapters together and made this project possible.

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EXECUTIVE SUMMARY 1. SCIRE Project overview The Spinal Cord Injury Rehabilitation Evidence (SCIRE) is a synthesis of the research evidence underlying rehabilitation interventions to improve the health of people living with SCI. SCIRE covers a comprehensive set of topics relevant to SCI rehabilitation and community re-integration. This project is intended to translate existing knowledge to health professionals to inform them of best practice. This research synthesis will also enable relevant decision-making in public policy and practice settings applicable to SCI rehabilitation. In addition, transparent evidence-based reviews can guide the research community and funding organizations to strategically focus their time and resources on the gaps in knowledge and identify research priorities. People with SCI and their families may also find the information useful to understanding their health care. The Spinal Cord Injury Rehabilitation Evidence developed from a research collaboration between Vancouver and London (Ontario) and involved their respective health centres (GF Strong Rehab Centre, St. Joseph’s Health Care), research institutions (International Collaboration on Repair Discoveries, Lawson Health Research Institute) and universities (University of BC, University of Western Ontario). 2. Methods Systematic Review An exhaustive search (keyword literature search, previous practice guidelines and systematic reviews, review articles) was used to identify published literature evaluating the effectiveness of any treatment or therapy related to SCI rehabilitation. Topics relevant to rehabilitation were selected with input from scientists and clinicians in the field of SCI rehabilitation, in addition to the SCIRE Advisory Committee (which included consumers with SCI and policy-makers). This search involved the review of over 17,000 titles and 8400 abstracts, and a final extraction and synthesis of almost 700 articles. A variety of study designs were included (from randomized controlled trials to case reports), however, controlled trials were given priority in generating conclusions. In order to provide transparent and unbiased evidence-based reviews, the rigor and quality of each study was scored on standardized scales by two independent reviewers (Physiotherapy Evidence Database Scale for randomized controlled trials and the Downs and Black Tool for all other studies). Following this individual study assessment, conclusions were drawn about the accumulated studies for each topic of interest (e.g., pressure ulcers) using a modified version of Sackett’s description of levels of evidence. In this 5 point scale, the strongest evidence, level 1, was assigned if the intervention was supported by at least one randomized controlled trial, while a level 5 was assigned if no critical appraisal existed, but perhaps was supported by clinical consensus. Conclusions were based on the levels, quality and concurring evidence. When conflicting data was present, an explanation was provided as to how the conclusions were derived. Outcome measure assessment Outcome measures used in spinal cord injury evaluation were identified by keyword search of the major electronic databases and through hand searches of noted spinal cord journals. Only measures with published studies of the psychometric (reliability and validity) properties within the spinal cord population were identified for review. The measures were categorized into the

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domains of the World Health Organization’s International Classification of Functioning, Disability and Health (body function/structure, activity and participation). A fourth category was created for quality of life measures. Approximately 160 measures were identified of which 63 were selected for review based on clinician interest. The measures were evaluated using elements of the Health Technology Assessment to assess the psychometric properties, interpretability, acceptability, and feasibility. Summary tables identifying the rigor and quality of the psychometric properties were constructed. A clinical conclusion is offered based on the synthesis of the review. 3. Findings from the Systematic Review of SCI Rehabilitation Given that the SCIRE consists of over 800 pages of evidence, we cannot represent all the findings here. What follows are selected findings which demonstrate the scope of the research and the value of the results. Rehabilitation Practice Earlier admission to specialized, interdisciplinary SCI care is associated with reduced length of total hospital stay and greater and faster rehabilitation gains with fewer medical secondary complications (especially pressure sores). Community Re-integration The average level of quality of life after SCI is slightly lower than in people without disability but a substantial number of people with SCI report good or excellent levels of quality of life. The severity of injury and other diagnostic factors do not significantly impact quality of life. Their influence may become significant through restrictions in community integration or social participation. Upper Limb Rehabilitation Upper limb muscle strength is identified as an important contributor to functional independence. Neuromuscular stimulation-assisted exercise (e.g., during arm ergometry) following a spinal cord injury is effective in improving muscle strength, preventing injury and increasing independence in all phases of rehabilitation. Practice of repetitive movements in conjunction with low intensity peripheral nerve stimulation may induce beneficial brain cortical changes, in addition to improved arm and hand function. Lower Limb Rehabilitation Body-weight supported treadmill exercise using a suspended harness is a relatively new treatment of interest. For patients less than 6 months post-SCI, body weight supported treadmill training has equivalent effects on gait outcomes to conventional rehabilitation consisting of overground mobility practice. Body weight-support gait training strategies can improve gait outcomes in chronic, incomplete SCI, but no single specific body weight-support strategy (overground, treadmill, with functional electrical stimulation) is more effective. Cardiovascular Health and Exercise There appears to be an earlier onset and increased prevalence of cardiovascular disease in individuals with SCI in comparison to the general population. Tetraplegics and paraplegics can improve their cardiovascular fitness and physical work capacity through aerobic exercise training (e.g., arm cycle or wheelchair ergometry), which are of moderate intensity, performed 20-60 min day, at least three times per week for a minimum of six to eight weeks.

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Respiratory Management Respiratory complications continue to be one of the leading causes of morbidity and mortality in people with spinal cord injury, especially among cervical and higher thoracic injuries. Unlike the cardiovascular system, the lungs and airways do not change appreciably in response to exercise training. For exercise training to improve respiratory function, the training intensity must be relatively high (70-80% of maximum heart rate) performed three times per week for six weeks. Bone Health There is a significant risk for lower extremity fragility fractures after SCI. Early assessment and ongoing monitoring of bone health is an essential element of SCI care. There is strong evidence from randomized controlled trials that support the use of medications for the prevention and treatment of bone loss following SCI. Non-pharmacological treatments have not been found to prevent bone loss in the first year, however, electrical stimulation can increase bone density over the area stimulated in people with SCI more than 1 year post-injury. Depression Depression is a common consequence of SCI. Cognitive behavioural interventions provided in a group setting appear helpful in reducing post-SCI depression. The benefits of drug treatment (including selective serotonin reuptake inhibitors and tricyclic antidepressants) in combination with psychotherapy may alleviate depression. However, pharmacological management for postSCI depression is largely extrapolated from studies in non-SCI populations. Programs to encourage regular exercise, reduce stress, and improve or maintain health are beneficial in reducing reports of depressive symptoms in persons with SCI. Sexual Health In men with SCI, erections are often not reliable or adequate for sexual intercourse since there may be difficulties with maintenance of the erection. The pharmacological agent, Phosphodiesterase Type 5 Inhibitors (PDE5i, Viagra®) can be used safely and effectively for treatment of erectile dysfunction in men with SCI and are recommended as first line treatment for erectile dysfunction after SCI. Bowel Management Multifaceted programs incorporating intereventions such as, nutrition, fluid consumption, routine bowel evacuation, may improve movement of substances through the colon as well as decrease the incidences of difficult bowel evacuations. Pharmacological agents such as cisapride, prucalopride, and metoclopramide are effective for the treatment of chronic constipation in persons with SCI. Bladder Management Disruption of the signals from the brain resulting from a SCI prevents normal voluntary voiding without assistance. Intermittent catheterization and spontaneous triggered voiding are associated with the lower complications compared to indwelling catheters. Intermittent catheterization may be difficult to continue at home for those with tetraplegia and complete injuries. Assistive devices may enhance compliance with intermittent catheterization for those with impaired hand function. Pain Management Pain following a SCI is common, often severe and has a significant effect on quality of life. A shoulder exercise protocol (consisting of shoulder stretching and strengthening) reduces the intensity of shoulder pain post-SCI. Reduce pain may be achieved from massage, heat, v

acupuncture or hypnosis. A number of pharmacological agents can provide pain relief, including the anticonvulsant Gabapentin, Intrathecal Baclofen, and Lidocaine through a subarachnoid lumbar catheter. Tricyclic antidepressants and Intrathecal Clonidine have not been shown to reduce post-SCI pain. Venous Thromboembolism Venous thromboembolism (blood clot) is very common in untreated spinal cord-injured patients. The pharmacological agent low molecular weight heparin is more effective than standard heparin in reducing the risk of venous thromboembolism post-SCI with less bleeding complications. Physical interventions such as pneumatic compression or pressure stockings may have some additional benefits when used in combination with pharmacological agents. Orthostatic Hypotension Orthostatic hypotension is an excessive reduction in blood pressure with changes in body position and can result in lightheadedness or dizziness. It is commonly experienced following SCI due to the loss of muscle activation. Although a wide array of physical and pharmacological measures are recommended for the general management of orthostatic hypotension, very few have been evaluated for use in SCI. Of the pharmacological interventions, only midodrine was found to be effective, while functional electrical stimulation is one of the only nonpharmacological interventions which demonstrates some evidence to support its use. Autonomic Dysreflexia Autonomic dysreflexia is a potentially life-threatening acute elevation of blood pressure commonly experienced post-SCI. The identification of the possible trigger and decrease of sensory stimulation to the spinal cord is the most effective prevention strategy. Urinary bladder irritation is one of the major triggers of autonomic dysreflexia following SCI. The pharmacological agents, nifedipine or captopril are commonly used and can prevent or control autonomic dysreflexia in SCI individuals. Heterotopic Ossification Heterotopic ossification, the formation of pathological bone in muscle or soft tissue, occurs frequently in the first two months following SCI. Anti-inflammatory medications or warfarin (anticoagulant) can reduce the risk of heterotopic ossification post-SCI. Once ossification is identified, the pharmacological agent, etidronate or radiation therapy can reduce the progression of heterotopic ossification. Nutrition There is an increased risk for obesity, abnormal lipid metabolism, cardiovascular disease, impaired glucose regulation and diabetes mellitus post-SCI. Standard dietary counseling (daily total fat <30% of total daily calories, saturated fat <10% of total daily calories, cholesterol <300 mg, carbohydrates equal to 60% of total daily calories) can reduce total cholesterol. A holistic wellness program can help people adopt healthy nutritional behaviours following a SCI. Vitamin deficiency is common post-SCI, therefore individuals should be screened and if needed, replacement therapy should be initiated. Pressure Ulcers Pressure ulcers are a serious, lifelong secondary complication of SCI. A number of prevention strategies exist to reduce the risk of pressure ulcers and appropriate seating is one important consideration. No one cushion is suitable for all individuals with SCI. Cushion selection should be based on a combination of pressure mapping results, individual characteristics and preference. Adding lumbar support to the wheelchairs of individuals with chronic SCI is unlikely vi

to have a role in pressure ulcer prevention post-SCI. A forward leaning position or the wheelchair tilted back position (> 65º) are effective methods of pressure relief. Spasticity Spasticity is the excessive involuntary motor activity of a muscle or muscle group reacting to external stimuli. It is a major obstacle for community and workplace integration following SC. Oral baclofen or intrathecal baclofen reduces muscle spasticity following SCI. A number of nonpharmacological interventions (transcutanous electrical stimulation, massage, assisted standing, ice) have short term effects on spasticity lasting several minutes to hours. Outcome measures Numerous outcome measures are available for use in SCI practice and research. Many SCI specific measures are gaining acclaim such as the Spinal Cord Independence Measure which is slowly replacing the Functional Independence Measure as the outcome of choice for assessing personal activities of daily living. Several new generic measures of participation in higher order social activities and life habits are available. These tools are conceptually well developed and support for psychometric properties is accumulating. 4. Limitations in SCI Rehabilitation Literature The task of compiling this vast amount of literature provided the SCIRE team a unique opportunity to appraise the body of SCI rehabilitation literature as a whole. There is a substantial amount of literature available in SCI rehabilitation as highlighted in the previous section. However, the SCIRE team noted several gaps and recurring methodological issues across different topics in SCI rehabilitation and highlight these limitations here. Our topics were selected by clinicians, researchers and consumers with SCI and not necessarily by the abundance of research papers in a particular area. Little or no information was available in several areas. Despite the inherent value we place on integrating an individual in their community, we do not know the best methods to facilitate successful re-entry into community life and literature was either absent or based on observational studies for this topic. There was also a dearth of literature concerning sexual and reproductive health of women with SCI that would potentially guide selection of contraception, enhancement of sexual adjustment and response or access to routine gynecological procedures. Women make up a significant proportion of the SCI population (one-quarter to one-third) and were underrepresented across all areas of SCI rehabilitation literature. For many areas, we rely on information based primarily on other medical conditions. Although guidelines exist for SCI related conditions such as depression, autonomic dysreflexia, and deep vein thrombosis, many of the recommendations are based on other patient populations (not SCI). SCI is a complex condition with effects and interactions on multiple systems and responses that are not always predictable. For example, a simple dietary intervention such as increased fibre, had a response in SCI (worsened constipation) which was opposite to what would be expected in able-bodied individuals (reduced constipation). The SCI rehabilitation literature suffers from several methodological shortcomings, including small, heterogeneous samples, few controlled trials, and a lack of consensus as to common outcome measures. Study samples consisted of people who had sustained different injuries: paraplegia and tetraplegia, complete and incomplete injuries, and acute and chronic injuries. This was prevalent throughout the current literature, despite the knowledge that physiological responses from interventions are different in these subgroups. As a result, a heterogeneous vii

sample can also wash out what might have been important effects for a subsample of the population. For example, bone health interventions depend on the stage of injury; preventing bone loss during the rapid bone mineral loss in the first 4-6 months compared with maintaining or improving bone during the relative stabilization after 1-2 years after SCI. However, some of the bone health studies included participants within a few months to several years post-injury representing physiologically different phases. Pharmacological interventions were supported by the largest proportion of randomized controlled trials (level 1 evidence) while other rehabilitation interventions were primarily supported by single group, pre-test/post-test studies (level 4 evidence). Without a comparable control group, one cannot determine if improvements are attributed to the intervention or other factors such as increased familiarity with the outcome measures, time post-injury or attention from the clinician. Furthermore, randomizing the subjects into the treatment and control group reduces the biases associated with patient selection. It was not surprising to see a number of interventions where the weaker evidence demonstrated positive effects, but the more rigorous controlled trials did not. For example, lower levels of study design (pre-test/post-test study or non-randomized trial) suggested that body-weight support treadmill training in sub-acute SCI resulted in better outcomes than conventional rehabilitation; however, stronger evidence from a single-blinded RCT suggested that no differences between body weight support treadmill training and conventional rehabilitation. Rigorous randomized trials with homogeneous groups require a large available source of patients. The number of new spinal cord injuries is relatively small compared to conditions like arthritis or heart disease. There is no doubt that multi-site trials are required if we strive to increase the certainty as to whether a treatment is effective or not in SCI rehabilitation. There is a lack of standardization when selecting the outcome measures for an intervention. For example, the chapter authors (Hsieh et al. 2006) noted that the spasticity interventions included 66 different outcome measures. No single outcome measure can capture the multidimensional nature of spasticity and its effects and studies should include effective outcome measures that meet minimum standards and that encompass the range of health outcomes relevant to the treatment and the patients. In addition, consensus on some common measures would assist the interpretation of results across studies. 5. Conclusions The SCIRE combined the efforts of expert scientists, clinicians, consumers and stakeholders to increase the accessibility of quality information in SCI rehabilitation. A broad range of topics are evaluated, and future editions will continue to update, improve and add new topics for people seeking information relevant to SCI rehabilitation from bed side to community. The preappraised, synthesized research from SCIRE can translate into improved health for Canadians by keeping health care professionals, scientists, policy-makers and consumers with SCI informed of the latest evidence.

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EDITORS Janice J Eng, PhD, BSc (PT/OT), is Professor, School of Rehabilitation Sciences, University of BC, GF Strong Rehab Centre and ICORD (Vancouver, Canada). Her program in neurological rehabilitation spans mechanistic research, clinical trials to knowledge translation. She is a Canadian Institutes of Health Research Scholar and Michael Smith Scholar. Robert Teasell, MD, FRCPC is Professor/Chair/Chief of the Department of Physical Medicine and Rehabilitation at the University of Western Ontario and Parkwood Hospital (SJHC). Dr. Teasell’s research interests are in evidence-based applications to clinical rehabilitation practice with a specific interest in neurorehabilitation, and chronic pain, particularly the role of personality in coping with pain. William C Miller, PhD, OT, is Associate Professor, School of Rehabilitation Sciences, University of BC and ICORD faculty. An epidemiologist by background, his expertise is in the area of measurement and examination of mobility limitations and daily occupations across diagnoses in older adults. He is a Canadian Institutes of Health Research Scholar. Dalton Wolfe, PhD is an Associate Scientist in the Program of Aging, Rehabilitation and Geriatric Care in the Lawson Health Research Institute, London, ON, Canada. Dr. Wolfe has a background in clinical neurophysiology and research methods. His current research interests are in the areas of health promotion and FES-assisted exercise for people with SCI. Andrea F Townson, MD, FRCPC is Clinical Assistant Professor in the Division of Physical Medicine and Rehabilitation, University of British Columbia and ICORD. She is Medical Manager, SCI Rehab Program at GF Strong Rehab Centre. Research interests include high lesion spinal cord injuries, ventilator dependency, fatigue and outcome measures. Jo-Anne Aubut, BA is a research assistant in the Department of Physical Medicine & Rehabilitation located at Parkwood Hospital. She has worked on a variety of research projects through the University of Western Ontario and the Lawson Health Research Institute in London, ON. Caroline Abramson, MA, is the Clinical Research Coordinator for the Division of Physical Medicine and Rehabilitation. She works with physiatrists and residents on a variety of research projects through the University of British Columbia and GF Strong Rehab Centre. Jane Hsieh, MSc, has over 15 years in clinical research in both the academic and biotechnology industry settings. Previously as the senior director of Clinical Program at AcordaTherapeutics, she oversaw a variety of phase 1, 2 & 3 studies mainly in SCI and MS populations. Her current activities inlcude consultation to both academic and industrial research groups. Sandra Connolly, BHScOT(C), OTReg. (Ont.) is an occupational therapist in the Spinal Cord Injury Rehabilitation Program at Parkwood Hospital, St. Joseph's Health Care London. ix

CONTRIBUTORS Maureen Ashe, PhD, PT School of Rehabilitation Sciences University of BC Vancouver, BC Najib Ayas, MD, MPH, FRCPC Faculty of Medicine University of BC Vancouver, BC Jeff Blackmer, MD, FRCPC Physical Medicine and Rehab University of Ottawa Ottawa, ON Sally Breen, RN, BSN, CRRN Sexual Health GF Strong Rehab Centre Vancouver, BC Geri Claxton, RN Outpatient Nursing GF Strong Rehab Centre Vancouver, BC B. Cathy Craven, MD FRCPC Bone Density Lab Toronto Rehabilitation Institute Toronto, ON Armin Curt, MD, FRCPC Faculty of Graduate Studies University of BC, ICORD Vancouver, BC Stacy Elliot, MD Department of Psychiatry University of BC, ICORD Vancouver, BC Susan J Forwell, PhD, OT(C) School of Rehabilitation Sciences University of BC, ICORD Vancouver, BC Chris Fraser, HBSc, RD Rehabilitation Program Parkwood Hospital London, ON Tal Jarus, PhD, OT School of Rehabilitation Sciences University of BC Vancouver, BC Lyn Jongbloed, PhD, OT(C) School of Rehabilitation Sciences University of BC Vancouver,BC David Keast, MD, FRCPC Outpatient Chronic Wound Management Parkwood Hospital London, ON Andrei Krassioukov, MD, PhD Department of Medicine University of BC, ICORD Vancouver, BC Tania Lam, PhD, PT School of Human Kinetics University of BC, ICORD Vancouver, BC Kate McBride, RN Sexual Health GF Strong Rehab Centre Vancouver, BC William B Mortensen, BScOT, MSc School of Rehabilitation Sciences University of BC Vancouver, BC Stephanie Muir-Derbyshire, MSc, SLP(C), Reg CASLPA Parkwood Hospital London, ON

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Vanessa Noonan, BScPT, MSc Dept of Orthopaedic Surgery University of BC Vancouver, BC Luc Noreau, PhD Department of Rehabilitation Laval University Quebec City, QC Steven Orenczuk, PsyD Rehabilitation Program Parkwood Hospital London, ON Emily Procter, BSc GF Strong Rehab Centre Vancouver, BC MaryAnn Regan, RN, BScN Spinal Cord Injury Rehabilitation Program Parkwood Hospital London, ON W Darlene Reid, PhD, PT School of Rehabilitation Sciences University of BC Vancouver, BC Candice Rideout, PhD (Candidate) Human Nutrition University of BC Vancouver, BC Bonita Sawatzky, PhD Dept of Orthopaedic Surgery University of BC Vancouver, BC Keith Sequeira, MD, FRCPC Physical Medicine & Rehab University of Western Ontario, Parkwood Hospital, London, ON

A William Sheel, PhD School of Human Kinetics University of BC, ICORD Vancouver, BC Jim Slivinski, MA Psychology Intern Parkwood Hospital London, ON Shannon Sproule, PT GF Strong Rehab Centre Vancouver, BC John Steeves, PhD John and Penny Ryan BC Leadership Chair, ICORD, UBC/VCHRI Vancouver, BC Linh Tu, BHSc Physical Medicine and Rehabilitation Parkwood Hospital, SJHC London, ON Darren Warburton, PhD School of Human Kinetics University of BC, ICORD Vancouver, BC Maura Whittaker, PT GF Strong Rehab Centre Vancouver, BC Shannon Wilkinson, BScOT Spinal Cord Unit GF Strong Rehab Centre Vancouver, BC

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CHAPTER ONE
Rehabilitation: From Bedside To Community Following Spinal Cord Injury (SCI)
Janice J Eng, PhD, BSc (PT/OT) William C Miller, PhD, OT

Table of Contents

1.1 Background ......................................................................................................................1-1 1.2 Epidmiology .....................................................................................................................1-2 1.2.1 Traumatic SCI .................................................................................................................1-2 1.2.2 Non-traumatic SCI ..........................................................................................................1-3 1.3 Recovery...........................................................................................................................1-3 1.3.1 Neuroplasticity ................................................................................................................1-4 1.3.2 Measures of Recovery ....................................................................................................1-4 1.4 Rehabilitation ...................................................................................................................1-6 1.5 Community Re-integration..............................................................................................1-7 References................................................................................................................................1-9

This review has been prepared based on the scientific and professional information available in 2005. The SCIRE information (print, CD or web site www.icord.org/scire) is provided for informational and educational purposes only. If you have or suspect you have a health problem, you should consult your health care provider. The SCIRE editors, contributors and supporting partners shall not be liable for any damages, claims, liabilities, costs or obligations arising from the use or misuse of this material. Eng JJ, Miller WC (2006). Rehabilitation: From Bedside To Community Following Spinal Cord Injury. In: Eng JJ, Teasell RW, Miller WC, Wolfe DL, Townson AF, Aubut J, Abramson C, Hsieh JTC, Connolly S, editors. Spinal Cord Injury Rehabilitation Evidence. Vancouver, p 1.1-1.11. www.icord.org/scire

Rehabilitation: From Bedside To Community Following Spinal Cord Injury (SCI)
1.1 Background The spinal cord extends from the foramen magnum (opening at the base of the skull) to the conus medullaris (most distal bulbous part of the cord) at the level of the first and second lumbar vertebrae. It consists of 31 segments associated with 31 pairs of spinal nerves (8 cervical, 12 thoracic, 5 lumbar, 5 sacral and 1 coccygeal). The ascending sensory nerves within the spinal cord receive and transmit sensory information to the brain. The descending motor nerves transmit information from the higher brain structures to various parts of the body to initiate motor functions such as movement and to regulate autonomic functions such as respiration and blood pressure. The spinal cord is also critical for transmitting and integrating information within the spinal cord. Figure 1.1
C2-3 C3-5 C5 C6 C7 C8 T1 Sternomastoid Diaphragm Elbow Flexors Wrist Extensors Elbow Extensors Long Fingers Flexors Small Finger Abductors

Cervical

Thoracic

T1-11 T7-L1

Intercostals Abdominals Muscle

Conus medullaris Lumbar Cauda Equina

Sacral

T11-L2 L2 L3 L4 L5 S1 S2-3 S2-4

Ejaculation Hip Flexors Knee Extensors Ankle Dorsiflexors Long Toe Extensor Ankle Plantarflexors Bowel / Bladder Penile Erection

Coccygeal

Spinal cord injury (SCI) which results in disruption of the nervous transmission can have considerable physical and emotion consequences to an individual’s life. Paralysis, altered sensation, or weakness in the parts of the body innervated by areas below the injured region almost always occur. In addition to a loss of sensation, muscle functioning and movement, individuals with SCI also experience many other changes which may affect bowel and bladder, presence of pain, sexual functioning, gastrointestinal function, swallowing ability, blood pressure, temperature regulation and breathing ability. Numerous secondary complications

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may arise from SCI including deep vein thrombosis, heterotopic ossification, pressure ulcers and spasticity. The recovery can be long from the acute hospital admission to the return of full participation in the individual’s community. Even those individuals who make significant gains in rehabilitation may experience difficulty when returning to pre-injury activities. Thus, SCI has a severe effect on quality of life. It also has an enormous cost on the health care system. Dryden et al. (2005) examined the health care costs following a SCI in Canada. The acute and rehabilitation care represented 68.2% of the total health care costs incurred over the first 6 years for an individual following an injury to the spinal cord. The direct costs of a spinal cord injury were estimated at $146,000 Canadian in the first year for a person with a complete traumatic injury and $42,000 for an incomplete injury. Annual costs in the subsequent 5 years post-injury were reported to be $5400 Canadian per person with a complete injury and $2800 for an incomplete injury (Dryden et al. 2005). Compared to age and gender-matched controls, individuals with SCI discharged from hospital are more likely to be re-hospitalized, have physician contact and use more hours of home care services (Dryden et al. 2004). The need for evidence-based SCI rehabilitation programs has never been greater given the enormous cost of SCI rehabilitation, the growing demands on the Canadian health care system and the devastating impact that an SCI has on the quality of lives of individuals. 1.2 Epidemiology Injuries to the spinal cord have been classified as either traumatic in cause (e.g., motor vehicle accidents, falls, violent incidences, diving) or non-traumatic (e.g., tumors, spinal stenosis, vascular). Traumatic SCI accounts for the larger proportion of SCI injuries, however, the exact proportion compared to non-traumatic SCI is difficult to ascertain because reporting of nontraumatic SCI has been inconsistent. The percent of traumatic SCI to overall SCI injury has been reported to range from 75% in Germany (Exner & Meinecke 1997), 61% in the United States (McKinley et al. 1999a) and 48% in the Netherlands (Schonherr et al. 1996). 1.2.1 Traumatic SCI Much of the following epidemiology data on traumatic spinal cord injury in Canada has been extracted from the 2006 Canadian Institute of Health Information Report on Traumatic SCI (CIHI 2006a) using 2003-2004 data from the Canadian National Trauma Registry (NTR). Over 950 traumatic spinal cord injuries occurred in 2003-2004 (CIHI 2006a). Reports of the annual incidence vary in part due to differing methods of identifying and tracking injuries, and due to regional differences. The annual incidence has been estimated at 52.5 per million population in Alberta (Dryden et al. 2003) and 46.2 to 37.1 per million population over the 1994 to 1999 period in Ontario (Pickett et al. 2003). The global incidence of SCI estimated primarily from developed countries ranges between 10.4 to 83 per million population per year when including only patients who survived before hospital admission (Wyndaele & Wyndaele 2006). In Canada, males comprise over three-quarters of these traumatic injuries with the majority occurring in those under 35 years of age. Motor vehicle accidents are the leading cause of SCI injury (43%), while falls are the second leading cause (36%) (NTR 1999). The number of spinal cord injuries resulting from falls are increasing due to the growing older adult segment of the population. This has contributed to the increase in age of a person with traumatic SCI (from average age 46 in 1994 to average 49 in 1998). In fact, we are now seeing a bimodal distribution of SCI in the population with one mode centralizing at approximately 30 years of age and another mode centralizing at 60 years of age. Interestingly, falls are the primary cause of

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spinal cord injury admissions in seniors (64%), while motor vehicle accidents are the leading cause in young adults (NRT 1999). Fractures of the vertebral column, in addition to spinal cord injury represent 71% of all SCI hospital admissions (NTR 1999). Of the SCI admissions, 44% result in paraplegia and 56% tetraplegia (NTR 1999). Traumatic SCI can be complex as motor vehicle accidents or other violent incidents often result in more than injury to the spinal cord. In particular, patients with the dual diagnosis of traumatic brain injury and spinal cord injury present a challenge to the rehabilitation professional as they are often agitated and have poor concentration. The percentage of SCI injuries which are accompanied by a traumatic brain injury are substantial, for example, Lida et al. (1999) reported that 35% of SCI had a traumatic brain injury. There appears to be a trend towards more severe injuries in Canada. In the 1970s, the Canadian Paraplegic Association (CPA) reported that about 25% of injuries resulted in tetraplegia and 75% paraplegia. Of the new injuries reported to CPA during 1999, 47% resulted in tetraplegia and 53% resulted in paraplegia. This increase in tetraplegic injuries concurs with a slight significant increase from 53.5% tetraplegia in the 1970s to 56.5% in 2000 at the facilities with the Model Spinal Cord Systems in the US (Jackson et al. 2004). A survey of the epidemiology literature (Wyndaele and Wyndaele 2006) suggests increasing proportions of tetraplegia with a global proportion of approximately two-thirds tetraplegia. There have been some suggestions that there are increasing numbers of incomplete lesions in some regions (Calancie et al. 2005). However, these finding are not consistent. The Model Spinal Cord Systems in the US (Jackson et al. 2004) reported an increase in complete injuries in the 1990s which has since dropped back to pre-1990 levels with just less than half of the injuries being complete. The Australian Spinal Cord Injury Registry reported increasing rates in elderly males, fall-related injury and incomplete tetraplegia and complete paraplegia over an eleven year period (O’Connor 2006). 1.2.2 Non-traumatic SCI There are many different causes of non-traumatic SCI, the more common conditions include spinal stenosis (narrowing of the spinal canal), tumor compression and vascular ischemia. Individuals with a non-traumatic SCI do not necessarily enter major trauma or rehabilitation centres and thus are not easily tracked in SCI registries or databases. Non-traumatic SCI has different demographics than traumatic SCI as spinal stenosis and spinal tumors are more common in adults over 50 years of age. In addition, specific diseases such as multiple sclerosis, paediatric spina bifida or poliomyelitis can also contribute to non-traumatic spinal cord injury and each has demographics specific to the condition. Overall, compared to traumatic SCI, individuals with non-traumatic SCI tend to be older with less severe injuries, more likely to be female, married, retired, and have an incomplete paraplegic injury (McKinley et al. 1999, 2002a, 2002b). Differences in demographics, clinical presentation and rehabilitation outcomes have important implications for management of nontraumatic SCI. 1.3 Recovery The majority of individuals experience some neurological recovery (changes in motor or sensory status) following a SCI, in addition to functional recovery. Given that all patients receive some

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treatment (e.g., pharmacological, self-care and mobility training), it is difficult to separate the contributions of spontaneous recovery with those from active rehabilitation in humans. 1.3.1 Neuroplasticity Spontaneous neuronal plasticity occurs through various mechanisms and has been demonstrated primarily in animal models. Recovery mechanisms following complete injuries may include recovery of nerve roots beside the lesion level, changes in the gray matter of the spinal cord at the lesion level, reorganization of existing spinal circuits and peripheral changes (Bradbury & McMahon 2006; Kern et al. 2005; Ding et al. 2005; Hagg & Oudega 2006; Ramer et al. 2005). The evidence for spontaneous axonal regeneration is limited as a small proportion of fibres regenerate and over a modest distance (Bradbury & McMahon 2006). However, cortical re-organization can occur, for example, Lotze et al. (2006) showed that cortical representation of elbow movements following a complete thoracic injury in humans was moved toward cortical areas which represented the injured thoracic regions. There is evidence that a pattern-generating spinal circuitry (also known as a central pattern generator) is retained following a complete injury which can produce stepping-like movements and activation patterns with epidural lumbar cord stimulation (Kern et al. 2005) or treadmill stimulation (Dietz et al. 2002). However, the functional consequences of these observations are yet to be determined. Incomplete injuries may have a greater extent of axonal sprouting and axonal growth (Ding et al. 2005; Hagg & Oudega 2006). In incomplete spinal cord injury in rats, transected hindlimb corticospinal tract axons sprouted into the cervical gray matter to contact short and long propriospinal neurons (Bareyre et al. 2004). Following cervical lesions of the rat dorsal corticospinal motor pathway which contains more than 95% of all corticospinal axons, there was spontaneous sprouting from the ventral corticospinal tract onto medial motoneuron pools (Weidner et al. 2001). This sprouting was paralleled by functional recovery. Ramer et al. (2005) suggested that if axonal regeneration occurs or if synaptic spaces become occupied with different axons, functional recovery will require retraining to optimize these new circuits. The neuroplastic changes which underlie spontaneous recovery may be enhanced by physical interventions (e.g., exercise, electrical stimulation) and pharmacological agents (Ramer et al. 2005). 1.3.2 Measures of Recovery Changes in the American Spinal Injury Association (ASIA) International Classification of Spinal Cord Injury, neurological level of injury and completeness of injury are often used to indicate human neurological recovery. ASIA International Standards for Neurological Classification of Spinal Cord Injury consists of 1) 5 category ASIA Impairment Scale (A-E), 2) motor score and 3) sensory score (ASIA 2002). Twenty-eight dermatomes are assessed bilaterally using pinprick and light touch sensation for the sensory score (maximum of 112 for pinprick and 112 for light touch sensation). Ten key muscles are assessed bilaterally with manual muscle testing for the motor score (maximum of 50 for lower limbs and 50 for upper limbs). The results are used in combination with evaluation of anal sensory and motor function as a basis for the determination of the ASIA Impairment Scale and the 5 categories are summarized below (ASIA 2002).

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Table 1.1 Descriptions of Categories from ASIA Impairment Scale
ASIA A: Complete injury where no sensory or motor function is preserved in sacral segments S4-S5. ASIA B: Incomplete injury where sensory, but not motor, function is preserved below the neurologic level and extends through sacral segments S4-S5. ASIA C: Incomplete injury where motor function is preserved below the neurologic level, and most key muscles below the neurologic level have muscle grade less than 3 (active full-range movement against gravity). ASIA D: Incomplete injury where motor function is preserved below the neurologic level, and most key muscles below the neurologic level have muscle grade greater than or equal to 3. ASIA E: Normal sensory and motor functions.

Neurological level of injury is the most caudal level at which both motor and sensory levels are intact and has been shown to change in some individuals over recovery. Completeness of injury are based on the ASIA standards where the absence of sensory and motor functions in the lowest sacral segments indicates a complete injury and preservation of sensory or motor function below the level of injury, including the lowest sacral segments indicates an incomplete injury. Sacral-sparing is an important indicator of motor recovery and provides evidence of the physiologic continuity of spinal cord long tract fibers with the sacral fibers at the end of the cord. The requirement of sacral sparing to identify an incomplete injury provides a more rigorous definition and less patients will convert from incomplete to complete injury over time when using this definition. Stauffer (1976) proposed that individuals with tetraplegia would recover one neurological level, although this has been revised in recent years to qualify that recovery of one neurologic level in subjects with tetraplegia depends on severity, initial level of the injury and the strength of muscles below the level of injury (Dittuno et al. 2005). Dittuno et al. (1992) reported that 70 to 80% of motor-complete tetraplegia subjects with some motor strength at the injury level would recover to the next neurologic level within 3 to 6 months. Although those with complete lesions are generally limited to improvements of one or two levels, subjects with incomplete lesions may exhibit recovery at multiple levels below the injury site (Dittuno et al. 2005). Triceps elbow extension (C7) is a significant determinant for functional independence in self-care for community-living individuals with tetraplegia (Welch et al. 1986). For those with complete paraplegia, Waters et al. (1992) reported that 73% of 108 patients (T2L2) did not change in neurological level at one year post-injury compared to the rehabilitation admission assessment. 18% recovered to the next neurological level, while 7% had 2 levels of recovery. For incomplete paraplegia, 78% of 45 cases (T1-L3) had no changes in neurological level between the first and 12th month but there was substantial improvement in motor function particularly within the first 3 months (Waters et al. 1994). 70% of this sample were able to ambulate within 1 or 2 years post-injury (27% without any devices). Patients with initial grade 2 hip flexor and knee extensor motor strength achieved community ambulation. In terms of function, individuals with a T2-T9 injury have some trunk control and may be able to stand using braces and an assistive device such as a walker. Although injuries below T11 have increased potential for ambulation with bracing, successful community ambulation often involves individuals with an injury at the L3 level or below. Marino et al. (1999) assessed data from 21 Model System SCI systems with 3585 individuals with SCI over the first year of recovery. They found that 10 to 15% of those with initial complete

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ASIA A injuries converted to incomplete injuries. For ASIA B injuries, 1/3 converted to ASIA C and 1/3 to ASIA D or E. For ASIA C injuries, over 2/3 converted to ASIA D. However, the accurate prediction of ASIA conversion can be fraught with problems. Burns et al. (2003) found that individuals with cognitive factors (e.g., traumatic brain injury, alcohol intoxication, analgesic administration, psychological disorders) and communication barriers (e.g., language barriers, ventilatory dependency) had a higher percent of ASIA conversion over the first year likely due to an inaccurate initial assessment. 1.4 Rehabilitation Rehabilitation has been defined by the World Health Organization as a progressive, dynamic, goal-oriented and often time-limited process, which enables an individual with an impairment to identify and reach his/her optimal mental, physical, cognitive and social functional level. Enhancing quality of life is regarded as an inherent goal of rehabilitation services and programs given their focus on interventions to minimize the impact of pain and physical and cognitive impairment, and on enhancing participation in work and everyday activities. SCI rehabilitation involves a multitude of services and health professionals and is initiated in the acute phase and continues with extensive and specialized inpatient services during the sub-acute phase. Inpatient rehabilitation is an important stepping stone towards regaining and learning new skills for independent living. Here patients engage in an intensive full day program with services which may include nursing, physical therapy, occupational therapy, respiratory management, medical management, recreation and leisure, psychology, vocational counseling, driver training, nutritional services, speech pathology, social worker, sexual health counseling, assistive device prescription and pharmaceutical services. Rehabilitation continues with planning for discharge back to the community and finally, re-integration into former or new roles and activities within the community. Family and peers have important roles throughout the rehabilitation process. In Canada, the median length of inpatient rehabilitation stay for traumatic SCI is 59 days with longer stays for those with complete injuries or tetraplegic injuries ranging from 49 days for those with incomplete paraplegia to 101 days to those with complete tetraplegia (CIHI 2006a). SCI has the longest inpatient rehab length of stay over all other rehabilitation patient groups except for burns (CIHI 2006b). Functional recovery is often measured by the Functional Independence Measure (FIM), an 18 item scale that is intended to measure caregiver burden and includes tasks related to cognition, mobility, bowel and bladder management and self-care. During inpatient rehabilitation, patients with complete tetraplegia have the lowest FIM admission score and make less change compared to those with incomplete or paraplegic injuries (CIHI 2006a). Persons with the dual diagnosis of spinal cord injury and traumatic brain injury achieve smaller functional gains in rehabilitation (Macciocchi et al. 2004). Compared to traumatic SCI, the non-traumatic SCI rehabilitation length of stay is shorter, with a lower FIM change and fewer medical complications including deep venous thrombosis, orthostatic hypotension, pressure ulcers, wound infections, spasticity, autonomic dysrelfexia were less likely (McKinley et al. 2002a, 2002b). The shorter length of stay may be a result of the less severe injury. However, the earlier discharge in metastatic tumors may reflect the terminal nature of the disease and patients and family may wish for the remaining time to be spent at home.

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1.5 Community Re-integration There is a fundamental belief among consumers with SCI that there needs to be a paradigm shift in the approach to rehabilitation from an institutionally based physical restoration model to a community-based independent living model (Rick Hansen SCI Network 2005). Going home is a frequent goal established by patients newly admitted to hospital and 79% of individuals with traumatic SCI injuries return home. Only 62% of individuals with complete tetraplegia return home with 15% discharged back to acute care and 18% to long term care (CIHI 2006a). In a study of high lesion SCI (C1-C4), it was found that 40% of these clients were discharged to extended care units post rehabilitation, while the majority of these respiratory dependent patients returned to the community (Anzai et al. 2006). Life expectancy is less than normal, particularly for people with tetraplegia and who are ventilator-dependent (NSCISC 2004). The life expectancy of a 40 year old paraplegic who has survived at least 1 year post-injury is 10 years less than a person without a SCI (NSCISC 2004). Although the mortality rate during the first 2 years after SCI has been reduced over the past 30 years, Strauss et al. (2006) noted that there has not been a substantial change in life expectancy following the second year post-injury. In contrast, there has been an increase in life expectancy over the last 2 decades in the general population. Given that the majority of traumatic SCI occur in young adults, return to work or school is of high importance, but often necessitates a change in vocation. Less than 18% of those employed at the time of injury were able to return to the same job (CPA 1997). Within 3-6 months post inpatient rehabilitation, 14% of people with SCI are employed, while 64% were employed prior to injury. Approximately 9% are students (roughly double the pre-injury status). The majority are unemployed (26%) or on disability status (35%) at 3-6 months follow-up (CIHI 2006a). Canadians living with SCI tend to have a higher level of education than the general Canadian population (CPA 1997). In a survey of Canadians who had been injured at least 5 years, 62% were unemployed while 38% are employed (CPA 1997). Education is key to employment – higher education or increasing education following injury result in more success with employment. Of those who find employment, 44% do so within 2 years of injury while 77% find employment within 5 years. Accessible infrastructure and disability support are two major areas which people with SCI feel would improve quality of life (RHMIMF 2004). When considering priorities for research, individuals living with SCI rank finding a cure for SCI similarly to developing advances in rehabilitation/therapy (RHMIMF 2004). Regaining arm and hand function has been cited as one of the most important priorities to tetraplegics, while regaining sexual function has been cited as the highest priority for paraplegics (Anderson 2004). Improving bladder and bowel function was important to both injury groups (Anderson 2004). Although the majority of participants indicated that exercise was important to functional recovery, more than half did not have access to exercise (Anderson 2004). Anderson (2004) emphasized the need for researchers to be aware of the needs of SCI consumers in their quest for discovery. The continuum of health care in the community includes mechanisms for people to access information resources about living with a SCI. However, it appears that people with SCI do not approach traditional health care sources for their information (e.g., physician, hospital). For people living with SCI, the internet was by far the number one source for information about SCI (48%), while support groups and media ranked higher than hospitals, books, rehab centres,

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physicians and peers (RHMIMF 2004). It appears that the internet can be an ideal medium for promoting health-related education. To facilitate accessibility of information, the SCIRE information is available on CD, print version, as well as through web-access (www.icord.org/scire). In a recent survey, the majority (70%) of individuals with SCI rated the quality of life of people with SCI as good or very good while 23% rated it as poor or very poor (RHMIMF 2004). It is encouraging that 65% of individuals with SCI felt that the quality of life of people with SCI has improved over the past 5 years (RHMIMF 2004). As enhancing quality of life is an inherent goal of rehabilitation, there is a continual challenge to close the gap between treatment activities and functional competence in the individual’s actual environment.

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References American Spinal Injury Association. Reference Manual for International standards for neurological and functional classification of spinal cord injury patients (revised 2002). Chicago: American Spinal Injury Association, 2002. Anderson KD. Targeting recovery: priorities of the spinal cord-injured population. J Neurotrauma. 2004;21:1371-1383. Bareyre FM, Kerschensteiner M, Raineteau O, Mettenleiter TC, Weinmann O, Schwab ME. The injured spinal cord spontaneously forms a new intraspinal circuit in adult rats. Nat Neurosci. 2004;7:269-277. Burns AS, Lee BS, Ditunno JF Jr, Tessler A. Patient selection for clinical trials: the reliability of the early spinal cord injury examination. J Neurotrauma. 2003;20:477-482. Calancie B, Molano MR, Broton JG. Epidemiology and demography of acute spinal cord injury in a large urban setting. J Spinal Cord Med. 2005;28:92-96. Canadian Institute for Health Information (2006a). Life after traumatic spinal cord injury: From inpatient rehabilitation back to the community. Analysis in Brief. Canadian Institute for Health Information (2006b). Inpatient rehabilitation in Canada 2004-2005. Canadian Paraplegic Association (CPA) (1997). Spinal Cord Injury Workforce Participation National Survey. Curt A, Keck ME, Dietz V. Functional outcome following spinal cord injury: significance of motorevoked potentials and ASIA scores. Arch Phys Med Rehabil. 1998;79:81-86. Ding Y, Kastin AJ, Pan W. Neural plasticity after spinal cord injury. Curr Pharm Des. 2005;11:1441-1450. Dietz V, Muller R, Colombo G. Locomotor activity in spinal man: significance of afferent input from joint and load receptors. Brain. 2002;125:2626-2634. Ditunno JF Jr, Stover SL, Freed MM, Ahn JH. Motor recovery of the upper extremities in traumatic quadriplegia: a multicenter study. Arch Phys Med Rehabil. 1992;73:431-436. Ditunno JF Jr, Burns AS, Marino RJ. Neurological and functional capacity outcome measures: essential to spinal cord injury clinical trials. J Rehabil Res Dev. 2005;42:35-41. Ditunno JF Jr, Cohen ME, Hauck WW, Jackson AB, Sipski ML. Recovery of upper-extremity strength in complete and incomplete tetraplegia: a multicenter study. Arch Phys Med Rehabil. 2000;81:389-393. Dryden DM, Saunders LD, Rowe BH, May LA, Yiannakoulia NY, Svenson LW, Shchopflocher DP, Voaklander DC. The epidemiology of traumatic spinal cord injury in Alberta, Canada, Can J Neurol Sci. 2003;30:113-121. Dryden DM, Saunders LD, Rowe BH, May LA, Yiannakoulias N, Svenson LW, Schopflocher DP, Voaklander DC. Utilization of health services following spinal cord injury: a 6-year follow-up study. Spinal Cord. 2004;42:513-525. Dryden DM, Saunders LD, Jacobs P, Schopflocher DP, Rowe BH, May LA, Yiannakoulias N, Svenson LW, Voaklander DC. Direct health care costs after traumatic spinal cord injury. J Trauma. 2005;59:443-449. Exner G, Meinecke FW. Trends in the treatment of patients with spinal cord lesions seen within a period of 20 years in German centers. Spinal Cord. 1997;35:415-419. Hagg T, Oudega M. Degenerative and spontaneous regenerative processes after spinal cord injury. J Neurotrauma. 2006;23:264-280. Jackson AB, Dijkers M, Devivo MJ, Poczatek RB. A demographic profile of new traumatic spinal cord injuries: change and stability over 30 years. Arch Phys Med Rehabil. 2004; 85:1740-1748. Kern H, McKay WB, Dimitrijevic MM, Dimitrijevic MR. Motor control in the human spinal cord and the repair of cord function. Curr Pharm Des. 2005;11:1429-1439.

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Lotze M, Laubis-Herrmann U, Topka H. Combination of TMS and fMRI reveals a specific pattern of reorganization in M1 in patients after complete spinal cord injury. Restor Neurol Neurosci. 2006;24:97-107. Macciocchi SN, Bowman B, Coker J, Apple D, Leslie D. Effect of co-morbid traumatic brain injury on functional outcome of persons with spinal cord injuries. Am J Phys Med Rehabil. 2004;83:22-26. Marino RJ, Ditunno JF Jr, Donovan WH, Maynard F Jr. Neurologic recovery after traumatic spinal cord injury: data from the Model Spinal Cord Injury Systems. Arch Phys Med Rehabil. 1999;80:1391-1396. McKinley WO, Seel RT, Hardman JT. Nontraumatic spinal cord injury: incidence, epidemiology, and functional outcome. Arch Phys Med Rehabil. 1999a;80:619-623. McKinley WO, Huang ME, Brunsvold KT. Neoplastic versus traumatic spinal cord injury: an outcome comparison after inpatient rehabilitation. Arch Phys Med Rehabil. 1999b;80:12531257. McKinley WO, Seel RT, Gadi RK, Tewksbury MA. Nontraumatic vs. traumatic spinal cord injury: a rehabilitation outcome comparison. Am J Phys Med Rehabil. 2001;80:693-699. McKinley WO, Tewksbury MA, Godbout CJ. Comparison of medical complications following nontraumatic and traumatic spinal cord injury. J Spinal Cord Med. 2002a;25:88-93. Mckinley WO, Tewksbury MA, Mujteba NM. Spinal stenosis vs traumatic spinal cord injury: a rehabilitation outcome comparison. J Spinal Cord Med. 2002b;25:28-32. National Spinal Cord Injury Statistical Center (NSCISC 2004). Annual Statistical Report for the Model Spinal Cord Injury Care Systems. National Trauma Registry - 2003 dataset, Canadian Institute for Health Information, 2003. National Trauma Registry - 1999 dataset, Canadian Institute for Health Information, 1999. New PW. Non-traumatic spinal cord injury: what is the ideal setting for rehabilitation? Aust Health Rev. 2006;30:353-361. O'Connor PJ. Trends in spinal cord injury. Accid Anal Prev. 2006;38:71-77. Ontario Traumatic Registry Analytic Bulletin – Major Head and Spinal Cord Injury Hospitalizations in Ontario – 2001/2002. Pickett W, Simpson K, Walker J, Brison RJ. Traumatic spinal cord injury in Ontario, Canada. J Trauma. 2003;55:1070-1076. Pickett GE, Campos-Benitez M, Keller JL, Duggal N. Epidemiology of traumatic spinal cord injury in Canada. Spine. 2006;31:799-805. Rick Hansen SCI Network (2004). Inventory of Services: An overview of SCI services across Canada. Rick Hansen Man-in-Motion Foundation (RHMIMF) (2004). Ipsos Reid SCI Community Survey. Rick Hansen SCI Network (2005). Cross-Canada Checkup. Interim Report of the National Consultations on SCI services in Canada – a qualitative overview. Schonherr MC, Groothoff JW, Mulder GA, Eisma WH. Rehabilitation of patients with spinal cord lesions in The Netherlands: an epidemiological study. Spinal Cord. 1996;34:679-683. Sommer JL, Witkiewicz PM. The therapeutic challenges of dual diagnosis: TBI/SCI. Brain Inj. 2004;18:1297-1308. Stauffer ES. Diagnosis and prognosis of acute cervical spinal cord injury. Clin Orthop Relat Res. 1975;112:9-15. Strauss DJ, Devivo MJ, Paculdo DR, Shavelle RM. Trends in life expectancy after spinal cord injury. Arch Phys Med Rehabil. 2006;87:1079-1085. Waters RL, Adkins RH, Yakura JS, Sie I. Motor and sensory recovery following incomplete paraplegia. Arch Phys Med Rehabil. 1994;75:67-72. Waters RL, Yakura JS, Adkins RH, Sie I. Recovery following complete paraplegia. Arch Phys Med Rehabil. 1992;73:784-789.

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Welch RD, Lobley SJ, O'Sullivan SB, Freed MM. Functional independence in quadriplegia: critical levels. Arch Phys Med Rehabil. 1986;67:235-40. Wyndaele M, Wyndaele JJ. Incidence, prevalence and epidemiology of spinal cord injury: what learns a worldwide literature survey? Spinal Cord. 2006 44:523-9.

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CHAPTER TWO
Methods of Systematic Reviews

Table of Contents
2.1 Introduction ......................................................................................................................2-1 2.2 Article Assessment..........................................................................................................2-2 2.2.1 Literature Search Strategy ..............................................................................................2-2 2.2.2 Quality Assessment Tool and Data Extraction................................................................2-2 2.3 Determining Levels of Evidence and Formulating Conclusions .................................2-3 Appendix 1. Specific Search Terms .....................................................................................2-5 Appendix 2. The PEDro Scale...............................................................................................2-8 Appendix 3. Downs and Black tool (Downs and Black 1998) ..........................................2-10 References..............................................................................................................................2-11

This review has been prepared based on the scientific and professional information available in 2005. The SCIRE information (print, CD or web site www.icord.org/scire) is provided for informational and educational purposes only. If you have or suspect you have a health problem, you should consult your health care provider. The SCIRE editors, contributors and supporting partners shall not be liable for any damages, claims, liabilities, costs or obligations arising from the use or misuse of this material. Methods of the Systematic Reviews. In: Eng JJ, Teasell RW, Miller WC, Wolfe DL, Townson AF, Aubut J, Abramson C, Hsieh JTC, Connolly S, editors. Spinal Cord Injury Rehabilitation Evidence. 2006: Vancouver, p 2.1-2.11. www.icord.org/scire

Methods of the Systematic Reviews
2.1 Introduction Providing a framework for evidence-base practice was championed in the early 1990s, although it was practiced and discussed in medical circles long before this. In 1992, the Evidence-Based Practice Working Group (EBPWG) described a new framework of using research to guide and augment the practice of medicine (Evidence-based Medicine Working Group 1992). Dr. David Sackett, a pioneer in the field and also a member of the original working group described evidence-based practice as: “Evidence based medicine is the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. The practice of evidence based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research.” (Sackett et al. 1996) Although the original definitions were framed for the practice of medicine, the practice has spread to all fields of health care with the more generic term “evidence-based practice”. Evidence-based practice does not ignore clinical experience and patient preferences, but weights these against a background of the highest quality scientific evidence that is available. The importance of clinical judgement was emphasized by Dr. Sackett in his original editorial: “Because it [evidence-based medicine] requires a bottom up approach that integrates the best external evidence with individual clinical expertise and patients' choice, it cannot result in slavish, cookbook approaches to individual patient care. External clinical evidence can inform, but can never replace, individual clinical expertise, and it is this expertise that decides whether the external evidence applies to the individual patient at all and, if so, how it should be integrated into a clinical decision.” Sackett et al. (1996) Acquiring and interpreting the evidence from the research literature can be daunting. Not only is there a wealth of ever changing information from multiple sources, but it is often difficult for a front-line clinician not intimately familiar with the research methods to interpret the results of a study. In addition, the interpretation is further complicated by the presence of multiple studies on an intervention, often with what appears to be conflicting messages. The Spinal Cord Injury Rehabilitation Evidence (SCIRE) is dedicated to providing up-to-date, accurate information about the effect of rehabilitation health-care for people with SCI. The SCIRE used a systematic and transparent procedure to assess and synthesize the evidence of the effects of rehabilitation healthcare interventions in SCI and is designed for health professionals inform them of best practice. Consumers with SCI and their families may also find the synthesis useful to better understand their health care. In addition, such a research synthesis will enable relevant decision-making in public policy and practice settings applicable to SCI rehabilitation. Lastly, transparent and unbiased evidence-based reviews will guide the research community and funding organizations to strategically focus their time and resources on the gaps in knowledge and identify research priorities.

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2.2 Article Assessment 2.2.1 Literature Search Strategy A systematic review was undertaken using multiple databases (MEDLINE/PubMed, CINAHL®, EMBASE, PsycINFO) to identify and synthesize all relevant literature published from 19802005. An initial broad search was performed with five types of SCI therapies searched: drug therapy, radiotherapy, diet therapy, rehabilitation therapy and therapy. To further refine the search, the search was limited to human subjects and articles published in English. Based on the above search criteria, the total number of references from all databases was 8007. Two investigators reviewed both the title of the citation and the abstract (of all 8007 references) to determine its suitability for inclusion. Articles’ suitability was based on the above inclusion criteria as well as the following exclusion criteria: less than half the reported population had a spinal cord injury; no measurable outcome associated with treatment; animal studies. Unless there were no other supporting literature, studies with less than 3 subjects were excluded. Meta-analyses, systematic reviews and review articles were identified at this point and studies cited with these works that were not identified in the original literature search, were also sought, through hand searching. The review was restricted to published works. MeSH headings were used with the keywords. Key words were paired with spinal cord injury, tetraplegia, quadriplegia or paraplegia Specific SCI rehabilitation topics (e.g., pressure ulcers) were identified by a multi-disciplinary team of expert scientists, clinicians, consumers with SCI and policy-makers. These specific topics were searched with additional keywords generated from expert scientists and clinicians in SCI rehabilitation familiar with the topic and more titles and abstracts were reviewed. The reference lists of previous review articles, key articles, systematic reviews and clinical practice guidelines were hand searched. It is known that hand searching may provide higher rates of return than electronic searching within a particular subject area (Hopewell et al. 2002). The number of titles and abstracts reviewed is approximately 8400. Additional keywords used for each specific topic are outlined in Appendix 1. 2.2.2 Quality Assessment Tool and Data Extraction Methodological quality of individual RCTs was assessed using the Physiotherapy Evidence Database (PEDro) tool (http://www.pedro.fhs.usyd.edu.au/scale_item.html). PEDro was developed for the purpose of accessing bibliographic details and abstracts of randomizedcontrolled trials (RCT), quasi-randomized studies and systematic reviews in physiotherapy. PEDro has been used to assess both pharmacological and non-pharmacological studies with good agreement between raters at an individual item level and in total PEDro scores (Foley et al. 2006). Maher et al. (2003) found the reliability of PEDro scale item ratings varied from "fair" to "substantial," while the reliability of the total PEDro score was "fair" to "good. Studies included in this review using a non-experimental or uncontrolled design (non-randomized comparative trials, cohort studies or retrospective studies) could not be assigned a PEDro score and were given a not applicable (n/a) designation. The PEDro is an 11-item scale, in which the first item relates to external validity and the other ten items assess the internal validity of a clinical trial. One point was given for each satisfied

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criterion (except for the first item, which was given a YES or NO), yielding a maximum score of ten. The higher the score, the better the quality of the study and the following cut-points were used where 9-10: excellent; 6-8: good; 4-5: fair; <4: poor. A point for a particular criterion was awarded only if the article explicitly reported that the criterion was met. The scoring system is detailed in Appendix 2. Two independent raters reviewed each article. Scoring discrepancies were resolved through discussion. All other studies with an intervention were assessed with the Downs and Black Tool (Downs and Black 1998) for methodological quality. This tool consists of 27 questions in the following subsections: Reporting, External Validity, Internal Validity – bias and Internal Validity – confounding (selection bias). The original tool range from 0 to 32. However, we modified the last question form a scale of 0 to 5 to a scale of 0 to 1 where 1 was scored if a power calculation or sample size calculation was present while 0 was scored if there was no power calculation, sample size calculation or explanation whether the number of subjects was appropriate. Thus, our modified version ranged from 0 to 28, with a higher score indicating higher methodological quality. The Downs and Black tool is attached in Appendix 3. Data were extracted to form tables. Sample subject characteristics (Population), nature of the treatment (Intervention), measurements (Outcome Measures) and key results are presented in the tables. In cases, where a single study overlapped into multiple chapters (e.g., treadmill training has effects on the cardiorespiratory, lower extremity and bone health), the results focus on the outcomes relevant to that chapter. 2.3 Determining Levels of Evidence and Formulating Conclusions Table 2.1 Five levels of evidence
Level Level 1 Research Design Randomized controlled trial (RCT) RCT Prospective controlled trial Cohort Level 3 Case control Pre-post Level 4 Post-test Case Series Observational Level 5 Clinical Consensus Case Report Description Randomized controlled trial, PEDro score ≥ 6. Includes within subjects comparison with randomized conditions and crossover designs Randomized controlled trial, PEDro score < 6. Prospective controlled trial (not randomized) Prospective longitudinal study using at least 2 similar groups with one exposed to a particular condition. A retrospective study comparing conditions, including historical controls A prospective trial with a baseline measure, intervention, and a post-test using a single group of subjects. A prospective post-test with two or more groups – intervention, then post-test (no pre-test or baseline measurement) using a single group of subjects. A retrospective study usually collecting variables from a chart review. Study using cross-sectional analysis to interpret relations. Expert opinion without explicit critical appraisal, or based on physiology, biomechanics or "first principles" Pre-post or case series involving one subject

Level 2

The levels of evidence used to summarize the findings are based on the levels of evidence developed by Sackett et al. (2000). The levels proposed by Sackett et al. (2000) were modified to collapse the subcategories within a level (e.g., level 1a, 1b, 1c) into a single level. This was performed to reduce the 10 categories from Sackett et al. (2000) to a less complex system from level 1 to level 5. We provided additional descriptions specific to the types of research designs encountered in SCI rehabilitation to facilitate the decision-making process. Sackett et al. (2000)

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distinguishes high and low quality randomized controlled trials (RCTs) into level 1b and level 2b, respectively. To provide a more reliable decision-making process, we required that a level 1 RCT had a PEDro score of greater than or equal to 6 (good to excellent quality), while a level 2 RCT had a PEDro score of 5 or less. The appropriateness of the control group was assessed per study. In some studies, an able-bodied group may not have been an adequate control for the particular intervention used, but simply provided “normative’ values for comparison. In those studies, the study was considered “not controlled” and the level of evidence reduced (e.g., level 4 pre-post). RCTs received priority when formulating conclusions. Conclusions were not difficult to form when the results of multiple studies were in agreement. However, interpretation became difficult when the study results conflicted. In cases where studies differed in terms of quality, the results of the study (or studies) with the higher quality score were more heavily weighted to arrive at the final conclusions. Sometimes, interpretation was difficult, for example, the authors needed to make a judgment when the results of a single study of higher quality conflicted with those of several studies of inferior quality. In these cases we attempted to provide a rationale for our decision and to make the process as transparent as possible. As emphasized by Sackett et al. (1996), the evidence from systematic research should be integrated with clinical expertise and patients' choice to form best practice.

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Appendix 1. Specific Search Terms Specific SCI rehabilitation topics were identified by a multi-disciplinary team of expert scientists, clinicians, consumers with SCI and policy-makers. These specific topics were searched with additional keywords generated from expert scientists and clinicians in SCI rehabilitation familiar with the topic and more titles and abstracts are reviewed. MeSH headings were used with the keywords. Key words were paired with spinal cord injury, tetraplegia, quadriplegia or paraplegia. The reference lists of previous review articles, systematic reviews and clinical practice guidelines were hand searched. It is known that hand searching may provide higher rates of return than electronic searching within a particular subject area (Hopewell et al. 2002). Chapter 3: Rehabilitation Practice: ("rehabilitation"[Subheading] OR "Rehabilitation"[MeSH]) AND "Spinal Cord Injuries"[MeSH] AND "Treatment Outcome"[MeSH] Chapter 4: Community Reintegration: accessibility, attendant care, attitudes, community + leisure + recreation, community involvement, community Involvement, community living, community participation, community reintegration, community reintegration, daily functioning, domestic life, employment, empowerment, environment + functioning, environment + reintegration, environment + social, environment + social + home, environmental policy, family involvement, HRQOL, intervention – trial, control group, treatment group; income support, independent living, interpersonal relations, leisure – intervention, control group, treatment, clinical trials, leisure + use of time, life happiness, life satisfaction, living independent, occupations, personal assistance, personal satisfaction, productivity, psychosocial rehabilitation, QOL – intervention, trial, control group, treatment group, recreation therapy, school education, self care, social environment, social interactions, social network, social policy, social roles, social support, socializing, use of technology, volunteer Chapter 5: Upper Limb: upper limb, FES and upper limb, exercise programs, upper limb injuries, splinting, specific researchers [Popovic…] Chapter 6: Lower Limb: 4-AP, 4-AP + ambulation, assisted walking device, walking, assisted rehabilitation device, biofeedback, body weight support, body weight supported treadmill training (BWSTT), brace, bracing, Clonidine, Cyproheptadine, EMG + feedback, epidural stimulation / epidural lumbar stimulation, FES + muscle, flexibility, gait, gait + bracing, gait + orthotics, gait devices, GM-1 ganglioside, knee-ankle-foot, leg + bracing, leg + FES, locomotion, locomotor training, lower extremity spasticity, orthotics, orthotics + lower limb, parawalker, robotics, salbutamol, scott-craig knee ankle foot orthosis, spasticity management, stepping, stretching, treadmill, trendelenburg gait, Vannini-rizzoli stabilizing orthosis, virtual reality, walking, weakness Chapter 7: Cardiovascular Exercise: cardiac output, cardiovascular disease, cardiovascular fitness, coronary heart disease, endothelium, epoetin alfa, FES + blood pressure, fludrocortisone, glucose intolerance, glucose sensitivity, hydralazine, lipid, lipid + metabolism, neuromuscular + blood, nifedipine, orthostatic hypotension, oxygen consumption, phenazopyridine, physiotherapy + blood, stroke volume, thromboembolism, ventilation, ventilatory threshold, VO2 Chapter 8: Respiratory: abdominal binder, acapello, assisted cough, asthma – incidence, prevalence, atelectasis, autogenic drainage, barotraumas, BiPAP, breathing exercises, bronchial lavage, bronchitis, bronchoscopy, cardiopulmonary function, chest physiotherapy, COPD – incidence, prevalence, CPAP, diaphragmatic pacemaker, dysphagia, exsufflation, 2-5

flutter, flutter device, flutter valve, forced expiratory technique, Garshick, glossopharyngeal breathing, incentive spirometry, insufflation, intermittent positive pressure breathing, intrapulmonary percussive ventilation, IPPB stretch, manual percussion, manual vibration, mechanical vibration, paripep , PEP / PEEP, percussion, phrenic pacemaker, pneumonia incidence, prevalence, positive pressure breathing, postural drainage, progressive ventilatory free breathing, pulmonary capacity, pulmonary complications – incidence, prevalence, pulmonary embolism, pulmonary health, pulmonary secretions, respiratory complications – incidence, prevalence, secretion removal, sleep apnea, smoking – incidence, prevalence, spirometry, synchronous intermittent mandatory ventilation, TheraPep, tidal volume, tracheostomy, ventilator weaning, ventilatory capacity, ventilatory failure – incidence, prevalence Chapter 9 Bone Health alendronate, Amino-bisphosphonates, bone + fracture, bone health, cyclic etidonate, exercise therapy, FES, heterotopic ossification, incidence + fracture, osteoporosis, pamidronate, skeletal + fracture, vibration Chapter 10 Depression: alcohol abuse, drug abuse, depression, anxiety, gender differences, sexuality, [specific researches: Krause, Noreau…], aging, sexual health, male and female, spinal cord, vocational issues, sexual issues, psychosocial Chapter 11 Sexual Health: autonomic dysreflexia, birth control, birthing, bladder + sex, bladder management + body image, bladder management + mitrofanoff, bladder management + sexual life, bladder management + suprapubic, body image, bowel + sex, Cesarean section, contraception, dysparunia, dyspareunia + infertility, ejaculation, ejaculatory disorder, electroejaculation, erection, female fertility, hypogonadism, ICSI, infertility + pregnancy, intercavernosal injection, intraurethral palette, intraurethro palette, urethra palette, IVF, labour, labour + delivery, marital, marital status + sexuality, menopause, menstruation, penile injection, post-partum, pregnancy, premature labour, semen quality, seminal emissions, sex, sex + depression, sex/sexual + foley catheter, sex/sexual + intermittent catheter, sexual adjustment, sexual changes, sexual function + medications, sexual functioning + foley catheter, sexual position, sexual relationships, sexual self-esteem, sexual self-views, sexuality, sexuality + depression, sperm/semen quality, sperm/semen retrieval, vacuum device, vaginal lubrication, Viagra, vibrator, vibrostimulation Chapter 12 Bowel Management: bowel management, cisapride, colonic, colostomy, constipation, dietary fibre, hemorrhoids, incontinence, irregular, laxative, neurogenic bowel, suppositories Chapter 13 Bladder: Bladder, Neurogenic"[MeSH] AND "Spinal Cord Injuries"[MeSH] Chapter 14 Pain: pain treatment, pharmacology, pain, surgical intervention, pain management Secondary complications Chapter 15 Venous Thromboembolism: Deep venous thrombosis, thrombosis, emboli, DVT, thromboembolism, heparin, vena cava filtration Chapter 16 Orthostatic hypotension: orthostatic hypotension, dysreflexia, autonomic, hyperreflexia, midodrine, postural hypotension, orthostatic intolerance, orthostatic tolerance, orthostatic stress, blood flow, blood flow + exercise, blood pressure, blood vessel health

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Chatper 17 Autonomic dysreflexia: AD, autonomic, dyreflexia, hyperreflexia, midodrine, fludrocortisone, beta-blockers, Viagra, nifedipine, phenazopyridine Chapter 18 Heterotopic Ossification: heterotopic ossification, excision surgery, etidronate Chapter 19 Nutrition: diabetes, energy requirements, energy needs, caloric intake, weight gain, obesity, overweight, prevention, body composition, cardiovasular disease risk, nutrient, supplementation, supplements, dietary, nutrition intervention, folate, vitamin B6, vitamin B12, omega 3 fatty acids, essential fatty acids, pressure ulcers, vitamin supplementation, mineral supplementation, vitamin C, vitamin A, zinc, iron, protein, diabetes risk, hydration/optimal hydration, cranberry juice, neurogenic bowel, dietary fibre, soluble fibre, insoluble fibre, fibre supplements, peristalsis, osteoporosis, osteopenia, bone mineral density, calcium, vitamin D, magnesium, renal stone/kidney stone and calcium intake/supplementation, urinary tract, hypercalcemia Chapter 20 Pressure Sores: pressure sores, ulcers Chapter 21 Spasticity: botox, baclofen, spasticity

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Appendix 2. The PEDro Scale (www.pedro.fhs.usyd.edu.au/scale_item.html) 1. “Subjects were randomly allocated to groups.” (in a crossover study, subjects were randomly allocated an order in which treatments were received). A point for random allocation was awarded if random allocation of patients was stated in its methods. The precise method of randomization need not be specified. Procedures such as coin-tossing and dice-rolling were considered random. Quasi-randomization allocation procedures such as allocation by bed availability did not satisfy this criterion. 2. “Allocation was concealed.” A point was awarded for concealed allocation if this was explicitly stated in the methods section or if there was reference that allocation was by sealed opaque envelopes or that allocation involved contacting the holder of the allocation schedule who was "off-site." 3. “The groups were similar at baseline regarding the most important prognostic indicators.” A trial was awarded a point for baseline comparability if at least one key outcome measure at baseline was reported for the study and control groups. This criterion was satisfied even if only baseline data of study completed-only subjects were presented. 4. “There was blinding of all subjects.” The person in question (subject, therapist or assessor) was considered blinded if he/she did not know which group the subject had been allocated to. In addition, subjects and therapists were only considered to be "blind" if it could be expected that they would have been unable to distinguish between the treatments applied to different groups. In drug therapy trials, the administrator of the drug was considered the therapist and was considered blinded if he/she did not prepare the drug and was unaware of the drug being administered. 5. “There was blinding of all therapists who administered the therapy.” (criteria 4.) 6. “There was blinding of all assessors who measured at least one key outcome” (criteria 4). 7. “Adequacy of follow-up.” For the purposes of this review, follow-up was considered adequate if all of the subjects that had been originally randomized could be accounted for at the end of the study. The interpretation of this criterion differs from that described by PEDro, where adequacy is defined as the measurement of the main outcome in more than 85% of subjects. 8. “Intention to treat.” All subjects for whom outcome measures were available received the treatment or control condition as allocated or, where this was not the case, data for at least one key outcome was analyzed by "intention to treat". For purpose of the present evidencebased review, a trial was awarded a point for intention-to-treat if the trial explicitly stated that an intention-to-treat analysis was performed. 9. “The results of between-group statistical comparisons are reported for at least one key outcome.” Scoring of this criterion was design dependent. As such, between groups comparison may have involved comparison of two or more treatments, or comparison of treatment with a control condition. The analysis was considered a between-group analysis if either a simple comparison of outcomes measured after the treatment was administered was made, or a comparison of the change in one group with the change in another was made. The comparison may be in the form of hypothesis testing (e.g. p-value) or in the form of an estimate (e.g. the mean, median difference, difference in proportion, number needed to treat, relative risk or hazard ratio) and its confidence interval. A trial was awarded a point for this criterion if between group comparison on at least one outcome measure was made and its analysis of comparison was provided. 10. “The study provides both point measures and measures of variability for at least one key outcome.” A point measure was referred as to the measure of the size of the treatment effect. The treatment effect was described as being either a difference in group outcomes, or as the outcome in (each of) all groups. Measures of variability included standard deviations, standard errors, confidence intervals, interquartile ranges (or other quartile 2-8

ranges), and ranges. Point measures and/or measures of variability that were provided graphically (for example, SDs may be given as error bars in a Figure) were awarded a point as long as it was clear what was being graphed (e.g. whether error bars represent SDs or SEs). For those outcomes that were categorical, this criterion was considered to have been met if the number of subjects in each category was given for each group.

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Appendix 3. Downs and Black tool (Downs and Black 1998) Reporting 1) Is the hypothesis/aim/objective of the study clearly described? 2) Are the main outcomes to be measured clearly described in the Introduction or Methods section? 3) Are the characteristics of the patients included in the study clearly described ? I4) Are the interventions of interest clearly described? 5) Are the distributions of principal confounders in each group of subjects to be compared clearly described? 6) Are the main findings of the study clearly described? 7) Does the study provide estimates of the random variability in the data for the main outcomes? 8) Have all important adverse events that may be a consequence of the intervention been reported? 9) Have the characteristics of patients lost to follow-up been described? 10) Have actual probability values been reported (e.g. 0.035 rather than <0.05) for the main outcomes except where the probability value is less than 0.001? External validity 11) Were the subjects asked to participate in the study representative of the entire population from which they were recruited? 12) Were those subjects who were prepared to participate representative of the entire population from which they were recruited? 13) Were the staff, places, and facilities where the patients were treated, representative of the treatment the majority of patients receive? Internal validity - bias 14) Was an attempt made to blind study subjects to the intervention they have received? 15) Was an attempt made to blind those measuring the main outcomes of the intervention? 16) If any of the results of the study were based on “data dredging”, was this made clear? 17) In trials and cohort studies, do the analyses adjust for different lengths of follow-up of patients, or in case-control studies, is the time period between the intervention and outcome the same for cases and controls ? 18) Were the statistical tests used to assess the main outcomes appropriate? 19) Was compliance with the intervention/s reliable? 20) Were the main outcome measures used accurate (valid and reliable)? Internal validity – confounding (selection bias) 21) Were the patients in different intervention groups (trials and cohort studies) or were the cases and controls (case-control studies) recruited from the same population? 22) Were study subjects in different intervention groups (trials and cohort studies) or were the cases and controls (case-control studies) recruited over the same period of time? 23) Were study subjects randomised to intervention groups? 24) Was the randomised intervention assignment concealed from both patients and health care staff until recruitment was complete and irrevocable? 25) Was there adequate adjustment for confounding in the analyses from which the main findings were drawn? 26) Were losses of patients to follow-up taken into account? 27) Did the study have sufficient power to detect a clinically important effect where the probability value for a difference being due to chance is less than 5%? 2-10

References
Downs SH and Black N. The feasibility of creating a checklist for the assessment of the methodological quality both of randomised and non-randomised studies of health care interventions. J Epidemiol Community Health (1998); 52:377-384. Evidence-Based Medicine Working Group (1992): A new approach to teaching the practice of medicine. JAMA: The Journal of the American Medical Association 268: 2420-2425. Fitzpatrick R, Davey C, Buxton MJ, Jones DR. Evaluation of patient-based outcome measures for use in clinical trials. Health Technology Assessment 1998;2:1 – 74. Foley NC, Bhogal SK, Teasell RW, Bureau Y, Speechley MR. Estimates of quality and reliability with the physiotherapy evidence-based database scale to assess the methodology of randomized controlled trials of pharmacological and nonpharmacological interventions. Phys Ther. 2006;86:817-24. Hopewell S, Clarke M, Lefebvre C, Scherer R. Handsearching versus electronic searching to identify reports of randomized trials. The Cochrane Database of Methodology Reviews 2002, Issue 4. Art. No. MR000001. Maher CG, Sherrington C, Herbert RD, Moseley AM, Elkins M. Reliability of the PEDro scale for rating quality of randomized controlled trials. Phys Ther. 2003;83:713-21. PEDro: http://www.pedro.fhs.usyd.edu.au/scale_item.html Sackett DL, Straus SE, Richardson WS, Rosenberg W, Haynes RB. Evidence-based medicine: how to practice and teach EBM. Toronto, Ontario: Churchill Livingstone, 2000. Sackett DL. Rules of evidence and clinical recommendations on the use of antithrombotic agents. Chest 1989;95:2S-3S. Sackett DL, Rosenberg WM, et al. Evidence based medicine: what it is and what it isn't. BMJ 1996;312:71-72. 52.

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CHAPTER THREE
Rehabilitation Practice And Associated Outcomes Following Spinal Cord Injury
Dalton L. Wolfe, PhD Jane TC Hsieh, MSc

Key Points Those with higher level and more severe injuries have longer rehabilitation LoS (Length of Stay. Rehabilitation LoS in the US has become progressively shorter up to the mid1990s. Most individuals make significant functional gains during inpatient rehabilitation. A significant proportion of people improve 1 AIS (ASIA Impairment Scale) grade in the first few months post-injury particularly those initially assessed AIS B and C. Increased therapeutic intensity may not necessarily lead to functional benefits, but data is scarce. Younger individuals with paraplegia are more likely to have shorter rehabilitation LoS than older individuals. Younger individuals are more likely to make greater functional gains during rehabilitation than older individuals. Younger individuals with tetraplegia (or in a mixed traumatic, non-traumatic sample) are more likely to make gains in neurological status during rehabilitation than older individuals. Individuals with non-traumatic SCI have reduced LoS and less functional improvement with rehabilitation as compared to those with traumatic SCI although controlled comparisons are limited to data from the US Model Systems. Neither gender nor race effects have been demonstrated for discharge destination, rehabilitation LoS and neurological or functional status in US Model Systems data. More specialized, interdisciplinary acute SCI care is associated with faster transfers to rehabilitation and may result in fewer medical secondary complications, more efficient functional gains and reductions in overall mortality. Earlier admission to specialized, interdisciplinary SCI care is associated with reduced length of total hospital stay and greater and faster rehabilitation gains with fewer medical secondary complications. Prospective studies with stronger designs are needed to strengthen the evidence and provide more direction as to the optimal model of care. Routine, comprehensive, specialist follow-up services may result in improved health.

Table of Contents
3.1 Introduction ......................................................................................................................3-1 3.2 Common Abbreviations Used In SCI Rehabilitation.....................................................3-1 3.3 Description of SCI Rehabilitation Outcomes ................................................................3-2 3.3.1 Describing SCI Rehabilitation Outcomes ........................................................................3-2 3.3.1.1 Health Delivery Indicators ............................................................................................3-3 3.3.1.1.1 Rehabilitation Length of Stay ....................................................................................3-3 3.3.1.2 Neurological and Functional Status .............................................................................3-6 3.4 Factors for Optimal Outcomes .......................................................................................3-9 3.4.1 Effect of Intensity on Rehabilitation Outcomes ...............................................................3-9 3.4.2 Effect of Age on Rehabilitation Outcomes ....................................................................3-10 3.4.3 Differences in Traumatic vs Non-Traumatic SCI Rehabilitation Outcomes...................3-14 3.4.4 Effect of Gender and Race on Rehabilitation Outcomes ..............................................3-18 3.5 Specialized vs General SCI Units (Acute Care)...........................................................3-21 3.6 Early vs Delayed Admission to Specialized SCI Units ...............................................3-24 3.7 Outpatient and Follow-up Care.....................................................................................3-30 3.8 Summary.........................................................................................................................3-31 Appendix – Studies Describing Rehabilitation Outcomes.................................................3-34 References..............................................................................................................................3-41

This review has been prepared based on the scientific and professional information available in 2005. The SCIRE information (print, CD or web site www.icord.org/scire) is provided for informational and educational purposes only. If you have or suspect you have a health problem, you should consult your health care provider. The SCIRE editors, contributors and supporting partners shall not be liable for any damages, claims, liabilities, costs or obligations arising from the use or misuse of this material. Wolfe DL, Hsieh, JTC (2006). Rehabilitation Practices and Associated Outcomes Following Spinal Cord Injury. In: Eng JJ, Teasell RW, Miller WC, Wolfe DL, Townson AF, Aubut J, Abramson C, Hsieh JTC, Connolly S, editors. Spinal Cord Injury Rehabilitation Evidence. Vancouver, p 3.1-3.44. www.icord.org/scire

Rehabilitation Practice And Associated Outcomes Following Spinal Cord Injury
3.1 Introduction The SCI rehabilitation practices of today were influenced greatly by the pioneering efforts of Sir Ludwig Guttman who was instrumental in the creation of specialized spinal units to care for injured soldiers returning to England during and after WWII (Guttmann 1967). Eventual adoption of this more specialized and integrated approach followed in many additional jurisdictions (Bors 1967; Bedbrook 1979), bolstered by reports of reduced mortality and enhanced long-term survival which was attributed in part to more effective management of secondary conditions associated with SCI (e.g., UTI’s, pressure sores, respiratory conditions) (Richardson & Meyer Jr. 1981; Le & Price 1982;. Geisler et al.1983). At present, the “ideal” scenario for modern SCI care is purported to be treatment in specialized, integrated centres with an interdisciplinary team of health care professional providing care as early as possible following injury and throughout the rehabilitation process with appropriate discharge to the community characterized by ongoing outpatient care and follow-up (Donovan et al. 1984; Tator et al. 1995). This is best facilitated under one roof or within an organized “system” which is distinguished by seamless transitions as patients proceed from acute care through rehabilitation to outpatient care. While it is generally accepted that this “ideal” more specialized, integrated approach should result in better outcomes, there is very little robust evidence that supports this directly. This is understandable, given the relatively low incidence of SCI, limitations in designing trials with adequate controls and the inherent difficulty in ascribing potential outcomes to such a multi-faceted process as rehabilitation. For these reasons, we have adopted a more lenient approach within the present chapter with respect to the reviewed articles as compared to most other chapters. Many of the articles presented in the current chapter do not investigate a specific intervention although they do describe rehabilitation outcomes and the various factors that are associated with producing optimal outcomes. Accordingly, when no specific intervention is assessed experimentally, a PEDro or Downs and Black (Downs & Black 1998) score is not provided. These articles were separated into five categories: Description of Rehabilitation Outcomes, Factors for Optimal Outcomes, Specialized vs. General SCI Units, Early vs. Delayed Admission to Specialized Units and Outpatient and Follow-up Care. In addition, in some studies the distinction between acute vs. rehabilitative care is somewhat blurred as studies may have been conducted in centers or systems where these services are more integrated. The present chapter is focused on issues associated with rehabilitation care and we have attempted to clearly identify when acute care practice may have been merged within the reporting of rehabilitation research results. 3.2 Common Abbreviations Used In SCI Rehabilitation AIS – ASIA Impairment Scale ASIA – American Spinal Injury Association (and associated International Guidelines for Neurological Classification) BI – Barthel Index 3-1

FIM – Functional Independence Measure LoS – Length of Stay MBI – Modified Barthel Index OT – Occupational Therapy SLT – Speech & Language Therapy PT – Physical Therapy (Physiotherapy) UTI – Urinary Tract Infection 3.3 Description of SCI Rehabilitation Outcomes Much research has been directed at describing outcomes following SCI rehabilitation and examining various factors that might be associated with good (or poor) outcomes. Ethical and practical considerations limit the application of randomized controlled designs or other experimental designs in investigating methods for enhancing patient outcomes. Typically, investigators employ case series, case control or pre-post trial designs and often utilize correlational or predictive analyses (e.g., univariate or multivariate regression) of large single or multi-centre patient databases to determine specific associations or factors that are associated with optimal rehabilitation outcomes. Often these studies are quite large in scope as investigators explore relationships among a variety of socio-demographic and injury-related variables as they endeavour to determine optimal rehabilitation practice. Given the inherent breadth of findings present in individual studies in this area in which large databases are mined for relationships among large arrays of variables, it is difficult to follow the same pattern of brevity and topic focus found in most chapters of the present review. In the present section we have taken a slightly different approach. First, a comprehensive table can be found in Section 3.9 Appendix 3.1 that lists specific studies in more detail and which outlines various findings directed at describing outcomes associated with comprehensive inpatient SCI rehabilitation. This is intended as an overall resource for those interested in the specific findings relating to outcomes associated with rehabilitation practice. In the text are more focused tables summarizing specific data culled from the more comprehensive table, thereby permitting an assessment of similar types of rehabilitation outcomes. This is intended for those interested in more specific information about particular issues pertaining to rehabilitation outcomes. The subsequent section then describes more focused investigations that examine the effect of the various factors in producing optimal outcomes. These include studies that assess the effect of the intensity of rehabilitation, age, gender and race on rehabilitation outcomes. 3.3.1 Describing SCI Rehabilitation Outcomes There are many types of outcomes that have been associated with SCI rehabilitation. In the present review, we will focus on the most commonly employed measures and have outlined these along with a few typical examples of outcome measurement tools in Table 3.1. In particular, these include measures that examine the effectiveness of health delivery as well as measures that assess functional, neurological and general health status of patients. As noted earlier, each of these measurement types will form the basis of separate summary tables following the overall more comprehensive table. It should be noted that other measures of obvious importance to SCI rehabilitation care providers and people with SCI such as measures of health-related quality of life and those that assess different facets of community integration (e.g., employment status, Reintegration to Normal Living Index) have not been included in the present chapter as they are considered in the chapter entitled “Community Reintegration Issues 3-2

Post Spinal Cord Injury”. In addition, studies examining health status have not been addressed in the present chapter as these typically report the incidence of specific secondary conditions (most notably, pressure sores and UTIs) and these will be described more fully in the specific chapters devoted to these issues. Table 3.1 Outcome Measure Types and Examples Relevant to SCI Rehabilitation
Outcome Measure Type Health Delivery Indicators Functional Status Neurological Status Health Status Specific Outcome Measures LoS, Hospital Charges, Discharge Destination FIM, MBI AIS, ASIA motor scores, Frankel Index Incidence of secondary complications

It should also be noted that specific outcome measurement tools can combine 2 of these outcome measure types such as in measures of efficiency. Most commonly, change scores for functional (e.g., FIM) or neurological (e.g., ASIA motor scores) measures are divided by LoS to get an average change for that particular measure, thereby providing an indication of the efficiency of the rehabilitation process in effecting change. Measures of this nature will be profiled in the sub-section for which the numerator is related. For example, ASIA motor score efficiency would be addressed under findings associated with neurological status. However, before these specific summary tables are presented, see Section 3.9 Appendix 3.1 for a more comprehensive table summarizing studies describing various SCI rehabilitation outcomes. 3.3.1.1 Health Delivery Indicators 3.3.1.1.1 Rehabilitation Length of Stay Several authors have made comparisons of rehabilitation length of stay (LoS) between countries or across other jurisdictions (Burke et al. 1985; Muslumanoglu et al. 1997; Pagliacci et al. 2003; Chan & Chan 2005). Additionally, others have noted the trend for progressively shorter LoS over the past several decades, especially in the US (De Vivo et al. 1991; Morrison & Stanwyck 1999; Eastwood et al. 1999). Stover noted that reductions in the 1970s and early 1980s were likely due to increased efficiency of rehabilitation teams (Stover 1995). More recent reductions in the US have been attributed to restrictions imposed by payers (Morrison & Stanwyck 1999). Table 3.2 summarizes various reports in the literature for LoS organized by jurisdiction and also by the time period for which the data was collected. Data were only included in this table if the underlying sample was deemed representative of an overall heterogeneous population of individuals with SCI (i.e., unselected sample of a single or multicentre study). Some data grouped for evaluating specific hypotheses has been included and this has been appropriately indicated. In addition, data from studies for which it was not clear that the purpose of admission was for comprehensive inpatient rehabilitation (and may have involved acute care) were not included. Table 3.2 Rehabilitation Length of Stay (by Country and Sample Period)
Study Tooth et al. 2003 Jurisdiction Australia (single centre) Population (N, Trauma &/or Nontrauma) 167, Trauma Sample Period 1993-1998 Length of Stay Result 83.0 (Median)

3-3

Study Scivoletto et al. 2005 Scivoletto et al. 2003 Pagliacci et al. 2005 Sumida et al. 2001

Jurisdiction Italy (single centre) Italy (single centre) Italy (multi-centre) Japan (multi-centre)

Population (N, Trauma &/or Nontrauma) 150, Trauma & Nontrauma 150, Trauma & Nontrauma 684, Trauma 123, Trauma

Sample Period 1997-2001 1997-2001 1997-1999

Length of Stay Result 112.4±69.3 98.7±68.13 135.5 185.6±130.4 (N=60) 267.8±171.6 (N=63)2 1 Early vs 2delayed admission 60.8±38.7 54.3±34.9 60.1±37.1 57.6±35.5 70.1±44.0 80.9±46.9 77.3±42.0 74.0±41.1 95.8 (N=66) 54.2 (N=61) 68.1 (1986 data only) 84.9 (N=185)1 87.7 (N=153)2 1 Specialist vs 2more general care 84.9 (N=185)1 2 87.7 (N=153) 1 2 Specialist vs more general care
1

1994-1997 1997 1996 1995 1994 1993 1992 1991 1990 1995 1991 1972-1986

Eastwood et al. 1999

USA (multi-centre)

3,904, Trauma

Morrison & Stanwyck 1999 Yarkony et al. 1990 Heinemann et al. 1989

USA (single centre) USA (single centre) USA (single centre)

127, Trauma 1382, Trauma 338, unknown

1981-1985

Yarkony et al. 1987

USA (single centre)

711, Trauma

1973-1980

Rehabilitation LoS is also known to vary according to neurological status and data from studies reporting LoS organized by level of injury (i.e., paraplegia vs. tetraplegia) or completeness are shown in Table 3.3. Again this is organized by jurisdiction (country) and the time period over which the sample was analyzed. Table 3.3 Rehabilitation Length of Stay (by Neurological Status
Study Jurisdiction Population (N, Trauma &/or Nontrauma) Sample Period Length of Stay Result (Mean – in days) (±SD if available) Incomplete paraplegia – 43.0 (All Medians) Complete paraplegia – 96.5 Incomplete tetraplegia – 64.5 Complete tetraplegia – 206.0

Tooth et al. 2003

Australia (single centre)

167, Trauma

1993-1998

3-4

Study

Jurisdiction

Population (N, Trauma &/or Nontrauma)

Sample Period

Length of Stay Result (Mean – in days) (±SD if available) AIS D paraplegia – 79.42±20.07 (N=3) AIS ABC low paraplegia – 52.00±1.41 (N=2) AIS ABC high paraplegia – 55.8±43.0 (N=2) AIS D tetraplegia – 143.75±69.25 (N=4) AIS ABC low tetraplegia – 215.9±56.1 (N=7) AIS ABC high tetraplegia – 146.5±75.4 (N=6) Paraplegia - 46.7 Tetraplegia – 61.9 Paraplegia - 82.2 Tetraplegia – 110.9 Paraplegia – 54.3 (1986 data only) Tetraplegia – 82.8 Paraplegia – 68.71, 70.72 Tetraplegia – 98.0, 103.4 1 Specialist (N=185) vs 2more general (N=153) care. Incomplete paraplegia – 1 2 46.3 , 50.6 Complete paraplegia – 62.2, 62.9 Incomplete tetraplegia – 59.7, 71.3 Complete tetraplegia – 90.4, 83.8 1 2 ( Early (N=284) vs later (N=377) admitted patients) Paraplegia – ~105 Tetraplegia – ~165 Incomplete paraplegia – 78.2 Complete paraplegia – 83.4 Incomplete tetraplegia – 107.6 Complete tetraplegia – 135.3

Chan & Chan 2005

China (Hong Kong) (single centre)

33, Trauma

2002

Morrison & Stanwyck 1999

USA (single centre)

127, Trauma

1995 1991

Yarkony et al. 1990

USA (single centre)

1382, Trauma

1972-1986

Heinemann et al. 1989

USA (single centre)

338, unknown

1981-1985

DeVivo et al. 1990

USA (single centre)

661, Trauma

1973-1985

Woolsey et al. 1985

USA (single centre)

100, Trauma

Unknown (pre 1985)

Yarkony et al. 1987

USA (single centre)

711, Trauma

1973-1980

Discussion As seen in Tables 3.2 and 3.3, rehabilitation LoS varies widely from country to country. While no investigators have systematically analyzed country-by-country variation it is apparent that the US has typically shorter rehabilitation LoS times than other countries reporting data. Most data has originated in the US, bolstered by the development of the US model systems database, with reports from other countries for the most part limited to a handful of descriptions of single-centre experience.

3-5

Within the US, it is clear that the trend for progressively shorter rehabilitation LoS has continued to at least the mid 1990’s. In 2 separate investigations, Morrison and Stanwyck (1999) and Eastwood et al. (1990) described reduced LoS from the period between the early 1990’s to the mid 1990’s. Eastwood et al. (1990) examined the large US Model systems database of individuals with traumatic SCI (N=3,904) and reported annual mean LoS values from 1990 to1997. For these years, the highest value was 80.9 days in 1992 and the lowest was 54.3 days in 1996. Mean LoS values for 1990-1992 seemed fairly stable at higher values, with 1994-1997 values lower and 1993 at an intermediate value. Morrison and Stanwyck (1999) performed a direct comparison of 1991 vs 1995 mean LoS values in the largest SCI rehabilitation in the US in order to assess the effect of shorter rehabilitation LoS on functional outcomes. These authors confirmed an even more striking difference between these 2 years given an average LoS of 95.8 days in 1991 as compared to 54.2 days in 1995 (p<0.001). Other reports have described reductions over earlier periods, most notably multi-centre investigations associated with the US Model Systems databases (De Vivo et al. 1991). It is uncertain if these trends have continued or if the same patterns have been seen in other countries. Also apparent from Table 10.5 is the relationship of longer LoS associated with higher level of injury and greater severity of injury. Similar patterns were seen in all studies describing rehabilitation LoS for individuals with varying injuries. That is, the greatest mean rehabilitation LoS values were seen for those with complete tetraplegia (especially high level) whereas the shortest mean values occurred for those with incomplete paraplegia (DeVivo et al. 1990; Tooth et al. 2003; Chan & Chan 2005). Conclusions There is Level 3 evidence (with US data only) that rehabilitation LoS has become progressively shorter up to the mid-1990s. No other jurisdiction has published data that supports this contention. There is Level 3 evidence that those with higher level and more severe injuries have longer rehabilitation LoS.

Those with higher level and more severe injuries have longer rehabilitation LoS. (Length of Stay) Rehabilitation LoS in the US has become progressively shorter up to the mid-1990s.

3.3.1.2 Neurological and Functional StatusError! Bookmark not defined. Several studies have identified patterns of neurological and/or functional improvement over the first few months post-injury. The majority of these studies examine neurological and/or functional status and associated changes between rehabilitation admission and discharge. In addition, the Consortium for Spinal Cord Medicine (1999) has published a review of expected neurological and functional outcomes following SCI. This Clinical Practice Guideline refers to the work of Bracken et al. (1993, 1997), Geisler et al. (1991) and Waters et al. (1994a, 1994b) in noting that over half of the expected recovery occurs in the first 2 months following injury and recovery may continue but slows noticeably after 3-6 months. This change in neurological status may represent the natural course of recovery, however, it is uncertain as to the extent that rehabilitation practices play in enhancing this recovery. 3-6

In addition, the reader is directed to the Consortium for Spinal Cord Medicine (1999) Clinical Practice Guideline for a comprehensive consensus review itemizing expected functional achievements for individuals at every level of SCI. Table 3.4 summarizes various reports in the literature for neurological and/or functional status organized by jurisdiction and also by the time period for which the data was collected. As above, data were only included in this table if the underlying sample was deemed representative of an overall heterogeneous population of individuals with SCI (i.e., unselected sample of a single or multi-centre study). Table 3.4 Neurological and/or Functional Status (by Country and Sample Period)
Study Jurisdiction and Sample Period Population (N, Trauma &/or Nontrauma) Outcome Measure • Australia (single centre) 1993-1998 • Neurological and/or Functional Change with Rehabilitation

Tooth et al. 2003

167, Trauma

FIM

↑ from 68.7 (admission) to 102.2 (discharge) due almost entirely to gains in motor FIM scores. Total FIM scores were lowest for those with complete tetraplegia and highest for those with incomplete paraplegia. Those with complete tetraplegia had the least change in FIM scores. 31% of people improved, 66% remained unchanged, and 3% deteriorated. 23% initially complete became incomplete and 40% of those initially incomplete improved. All groups showed ↑ in FIM motor scores from admission to discharge but these were only significant for tetraplegia ASIA D. All patient groups (i.e., levels and severity of injury) had similar FIM motor scores at discharge as noted by American Consortium for Spinal Cord Medicine (1999). ↑ was associated with ASIA B and C, shorter LoS, earlier admission and no complications (especially pressure sores). ↑ in ASIA motor scores and light touch scores for those with incomplete injuries but not complete injuries. FIM showed ↑ f for those with incomplete injuries and those with complete paraplegia but not complete tetraplegia.

• Burke et al. 1985 Australia (single centre) 262, Trauma Frankel

• China (Hong Kong) (single centre) 2002

Chan & Chan 2005

33, Trauma

FIM

Pagliacci et al. 2003

Italy (multi-centre) 1997-1999

684, Trauma

• AIS

• Mϋslϋman-oğlu et al. 1997 Turkey (single centre) 1992-1995 52, Trauma & Nontrauma ASIA FIM

3-7

Study

Jurisdiction and Sample Period

Population (N, Trauma &/or Nontrauma)

Outcome Measure •

Neurological and/or Functional Change with Rehabilitation

DeVivo et al. 1991

USA (multi-centre) 1973-1990

13,763, Trauma

AIS FIM

• •

Proportion showing ↑ were 10.3% (A), 45.2% (B), 55.9% (C), 7.3% (D) vs no change 89% (A), 50.3% (B), 41.5% (C), 90.5% (D) vs declined 4.5% (B), 2.6% (C), 2.0% (D) From 1973-1990 the proportion of incomplete patients increased from 40% to 55.2%. Average FIM gain was 37 (incomplete paraplegia, 36 (complete paraplegia), 34 (incomplete tetraplegia and 15 (complete tetraplegia). ↑ in total scores & self-care and mobility subscores. greater ↑ for incomplete vs complete and for those with paraplegia vs tetraplegia.

Yarkony et al. 1987

USA (single centre) 1973-1980

• 711, Trauma MBI •

Discussion The AIS represents an internationally recognized system for the classification of individuals with SCI, and as such, has been employed to characterize overall improvement in the neurological status of people with SCI (ASIA 2002). The AIS is an ordinal 5 grade scale classifying individuals from “A” to “E” with “A” designating those with complete SCI and “E” designating individuals with normal sensory and motor function. Most notably, Pagliacci et al. (2003) and DeVivo et al. (1991) employed large multi-centre databases and found that individuals with incomplete injuries (especially AIS B or C) were more likely to improve at least 1 grade over the course of rehabilitation. In particular, DeVivo et al. (1991) reported that 45.2% and 55.9% of those initially admitted as AIS B and C respectively improved at least 1 AIS grade as compared to only 10.3% and 7.3% of individuals initially classified as AIS A or D respectively. Similarly, many individuals also make significant functional gains during comprehensive inpatient rehabilitation. Most often functional status has been assessed at admission and discharge from rehabilitation using the FIM (Vivo et al. 1991; Muslumanoglu et al. 1997; Tooth et al. 2003; De Chan & Chan 2005) or MBI (Yarkony et al. 1987). Typically, functional gains are greater with rehabilitation for those with incomplete injuries as compared to complete injuries and for those with paraplegia as compared to those with tetraplegia (De Vivo et al. 1991; Muslumanoglu et al. 1997;Tooth et al. 2003; Chan & Chan 2005). In particular, DeVivo et al. (1991) reported similar average FIM gains for those with incomplete and complete paraplegia and incomplete tetraplegia (i.e., 37, 36 and 34 respectively) but much reduced gains for those with complete tetraplegia (i.e., 15). For the most part increases seen in the FIM have been attributed to motor FIM changes with little change in cognitive FIM scores at least partly due to an apparent ceiling effect (Chan & Chan 2005). Conclusions There is Level 4 evidence that a significant proportion of people (~50%) initially assessed as AIS B and C will improve by at least 1 AIS grade in the first few months post-injury 3-8

concomitant with inpatient rehabilitation. Fewer individuals (~10%) initially assessed as AIS A and D will improve by 1 AIS grade. There is Level 4 evidence that individuals make significant functional gains during inpatient rehabilitation, more so for those with complete and incomplete paraplegia and incomplete tetraplegia. Most individuals make significant functional gains during inpatient rehabilitation. A significant proportion of people improve 1 AIS (ASIA Impairment Scale) grade in the first few months post-injury particularly those initially assessed AIS B and C.

3.4 Factors for Optimal Outcomes 3.4.1 Effect of Intensity on Rehabilitation Outcomes Although it is commonly assumed that the therapies delivered during inpatient rehabilitation are effective, there is generally little direct evidence that demonstrates a clear relationship between typical therapeutic practice and enhanced functional outcomes (Heinemann et al. 1995). Moreover, there is no evidence that establishes a recommended intensity or amount of therapy that should be delivered to produce a desired result. In SCI rehabilitation, there exists a paucity of studies that examine this issue. Table 3.5 Individual Studies - Intensity of Rehabilitation
Author Year; Country Score Research Design Total Sample Size Methods Outcome

Heinemann et al. 1995; USA Downs & Black score=18 Case Series Initial N=264; Final N=246

Population: SCI and ABI, SCI subjects had a mean of 38.9 years old and were 79% male. Treatment: Variation in therapy intensity (OT, PT, SLT, Psych). Also examined effect of various other factors including LoS, Interruptions, Onset days, Admission scores and age. Outcome Measures: FIM (motor, cognitive, total), FIM Efficiency (motor or cognitive) all collected at Discharge.

(SCI findings only) 1. When analysed together, none of the individual therapy intensities were predictive of improved outcomes. When analysed individually, very little was significant in the prediction with only greater LoS associated with greater achievement of potential motor gains (p<.05) and interrupted rehab associated with less achievement of potential motor gains (p<.05). 2. Patients with > intervals between onset and admission had less motor function at discharge, achieved less of their potential motor gains and made less efficient motor gains (all p<.05). 3. Therapy intensity was predicted to a small degree by the various functional, demographic and medical variables (psychology intensity had highest explained variance with 26.3% ; SLT 17.2%, All therapies combined 16.6%, OT 7.3%, PT 6.5%). 4. People with lower cognitive and motor function at admission receive more

3-9

Author Year; Country Score Research Design Total Sample Size

Methods

Outcome

intense therapy (psychology and all p<.001, speech & OT - p<.01, PT p<.05);

Discussion Heinemann et al. (1995) employed a case series design to examine the effect of increased therapeutic intensity on functional rehabilitation outcomes as indicated by motor, cognitive and total FIM scores as well as FIM efficiencies. These investigators performed a comprehensive chart review of patients with SCI (N=106) and traumatic brain injury (N=140) to determine the number of 15-minute therapy units delivered in the provision of PT, OT, SLT and Psychology services. They then performed multiple regression analyses to determine if the amount of therapy was associated with positive outcomes. For the most part, there was little evidence that increased therapeutic intensity had any effect on improving outcomes for the SCI sub-sample although the paucity of well-controlled studies in this area limits the strength of the conclusions that can be drawn. Conclusions There is Level 4 evidence based on a single case series that increased therapeutic intensity may not be associated with any functional benefit as measured by the FIM.

Increased therapeutic intensity may not necessarily lead to functional benefits, but data is scarce.

3.4.2 Effect of Age on Rehabilitation Outcomes Historically, traumatic SCI has been viewed as a young, male concern although there have been recent shifts in the demographics of SCI such that an increasing proportion of recently injured individuals are older (both male and female). In fact, recent epidemiological evidence from Ontario, Canada found that the highest rates of SCI-related hospital admission following trauma in this jurisdiction was for those over 70 years of age although the frequency of specific etiologies (e.g., falls vs motor vehicle crashes) varied with age (Pickett et al. 2003). In the US the average age at injury has increased steadily over the last 30 years with the US Model Systems National SCI Statistical Center (2006) reporting an average age of injury of 38.0 years for the period from 2000-2006 as compared to 28.7 years for the period from 1973-1979. In addition, many centers in various jurisdictions around the world also provide rehabilitation services to individuals with spinal cord damage as the result of a variety of non-traumatic etiologies and often these people are much older than those injured due to trauma (McKinley et al. 2001; McKinley et al. 2002; Scivoletto et al. 2003; New 2005). Given these trends for increasing age in those undergoing rehabilitation it is important to understand the effects of age on rehabilitation outcomes. Several investigators have employed retrospective assessments of single or multi-centre patient databases to examine this issue (Cifu et al. 1999a; Cifu et al. 1999b; Seel et al. 2001; Scivoletto et al. 2003; Kennedy et al. 2003). 3 - 10

Table 3.6 Individual Studies – The Effect of Age on Rehabilitation Outcomes
Author Year; Country Research Design Total Sample Size Methods Population: Traumatic and non-traumatic SCI, 147 males, 45 females, Mean age=40.7±16.5 years, (152 aged 16-54, 40 aged 55-85), incomplete tetraplegia (23%), complete tetraplegia (21%), complete paraplegia (34%) and incomplete paraplegia (22%), Mean time post-injury to admission=28.8 days. Treatment: No treatment per se, but various outcomes associated with inpatient rehabilitation focusing on goal attainment in younger vs. older patients. Outcome Measures: Needs Assessment Checklist (NAC) collected within 2 weeks of mobilization and within 6 weeks of discharge. 1. Outcome Improvements were noted in ↓ “percentage to be achieved" scores for all 9 areas of need (p<0.0001). No significant differences were seen between age groups. Those with complete lesions showed greater improvement in bowel management than those with incomplete lesions (p<0.005) and those with tetraplegia showed greater improvement in the area of skin care than those with paraplegia group (p<0.005) Otherwise no other differences. Mobility needs of older subjects were significantly higher compared to the younger subjects (p<0.005) initially, but lower for the community score (p=0.01). Higher scores (i.e., more unmet need) assessed close to discharge were noted for older vs younger for the areas of skin management (p<0.01), bladder management (p<0.01), bowel management (p<0.05) and mobility (p<0.01). Although LoS was longer for younger patients (111.3±63.88 vs 89±69.9, p<0.008) which was related to a higher incidence of incomplete lesions and etiology, a matched-block subanalysis (N=130) showed differences were not significant. Neurological recovery was more frequent with younger group (p=0.006) and for those at ASIA C. Matched group sub-analysis showed more ASIA grade (p=0.027) and motor score improvements in younger group. Gains for independence of daily living measures (BI and RMI) were significantly greater for younger group (p<0.001). Younger age group had more people reach independent walking levels on WISCI than in older group (p<0.004). Similar findings for related subscales in BI and RMI. Younger age group had more people reach autonomous bladder (p=0.005) and bowel control (p=0.014) than in older group. Similar findings for bladder subscales in BI.

2.

Kennedy et al. 2003;UK Case Control (Inadequate control) Initial N=200; Final N=192

3.

Scivoletto et al. 2003; Italy Case Control Initial N=284; Final N=284

Population: Traumatic (105) and nontraumatic (179) SCI, 184 males, 100 females, Mean age=50.4±19.3 (12-86) years, cervical (81), thoracic (148), lumbosacral (55), ASIA A-D, Mean time post-lesion to admission was 56.9±43.9 days. Treatment: No treatment per se, but various outcomes associated with inpatient rehabilitation focusing on younger (<50) vs older (>50) patients. Mean LoS was 98.7±68.1 days. Outcome Measures: LoS, ASIA Impairment Scale, ASIA Motor Index, Barthel Index (BI), Rivermead Mobility Index (RMI), Walking Index for SCI (WISCI), Discharge Destination. All collected at admission and discharge.

1.

2.

3.

4.

5.

3 - 11

Author Year; Country Research Design Total Sample Size

Methods Population: Traumatic SCI from US Model Systems database, 83% male, Mean age=31.72±12.68 (18-92) years, paraplegia, ASIA A-D. Treatment: No treatment per se, but various outcomes associated with inpatient acute and rehabilitation care focusing on age effects by comparing results between 11 age categories. Mean acute LoS was 13.2±16.92 days. Mean rehabilitation LoS was 56.76±34.28 days. Outcome Measures: LoS, Charges, ASIA motor index score, Functional Independence Measure (FIM), change scores and efficiencies for FIM and ASIA motor index. All collected at admission to acute care and admission to rehabilitation care and discharge. 1. 2.

Outcome FIM improvement was less for people ≥ 60 than those younger. There were no significant differences in ASIA motor index scores, change scores or efficiency scores across different ages. No systematic significant differences were noted for acute care LoS or hospital charges. Rehabilitation LoS was longer and associated hospital charges greater for older individuals (trend beginning for those > 54 and peaking in the 6064 age group). Younger age groups were more likely injured as a result of vehicular crashes or violence while older groups were more likely injured as a result of falls or other events including being struck by falling objects, pedestrian accidents and medical/surgical complications. The younger the age group, the greater the FIM motor score improvement and greater FIM motor efficiency. The younger and middle age groups had significantly greater ASIA motor index score increases and efficiency than the older age group. No systematic significant differences related to age were noted for acute care or rehabilitation Length of Stay or hospital charges. The older the age group, the more likely individuals would be discharged to an institutional setting.

3. 4.

Cifu et al.1999; USA Case Control (Inadequate control) Initial N=2,169; Final N=2,169

5.

Cifu et al. 1999; USA Case Control Initial N=375; Final N=375

Population: Traumatic SCI from US Model Systems database, male and female, 3 equal (N=125) age groups (18-34, 35-64, >64) matched for neurological level and completeness, tetraplegia, ASIA A-D, 85% admitted within 21 days post-injury. Treatment: No treatment per se, but various outcomes associated with inpatient acute and rehabilitation care focusing on age effects by comparing results between 3 age categories. Outcome Measures: LoS, Charges, ASIA motor index score, Functional Independence Measure (FIM), change scores and efficiencies for FIM and ASIA motor index, Discharge destination. All collected at admission to acute care and admission to rehabilitation care and discharge. Population: Traumatic SCI from US Model Systems database, male, female, 3 equal (N=60) age groups (18-39, 40-59, >59) matched for neurological level and ASIA classification, paraplegia, ASIA A-D, 84% admitted within 21 days post-injury. Treatment: No treatment per se, but various outcomes associated with inpatient acute and rehabilitation care focusing on age effects by comparing results between 3 age categories. Outcome Measures: LoS, Charges, ASIA motor index score, Functional Independence Measure (FIM), change scores and efficiencies for FIM. All collected at admission to acute care and

1.

2.

3.

4.

1.

Seel et al. 2001; USA Case Control Initial N=180; Final N=180

2.

3. 4.

FIM improvement was greater for the younger and middle group that for the older group (p<0.001). FIM efficiency was greater for the young group as compared to the 2 older groups (p<0.001). There were no significant differences in ASIA motor index scores at any of the time points across the different ages. No systematic significant differences were noted between the 3 age groups for acute care LoS or hospital charges. Rehabilitation LoS was significantly shorter for younger than middle or older groups. There was no difference

3 - 12

Author Year; Country Research Design Total Sample Size

Methods admission to rehabilitation care and discharge. 5.

Outcome in associated hospital charges for the 3 groups. All age groups were equally likely to be discharged to a private residence (≥92%).

Discussion Similar approaches involving case control study designs have been employed by various investigators to examine the effect of age on rehabilitation outcomes. However, in the present review, studies employing some form of matching across different age groups were assessed as representing a higher level of evidence (i.e., Level 3) (Cifu et al. 1999b; Seel et al. 2001; Scivoletto et al. 2003) as compared to those deemed as having an inadequate method of controlling for potential confounds (i.e., Level 4) (Cifu et al. 1999a; Kennedy et al. 2003). Several of these studies have demonstrated differences between age groups for a variety of rehabilitation outcomes although there were also some contradictory findings within these studies, albeit some of this may have been due to variation between the sampling frames and methods employed in each study. For example, Seel et al. (2001) and Cifu et al. (1999a) reported reduced rehabilitation LoS for those with paraplegia due to trauma whereas no differences were seen in investigations of those with tetraplegia due to trauma (Cifu et al. 1999b) and also with the mixed sample of people with both traumatic and non-traumatic SCI (Scivoletto et al. 2003). Conversely, all studies examining functional change showed that younger individuals demonstrated greater functional improvements as indicated by increases with the FIM (i.e., motor FIM scores, change scores, efficiencies) (Cifu et al. 1999a; Cifu et al. 1999b; Seel et al. 2001) or BI (Scivoletto et al. 2003). These similar results were obtained from studies involving those with paraplegia (Cifu et al. 1999a; Seel et al. 2001), tetraplegia (Cifu et al. 1999b) and a mixed sample comprised of those with both traumatic and non-traumatic SCI (Scivoletto et al. 2003). On the other hand, Kennedy et al. (2003) employed the Needs Assessment Checklist (NAC) developed internally at Stoke-Mandeville, UK and demonstrated that there were few systematic age-related differences associated with goal attainment in a mixed traumatic, nontraumatic sample. The NAC is a client-focused outcome measure that assesses the degree to which specific behavioural outcomes particularly relevant to the client are achieved. In addition to functional outcomes, effective rehabilitation has also been associated with increases in neurological status as indicated by AIS or ASIA motor scores. Of the studies reviewed and possessing measures of neurological status, both studies limited to those with paraplegia showed no age effects (Cifu et al. 1999a; Seel et al. 2001;). Conversely, similar studies of those with tetraplegia or a mixed traumatic and non-traumatic SCI sample demonstrated that younger individuals were more likely to make significant neurological gains during inpatient rehabilitation (Cifu et al. 1999b; Scivoletto et al. 2003). Conclusions There is Level 3 evidence that significantly shorter rehabilitation LoS is associated with younger vs older individuals with paraplegia. The same may not be true for those with tetraplegia or for mixed cohorts involving traumatic and non-traumatic SCI.

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There is Level 3 evidence that younger as compared to older individuals are more likely to obtain greater functional benefits during rehabilitation. There is Level 3 evidence that significant increases in neurological status during rehabilitation are more likely with younger than older individuals with tetraplegia or for mixed cohorts involving traumatic and non-traumatic SCI. The same may not be true for those with paraplegia. Younger individuals with paraplegia are more likely to have shorter rehabilitation LoS than older individuals. Younger individuals are more likely to make greater functional gains during rehabilitation than older individuals. Younger individuals with tetraplegia (or in a mixed traumatic, non-traumatic sample) are more likely to make gains in neurological status during rehabilitation than older individuals.

3.4.3 Differences in Traumatic vs Non-Traumatic SCI Rehabilitation Outcomes Those individuals sustaining damage to the spinal cord due to non-traumatic causes are often treated in specialized inpatient SCI rehabilitation centres more commonly associated with those with SCI due to traumatic etiologies. Various reports have estimated that one-quarter to one half of all cases seen in specialized SCI rehabilitation centers are associated with non-traumatic etiologies (Muslumanoglu et al. 1997; McKinley et al. 1999b; van der Putten et al. 2001). Despite these significant numbers, relatively little systematic research is directed at nontraumatic SCI (van der Putten et al. 2001; McKinley et al. 2002). Common causes of nontraumatic SCI includes space occupying lesions such as tumours or prolapsed intervertebral discs, spondylosis such as that seen with degenerative spinal changes resulting in compression of the spinal cord, vascular ischemia as in arteriovenous malformations or spinal infarction, inflammation (e.g., idiopathic transverse myelitis, tropical spastic paraparesis, sarcoid) and those associated with congenital or familial etiologies ( Adams & Salam-Adams 1991; McKinley et al. 1999b; McKinley et al. 2001). Although estimates of the incidence of non-traumatic SCI have been provided (e.g., 8 per 100,000) (Kurtzke 1975), it is difficult to ensure accuracy given the heterogeneous nature of non-traumatic SCI and the variety of facilities and programs where these patients may receive care. Studies comparing those with damage to the spinal cord due to non-traumatic vs. traumatic etiologies have demonstrated a variety of systematic differences between these 2 patient groups. In general, those with non-traumatic SCI are more likely to be older, female, have paraplegia and have an incomplete injury than those with traumatic SCI (McKinley et al. 1996; McKinley et al. 2001; McKinley et al. 2002; New 2005). In the present section, we review the studies characterizing rehabilitation outcomes between those with SCI due to non-traumatic vs traumatic causes. Table 3.7 Individual Studies – Non-Traumatic SCI and Rehabilitation Outcomes
Author Year; Country Research Design Total Sample Size McKinley et al. 2001; USA Case Control Methods Population: Non-traumatic SCI (n=87) from a single centre vs traumatic SCI (n=87) from the US Model Systems 1. Outcome As compared to those with trauma (after matching), those with nontraumatic SCI had …

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Author Year; Country Research Design Total Sample Size Initial N=174; Final N=174

Methods database; Matched on level and completeness of lesion and age; 2/3rds 3059 years, 1/3rd 60+ years; 93% were admitted within 21 days of injury; 68% were paraplegic; AIS C 36%, AIS D 41%. Treatment: No treatment per se, outcomes associated with non-traumatic vs traumatic rehabilitation. Outcome Measures: LoS, charges, motor FIM (score, change and efficiency). Collected at admission to and discharge from rehabilitation. Population: Non-traumatic SCI secondary to stenosis (n=81) vs traumatic SCI (n=102) within a single centre; Matching from N=381 sample on paraplegia vs tetraplegia and completeness. Treatment: No treatment per se, but various outcomes associated with nontraumatic (stenosis) vs traumatic SCI rehabilitation. Outcome Measures: LoS, charges, Discharge rates to home, FIM (score, change and efficiency). Collected at admission to and discharge from rehabilitation. 2. 3. 4. 5. 6.

Outcome ↓ rehabilitation LoS (22.46 vs 41.49days) (p=0.000) ↓ overall charges (p=0.003) and ↓ daily charges (p=0.019) no difference on motor FIM at admission and motor FIM efficiency with rehabilitation ↓ motor FIM at discharge and ↓ motor FIM change no difference in discharge destination.

1.

McKinley et al. 2002; USA Case Control Initial N=381; Final N=183

2.

As compared to those with trauma (before matching), those with stenosis were significantly (p<0.01) … • older (64.1 vs 44.4). • more likely female (38.8 vs 21.2%) • more likely to have paraplegia (69.4% vs 45.5%) • more likely to be incomplete injury (AIS C or D) (100% vs 49.3%) As compared to those with trauma (after matching), those with stenosis had significantly (p<0.05) … • ↓ LoS (22.1 vs 32.2 days) • ↓ charges •  admission FIM and FIM motor scores • ↓ total and motor FIM change and FIM efficiency • no difference in discharge FIM totals • No difference in discharge destination. As compared to those with trauma (before matching), those with neoplastic cord compression were … • older (57.8 vs 30.45). • more likely to have paraplegia (88.2% vs 52.5%) • more likely to be incomplete (88.2% vs 56.7% As compared to those with trauma (after matching), those with neoplastic cord compression … • had ↓ LoS (25.17 vs 57.46 days) • had ↓ motor FIM change • had ↓ motor FIM scores at discharge • no different FIM efficiency • no different for discharge destination

McKinley et al. 1999; USA Case Control Initial N = 4,035; Final N=58

Population: Non-traumatic SCI secondary to neoplastic cord compression admitted over 5 years (within a single centre (n=29) vs traumatic SCI (n=29) from the US Model Systems database matched by age, level of injury and AIS; Age = 57.8 years; AIS AD; C4-L2. Treatment: No treatment per se, but various outcomes associated with rehabilitation care of non-traumatic (neoplastic cord compression) vs traumatic SCI. Outcome Measures: LoS, Discharge destination, FIM (total score, change and efficiency). Collected at admission to and discharge from rehabilitation.

1.

2.

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Author Year; Country Research Design Total Sample Size

Methods Population: Non-traumatic SCI; median age=69 years (29-86); AIS B-D tetraplegia 32.9%, AIS A paraplegia=8.6%, AIS B-D= 58/6%; 78.6% had relatively fast onset (<7 days) and were admitted to rehabilitation=30.9 days, 21.4% had gradual onset and were admitted=11.0 months. Treatment: No treatment per se, outcomes associated with non-traumatic SCI rehabilitation. Outcome Measures: Demographics, clinical characteristics, LoS, Discharge setting, level of lesion and AIS, FIM, mobility, bowel and bladder function. Collected at admission to and discharge from rehabilitation. Population: Non-traumatic SCI; mean age=55 years (16-88); 54% male; cervical 49%, upper thoracic 21%, lower thoracic and lumbar 22%; Time from onset to rehabilitation=4.8 years (0.1-32 years). Treatment: No treatment per se, but optimal outcomes were regressed against various factors associated with nontraumatic rehabilitation. Outcome Measures: Demographics, clinical characteristics, level of lesion and AIS, FIM motor score and change score. Collected at admission to and discharge from rehabilitation. Population: Non-traumatic SCI secondary to neoplastic cord compression admitted over 5 years within a single centre; Mean age=64 years; 18 men, 14 women. Treatment: No treatment per se, but outcomes associated with rehabilitation care. Outcome Measures: Medical complications, AIS, LoS, bladder function, FIM, Discharge destination. All collected at admission to and discharge from rehabilitation. Level of ambulation and dressing ability assessed at 3-15 months post-discharge. 1. 2.

Outcome LoS =55.8 days (7-413 days).  FIM motor scores during rehabilitation from 40.8 to 67.1, cognitive FIM showed no change due to initial ceiling effect. 17.7% overall and 26.9% over the age of 70 were discharged to a nursing home. Those subjects male, younger, more mobile, more independent bowel and bladder function and less severe AIS grades were more likely to be discharged home. Major non-traumatic classifications were tumour (32.9%), degenerative (25.7%), vascular (14.3%) and other (27.1%). LoS = 31.5 days (9-184 days).  FIM motor score was associated with lower score on admission and reduced time between onset-admission (overall predictive model). Age (i.e., younger), etiology (i.e., hereditary pathology) and lesion level (i.e., cervical) were individually associated with improved functional outcomes but did not improve prediction of overall model.

3. 4.

New et al. 2005; Australia Case Series Initial N=70; Final N=62

5.

1. 2.

Van der Putten et al. 2001; England, UK Case Series Initial N=100; Final N=100

3.

1. 2.

3. 4.

McKinley et al. 1996; USA Case Series Initial N=32; Final N=20

5.

LoS = 27 days (7-54 days). People showed significant  in 9 FIM categories (0<0.005) associated with mobility and self-care during rehabilitation. 11 individuals improved from AIS C to D at discharge. 27/32 were discharged home, 4 transferred for medical reasons (and died within 2 months) and 1 died before discharge. Of 20 people with assessed at 3-15 month follow-up, 16 had maintained mobility and dressing function as compared to discharge. However, 12/20 had eventually died at a mean of 101 days post-discharge.

Discussion Studies examining non-traumatic SCI typically make use of retrospective case series designs describing rehabilitation outcomes directly (McKinley et al. 1996; van der Putten et al. 2001; New 2005) or involve case control designs employing matching techniques to make comparisons with traumatic SCI while controlling for such things as age and level and 3 - 16

completeness of injury (McKinley et al. 1999; McKinley et al. 2001; McKinley et al. 2002). As noted above, those with non-traumatic SCI were more likely to be older, female, have paraplegia and have an incomplete injury than those with traumatic SCI (McKinley et al. 1996; McKinley et al. 2001; McKinley et al. 2002; New 2005). When direct comparisons of traumatic and non-traumatic SCI of various etiologies have been conducted using matching procedures, it is clear that shorter rehabilitation LoS was seen for those with non-traumatic SCI (McKinley et al. 2001). In addition, this shorter LoS was associated with reduced hospital charges for both an overall and a per diem basis (McKinley et al. 2001). These findings were replicated with similar studies examining subsets of those with non-traumatic SCI including those with stenosis (McKinley et al. 2002) and those with neoplastic cord compression (McKinley et al. 1999). However, these findings have only been established with data from the US Model Systems. For example, others have reported longer rehabilitation LoS (van der Putten et al. 2001; New 2005) although these reports were conducted in other jurisdictions (i.e., Australia, UK respectively) and employed case series designs such that direct comparisons with traumatic SCI were not possible. None of the studies employing matching procedures noted differences in discharge destinations for those with non-traumatic SCI as compared to those with traumatic SCI (McKinley et al. 1999; McKinley et al. 2001; McKinley et al. 2002). although New et al. (2005) did note that within nontraumatic subjects, those individuals male, younger, more mobile, more independent with bowel and bladder function and having less severe AIS grades were more likely to be discharged home. In addition, the relatively poor prognosis and low survival rate of those with neoplastic cord compression has specific implications for discharge disposition (McKinley et al. 1996) although no specific differences were noted in a matched comparison (McKinley et al. 1999). All studies reviewed employed the FIM to assess the functional status of individuals and generally demonstrated improved function with rehabilitation. Typically, motor FIM scores were employed or in the event total FIM scores were used it was acknowledged that changes were due primarily to the motor FIM subscale given a ceiling effect associated with the cognitive FIM subscale (McKinley et al. 1999; New 2005). For the most part, improvements seen in FIM during rehabilitation for non-traumatic SCI were lesser as those compared to traumatic SCI as reflected by lower FIM change scores (McKinley et al. 1999; McKinley et al. 2001; McKinley et al. 2002). When examining a mixed population of non-traumatic SCI, there were no differences between trauma and non-trauma groups with respect to admission FIM but there was a reduced FIM at discharge for the non-traumatic group accounting for the lower FIM change score (McKinley et al. 2001). This lower FIM change did not result in a lower FIM efficiency given the reduced LoS for the non-traumatic group. When examining only those with stenosis vs those with traumatic SCI, those with non-traumatic SCI had higher FIM scores on admission, similar scores on discharge, resulting in reduced change scores and lower efficiency (McKinley et al. 2002). On the other hand, those with neoplastic cord compression demonstrated similar FIM scores on admission, reduced scores on discharge, resulting in reduced change scores but no difference in efficiency (McKinley et al. 1999). Van der Putten (2001) assessed a variety of factors using multiple linear regression techniques in order to predict those most associated with increases in FIM motor scores during rehabilitation. They included 100 consecutively admitted patients with non-traumatic SCI with rehabilitation periods of > 1 week. The primary factors associated with improved motor FIM scores accounting for 54% of the variance were having a lower score on admission and reduced time between symptom onset-admission. Age, specific diagnostic subgroup (i.e., spaceoccupying, vascular, spondylosis, inflammation or hereditary), or lesion level did not improve the prediction significantly.

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Conclusions There is Level 4 evidence that those with non-traumatic SCI are more likely to be older, female, have paraplegia and have an incomplete injury as compared to those with traumatic SCI. There is Level 3 evidence that those with non-traumatic SCI have generally reduced rehabilitation LoS, reduced hospital charges but similar discharge destinations as compared to those with traumatic SCI. There is Level 3 evidence that those with non-traumatic SCI have generally reduced motor FIM improvement during rehabilitation as compared to those with traumatic SCI.

Individuals with non-traumatic SCI have reduced LoS and less functional improvement with rehabilitation as compared to those with traumatic SCI although controlled comparisons are limited to data from the US Model Systems.

3.4.4 Effect of Gender and Race on Rehabilitation Outcomes Potentially, there are many additional factors that may affect rehabilitation outcomes following inpatient SCI rehabilitation. Two of these factors include gender and race, although neither has been examined comprehensively. With respect to gender effects, studies investigating rehabilitation outcomes associated with women have focused on long-term psychosocial outcomes associated with issues such as marriage or motherhood or issues associated with community and vocational reintegration (Westgren & Levi 1994; DeVivo et al. 1995; Shackelford et al. 1998; Krause et al. 1998). Studies of the effects of race on rehabilitation outcomes have been limited to evaluations of the differences between whites and African Americans using US Model Systems data (Meade et al. 2004a; Putzke et al. 2002), although as with studies of gender, investigations of the effects of race have focused more on vocational issues and satisfaction with life (James et al. 1993; Krause et al. 1998; Krause 1998; Meade et al. 2004b). Table 3.8 Individual Studies – The Effect of Gender and Race on Rehabilitation Outcomes
Author Year; Country Research Design Total Sample Size Methods Population: Traumatic SCI from US Model Systems database; matched white vs African American subjects matched by level of function, ASIA Impairment Scale, age and primary care sponsor; 84.2% male; age=34.2±15.3 years; tetraplegia, paraplegia; ASIA A-D. Treatment: No treatment per se, but various outcomes associated with inpatient acute and rehabilitation care focusing on race effects by comparing outcomes of African Americans and whites. Outcome Measures: ASIA motor index scores, FIM motor score, Medical complications, discharge disposition, 1. 2. 3. Outcome No significant differences between whites vs African Americans for ASIA and FIM motor index scores. No significant differences for discharge disposition (P=0.622). African Americans were more likely to be injured as a result of violence and whites were more likely to be injured in MVCs. African Americans were significantly more likely to receive laparotomies (p<0.001) and be catheter free in comparison to caucasians. Whites were more likely to receive spine surgeries (p<0.001) and have

Meade et al., 2004; USA Case Control Initial N=628; Final N=628

4.

5.

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Author Year; Country Research Design Total Sample Size

Methods medical procedures and medical management. Collected at admission to acute care and admission to and discharge from rehabilitation.

Outcome more suprapubic cystomies in comparison to African Americans. No significant differences between racial groups in the occurrence of medical complications during either acute care or rehabilitation.

6.

Greenwald et al., 2001; USA Case Control Initial N=1074; Final N=1074

Population: Traumatic SCI from US Model Systems database; matched male vs female by level of function, AIS and age; 50% were 18-34 years, 42% were 36-64 years and 8% were >64 years old; tetraplegia, paraplegia; ASIA A-D; 86% were admitted to Model systems within 21 days post-injury. Treatment: No treatment per se, outcomes associated with inpatient acute and rehabilitation care focusing on gender effects. Outcome Measures: Length of Stay, Charges, ASIA motor index total score, FIM motor score, FIM motor change scores, FIM motor efficiency scores, and medical complications. Collected at admission to acute care and admission to and discharge from rehabilitation.

5.

No significant differences were seen for acute care or rehabilitation Length of Stay or charges between males and females. 6. No significant differences were seen in discharge destinations between males and females. 7. No significant differences were seen in admission, discharge, or change scores for both functional (i.e., FIM) and neurological (i.e., ASIA) assessments between males and females. 8. Gender differences in the development of complications during rehabilitation, notably, pressure sores (p<0.001) and DVTs (p=0.003) were more likely in men. 9. Younger patients had better functional outcomes than older patients with significantly higher FIM motor scores at discharge. 10. Older patients had significantly greater ASIA motor scores on admission and discharge than middle-aged patients, who had significantly greater scores than younger patients. Study 1 1. Significant differences between race were not found relating to any of the outcome measures including FIM, Length of Stay (acute or rehabilitation care), Discharge destination and charges (p>0.05). 2. The 2 groups were significantly different (p<0.001) on numerous other demographic and injury-related factors including age, education, gender, race, marital and occupational status, lesion level, and injury duration. Study 2 No significant differences were seen with SWLS, SF-12 and CHART (p=0.25). None of the medical outcome variables differed significantly (p>0.05) with race, including days rehospitalized and number of rehospitalizations in the previous year, impairment level, and total medical

Putzke et al. 2002; USA Case Control Study 1: Initial N=2438; Final N=374 Study 2: Initial N=3301; Final N=316

Population: Traumatic SCI admitted within 1 day of injury to integrated (acute and rehabilitation) US Model Systems Center (Study 1: eligible N=2438) or having 1 year or later follow-up data in the US Model Systems database (Study 2: eligible N=3301), matched white and African American by various injury and demographic factors, tetraplegia, paraplegia, complete, incomplete, Study 1: Age=34.8±15.9 (white) & 35.3±15.6 (African American) years, Gender 90% male (both groups), Study 2: Age=37.7±12.2 (white) & 37.8±12.0 (African American) years, Gender 93% male (both groups). Treatment: No treatment per se, but race effects on various outcomes associated with integrated acute and rehabilitation care (study 1) or long-term (study 2) studied by comparing results between whites and African Americans. Outcome Measures: Study 1: FIM motor

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Author Year; Country Research Design Total Sample Size

Methods and efficiency scores, Length of Stay, Discharge destination, medical complications, Charges. Study 2: FIM motor and efficiency scores, CHART, Satisfaction with Life Scale (SWLS), SF-12 (measured the individual’s perception of his/her health status), medical complications and number of hospitalizations. All collected at admission, discharge or at annual follow-up (Study 2 only).

Outcome complications. Despite non-significant results with multivariate analyses, univariate analyses were also conducted and were generally non-significant except that whites reported less handicap on the CHART mobility subscale (p=0.03). As with Study 1, both groups differed significantly on numerous demographic and injury-related factors (p<0.001).

Discussion Greenwald et al. (2001) employed a mixed, block design, matching male and female subjects so as to control for covariant effects of injury characteristics (level and AIS) and age at injury. They retrospectively analyzed 1,074 subjects over a 10-year period from 1988-1998 by using US Model Systems data culled from 20 different SCI centers from a variety of geographic regions. In general, there were no significant differences between males and females for rehabilitation outcomes including discharge disposition, LoS, FIM motor scores (including change scores and efficiencies) or ASIA motor scores. There were also no reported gender-related differences for the incidence of most medical complications encountered during rehabilitation stay including pneumonia, autonomic dysreflexia, pulmonary embolism, cardiac arrest, kidney calculi or gastrointestinal hemorrhage. However, men did have significantly higher rates for DVT and pressure sores although the authors reported that these differences were not robust and did not result in increased stays, charges or lower functional outcomes. Similar case control designs employing matched groups of whites vs. African Americans from the US Model Systems database have also been employed to examine race effects on rehabilitation outcomes. Putzke et al. (2002) matched race groups according to age, education, gender, occupational status, impairment level, etiology, primary sponsor of care and geographic region whereas Meade et al. (2004) matched according to level of injury, AIS, age and primary sponsor of care. By controlling for all these variables, these authors were able to establish that race acts more as a proxy variable than a predictor of outcomes (Putzke et al. 2002). For example, differences did exist in a wide variety of demographic, rehabilitation outcomes and specific medical conditions provided to African Americans vs. whites when considering but these were generally accounted for by socio-demographic and etiological differences associated with these groups (Putzke et al. 2002; Meade et al. 2004). For example, African Americans were significantly more likely to be injured as the result of violence and have 11th grade education or less while whites were more likely injured as a result of motor vehicle crashes and had high school education or more (Putzke et al. 2002; Meade et al. 2004). For the most part, there were no differences between the two groups with respect to rehabilitation outcomes when the variables noted above were accounted for in the matching process. Conclusions There is Level 3 evidence that there is no difference with respect to gender on discharge destination, rehabilitation LoS and neurological or functional outcomes associated with rehabilitation. 3 - 20

There is Level 3 evidence that there is no difference with respect to race (white vs African-American) on rehabilitation LoS and neurological or functional outcomes associated with rehabilitation that are not otherwise explained by socio-demographic or etiological differences.

Neither gender nor race effects have been demonstrated for discharge destination, rehabilitation LoS and neurological or functional status in US Model Systems data.

3.5 Specialized vs General SCI Units (Acute Care) Donovan et al. (1984) contend that best practice for SCI care consists of a situation in which every individual sustaining a SCI is admitted to an integrated, comprehensive system where expertise, facilities and equipment are focused on optimal patient care and cost effectiveness. At the other extreme is the situation condemned by Bedbrook and Sedgley (1980), of piecemeal care for those with SCI characterized by “the occasional patient being treated by the occasional doctor”. In practice, care provided by most SCI centers likely falls somewhere in between these extremes of specialized vs. general care. The present section outlines the studies that are focused on examining the hypothesis that care provided through specialized SCI centers is more efficient and effective than that delivered at general centers. The reader should note that while the majority of these studies were conducted from rehabilitation centers the experimental manipulation of interest concerns the degree to ehich specialist care is delivered during acute care period. Table 3.9 Individual Studies – Specialized vs General SCI Units
Author Year; Country Research Design Total Sample Size Methods Population: 338 SCI admitted to Rehabilitation, paraplegia, tetraplegia, complete, incomplete. Treatment: N=185 initially treated in a specialized short-term acute care unit; Control: N=153 initially treated in general hospitals. Outcome Measures: Modified Barthel index (MBI), MRSCICS Patient Functional Level Scheme, Length of Rehabilitation Stay (LoS), Efficiency of Rehabilitation Gains (MBI / natural logarithm of LoS) 1. Outcome Those receiving specialized care made functional gains with significantly greater efficiency and were transferred to rehabilitation significantly faster (p<.001). A significantly greater number of people were transferred from general centers with spine instability than from specialized SCI centers (p=.02). There was no difference between specialized and general acute care with respect to functional status at rehabilitation admission or discharge nor on rehabilitation LoS. Those admitted from the specialized SCI unit had significantly improved joint motions (i.e., reduced contractures). More had normal range of motion (p<0.05) and fewer abnormalities. Those admitted from the specialized SCI unit were admitted significantly earlier for rehabilitation as compared

Heinemann et al. 1989; USA Case Control Initial N=338; Final N=338

2.

3.

Yarkony et al. 1985; USA Case Control Initial N=181; Final N=181

Population: Traumatic SCI admitted to a specialized rehabilitation unit; Males (n=149) and females (n=32); Avg age 28 years; Tetraplegia (54%), paraplegia (46%); incomplete (58%), complete (42%). Treatment: Comparison of those treated acutely in a specialized interdisciplinary spinal unit (n=90) vs a general hospital unit (n=91).

1.

2.

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Author Year; Country Research Design Total Sample Size

Methods Outcome Measures: Joint motion, time to rehabilitation admission, all collected at admission to rehabilitation. 3.

Outcome to those admitted from the general hospital unit (p<0.01). Those admitted earlier to rehabilitation had reduced numbers of contractures (p<0.01). Those with tetraplegia had an increased incidence of contractures (p<0.01). Subjects who were cared for in the integrated, specialized unit (Australia) encountered the fewest complications. (no statistical analysis was performed) People sustained progressively more complications with longer periods of delayed admission (US Model Systems). Individuals admitted at these longer delays were cared for initially in general hospital units.

Donovan et al. 1984; USA / Australia Case Control Initial N=1,672; Final N=1,672

Population: Traumatic SCI, admitted to a specialized, integrated rehabilitation unit in Australia (n=66) vs those admitted to the US Model Systems (n=1606); tetraplegia, paraplegia; incomplete, complete. Treatment: Those treated in an integrated, specialized interdisciplinary spinal unit (Australia) admitted <48 hours post-injury vs those admitted to the US Model Systems at 1-15, 16-30, 31-45 or 46-60 days post-injury (reflecting progressively less specialized care). Outcome Measures: Incidence of 7 complications collected at 1-15, 16-30, 3145 or 46-60 days post-injury. Population: traumatic SCI; 201/220 consecutive admissions to a newly established specialized interdisciplinary acute SCI unit vs 351 admissions to one of two general hospital trauma units; tetraplegia, paraplegia; incomplete, complete; Male/female ~ 4/1; Median age 27 years (SCI Specialist unit), 32.0 years (general hospital). Treatment: Comparison of those treated in a SCI specialist spinal unit (1973-1981) vs a general hospital trauma unit (1947-1973). Outcome Measures: LoS, Mortality rate, Cord Injury Neurological Recovery Index. All collected at 6 months (complete) or 12 months (incomplete).

1.

2.

1.

Tator et al. 1995; Canada Case Control Initial N=552; Final N=552

2.

3.

Subjects who were admitted to the specialized SCI unit had significantly shorter acute care LoS than those admitted to the general units (p<0.001). Within the specialized unit subsample, an increased delay from accident to admission resulted in longer LoS (p=0.032). Subjects who were admitted to the specialized SCI unit had significantly reduced mortality than those admitted to the general units (p=0.022). This was especially evident in those with complete SCI. Subjects who were admitted to the specialized SCI unit had significantly greater neurologic recovery (p<0.001).

Discussion The majority of the studies examining the effect of specialist vs. general SCI care settings focused on this issue during the acute period of care only, with the primary outcome measures being taken at admission to rehabilitation and no follow-up after this point. Of the four studies reviewed, only one investigated the results associated with a specialized, integrated unit comprised of both acute and rehabilitation services (Donovan et al. 1984). In this study, rates of six of seven different medical secondary complications typically encountered by individuals with SCI were lowest for the cohort admitted initially (i.e., typically within 48 hours post-injury) to the specialist SCI centre. This cohort was analyzed retrospectively with complication rates determined at various times throughout rehabilitation (i.e., 1-15, 16-30, 31-45, 46-60 days) and compared with those being admitted to specialist SCI centers from more general care settings at similar time periods. Most striking was the absence of decubitis ulcers during any time period 3 - 22

for those under more specialized care vs. a progressively greater incidence for those with greater time spent in general care. No statistical analysis was conducted for this study. In the remaining 3 studies all comparisons were limited to specialized vs. general acute care and were retrospective in nature. Two of these studies compared subjects as they were being admitted for comprehensive rehabilitation (Yarkony et al. 1985; Heinemann et al. 1989). In both studies, patients were transferred significantly faster to comprehensive inpatient rehabilitation from more specialized acute care settings than from general hospital settings. In the remaining study by Tator et al. (1995), the same issue was investigated by examining outcomes associated with a seven year experience of a newly developed specialist SCI unit as compared to historical data culled from pre-existing trauma units reflecting more general settings (Tator et al. 1995). In this study, subjects were also transferred to rehabilitation faster from the specialist SCI unit resulting in a reduced length of stay (LoS) in acute care. In general, all of these studies demonstrated improved medical outcomes associated with more specialized care. In addition to the reduced complication rates noted above by Donovan et al. (1984), others have noted that more specialized acute care resulted in less spine instability (Heinemann et al. 1989) and significantly improved joint motion with reduced incidence of contractures (Yarkony et al. 1985) upon admission to a comprehensive rehabilitation program. In addition, reduced mortality and improved neurological recovery (as demonstrated by higher scores on the Cord Injury Neurological Recovery Index) were seen in the newly developed specialist SCI unit as compared to the data from pre-existing general trauma units (Tator et al. 1995). It should be noted that a gradual reduction of mortality was seen over the entire study period and that reductions attributed to the specialist unit might also be due to many general gradual improvements in medical care, especially as a historical control was used as the primary basis for comparison. Only one study has examined the functional benefits realized during rehabilitation associated with SCI-specific acute care vs. that delivered in more general settings. Heinemann et al. (1989) used the Modified Barthel Index to show that those individuals receiving more specialist care made functional gains during subsequent rehabilitation with significantly greater efficiency (i.e., functional change/LoS) than those referred from general settings. No statistically significant differences were seen between the specialist vs. general groups for either admission or discharge functional levels nor were significant differences seen with LoS. There was, however, a significant reduction in the time from injury to rehabilitation admission for those receiving care in the specialist SCI unit. This implies an overall reduced length of total hospitalization for this group, although this data was not reported. Functional benefits associated with early admission and reduced LoS will be reviewed in the next section. A primary limitation of all studies reported here was the use of retrospective data collection methods and in the case of Tator et al. (1995), the use of historical controls. Another important limitation of some of these studies is the failure to control for (or at least adequately describe) the time to admission to initial care following injury, especially with respect to control subjects (e.g., Donovan et al. 1984; Yarkony et al. 1985; Heinemann et al. 1989). This is an important confounding variable as early admission to a specialized system of care is likely associated with better outcomes as demonstrated in the following section. Therefore, the present conclusions are limited to a Grade 3 level of evidence and some findings have been reduced to Grade 4 if not corroborated and involving inadequate controls. While more carefully controlled prospective studies would be difficult to implement, they would be required to strengthen the evidence in this area.

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Conclusions - Benefits of Specialized vs General SCI Units Based on several retrospective, case-control studies there is Type 3 evidence that individuals cared for in interdisciplinary, specialist SCI acute care units soon after injury (most being admitted within 48 hours) begin their rehabilitation program earlier. There is Level 3 evidence that individuals cared for in interdisciplinary, specialist acute care SCI units have fewer complications upon entering and during their rehabilitation programs. There is Level 4 evidence that individuals initially cared for in interdisciplinary, specialist acute care SCI units make more efficient functional gains during rehabilitation (i.e., more or faster improvement). There is Level 4 evidence that individuals cared for in interdisciplinary, specialist SCI units have reduced mortality.

More specialized, interdisciplinary acute SCI care is associated with faster transfers to rehabilitation and may result in fewer medical secondary complications, more efficient functional gains and reductions in overall mortality.

3.6 Early vs Delayed Admission to Specialized SCI Units As noted by others and in the previous section, earlier as opposed to delayed admission to interdisciplinary, specialized SCI units has been associated with a variety of beneficial outcomes (DeVivo et al., 1990). The question of whether earlier admission to an organized system leads to enhanced outcomes is inexorably linked to the question of specialist vs general care for individuals with SCI. In all studies in this and the preceding section the authors framed their studies as addressing either the question of delay or the question of interdisciplinary, specialist care yet similar designs were employed for each (i.e., retrospective case control). For those subjects experiencing a delay to admission to a specialized SCI unit, it was either presumed or established that preceding acute care was conducted at a general hospital unit. The author simply chose to characterize this as either a delay or more general care. For the present review we have maintained this distinction as originally intended by each author, especially, as in some cases, there is little or no verification of the general nature of the pre-admission care or the time of first admission, respectively. However, the reader is advised that the specific findings and conclusions reached in both sections are most likely associated with a delay to an interdisciplinary, specialized acute or rehabilitation SCI unit with prior care delivered at a general hospital facility. In addition, much variation exists in the literature that addresses the question of delayed admission. There is no uniform or accepted definition of what constitutes a delay and this varies depending on the context of the study, most notably whether it is conducted from an acute vs rehabilitation perspective. For the present review, all studies which examine this question by comparing 2 or more groups within the first week post-injury have been examined separately

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from those with an initial time period greater than 1 week post-injury. These have been termed 1) Acute and 2) Post-acute studies, respectively. Table 3.10 Individual Studies – Early vs Delayed Admission (Acute Studies)
Author Year; Country Research Design Total Sample Size Methods Population: 661 people with SCI admitted to a US Model Care System Centre with specialized SCI rehabilitation services. Subjects included those with tetraplegia and paraplegia and also those with incomplete vs complete injuries but frequencies were not provided. Average ages for early vs delayed admission groups were 29.5 and 32.0 years old respectively. Treatment: No tx per se, comparison of those admitted earlier (< 24 hours post injury) vs later (> 24 hours) to a specialized integrated spinal unit (i.e., combined acute care and rehabilitation). Subjects were sub-grouped into i) paraplegia, incomplete, ii) paraplegia, complete, iii) tetraplegia, incomplete, iv) tetraplegia, complete. Outcome Measures: Length of Stay (LoS), Hospital charges, Incidence of medical complications, Neurologic recovery, Mortality all collected at Discharge. 1. Outcome Those with complete paraplegia (p=0.0169) & incomplete tetraplegia (p=0.0001) admitted earlier (<24 hours) had significantly shorter total hospitalization LoS. A similar trend for those with incomplete paraplegia (p=0.0568), no difference for those with complete tetraplegia (p=0.928). Mean hospital charges were less for subjects with complete (p=0.0099) and incomplete (p=0.0134) tetraplegia who were admitted earlier. Similar trend for those with incomplete paraplegia (p=0.0607), no difference for complete paraplegia (p=0.4777). In general, no overall differences were seen in the development of medical complications between the early vs late admission groups. A few differences for incidence specific complications. Trend for increased neurologic recovery with early admission in that 10/315 (3.2%) vs 4/401 (1.0%) in early vs late groups had complete recovery (p=0.08). Author warns of bias in this finding. Mortality comparisons not possible within sample for early vs late admission groups. Comparison with historical data suggests enhanced survival rates with early admission. Subjects who were admitted earlier (<24 hours) had significantly fewer contractures than those admitted later (>24 hours – 60 days) (p=0.05). Other factors associated with an increased incidence of contractures included tetraplegia vs paraplegia (p<0.01), presence of a pressure ulcer (p=0.05), co-existence of head injury (p<0.05).

2.

DeVivo et al. 1990; USA Case Control Initial N=661; Final N=661

3.

4.

5.

Daylan et al. 1998; USA Case Control Initial N=482; Final N=482

Population: 482 men and women with traumatic SCI admitted to a US Model Systems SCI Centre with specialized SCI acute care and rehabilitation services. Subjects included those with tetraplegia (256) & paraplegia (226) and ASIA A, B, C (362) & D (120). Treatment: No tx per se, comparison of those admitted 1. (< 24 hours post injury) vs 2. (> 24 hours – 60 days post-injury) to a specialized spinal acute care and rehabilitation unit. Outcome Measures: Incidence of contractures during initial post-traumatic hospitalization.

1.

2.

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Table 3.11 Individual Studies – Early vs Delayed Admission (Post-Acute Studies)
Author Year; Country Research Design Total Sample Size Methods Population: SCI, tetraplegia, paraplegia, complete, incomplete, traumatic. Treatment: No tx per se, comparison of those admitted to a specialized Spinal Rehabilitation unit at one of 3 time periods following injury (<30 days, 31-60 days, > 60 days). Outcome Measures: LoS, ASIA motor scores and impairment grade, Barthel Index (BI), Rivermead Motor Index (RMI), Walking Index for SCI (WISCI), Efficiency measures for all were calculated by dividing by LoS. 1. Outcome Those admitted earliest (<30 days) had significantly  performance on activities of daily living (i.e., Barthel Index scores) at discharge than those with longer delays (>60 days) (p=.006). They also demonstrated significantly greater changes (p=.003) and greater efficiency (p<.001) for the Barthel Index. Those admitted the earliest (<30 days) had significantly better mobility (i.e., RMI) at discharge than those with longer delays (>60 days) (p=.03). They also demonstrated significantly greater changes (p=.001) and greater efficiency (p=.04) for the RMI. There were no significant differences between the early vs later admissions with respect to walking (WISCI) or ASIA motor scores (p=.63 or p=.81). Those admitted earliest had the shortest LoS; these differences were not significant (p=.15). Those admitted with a delay (> 7 days) following referral had significantly longer LoS (p<.001). This was for people with both complete (N=59) and incomplete (N=29) injuries but not for those without spinal cord damage (N=24). More severe injuries (as determined by Injury Severity Scores) were more likely to have longer LoS (Spearman’s = 0.593, p<0.0001). Those who were admitted with a delay between injury and referral (>3 days) did not differ on LoS with those who did not experience a delay (p=0.44). The primary reasons for delays between referral and admission for those with complete injuries were I) achieving medical stability and ii) absence of beds. For those with incomplete injuries the same primary reasons were identified but in reverse order. Those admitted earlier had significantly shorter total hospitalization LoS (p<.01). Those admitted earlier with tetraplegia had fewer medical complications and less frequent spinal surgery vs those admitted later (no group analysis performed). Those admitted earlier with paraplegia had no difference in

Scivoletto et al. 2005; Italy Case Control Initial N=150; Final N=150

2.

3.

4.

Population: SCI, tetraplegia, paraplegia, traumatic. Treatment: No tx per se, comparison of those admitted to a specialized integrated spinal unit (i.e., combined acute and rehabilitation) with or without a delay between injury and referral (>3 days) and between referral and admission (>7 days). Outcome Measures: LoS. Amin et al. 2005; England Case Control Initial N=432; Final N=432

1.

2.

3.

4.

Oakes et al. 1990; USA Case Control Initial N=197; Final N=197

Population: 197 people with traumatic SCI admitted within 1 year of injury to a Level 1 trauma Centre with specialized SCI rehabilitation services. Male / female (158 / 39); Tetraplegia / paraplegia (102 / 95); Average ages for groups were 27.2 –32 years old. Treatment: No tx per se, comparison of those admitted earlier (< median) vs later

1. 2.

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Author Year; Country Research Design Total Sample Size

Methods (> median) to a specialized integrated spinal unit (i.e., combined acute care and rehabilitation). Subjects were grouped by tetra vs para and by early vs late admission by median admission values of 11 (Tetra) vs 21 (Para) days. Outcome Measures: LoS, incidence of medical complications, incidence of surgical intervention. Population: 123 people with SCI admitted to a Japanese Hospital System with specialized SCI rehabilitation services following acute care. Subjects included those with tetraplegia and paraplegia (frequencies not provided) with ASIA A (51), B (8), C (35) and D (29). Treatment: No tx per se, comparison of those admitted earlier (< 2 weeks post injury) vs later (> 2 weeks) to a specialized spinal rehabilitation unit. Subjects were sub-grouped into i) tetraplegia, ii) paraplegia, iii) central cord. Outcome Measures: LoS, FIM, FIM motor score, FIM gain, FIM efficiency all collected at Discharge.

Outcome medical complications and more frequent spinal surgery. Similar reductions in total hospitalization LoS with earlier admissions for both those with tetraplegia (p<.01) and paraplegia (p<.05) in a re-analysis of the sample with groupings based on admissions < 24 hours vs > 24 hours post-injury. Subjects who were admitted earlier (<2 weeks) had significantly shorter LoS than those admitted later (p<0.0005). FIM gain (p<0.0001) and FIM efficiency (p<0.0001) were significantly greater for subjects admitted earlier vs later. Note: the early admission subjects had lower initial motor and total FIM scores than did the delayed admission group (p<0.05). Correlations between ASIA motor and FIM scores in various subgroups and at admission and discharge yielded a variety of associations ranging from very weak to strong correlations (r=0.03-0.92) with the majority of these correlations significant (p<.05). Subjects with paraplegia who were admitted earlier (<1 week and < 2 months) had significantly shorter LoS than those admitted later (p<0.05). Subjects with tetraplegia who were admitted earlier (<1 week) had significantly shorter LoS than those admitted later (>2 months) (p<0.05). The incidence of most secondary conditions did not differ between early vs later admissions for those with paraplegia or tetraplegia. However, those with paraplegia or tetraplegia did have lower incidence of pressure sores with earlier admission (<1 week) (p<0.001).

3.

1.

2.

Sumida et al. 2001; Japan Case Control Initial N=139; Final N =123

3.

Aung & El Masry 1997; UK (Wales) Case Control Initial N=219; Final N=219

Population: 173 men (mean age 35.5) and 46 women (mean age 44.2) with traumatic SCI admitted to a Spinal Injuries Centre with specialized SCI acute care and rehabilitation services. Subjects included those with tetraplegia (116) and paraplegia (103). Treatment: No tx per se, comparison of those admitted 1. (< 1 week post injury) vs 2. (< 2 month) vs 3. (> 2 months) to a specialized spinal acute care and rehabilitation unit. Outcome Measures: LoS, incidence of secondary complications all collected at discharge (i.e, during initial post-traumatic hospitalization).

1.

2.

3.

Discussion The present section describes a series of studies in which investigators examined the effect of delayed admission to a specialist SCI unit. However, there is not a common definition of what constitutes a “delayed” admission. Therefore, to assist the reader in summarizing these delays, the details of the various time frames under examination are outlined along with their respective results in Table 3.12.

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Table 3.12 Studies Examining Delayed Admission to SCI Unit
Study DeVivo et al. 1990 Experimental Groups (time post-injury) • • • • • • • • • or • • • • or • • • • • • <= 24 hours* > 24 hours <= 24 hours* > 24 hours <= 30 days* 30-59 days > 60 days <= 3 days > 3 days <= 7 days from referral* > 7 days from referral <= 11 days (for tetra)* > 11 days <= 21 days (for para)* > 21 days <= 2 weeks* > 2 weeks <= 1 week* < 2 months LoS Functional Status Neurological Status LoS Secondary complications + + + Outcome Measure LoS Secondary complications Neurological Status Secondary complications (contractures) LoS Functional Status Neurological Status LoS LoS LoS Secondary complications Result + ~ + ~ + + + + (tetra only)

Daylan et al. 1998

Scivoletto et al. 2005

Amin et al. 2005

Oakes et al. 1990

Sumida et al. 2001

Aung & El Masry 1997

(*= Condition with most positive result, + = Positive results, ~ = Trend, - = No effect)

Two acute studies were reviewed which each employed retrospective, 2 group (case control) designs with a definition of 24 hours as to what constituted an “early” vs a “delayed” admission (DeVivo et al. 1990; Dalyan et al. 1998). Each study examined a fairly large cohort admitted to a multidisciplinary, specialized SCI unit (i.e., US model system center) within 24 hours post-injury vs those admitted after 24 hours. Neither study reported the actual injury to admission times for the “delayed” admission group and both failed to provide information about the referral sources (e.g., specialist vs. general nature). DeVivo et al. (1990) noted that total hospital LoS (i.e., acute and rehabilitation) was reduced for all patient groups except for those with complete tetraplegia when admission was not delayed. Mean hospital charges were also reduced for early admission subjects except those with complete paraplegia and there were some reductions in the incidence of specific medical complications with early admission for some patient groups, most notably a trend for a reduction in pressure sores for all but those with incomplete paraplegia. In addition these authors also reported a trend for increased neurologic recovery and reduced mortality with earlier admission, although they also noted methodological concerns associated with the actual measures employed. Dalyan et al. (1998), in a study focusing on the development of contractures, noted an increased incidence of contractures for those admitted within 24 hours to a specialized unit. Of the studies examining time periods longer than one week (i.e., post-acute), five studies have been reviewed (Oakes et al. 1990; Aung & el Masry 1997; Sumida et al., 2001; Amin et al. 2005; Scivoletto et al. 2005). The initial admission delays examined ranged from 1 week (Aung & el Masry, 1997) to 1 month (Scivoletto et al. 2005). All studies employed retrospective case 3 - 28

control designs and all examined LoS for the entire period of initial hospitalization as a primary outcome measure. In all cases, those admitted earlier had reduced LoS, regardless of the considerable variation between studies in the definition of what constituted a delay in admission. It should be noted that this difference was statistically significant for all studies but one; for which it was reported as a trend (p=0.15). This study examined the longest delay of 1 month (Scivoletto et al. 2005). Functional benefits were also demonstrated for individuals admitted earlier. Scivoletto et al. (2005) reported that those admitted earlier than 1 month had significantly greater gains and greater efficiency associated with the Barthel Index as well as greater mobility gains and efficiency as measured by the Rivermead Mobility Index but there was no difference with respect to walking as measured by the Walking Index for SCI (WISCI). Similarly, Sumida et al. (2001) reported increased Functional Independence Measure (FIM) gains and efficiencies for those admitted earlier than 2 weeks post-injury as compared to those admitted later. Interestingly, these investigators also showed that for a majority of the various patient groups tested (i.e., paraplegia and tetraplegia, early and late), significant associations were seen between a measure of function (i.e., FIM) and a measure of impairment (i.e., ASIA motor scores). However, Scivoletto et al. (2005) found no effect of early vs. late admission on ASIA motor scores. Other investigators examined the role of early vs late admission on the incidence of secondary medical complications. Oakes et al. (1990) reported that earlier admissions were associated with a reduced incidence of secondary medical complications in those with tetraplegia and Aung and el Masry (1997) noted a reduction in the number of pressure sores for all subjects with earlier admission. Despite the apparent benefits of earlier admission to a multidisciplinary, specialized integrated SCI unit, there are significant issues which serve to constrain the strength of evidence in this area. First and foremost is the retrospective nature of all studies conducted to date. It is difficult to ascertain how comparable the “early” vs “later” groups truly are with respect to potential confounding variables. In particular, there is a paucity of information on the pre-admission level of care and medical status, especially for the delayed admission groups. In addition, it is difficult to discern the potential role that medical status or the presence of secondary medical complications may have played in admission delays. The retrospective nature of the studies outlined in this and the previous section makes it difficult to determine if individuals prone to complications and with poorer medical status would have naturally comprised a greater proportion of the delayed admission groups. Therefore, as noted earlier, more carefully controlled prospective studies would be required to strengthen the evidence in this area. Conclusions - Benefits of Early vs Later Admission Based on several retrospective, case-control studies there is Type 3 evidence that individuals admitted earlier to interdisciplinary, integrated specialist SCI units have a shorter total hospitalization length of stay than those admitted later. There is Level 3 evidence that individuals admitted earlier to interdisciplinary, integrated specialist SCI units make greater functional gains in a shorter period of time (i.e., greater efficiency) than those admitted later. There is Level 3 evidence that individuals admitted earlier to interdisciplinary, integrated specialist SCI units have fewer secondary medical complications (especially pressure sores) than those admitted later.

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Because of the variability between studies as to what constitutes “early” admission to interdisciplinary, specialist integrated SCI units it is not possible to determine a specific period for optimal admission. At least one study has demonstrated benefits with an early admission described as anything within 30 days post-injury. The majority of studies defined early admissions as 1-2 weeks post-injury, while studies focused on acute care describe early admission as within 24 hours post-injury. Earlier admission to specialized, interdisciplinary SCI care is associated with reduced length of total hospital stay and greater and faster rehabilitation gains with fewer medical secondary complications. Prospective studies with stronger designs are needed to strengthen the evidence and provide more direction as to the optimal model of care. 3.7 Outpatient and Follow-up Care Various authors have noted the importance of providing continued, regular, specialized followup care following discharge from rehabilitation (Ernst et al. 1998; Cox et al. 2001; Dryden et al., 2004). In a recent review, Bloemen-Vrencken et al. (2005) described various follow-up programmes for persons with SCI. These authors noted that the vast majority of the papers in this area offered little more than a description of the program with 5 of these being identified as either experimental or quasi-experimental in nature. Of these, 3 studies were focused on evaluations of telemedicine or nursing education for the prevention of pressure sores or UTIs (Barber et al. 1999; Phillips et al. 1999; Phillips et al., 2001), whereas the remaining two had broader goals of general heath and well-being (Dinsdale et al. 1981; Dunn et al. 2000). Those articles evaluating programs addressing specific goals (i.e., pressure sores or UTIs) will be reviewed in the chapters related to these specific issues. The present section focuses on those studies with more generic aims. Cox et al. (2001) performed a needs assessment of 54 community-dwelling individuals with SCI using structured telephone interviews and reported a perceived high need for a specialist, multidisciplinary SCI outreach service. Some of the issues identified as the greatest areas of need included dealing with physical changes, transportation, work issues, ongoing education and pain management. The primary barriers to needs being met were overwhelmingly related to limitations of local expert knowledge but also included inadequate funding, complicated processes or service fragmentation and no knowing where to go for help. Preferred service delivery options in order of preference included telephone advice, home visits, SCI outpatient clinics, community-based service and regional hospital clinics (Cox et al. 2001). Similar suggestions have been provided by clinicians, especially as they observe the consequences of inadequate care received by some individuals upon discharge from inpatient rehabilitation programmes (Vaidyanathan et al. 2004). Despite these reports, little direct evidence has been established for the effectiveness of different methods of providing follow-up care. Table 3.13 Individual Studies – Outpatient and Follow-up Care
Author Year; Country Score Research Design Total Sample Size Dunn et al. 2000; USA Downs & Black score=12 Methods Outcome

Population: People with SCI receiving SCI-specialist follow-up care (N=235) vs

1.

Those receiving regular follow-up scored higher on all 3 subscales of

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Prospective Controlled Trial (inadequate control) Initial N=371; Final N=371

those not (N=136); Age = 56.6 vs 47.9; Gender = 99% Male vs 66% Male; paraplegic, tetraplegic; complete, incomplete; Time since injury = 19.4 vs 18.2 years. Treatment: Follow-up care (routine checkups in SCI Outpatient Clinic) vs no Followup care (presumably problem-based primary care). Outcome Measures: Secondary Condition Surveillance Instrument (SCSI), Check Your Health (CYH) Questionnaire. One time survey of both groups.

2.

CYH, Health (p=0.0068), Independence (p=0.005) and Absence of Depression (p<0.0001). Those receiving regular follow-up reported similar secondary conditions as those without routine follow-up but with reduced frequency and rated it as less severe.

Discussion Dunn et al. (2000) performed an exploratory study of the value of receiving regular, comprehensive outpatient health care follow-up as compared to those who were deemed to have no access to these services. Although this investigation was limited by a poor description of the specific services offered to both the experimental and control groups, there were significant differences in the perceived health, independence, and absence of depression in those seen regularly in outpatient clinics. In addition, this group had significantly less frequent occurrences of specific secondary conditions and also rated the severity of these conditions as less than those having no access to these clinics (Dunn et al. 2000). Although this trial was prospective in nature and attempted a quasi-experimental controlled methodology, the potential confounds (i.e., gender, completeness, race, age, veteran status) varied greatly between the experimental and control groups. In addition, it was uncertain if selection bias may also have been an issue, as the authors did not specify what percentage of individuals within their own service provision cohort refused or did not receive regular outpatient care. These limitations resulted in this study being assessed as having a Level 4 level of evidence. Conclusions There is Level 4 evidence that provision of routine, comprehensive, specialist follow-up services may result in perceived improvements of health, independence and less feelings of depression. Routine, comprehensive, specialist follow-up services may result in improved health

3.8 Summary There is Level 3 evidence (with US data only) that rehabilitation LoS has become progressively shorter up to the mid-1990s. No other jurisdiction has published data that supports this contention. There is Level 3 evidence that those with higher level and more severe injuries have longer rehabilitation LoS. There is Level 4 evidence that a significant proportion of people (~50%) initially assessed as AIS B and C will improve by at least 1 AIS grade in the first few months post-injury

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concomitant with inpatient rehabilitation. Fewer individuals (~10%) initially assessed as AIS A and D will improve by 1 AIS grade. There is Level 4 evidence that individuals make significant functional gains during inpatient rehabilitation, more so for those with complete and incomplete paraplegia and incomplete tetraplegia. There is Level 4 evidence based on a single case series that increased therapeutic intensity may not be associated with any functional benefit as measured by the FIM. There is Level 3 evidence that significantly shorter rehabilitation LoS is associated with younger vs older individuals with paraplegia. The same may not be true for those with tetraplegia or for mixed cohorts involving traumatic and non-traumatic SCI. There is Level 3 evidence that younger as compared to older individuals are more likely to obtain greater functional benefits during rehabilitation. There is Level 3 evidence that significant increases in neurological status during rehabilitation are more likely with younger than older individuals with tetraplegia or for mixed cohorts involving traumatic and non-traumatic SCI. The same may not be true for those with paraplegia. There is Level 4 evidence that those with non-traumatic SCI are more likely to be older, female, have paraplegia and have an incomplete injury as compared to those with traumatic SCI. There is Level 3 evidence that those with non-traumatic SCI have generally reduced rehabilitation LoS, reduced hospital charges but similar discharge destinations as compared to those with traumatic SCI. There is Level 3 evidence that those with non-traumatic SCI have generally reduced motor FIM improvement during rehabilitation as compared to those with traumatic SCI. There is Level 3 evidence that there is no difference with respect to gender on discharge destination, rehabilitation LoS and neurological or functional outcomes associated with rehabilitation. There is Level 3 evidence that there is no difference with respect to race (white vs African-American) on rehabilitation LoS and neurological or functional outcomes associated with rehabilitation that are not otherwise explained by socio-demographic or etiological differences. Based on several retrospective, case-control studies there is Type 3 evidence that individuals cared for in interdisciplinary, specialist SCI acute care units soon after injury (most being admitted within 48 hours) begin their rehabilitation program earlier. There is Level 3 evidence that individuals cared for in interdisciplinary, specialist acute care SCI units have fewer complications upon entering and during their rehabilitation programs.

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There is Level 4 evidence that individuals initially cared for in interdisciplinary, specialist acute care SCI units make more efficient functional gains during rehabilitation (i.e., more or faster improvement). There is Level 4 evidence that individuals cared for in interdisciplinary, specialist SCI units have reduced mortality. Based on several retrospective, case-control studies there is Type 3 evidence that individuals admitted earlier to interdisciplinary, integrated specialist SCI units have a shorter total hospitalization length of stay than those admitted later. There is Level 3 evidence that individuals admitted earlier to interdisciplinary, integrated specialist SCI units make greater functional gains in a shorter period of time (i.e., greater efficiency) than those admitted later. There is Level 3 evidence that individuals admitted earlier to interdisciplinary, integrated specialist SCI units have fewer secondary medical complications (especially pressure sores) than those admitted later. Because of the variability between studies as to what constitutes “early” admission to interdisciplinary, specialist integrated SCI units it is not possible to determine a specific period for optimal admission. At least one study has demonstrated benefits with an early admission described as anything within 30 days post-injury. The majority of studies defined early admissions as 1-2 weeks post-injury, while studies focused on acute care describe early admission as within 24 hours post-injury. There is Level 4 evidence that provision of routine, comprehensive, specialist follow-up services may result in perceived improvements of health, independence and less feelings of depression

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Appendix – Studies Describing Rehabilitation Outcomes Table 3.14 Individual Studies Describing SCI Rehabilitation Outcomes
Author Year; Country Research Design Total Sample Size Methods Population: Traumatic SCI, 82% male, Mean age=28.3 years, tetraplegia (55%), paraplegia (45%), incomplete, complete, Mean time post-injury to admission=28.8 days. Treatment: No treatment per se, but outcomes associated with inpatient rehabilitation. LoS 69.6 + 39.2 days. Outcome Measures: LoS, Modified Barthel Index (MBI) collected at admission and discharge. 1. Outcome Tetraplegics had significantly longer stays in rehabilitation than the paraplegic group (121 vs 81 days, p<0.001). Those who were diagnosed with incomplete lesions also had significantly shorter stays than those diagnosed with complete injuries regardless of level of injury (p=0.001). Incomplete (107.6 days) vs complete (135.3) tetraplegia and incomplete (78.2 days) vs complete (83.4) paraplegia. Overall, patients showed significant increases in total MBI and self-care and mobility MBI subscores (p<0.001). Improvements and discharge scores were greater for incomplete vs complete (p<0.001) and for those with paraplegia vs tetraplegia (p<0.001). Significant improvements were noted in the MBI self care subscores, MBI mobility subscores and MBI total scores from admission to discharge (p<0.001 for all). At least 70% of patients were independent on each of the individuals tasks comprising the MBI at discharge. 89% of patients were discharged home. Continent spontaneous voiding was achieved by 84% at discharge as compared to 23% at admission. Regulation of bowel management was achieved by 99% at discharge as compared to 54% at admission. Medical complications requiring management occurred in 66.7% of patients during rehabilitation. Most gains in motor and sensory scores were found in first year. An average of 35 motor points (18% during acute care, 53% during rehabilitation, 8% during the remainder of the year) and 46 sensory points (46% during acute care, 46% during rehabilitation, 8% during the remainder of the year) were recovered. Younger individuals (<18) had more improvement in motor scores but not sensory scores than older people (p=0.002). People with Brown Sequard and

Yarkony et al. 1987; USA Case series Initial N=711 Final N=711

2.

Roth et al. 1990; USA Case series Initial N=81 Final N=81

Population: Traumatic central cord syndrome, 67 males, 14 females, Age=45.5±20.0 years Tetraplegia, Frankel C and D, Mean time post-injury to admission=29.8±18.0 days. Treatment: No treatment per se, but outcomes associated with inpatient rehabilitation. LoS 69.6 + 39.2 days. Outcome Measures: Modified Barthel Index (MBI) collected at admission and discharge.

1.

2. 3. 4. 5.

Pollard & Apple 2003; USA Case Series Initial N=412 Final N=95

Population: Patient Database (N=412), traumatic, incomplete tetraplegia admitted within 90 days post-injury (N=95). Treatment: No treatment per se, but various outcomes associated with inpatient acute care and rehabilitation. Main factors examined were effect of intravenous steroids, early definitive surgery (<24 hours after injury) and early decompression surgery. Mean acute care LoS was 15±16 days and mean rehabilitation LoS was 47±30 days. Outcome Measures: Change in sensory score, final sensory score, change in motor

1.

2.

3.

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Author Year; Country Research Design Total Sample Size

Methods score, final motor score. All collected at admission and discharge (also for some at time of injury and 1, 2, 3 years post-injury or the latest anniversary). 4.

Outcome Central Cord injuries had more improvement in motor scores but not sensory scores than those with anterior cord (p=0.019). There was no effect of methylprednisolone (MP) administration, early anterior decompression, decompression of stenosis without fracture, gender or race. Those with MP administration did have greater improvements in sensory scores (p=0.027) although there was no difference in the final sensory score for those with and without MP. Overall, significant increases were seen from admission to discharge with total MBI (p<0.001), self care subscore (p<0.001) and mobility subscore (p<0.001). Discharge functional status was dependent on the admission functional status (p<0.001) and the rehab LoS (p<0.05) but not on acute care LoS, level of paraplegia or presence of surgical stabilization. No statistically significant differences were noted between those with high vs low paraplegia on 14 of the 15 components of the MBI other than low paraplegic patients were more likely to walk 50 yards (p<0.001). All patient groups (i.e., levels and severity of injury) had similar FIM motor scores at discharge as noted by American Consortium for Spinal Cord Medicine. All groups showed increases in FIM motor scores from admission to discharge but these were only significant for tetraplegia ASIA D (p<0.05) given small group sizes. Little change in cognitive FIM was seen between admission and discharge due to ceiling effects. FIM motor scores generally continued to increase at 1 and 3 months postinjury although small N sizes and missed follow-ups precluded statistical significance. LoS was generally longer for tetraplegia (low level was significant, p<0.0005) although there were low N’s for each group (varied from 52.0-215.9 days).

Yarkony et al. 1990; USA Case series Initial N=184 Final N=184

Population: Traumatic Complete Thoracic SCI, 81% male, Mean age=27.2±11.4 years, Mean time post-injury to admission=46 days. Treatment: No treatment per se, but outcomes presented associated with inpatient rehabilitation. Length of stay 84 days. Outcome Measures: Modified Barthel Index (MBI) collected at admission and discharge.

1.

2.

3.

Population: Traumatic SCI, 30 males, 3 females, Age=48.4±15.6 years, 24 tetraplegia and 9 paraplegia. Treatment: No treatment per se, but various outcomes associated with inpatient rehabilitation. Outcome Measures: FIM, LoS. All collected at admission, discharge, and 1 and 3 months post-discharge. Chan & Chan 2005; Hong Kong, China Case Series Initial N=33 Final N=33

1.

2.

3. 4.

5.

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Author Year; Country Research Design Total Sample Size

Methods Population: Gender: 51 males, 17 females, Age=43 years. Treatment: No treatment per se, but LoS is modeled (predicted) by various measures associated with inpatient rehabilitation. Outcome Measures: LoS and various predictor variables (age, gender, ADLs, subjective well-being and cognitive-social skills). Predictor variables collected at admission to inpatient rehabilitation. Population: Traumatic (42) and nontraumatic (10) SCI, 32 males, 20 females, Age=36.4 ±17.7 (5-75) years, complete (6) and incomplete (18) tetraplegia and complete (9) and incomplete (19) paraplegia. Treatment: No treatment per se, but various outcomes associated with inpatient rehabilitation of 93.9 ±44.95 (14-258) days. Outcome Measures: Motor scores, light touch scores and FIM. All collected at admission, discharge, and 1 year postdischarge (N=10 only). 1.

Outcome Performance on ADLs was the only direct predictor of LoS, while subjective well-being and gender affect LoS indirectly through other predictors (subjective well-being via ADLs). LoS increases as ADL performance deteriorates. Clients with good subjective well-being scores will tend to perform better on ADLs, resulting in shorter LoS. Neurological assessments (Motor scores and light touch scores) showed increases from admission to discharge for those with incomplete injuries (p<0.001) but not complete injuries. FIM showed increases from admission to discharge for those with incomplete injuries (p<0.05) and those with complete paraplegia (p<0.05) but not complete tetraplegia. FIM scores (p<0.05), but not motor scores or light touch scores showed significant increases from discharge to 1 year post-discharge in a subsample of 10 with paraplegia. In general, the group with shorter LoS did not differ dramatically from the group with longer LoS. Subjects also spent less time in PT and OT from 1991 to 1995 (p<0.001). There were higher discharge scores for bowel management, stairs, manual locomotion, rolling supine to prone and rolling side to side for those with longer LoS in paraplegics. No significant differences were seen in tetraplegic patients. (Many results showing no differences not presented). Post discharge performance skills in those with tetraplegia showed that those with shorter LoS had higher function in the following areas: bathing (p=0.39), bed transfer (p=0.27), and toilet transfer (p=0.047). For those with paraplegia, the shorter LoS group was higher in the following areas: grooming (p<0.011), upper body dressing (p=0.003), car transfer (p=0.018) and manual locomotion (p=0.031). The proportion of subjects who reported UTIs, pressure sores and pain was higher in the shorter LoS group. Rehabilitation Length of Stay decreased over study period from 56.5

Chung et al. 2003; Taiwan Case Series Initial N=68 Final N=68

2.

1.

Mϋslϋmanoğlu et al. 1997; Turkey Pre-Post Initial N=52 Final N=10

2.

3.

Morrison & Stanwyck, 1999; USA Case Control N = 127

Population: 127 males and females with acute traumatic SCI with motor complete paraplegia or tetraplegia (C5-L2) admitted for acute rehabilitation. Ages range from 11-60 years (mean 28.81). Treatment: No treatment per se, but effect of Length of Stay on functional and medical status was examined by comparing those admitted in 1991 vs those in 1995. (LoS was significantly reduced in 1995, p<0.001). Outcome Measures: FIM (Individual scores for 11 items), Functional motor skills (5 skills, custom), Locomotor skill (5 skills, custom), incidence of medical complications (pressure sores, UTIs, pain), employment status all collected at discharge and 2 month post-discharge.

1.

2.

3.

4.

Yarkony et al. 1990; USA

Population: Traumatic SCI, 83% male, incomplete tetraplegia (30%), complete

1.

3 - 36

Author Year; Country Research Design Total Sample Size Case Series N=1,382

Methods tetraplegia (27%), complete paraplegia (27%) and incomplete paraplegia (16%). Treatment: No treatment per se, but various outcomes associated with inpatient rehabilitation. Outcome Measures: LoS, Discharge destination.

Outcome days in 1974 to 68.1 days in 1986 (82.8 for tetraplegia and 54.3 for paraplegia). Days hospitalized prior to rehabilitation admission decreased over the years of the study from 56.5 days in 1974 to 33.4 days in 1986. 93% were discharged to a private residence 5% to nursing homes. Of 4,934 admitted within 24 hours post-injury, the proportion showing increases in ASIA were 10.3% (A), 45.2% (B), 55.9& (C), 7.3% (D) vs no change 89% (A), 50.3% (B), 41.5% (C), 90.5% (D) vs declined 4.5% (B), 2.6% (C), 2.0% (D). Some people continued to improve neurologically for up to 18 months after discharge, thereafter only rarely. From 1973-1990 the proportion of incomplete patients discharged increased from 40% to 55.2% whereas the proportion of complete patients decreased accordingly. Of 751 patients, average FIM gain was 37 (incomplete paraplegia, 36 (complete paraplegia), 34 (incomplete tetraplegia and 15 (complete tetraplegia). Total hospital LoS declined from 19741989. For tetraplegia it went from 149.6 to 92.4 days and for paraplegia from 122.3 to 74.9 days. 94.1% patients were discharged to a private residence, 4.0% to nursing homes, 1.5% to other hospitals. Of 1,306 followed 10 years, 98.0% resided in private residences. 51.2% of those with grade 9-11 completed high school within 5 years after injury and 11.6% of those with high school education completed a higher academic degree within 5 years. The proportion of people employed increased from 12.6% 2 years after injury to 38.3% 12 years after injury. In the second year post-discharge, 35.7% of people were rehospitalized and this declined to 25% at 12 years. Overall survival rate was 76.9%. During the first 12 years after injury, cumulative survival rate increased to 88% of what it would be in the absence of injury. Highest causes of death were pneumonia, pulmonary embolism and septicemia (due to pressure sores, respiratory infections or UTIs).

2.

3. Population: US Model Systems database, Traumatic SCI, Gender: 82.3% males, Age=30.5±14.9 years, Tetraplegia, Paraplegia, ASIA A-E. Treatment: No treatment per se, but various outcomes associated with inpatient acute care, rehabilitation and follow-up. Outcome Measures: ASIA, FIM, Total hospital LoS, Discharge destination, Education, Employment, Marital status, Readmission, Mortality. Collected at admission, discharge and in some cases annually thereafter. 1.

2.

3.

4. DeVivo et al. 1991; USA Case Series Initial N=13,763 Final N=13,763

5.

6.

7. 8. 9.

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Author Year; Country Research Design Total Sample Size

Methods Population: Multi-centre Italian prospective survey, Traumatic SCI, Gender: 80.1 % males, Age: mean=38.5, median=33.7 (1194) years, Tetraplegia, Paraplegia, ASIA AE. Treatment: No treatment per se, but various outcomes associated with inpatient acute care and rehabilitation. 7 participating centers provided integrated acute and rehabilitation care while 30 centres provided only rehabilitation care. Outcome Measures: ASIA (neurological status), various complication incidence, LoS, Bladder management method, Bowel status, Feeling of dependency, Discharge destination. Collected at admission and discharge. 1.

Outcome Neurological improvement was associated with ASIA B and C, shorter LoS, greater chance of seeing neurological improvement with earlier admission (3-30 days vs > 30 days, p<0.001). Presence of complications (especially pressure sores) on admission or during stay reduced likelihood of attaining neurological improvement. Multivariate analysis also showed incompleteness was independently predictive of improvement. Average rehabilitation LoS was 135.5 days (median 122 days). Longer LoS was associated with younger age, longer time from injury to admission, previous place of management, surgical management, tetraplegia, completeness, presence of complications at admission or during stay and marginally, admission to an integrated (vs Rehab only) centre. 81.9% of people were discharged to home (private residence). Increased likelihood of being discharged home were seen with paraplegia, bladder and bowel autonomy, absence of pressure sore on discharge, longer Length of Stay and marginally, younger age. Bladder autonomy was attained in 65% of patients. Reduced likelihood of achieving bladder autonomy was seen with tetraplegia, completeness, at least 1 complication, longer time from injury to admission, longer LoS. Reduced likelihood of feelings of dependency was associated with paraplegia, neurological improvement, discharge home, bladder and bowel autonomy, no pressure sores and incompleteness. Multivariate analysis also showed a shorter time between injury and admission was independently predictive of lower feelings of dependency. Mean acute care LoS was 45.6±35.9 days and median rehabilitation LoS was 83 days (3-317 days) (Mean = 99.6 days). Rehabilitation LoS was significantly longer for those with complete tetraplegia as compared to those with incomplete tetraplegia or incomplete/complete paraplegia (p<0.001).

2.

Pagliaccu et al. 2003; Italy Case Series Initial N=684 Final N=684

3.

4.

5.

Tooth et al. 2003; Australia Case SeriesInitial N=587 Final N=167

Population: Traumatic SCI, 77.8% males, Age=34.9±17.1 (13-90) years, incomplete tetraplegia (47.9%), complete tetraplegia (13.2%), incomplete paraplegia (16.2%) and complete paraplegia (22.8%). Treatment: No treatment per se, but various outcomes associated with admission to an integrated unit for acute and rehabilitation care. Sub-analysis focused on effects of level of impairment as

1.

2.

3 - 38

Author Year; Country Research Design Total Sample Size

Methods measured by neurological status and by the Australian National Sub-acute and Nonacute Patient Classification System (ANSNAP) on Length of Stay. Outcome Measures: LoS, FIM (motor, cognitive and total), Discharge destination. All collected at admission and discharge. 3.

Outcome Mean total FIM increased from 68.7 (admission) to 102.2 (discharge) due almost entirely to gains in motor FIM scores. Total FIM scores were lowest for those with complete tetraplegia and highest for those with incomplete paraplegia with significant differences found between the various neurological categories. Those with complete tetraplegia had the least change in FIM scores. 75.4% were discharged to a community dwelling and 10.8% to a transitional rehabilitation program. Those with greater impairment were less likely to be discharged to a community setting (i.e., 92.6% with incomplete paraplegia vs 72.7% with complete tetraplegia). AN-SNAP-predicted LoS was generally much shorter than actual LoS. 31% of people improved neurologically as indicated by Frankel, 66% remained unchanged, and 3% deteriorated. 23% initially complete became incomplete and 40% of those initially incomplete improved. Of those discharged “normally”, Total hospital LoS ranged from 113 (D, E paraplegia) to 282 (A, B tetraplegia) days with completeness having a greater impact on stay than level. 69.1% of people were discharged catheter-free with 14.9% (26.4% of females and 12.0% of males) discharged with an indwelling catheter. 77.9% were discharged with sterile urine. 77% could dress themselves independently at discharge (95% with complete paraplegia and 27% with complete tetraplegia). 79% could transfer independently at discharge. 40% with complete tetraplegia could drive with hand controls at discharge.

4.

5. Population: 209 males, 53 females, Frankel A-E, tetraplegia and paraplegia. Treatment: No treatment per se, but various outcomes associated with admission to an integrated unit for acute and rehabilitation care. Outcome Measures: Frankel scale, Mortality, Urinary tract management and pathogen status, physical independence (Walking, Dressing, Transfers, Driving, Finances), Total hospital LoS. All collected at admission and discharge. 1.

2.

Burke et al. 1985; Australia Case Series Initial N=352 Final N=262

3.

4.

5. 6. Population: 100 traumatic SCI in VA SCI Service, all males, tetraplegia (62) and paraplegia (38), incomplete (27) and complete (73), time post-injury: < 1 month (59), < 2 months (28), > 2 months (13). Treatment: No treatment per se, but various outcomes associated with inpatient rehabilitation. LoS = 3.3 (paraplegia) and 5.5 months (tetraplegia). Outcome Measures: Attainment of

Woolsey, 1985; USA Downs & Black score:n/a Case Series Initial N=100 Final N=96

No statistical analysis. 1. The higher the injury, the more likely an individual did not meet goals of selfcare and mobility. 2. 83/100 were discharged to their homes, 13 to nursing homes.

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Author Year; Country Research Design Total Sample Size

Methods functional goals by discharge or in some cases later follow-up. Population: Traumatic SCI from US Model Systems database, age categories from <21 to >51, 80.9% males, tetraplegia and paraplegia, incomplete and complete. Treatment: No treatment per se, but various outcomes associated with inpatient rehabilitation to predict LoS, rehospitalization, residence, days out of residence (QoL) and pressure sores. Outcome Measures: Rehabilitation LoS, rehospitalization, residence, days out of residence (QoL), pressure sore incidence and many predictor variables. Collected at admission, discharge and 1 year postinjury. 1.

Outcome

2.

Eastwood et al. 1999; USA Case Series Initial N=5,180 Final N=3,904

3.

4.

5.

Rehabilitation LoS was reduced from 74.1 days in 1990 to 60.8 days in 1997 (p<0.001). Acute care LoS was 21 days in 1990 and 20 days in 1991. Many variables significantly predicted increases in LoS at p<0.001 level of significance (in descending order): low admission FIM, earlier discharge year, complete tetraplegia, indwelling catheter, intermittent catheterization, condom catheter. Other variables included being African-American, having a high-school education or less, being married, being <21 years old and being retired or engaged in other nonpaid activities. Individuals initially discharged to a skilled nursing facility were more likely to return home by 1 year if they were young, had higher admission and discharge FIM scores, greater FIM change, if they were able to leave the institution more frequently and more likely to use IC vs indwelling catheter. Individuals were more likely to be rehospitalized if they had lower discharge FIM scores, complete paraplegia, having an indwelling catheter or using intermittent catheterization and with a shorter rehabilitation Length of Stay. Predictors of having pressure sores at year 1 were having complete paraplegia, not having incomplete tetraplegia, lower FIM scores and older age.

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Yarkony GM, Roth EJ, Meyer PR, Jr., Lovell L, Heinemann AW, Betts HB. Spinal cord injury care system: fifteen-year experience at the Rehabilitation Institute of Chicago. Paraplegia 1990; 28:321-329.

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CHAPTER FOUR
Community Reintegration Following Spinal Cord Injury
William C Miller, PhD, OT Susan J Forwell, PhD, OT(C), FCAOT Luc Noreau, PhD Lyn Jongbloed, PhD, OT Emily S Procter, BSc Caroline Abramson, MA

Key Points Attitudes towards disability may be positively influenced by having contact with an individual with SCI. For women with SCI, a supportive social network may positively influence their ability to participate in an occupation. The main barriers to community reintegration are barriers in the natural environment, transport, home services, health care and government policies. Assistive equipment, such as modified vans and environmental control units, may contribute to better reintegration. Consumer-directed personal assistance services and independent living programs may facilitate community reintegration; however, services are not always available. Successful community reintegration may promote productivity and physical and mental well-being. Employment specialists may aid in the process of job placement and work reintegration. There is a dearth of high quality research in this field therefore conclusions are based on observational research methodology. At discharge from a rehabilitation unit there is improvement in self care and mobility that is preserved for 1 year. Persons with tetraplegia who completed a driving training program were more likely to drive if younger in age, were able to perform transfers independently, had a lower level of SCI, drove prior to SCI and were employed and involved in sports. Employment following SCI was positively correlated to being male, and having more years since injury, younger age, the ability to drive a car, a higher education and a professional job prior to the SC. Having tetraplegia has a negative impact on gaining and maintaining employment. Employed persons with SCI had greater satisfaction with employment and finances while those unemployed had lower activity levels and higher economic dissatisfaction. Persons with disabilities experience discrimination and are less likely to obtain an interview or be hired. Facilitators for leisure involvement are social support, being healthy and being employed or attending school. Barriers are lack of physical ability, health concerns, cost, and lack of opportunity or interest. Participation in leisure occupations have a positive impact on adjustment to SCI, physical independence, mobility, hours in activities of daily living and social integration. Use of the GAMEWHEELS system showed physiological and motivational benefits for engaging in wheelchair exercise.

FES is a motivator to engage in exercise and standing, augments ability to do more things and enhances the sense of well-being. Drawbacks included lack of time to use the system and reluctance to wear all day. Average level of QOL after SCI is slightly lower than in people without disability but a substantial number of people with SCI report good or excellent QOL. Severity of injury and other diagnostic factors do not significantly impact QOL. There influence may become significant through restrictions in community integration/social participation. A limited amount of variation in QOL has been explained by quantitative research methods. Qualitative reports suggest that factors affecting QOL after SCI do not seem to differ from those impacting QOL in people without disability. They are related to life issues such as achieving meaningful social roles, having control over one’s life and maintaining adequate access to the environment. Overall, there is a paucity of information from clinical trials on the most appropriate interventions favouring subjective QOL on people with SCI and their significant others. QOL can be indirectly enhanced through use of an exercise program designed to reduce pain and stress. Providing group therapy to spouses of individuals with SCI can decrease their symptoms of depression, anxiety, psychological distress with a potential impact on QOL.

Table of Contents
4.1 Introduction ......................................................................................................................4-1 4.2 Environment .....................................................................................................................4-2 4.2.1 Social Environment .........................................................................................................4-3 4.2.2 Other Environmental Factors ..........................................................................................4-4 4.2.2.1 Physical Environment ..................................................................................................4-5 4.2.2.2 Institutional Environment..............................................................................................4-7 4.2.3 Summary – Environment ..............................................................................................4-10 4.3 Occupation .....................................................................................................................4-11 4.3.1 Daily Living Activities ....................................................................................................4-11 4.3.2 Work..............................................................................................................................4-13 4.3.3 Leisure and Recreation.................................................................................................4-17 4.4 Quality of Life .................................................................................................................4-20 4.4.1 QOL Definitions and Models .........................................................................................4-21 4.4.2 Exploring QOL after SCI from a Scientific Perspective .................................................4-22 4.4.3 Quantitative Measurement Approach of QOL Determinants.........................................4-22 4.4.4 Qualitative Research Methods to Understand QOL and its Determinants....................4-25 4.4.5 Trials Examining QOL as an Outcome .........................................................................4-25 4.4.6 Summary – QOL ...........................................................................................................4-28 4.5 Summary – Community Reintegration.........................................................................4-28 References..............................................................................................................................4-31

This review has been prepared based on the scientific and professional information available in 2005. The SCIRE information (print, CD or web site www.icord.org/scire) is provided for informational and educational purposes only. If you have or suspect you have a health problem, you should consult your health care provider. The SCIRE editors, contributors and supporting partners shall not be liable for any damages, claims, liabilities, costs or obligations arising from the use or misuse of this material. Miller WC, Forwell SJ, Noreau L, Jongbloed L, Procter ES, Abramson C. (2006). Community Reintegration Following Spinal Cord Injury. In: Eng JJ, Teasell RW, Miller WC, Wolfe DL, Townson AF, Aubut J, Abramson C, Hsieh JTC, Connolly S, editors. Spinal Cord Injury Rehabilitation Evidence. Vancouver, p 4.1-4.37. www.icord.org/scire

Community Reintegration Following Spinal Cord Injury
4.1 Introduction There are more than 286,000 North Americans currently living with a spinal cord injury (SCI) and incidence rates suggest that approximately 1000 Canadians and 11,000 Americans survive a traumatic SCI each year (Canadian Paraplegics Association [CPA] 2000; National Spinal Cord Injury Database 2005). The majority of injuries occur in males (75%) and over 60% occur in individuals under the age of 50 (median age 35 years) (Dryden et al. 2003). Over the past 20 years, the life expectancies of individuals have improved vastly due to advances in medicine with life expectancy reaching to within 10% of the general population. As a result the number of individuals living with SCI is steadily increasing (CPA 2000). The journey from acute care through inpatient rehabilitation and back to community living following a spinal cord injury is one that is filled with challenges. Individuals with SCI face numerous secondary medical conditions including spacticity, pain, pressure ulcers, bladder infections, depression and anxiety, all of which can make daily tasks of living demanding and, at times, impossible. Beyond impairments the severity of disability for SCI survivors spans the dependence – independence continuum. The usual simple self-care activities of dressing, bathing or getting around, for example, can be monumental. For instance, even individuals who are capable of dressing independently often don’t because of the time (up to an hour) and effort required (Weingarden & Martin 1989). Walking with or without a walking aid(s) or use of a wheelchair for mobility can result in an increased energy cost that ranges from 9-74% depending on the floor surface (Waters & Lundsford 1985; Glasser et al. 1995) and the condition of the wheelchair (Sawatzky et al. 2005) compared typical bipedal walking. Returning home after rehabilitation is the most common goal of individuals with SCI. On average 75% of those who survive their trauma return to a private residence including over 60% with complete tetraplegia (CIHI 2006). Interestingly even the majority of individuals with high cervical lesions who are respiratory dependent can return to the community to live out the majority of their lives (Anzai et al. 2006). The direct cost of SCI to the Canadian healthcare system is estimated to be $750 million each year (Rick Hansen Foundation 2006) with an average $530,000 resulting from new injury for hospitalization alone (SmartRisk 1998). The overall economic burden of healthcare for idividuals with SCI in Canada is between $1.25 million and $25 million each during their lifetime depending on injury severity (Rick Hansen Foundation 2006). Sixty-two percent of individuals with SCI are employed prior to injury and only 10-14% return to work post injury (CIHI 2006). The lost contributions from these potentially employable individuals to the economy and tax base is substantial in addition to the loss of productivity by family caregivers who stop or reduce employment to take on this role. The environment surrounding the delivery of rehabilitation services has changed substantially over the decade. Cost containment strategies have emphasized efficiency and effectiveness resulting in reduced hospital length of stay (Rhoads et al. 1992; Holcomb 2000). As a result of

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the shorter hospitalization prior to discharge, people with spinal cord injuries have more complex needs, are more dependent and use more equipment than they did 10-15 years ago. An advantage associated with reduced length of stay is that the home environment usually promotes recovery. But the transition to the community needs to occur with appropriate supports to facilitate successful integration. The complex requirements of those with SCI and the fact that their disabilities are permanent, suggest there are wider gaps in supports which have profound impact for these people and their family members. Transition is a difficult process, made even more challenging by lack of/gaps in support. Successful transition from hospital to the community is influenced by a combination of factors at the individual, social/family, environmental and provincial policy levels (White & Holloway 1990; Pollack et al. 1992; Clandinin & Connelly 1994). The term community reintegration is used to refer to returning to the mainstream of family and community life, engaging in normal roles and responsibilities, actively contributing to ones social groups and of society as a whole (Dijkers 1998). Thus successful reintegration means resumption of those occupations that are important to each individual, such as taking care of oneself and participating in productive occupations of work and leisure. The environment, whether social, institutional, cultural or physical, can either create barriers or facilitate access to the community at large. Without exception successful reintegration can lead to improved quality of life (Anderson 2004). This chapter summarizes the results of selected studies to provide an overview of community reintegration post SCI. The chapter incorporates research about the person engaging in occupations and in context to the environment. The issues related to participation are described as self care, work and leisure while the environmental issues are primarily related to social aspects of study in SCI. This chapter closes with a review of evidence related to quality of life, an area of research that brings together the impact of participation and the environment relative to community reintegration. 4.2 Environment Rehabilitation assists persons with spinal cord injuries to regain independence and during this time, the primary focus is on the individual. Following discharge into the community, the emphasis shifts to people engaging, or attempting to engage, in activities that are important to them and this is strongly influenced by the environment. Broadly defined as the cultural, institutional, physical and social aspects that surround the individual (Law et al. 1997), the environment is the dynamic and inseparable situational context that shapes what a person chooses to do, how successful and how satisfied they are in doing it. The environment can support people or constrain them in their performance of activities and thus has a powerful impact on community re-integration. A review of studies on the impact of the environment on the community integration of those with spinal cord injuries indicates that the term ‘environment’ is infrequently used. This is likely because the environment is a broad construct which includes the social environment as well as health and social policies. Many of the studies below focus on one aspect of the environment. In this chapter, studies related to the environment are divided into two areas: the social environment, and other environmental factors. The social environment includes the individual’s network of friends and family members as well as societal attitudes about disability and spinal cord injury. Other environmental factors include adapted vans for transportation, environmental control units, government policies that influence the availability and accessibility of

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transportation and the availability of personal assistance in the home. The studies are summarized in Table 4.1 below. 4.2.1 Social Environment The social environment can be defined as social and cultural institutions and processes that influence the life of an individual. Family members and friends form the person’s social network and provide him/her with social support and encouragement. People who experience a spinal cord injury have to deal with changes in their social network as well as changes in how they are perceived by society. Table 4.1 Social Environment
Author Year; Country Score Research Design Total Sample Size Methods Population: 45 non-disabled students (27 treatment, 18 control) and 18 disabled patients, mean age 27.4 years, 13 C2-C6 (quadriplegic), 5 T7-T12 (paraplegic); DOI 2wk - >1yr. Treatment: Information and social meetings between female students and individuals with SCI. The comparison group had information alone. After the activity the students had posttest measurements, and patients had a verbal posttest Outcome Measures: Attitude Toward Disabled Person (ATDP) scale, Student Comfort Level Scale (SCLS), Patient Comfort Level Scale (PCLS), Student Satisfaction Measurement Form (SSMF), Patient Satisfaction Measurement Form (PSMF), Patient Post-Measurement (PPM) form. Population: all female, age range 2561yrs, traumatic or non-traumatic, 4 cervical (tetraplegia) and 9 thoracic (paraplegia), DOI 2-11yrs. Treatment: Two interviews obtaining etiology info and current situation regarding social network and their ability to participate in occupation. Outcome Measures: perceptions of change in social network and participation. Outcome 1. There was a significant difference between the groups on their pre- and post-scores for the Attitude Toward Disabled Persons scale (F=7.36, p=.001) (treatment group (t=5.6, p<.001), comparison group (t=2.5, p<.05)). 2. Significant positive correlation between prior degree of contact and changes in ATDP scores of the treatment group (r=.49, p<.01). 3. 60%-100% of the patients found that the contact experience affected boredom, morale, social skills and a sense of attractiveness to the opposite sex from moderately to very much so. 4. 67% of the women students returned to see the patients whom they were originally introduced (~weekly). 1. The women described an emotional need for social support and practical social support in order to participate in occupation. 2. The women reported having developed new habits through close cooperation with members in the social network. 3. They felt that they had become more responsible for the development of their relations. Some relations improved, others deteriorated and several new ones were made with other persons with disabilities.

Haney & Rabin 1984; USA Downs & Black score=13 Post-test Initial N=45; Final N=18

Isaksson et al. 2005; Sweden Downs & Black score=8 Observational N=13

Discussion The social environment includes societal attitudes and values as well as networks of relationships. The studies above suggest that the social environment may be a powerful factor in community integration of people with SCI. The complex interactions between the social environment and those with spinal cord injuries are difficult to study. Popular culture tends to present people with disabilities as tragic victims and

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attitudes towards those with SCI may be biased by these stereotypes, by the lack of social recognition of people with SCI and other disabilities and by a lack of exposure to individuals with disabilities. Simply reading or watching a television program about a person with SCI may not be sufficient to change attitudes. In their experiment, Haney & Rabin (1984) demonstrate that individuals’ attitudes can be positively influenced by exposure to people with SCI. Developing a relationship with a person with SCI will likely reduce stigma by enabling people to recognize that those with SCI are similar to them and contribute to the opportunity for individuals with SCI to reintegrate into the community. Introducing people with spinal cord injuries to young people who have never been exposed to someone with a severe disability may also be a good strategy to influence society’s invisible barrier, thereby promoting community re-integration. Isaksson et al. (2005) describe how practical and emotional support assisted women with SCI to participate in occupation. Although not evidenced in the literature, it seems plausible that individuals who have experienced a SCI may need support following the injury as they deal with changed relationships. Strategies that encourage them to be assertive in developing new relationships may be warranted. Conclusion There is Level 4 evidence from a single post-test study that having contact with a person who has an SCI has a significant impact on attitudes towards disability. There is Level 5 evidence based on a qualitative study that SCI results in a changed social network - some relationships are lost but others improve. Attitudes towards disability may be positively influenced by having contact with an individual with SCI. For women with SCI, a supportive social network may positively influence their ability to participate in an occupation.

4.2.2 Other Environmental Factors In this chapter, studies on other environmental factors focus on equipment and services that assist people with SCI to function in the community. These include adapted vans and environmental control units (physical environment, see Table 4.2) as well as follow-up services after discharge, independent living services, personal assistance services and support to reenter competitive employment (institutional environment, see Table 4.3). Government policies have a large impact on availability of equipment and services and on definitions of eligibility. Policies are purposeful sets of actions aimed to address identified social problems in a particular way. Policy may address structures (e.g. resources), processes (e.g. access, roles) and outcomes (e.g. justice, equity) (Boyce 2002).

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4.2.2.1 Physical Environment Table 4.2 Physical Environment
Author Year; Country Score Research Design Total Sample Size Methods Population: 2762 subjects (78%M, 22%F), DOI: 30% 1yr, 20% 5yrs, 15% 10yrs, 13% 15yrs, 13% 20yrs, 10% 25yrs. Treatment: Initial information from National Spinal Cord Injury database. Also inperson or telephone interviews. Outcome Measures: Craig Hospital Inventory of Environmental Factors - Short Form (CHIEF-SF), Craig Handicap Assessment and Reporting Technique (CHART-SF), FIM instrument, Satisfaction with Life Scale (SWLS). Outcome 1. The top five environmental barriers reported by the CHIEF scores were barriers in the natural environment, transportation, help at home, health care and government policy. 2. Significant predictors of higher CHIEF total scores (i.e. more perceived environmental barriers): mid age range at time of injury, female, minority ethnicity, more recent injury, more severe injury, higher degree of activity limitations (p<0.05 for all). 3. Significant predictors of low CHART total scores (i.e. low participation): older age at time of injury, minority ethnicity, less education, being unmarried at injury, higher level of injury, injury by falling or violence and low FIM scores. 4. Significant predictors of low life satisfaction: more recent injury, high scores of physical/structural, services/assistance and attitudes/support (CHIEF) and low scores on mobility, occupation and social integration (CHART). Equipment Utilization 1. No significant changes over time in use of power wheelchairs, house hold lifts, adaptive bathroom equipment or vans. Participation 2. Hours/day out of bed and # of days out of the house remained constant. 3. Hours spent reading and listening to radio were significantly higher in phase 1 compared to phase 2 (p=0.02). 4. Participation was correlated to age – older individuals spent fewer hours out of bed and out of the house compared to younger individuals and participated in fewer leisure activities at home (phase 3) (p<0.01). Self Esteem and QOL 5. 94% of participants stated they were glad to be alive. Access to Equipment 6. Having a van with a lift caused increased time spent out of bed (p<0.02) and correlated to increased hours spent out of the house (p<0.01) in phases 2 and 3.

Whiteneck et al. 2004; USA Downs & Black=12 Observational N=2762

Population: from initial sample, n=58 completed all three phases of testing mean age 43yrs, 40 C1-C4, 11 C3, 6 C2, 1 C1, mean DOI 18.5yrs. Treatment: In-person interviews and chart review. Outcome Measures: High Quadriplegia Questionnaire (HQQ), Level of Free Time Activities Scale, and Rosenberg Self Esteem Scale (RSE). Bushnik 2002; USA Downs & Black score=11 Observational N=168

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Author Year; Country Score Research Design Total Sample Size

Methods Population: mean age 24.2yrs, 89.7% males, injuries C6 and above, tetraplegia. Treatment: Structured interview. Outcome Measures: Environmental Control Unit (ECU) use.

Outcome 1. 93% of the subjects perceived the ECU as increasing their independence. 2. Operation of the telephone was indicated as the most important function (61%), followed by TV (21%). 3. Of the subjects who worked or went to school, only two used their ECUs for those purposes. 4. Subjects felt comfortable for longer periods without attendant care when the ECU was available. 5. Some of the subjects felt that they had received inadequate training (30%) and that their attendants lacked understanding of the ECU (36%).

McDonald et al. 1989; USA Downs & Black score=5 Observational N=29

Discussion People with SCI have reduced physical abilities and consequently require specific equipment to function in their environment. The studies above illustrate the following associations: a) various demographic characteristics and perceived environmental barriers, b) having a van with a lift and increased time out of bed and out of the house, and c) the increased control of telephones and televisions with the use of environmental control units; however, the study designs limit the conclusions that can be drawn from these associations. It should be noted that obtaining equipment such as environmental control units and vans requires considerable personal financial means and/or public support. The support team should investigate an individual’s eligibility for various sources of income, services and equipment. Conclusion There is very limited (Level 5) evidence that people with SCI consider the following factors as the main barriers to community integrations: barriers in the natural environment, transport, help at home, health care and government policy. There is very limited (level 5) evidence from two observational studies that assistive equipment may promote increased activity and participation in and outside of the home. The main barriers to community reintegration are barriers in the natural environment, transport, home services, health care and government policies. Assistive equipment, such as modified vans and environmental control units, may contribute to better reintegration.

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4.2.2.2 Institutional Environment Table 4.3 Institutional Environment
Author Year; Country Score Research Design Total Sample Size Methods Population: sex, age, injury location and etiology-matched groups. Treatment: Randomization into a community based or hospital based SCI rehabilitation program. (Hospital = physiatrist and physician, assessments at 6wks and 6-12mo post-injury; Community = physician, with rehabilitation nurse to lead assessment/follow-up). Outcome Measures: Comparison of physical and psychosocial variables at one year post-discharge from the Rehab Centre. Outcome Physical Well Being 1. Bladder function: Community based n=12 (residual urine 100cc's n=4 sterile urine n=4 requires catheter n=1) Hospital based n=11 (residual urine 100cc's n=5; sterile urine n=4; requires catheter n=3) 2. Bowel function: more use of enemas by the hospital based program. 3. Hospital Readmissions: n=7 community; n=13 hospital. 4. ADL’s: similar between groups. Psychological Functioning 1. Professional emotional support: n=5 community; n=2 hospital. 2. Major emotional crisis: n=3 community; n=1 hospital. 3. “Good” adjustment: n=8 community; n=6 hospital. Social Vocational Functioning 1. Both groups have similar integration, spare more extensive use of health agency and vocational support by the community group. 1. Participants with TBI were significantly more productive than participants with SCI (74.5% of TBI vs. 28.9% of SCI). 2. 70% of SCI participants reported receiving weekly assistance compared to less than 15% of TBI participants. 3. Productivity status was correlated to the subjective experience of community integration (r=-.4013, p<.0001). 1. Changed personal relationships owing to lack of access to primary care services or durable medical equipment. And greater need to rely on others due to this. 2. Depression, frustration, stress, and devaluation were frequently reported, but 4x as much by women (p=0.012). 3. A general deterioration in health was the most frequent complaint regarding physical health. 1. An initial MANOVA showed significant differences (Wilk's Lamda=.32; p<.01) in outcomes between the 2 groups. 2. In terms of overall health, those in the self managed care group had significantly higher scores on Rand-36 (i.e. perceived better health). 3. Fewer persons in the self managed

Dinsdale et al. 1981; Canada PEDro=1 RCT N=23

Harker et al. 2002; Canada Downs & Black score=13 Observational N=487

Neri & Kroll 2003; USA Downs & Black score=12 Observational N=30

Population: 440 SCI, mean age 39.7yrs, 46.5% paraplegia, 53.6% tetraplegia, 89.7% incomplete, 10.4% % complete, mean DOI 27.4yrs. (Demographics for TBI patients not reported here, n=47.) Treatment: mailed surveys (SCI patients), in-person interviews (TBI patients). Outcome Measures: Independent living outcomes (DeJong & Hughes 1982), Reintegration to Normal Living Index, environmental support. Population: mean age 44yrs, 16 women and 14 men, cerebral palsy, multiple sclerosis and SCI (10 in each category). Treatment: semi-structured, in-depth telephone interviews. Outcome Measures: perceptions of barriers, access, participation, experience.

Prince et al. 1995; USA Downs & Black score=12 Observational N=71

Population: Agency-Provided Model (n=29, mean age=35.3 yrs, tetraplegia C1C4, complete, mean 7.9yrs post-injury), Self-Managed Model ( n=42, mean age 37.1 yrs, tetraplegia C1-C4, complete, mean 11.5yrs post-injury). Treatment: Telphone interview. Outcome Measures: Personal Assistance

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Author Year; Country Score Research Design Total Sample Size

Methods Satisfaction Index (PASI), Personal Independence Profile (PIP), Craig Handicap Reporting Technique (CHART), Rand-36, Life Satisfaction Index-Acute (LSI-A). Population: n=24 (intervention), mean age: 38.6yrs, 14% ASIA D, 35% paraplegia ASIA A,B,C, 51% tetraplegia ASIA A,B,C; n=56 (control) mean age 34.4yrs. Treatment: Questionnaires. Outcome Measures: The Independent Living Services Evaluation Questionnaire, Craig Handicap Reporting Technique (CHART), Satisfaction With Life Scale (SWLS), Personal Independence Profile (PIP), Institutional and CIL Surveys.

Outcome group reported hospitalization during the past 6 mos (19% vs. 31%). 4. The self-managed care group perceived having more control over their day-to-day lives and personal care (from mean PIP scores, p<0.01). Independent Living Services (ILS) Received and Reported Needs 1. Both groups reported a similar number of unmet and met needs. 2. Participants of the program used support services more frequently and were more satisfied compared to program non-participants and (p<0.01). 3. Program participants were more likely to report assistance from government benefits, vocational services and legal advocacy while non participants were more likely to report assistance from insurance sponsors and from personal attendants. 4. The most commonly reported unmet needs while using ILS were legal rights, recreation, and obtaining government benefits. Program Intervention 1. Participants and non-participants levels of control, QOL and societal participation along the five domains of CHART were not significantly different. 2. PIP - personal independence was significantly lower for those who received housing services or had unmet needs compared to those without housing or unmet needs (p<0.005). Those without needs for legal services had higher PIP, QOL and CHART scores (p<0.01). 3. Overall there was no benefit noted for the ILS follow-up program. 1. PAS were more likely to be "extremely" or "very" satisfied than the WL grp (non-consumer directed) on the 6 individual PASI items. 2. 85% of PAS and 59.4% of WL were “extremely” or “very” satisfied with the cost of PA. 3. 88.3% of PAS and 46.9% of WL were “extremely” or “very” satisfied with the amount of control they had over the choice of PA. 4. 93.3% of PAS and 59.4% of WL were satisfied with the amount of authority they had to direct their PA’s. 5. 53.3% of PAS and 31.3% of WL were “extremely” or “very” satisfied with the availability of assistance in an emergency.

Forchheimer & Tate 2004; USA Downs & Black score=10 Case Series N=81

Population: n=92 (n=60 consumerdirected PA, n=32 on waiting list), mean age: 41.7yrs (PAS group), 43.7yrs (WL group), 51 males and 41 females. Treatment: Mail or telephone survey. Outcome Measures: Personal Assistance Satisfaction Index (PASI). Beatty et al. 1998; USA Downs & Black score=8 Observational N=92

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Author Year; Country Score Research Design Total Sample Size

Methods Population: 2 males, 1 female, age range 38-53yrs, traumatic SCI, C5-C7 tetraplegics, DOI range 11-34 yrs. Treatment: Employment specialists lead job development and restructuring ventures, involving the SCI individual and identified potential businesses. Outcome Measures: the effect of supported employment and assistive technology on job placement. Population: Individuals with cerebral palsy, multiple sclerosis, or SCI. Treatment: Survey. Outcome Measures: rates of access to assistive equipment and medical rehabilitation services, health plan type.

Outcome 1. Two individuals required only low technological accommodations (e.g. learning a computerized cash and book database system, electronic letter opener) to support their return to work. 2. One individual required more intense support, as well as more conscious workplace cooperation, prior to independent work. An employment specialist stayed on the job site full-time for ~3mos. 1. 56.5% and 39.6% indicated that they needed assistive equipment in the last 12 and 3 months, respectively. 2. Of those who indicated a need in each area, 28.4% and 52.2% did not receive assistive equipment and rehabilitation services, respectively, each time they were needed. 1. A positive relationship was found between the adequacy of personal assistance and the ability of individuals disabled primarily by stroke, SCI, or traumatic brain injury (TBI) to maintain good physical & mental health. Inadequate PA led to extended hospital stays, threats to safety, poor nutrition, & poor personal hygiene. 2. Reliance on family alone for assistance was considered inadequate and common adverse effects were burnout, family role changes & economic strain. 3. Persons with the best health combined assistance by relatives & unrelated persons.

Inge et al. 1998; USA Downs & Black score=8 Observational N=3

Bingham & Beatty 2003; USA Downs & Black score=7 Observational N=500

Nosek 1993; USA Downs & Black score=4 Observational N=41

Population: 7 physicians, 8 PTs, 7 OTs, 9 social workers, and 10 nurses in 5 rehab hospitals. Treatment: Standardized, open-ended, taped interviews by trained interviewers who were also users of PA services. Outcome Measures: views and experience of/with PA services.

Discussion The above studies illustrate aspects of the institutional environment faced by those with SCI – independent living services, consumer and non-consumer directed personal assistance services, financial aid services and job placement. The health care system is of primary importance during the acute care and rehabilitation phases of treatment of people with SCI. Once these people have been discharged and are in the community, other factors and resources assume considerable importance. People want assistance with self-care at home, they desire the ability to move around freely in their communities, and they want to work. As noted previously, it can be a considerable financial burden to access personal assistance services and government or insurance support is not always obvious or available.

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Conclusion There is moderate (Level 2) evidence from one RCT study that a community based system for post discharge monitoring in no more effective in terms of community integration than a hospital based system. There is very limited (Level 5) evidence from one observational study that productivity was correlated to the individuals’ subjective experience of community reintegration. There is very limited (Level 5) evidence from two observational studies that a positive relationship exists between the adequacy of personal assistance and the physical and mental health of those with SCI. There is very limited (Level 5) evidence from two observational studies that people who receive consumer directed personal assistance services are more satisfied with services than those who receive services that are not consumer directed. There is limited (Level 4) evidence from one case series that an independent living follow-up program is more beneficial than no program. There is very limited (Level 5) evidence from one observational study that supported employment assists job placement of some people with SCI. There is very limited (Level 5) evidence from one observational study that individuals with disabilities did not receive adequate equipment or services on more than half of the occasions in which they were requested. Consumer-directed personal assistance services and independent living programs may facilitate community reintegration; however, services are not always available. Successful community reintegration may promote productivity and physical and mental wellbeing. Employment specialists may aid in the process of job placement and work reintegration. There is a dearth of high quality research in this field therefore conclusions are based on observational research methodology.

4.2.3 Summary – Environment There are limitations to examining the impact of the environment on community reintegration of persons with spinal cord injuries. The environment is not easily manipulated as an independent variable. Consequently, many of the studies are not experimental in design. They describe the impact of social policies or access to health care on a sample and may use regression analysis to assess which factors are the most significant influences on an outcome. Overall, the evidence provided in most of the above studies is insufficient to warrant firm conclusions in this field of study.

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4.3 Occupation Occupation, meaning the way and means by which people occupy themselves in meaningful activities, may refer to time limited activities such as preparing meals, enormous undertakings such as years of training to compete in the Olympics, or monumental milestones such as taking the first steps after a SCI or returning to work after months of retraining. Because occupation refers to a broad range of activities that occupy daily lives it is useful to have a system to organize such activities into occupational groupings. Occupations may be categorized by the routines or sequences, the physical environment(s) in which they are completed, the social network involved (or not, as the case may be) or the nature of the activities. For the purposes of community integration for persons with SCI, which involves the transition to daily occupations in one’s relevant community, the nature or type of activity as typically described in the literature is used in this chapter. As such, the following occupational groupings are described: activities of daily living, work, and leisure. The literature that examines interventions that enhance the experience of activities of daily living tasks, work and leisure is in its infancy and is limited to evidence level 4 and 5 studies. It is these preliminary studies that are summarized here. 4.3.1 Daily Living Activities Daily living activities refers to tasks completed to take care of oneself and the surroundings and includes eating, dressing, bathing, grooming, dental hygiene, meal preparation and maintaining the home. Also grouped in this category is function related to mobility and includes standing, transfers, walking and driving. Often it is these very basic occupations that are interrupted with SCI, though following rehabilitation, there is improved performance in self care and mobility skills (Lysack et al. 2001). In the community, the use of standing frames showed several benefits and few drawbacks (Dunn et al. 1998) and a driver-training program was successful for persons with tetraplegia who had driven prior to SCI, had a lower level of SCI, were able to perform bed, tub and toilet transfers and dressed their lower extremity (Kiyono et al. 2001). In society, ability for adults to perform personal self care functions is a basic and assumed independent skill set. The impact of traumatic SCI can dramatically alter that independence and change subjective evaluation of oneself and future possibilities. Lysack and colleagues (2001) show that with rehabilitation most function, though modified, can be restored. Table 4.4 Daily Living Activities
Author Year; Country Score Research Design Total Sample Size Methods Population: 21 complete, 34 incomplete, mean age at admit: 38.8 yrs, at discharge: 37.7 yrs, at f/u: 43.2 yrs. Intervention: 3 structured questionnaires administered by an OT assistant at admission, at discharge, and at 1 year post injury. Outcome Measures: Functional Independence measure (FIM), self-care questionnaires (focused on eating, bathing, dressing, and grooming). 1. Outcome Self Care Importance: at admission 76% eating independence was of "upmost importance", 84% at discharge & 92% at 12 mo f/u. Bathing independently, dressing, & grooming followed a similar trend. Self Care Expectations- at admission 70% of pts expected to eat "all by themselves without any help at all", 15% had goal of independence & 15% thought they would need some personal assistance. Actual Self Care Performance subjects underestimated their skills at admission for eating, bathing, dressing (p<0.001) & grooming (p<0.003), but showed improvements in mean FIM

Lysack et al. 2001; USA Downs & Black score=17 Observational Cross-sectional Design N=55

2.

3.

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Author Year; Country Score Research Design Total Sample Size

Methods

Outcome motor scores from 22.2 to 47.6 (p<0.0005). Subjects tended to rank skills that they did well with more importance that other life tasks. This was apparent for all skills, but was significant only for grooming & dressing (p<0.02 and p<0.05, respectively).

4.

Discussion The data suggests that over 90% of persons with SCI are eating and feeding themselves independently (Lysack et al. 2001). This prospective study (n=55) that included three data collection points (admission to a rehabilitation unit, discharge and 1-year follow-up) showed that at discharge (n=45) significant gains were demonstrated in the performance of the daily activities specifically related to personal self care and mobility and that this function was preserved at the 1-year follow-up (n=25). Regrettably, there are no intervention trials for other daily living tasks such as bathing, maintaining the home, or meal preparation. Conclusion There is level 5 evidence (1 cross sectional study) that suggests that at discharge from a rehabilitation unit there is improvement in self care and mobility that is preserved for 1 year. At discharge from a rehabilitation unit there is improvement in self care and mobility that is preserved for 1 year.

Driving is one of the key elements of community reintegration. It provides access to the larger community and is highly valued. The consequences of SCI can complicate the level of independence related to driving. Table 4.5 Driver Training
Author Year; Country Score Research Design Total Sample Size Methods Population: mean age 34.5 yrs; all complete injuries. Intervention: Subjects completed the Driver training program at Nagano Rehabiliation Centre. Driving ability was subdivided into three categories independant, assisted, or unable. Outcome Measures: car driving status, vocational and sport questions. 1. 2. 3. 4. Outcome As SCI level and age increased, the ability to drive decreased. 20/33 subjects that were able to drive after training had driven before their SCI. Toilet transfer was most correlated with driving ability. 27/31 (87%) of subjects who could transfer from the toilet independently were able to drive independently (p<0.0001).

Kiyono et al. 2001; Japan Downs & Black score=13 Observational N=62

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Discussion Kiyono et al. (2001) showed that of the 62 patients with tetraplegia involved in a driver-training program 33 were able to drive following the training. Ability to drive was positively related to independence in activities of daily living (p<.001), specifically toilet, bed and tub transfers as well as lower extremity dressing. It was also related to lower level of SCI, a younger age, driving a car prior to SCI, being employed and active participation in sports. Conclusion There is level 5 evidence (1 observational study) suggesting that following a driving training program, persons with tetraplegia who drove tended to be of younger age, have a lower level of SCI, drove prior to injury, were able to perform independent transfers, employed and involved in sports.

Persons with tetraplegia most likely to drive following a driver training program were younger in age, were able to perform transfers independently, had a lower level of SCI, drove prior to SCI and were employed and involved in sports.

4.3.2 Work Being employed or having productive and meaningful responsibility is an important and critical aspect for adults in society, despite disability. It is, however, acknowledged that for persons with SCI certain work is better suited for individuals with injuries at different lesions and is related to several factors. The literature related to employment for persons with SCI primarily focuses on factors contributing to obtaining, returning to, and staying employed as well as adjustment after SCI. There is general consensus in level 5 evidence cross-sectional studies that a number of factors are associated with or predictive of post-injury employment. Table 4.6 provides a summary of these factors as well as the positive or negative direction of the impact. Table 4.6 Factors Contributing to Employment Among Individuals with SCI
Factors identified to have a relationship with employment among SCI Demographic Characteristics Male gender Impact ( + positive; - negative) + + + + (more yrs) + (more yrs) Study (N) 234 259 277 195 259 301 195 231 418 192 114 170 5925 154 Study reference Tomassen et al. 2000 Krause 2003 Ville & Ravaud 1996 Anderson & Vogel 2002 Krause 2003 Krause 1996 Anderson & Vogel 2002 Krause & Anson 1996 Noreau et al. 1999 Young & Murphy 2002 Castle 1994 Tate et al. 1993 Meade et al. 2004 Crewe & Krause 1990

Level of injury (cervical or tetraplegia)

Years since injury

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Factors identified to have a relationship with employment among SCI

Impact ( + positive; - negative)

Study (N)

Study reference Tate et al. 1993 Krause & Anson 1996 Tomassen et al. 2000 Krause & Anson 1996 Tate et al. 1993 Noreau et al. 1999 Ville & Ravaud 1996 Tomassen et al. 2000 Krause 2003 Krause & Anson 1996 MacKenzie et al. 1986 Goldberg & Freed 1982 Ville & Ravaud 1996 Noreau et al. 1999 Castle 1994 Tomassen et al. 2000 Krause 2003 Goldberg & Freed 1982 MacKenzie et al. 1986 Tate et al. 1993 Meade et al. 2004 Krause 2003 Tomassen et al. 2000 Krause 2003 Ville & Ravaud 1996 Young & Murphy 2002 Anderson & Vogel 2002 Tomassen et al. 2000 Anderson & Vogel 2002 Anderson & Vogel 2002 Noreau et al. 1999 Castle 1994 Anderson & Vogel 2002 Krause & Anson. 1996 Krause 1996 Anderson & Vogel 2002 MacKenzie et al. 1986 Krause & Anson 1997 Goldberg & Freed 1982 Goldberg & Freed 1982 Krause & Anson. 1996 Yavuzer & Ergin 2002 McNeal et al. 1999

Age Age at time of injury

Higher education pre-injury

Education & training post injury Higher number of children Higher income Private insurance Racial & ethnic minorities Ability to return to pre-injury job1 Pre-injury work of light to moderate physical intensity Professional job-type pre-injury1 Independent living Independence in daily activities Ability to drive independently Health issues (UTIs, spasticity, pressure sores etc.) Lower activity level Use of illicit drugs Presence of social network Quality of Life with SCI Motivation to work Includes vocation and/or education goals In-accessibility of the workplace Job accommodations

+ (more yrs) 170 + (less yrs) 301 + (ages 36-45yrs) 234 + (younger) 301 + (younger) 170 + (younger) 418 + (before 15 yr) 277 + 234 + 259 + 301 + 266 + 24 + 277 + 418 + 114 + 234 + 259 + 24 + 301 + 170 5925 Pre-injury job factors + 259 234 + + + + + + + + + + + + + 259 277 192 Personal issues 195 234 195 195 418 114 195 231 256 195 Psycho-social factors 301 362 24 Discharge planning from hospital/rehab 24 Workplace issues 231 70 96 School participation and performance among adolescents 53 53 53

+ +

Curriculum changes/ modifications Human assistance In-accessibility of school

+ + -

Dudgeon et al. 1997 Dudgeon et al. 1997 Dudgeon et al. 1997

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Factors identified to have a relationship with employment among SCI Lack of transportation

Impact ( + positive; - negative)

Study (N)

Study reference Dudgeon et al. 1997 Dudgeon et al. 1997 Dudgeon et al. 1997

- (extra-curricular 53 participation) - (extra-curricular Health concerns 53 participation) Adaptive writing techniques + 53 1 Also associated with a much shorter interval between injury and return to work.

Discussion Several factors emerged in repeated studies to have significant impact on the employment of persons with SCI. In 4 studies, the factor of being male was shown to have a significant impact, of which 3 studies suggested it was positive (across studies total n = 770) and one study (n = 195) indicated it had a negative impact. There are 4 studies that suggest years since injury had an impact on employment with 3 of these showing that more years had a positive impact (total n = 6249 across studies) and one study (n = 301) indicated that fewer years post-injury was positively related. In 8 studies, having tetraplegia (total n = 1880) was found to have a negative impact, while higher education prior to the SCI (total n = 1893 across studies) had a positive impact on employment. Employment is also positively related to the factors of younger age (3 studies, total n = 705), professional pre-injury job (3 studies, total n = 728) and ability to drive a car (3 studies, total n = 727). Conclusion There are several level 5 evidence studies that show the following factors have a positive impact on employment: male, more years since injury, younger age, car driving ability, higher education and professional job prior to the SCI. Many studies also show that having tetraplegia has a negative impact on gaining and maintaining employment. Being male, more years since injury, younger age, the ability to drive a car and having a higher education and a professional job prior to the SCI positively impact employment. Having tetraplegia has a negative impact on gaining and maintaining employment.

In terms of adjustment to SCI, being employed significantly facilitates the coping and adjustment to disability. Table 4.7 Employment
Author Year; Country Score Research Design Total Sample Size Methods Population: n=559 highly qualified disabled applications, n=557 highly qualified AB applications, n=556 modestly qualified disabled applicants n=556, modestly qualified AB applicants. Intervention: Fictional resumes of varying qualities were randomly assigned to be sent to one of four companies in Outcome Effect of Qualifications 1. Across all company sizes, disabled persons had less chance of obtaining an interview irrespective of their qualifications (p<0.01). 2. Highly qualified disabled applicants had fewer favorable

Ravaud et al. 1992; France PEDro=2 RCT N=2228

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Author Year; Country Score Research Design Total Sample Size

Methods France. Outcome Measures: level of response to application (negative or positive), effect of qualification, effect of company size.

Outcome

Krause 1992; USA Downs & Black score=11 Observational N=135

responses (2.60%) compared to highly qualified AB applicants (4.54%). 3. Modestly qualified disabled applicants had fewer favorable responses (1.24%) compared to modestly qualified AB applicants (3.95%). Effect of Company Size 4. The larger the company (>500), the greater the chance of discrimination against highly qualified disabled applicants (p<0.01). 5. For modestly qualified applicants, discrimination was more visible in smaller companies (200-499 employees; p<0.001) compared to larger ones (>500 employees; p<0.06). Population: age at beginning of study: 1. During 15 yrs there was an increase 45.6 yrs, mean DOI: 24.4 yrs, 82% men, in married individuals (1974=31.9%, 68% had tetraplegia, 32% had paraplegia. 1985=48.9%) and a decrease in the Sample size n=154 (in 1985) and n=135 number of single people (in 1992 at follow-up). (1974=60.7%, 1989=37.8%). Intervention: Completion of a 2. More participants were working in questionnaire. This was the 15-year 1989 (50%) than in 1974 (44%). follow-up from phase one of an earlier 3. There were significant increases in study. years of education (p<0.001), sitting Outcome Measures: Life Situation tolerance (p<0.05), satisfaction with Questionnaire (LSQ). employment (p<0.05) and satisfaction with finances (p<0.05). 4. There were significant correlations between the two times for interpersonal (r=+.31) and activity (+.45) items. Population: age at time 2 40.5±7.3yrs, mean DOI 20±5.3yrs. Intervention: Survey at time 1 and time 2 (11 year follow-up). Outcome Measures: Life Situation Questionnaire (LSQ). 1. Those who made positive transitions (POS) into work were significantly younger (p<0.05) and had a shorter DOI (p<0.01). POS and employed individuals had significantly higher education than those chronically unemployed (p<0.001). Unemployed and POS groups had a significantly higher proportion of quadriplegics (p<0.05) and chronically unemployed individuals had lower activity scores compared to the employed groups (p<0.001). POS group had significantly lower interpersonal dissatisfaction compared to the other grps (p<0.05).

2.

Krause 1996; USA Downs & Black score=15 Observational N=142

3.

4.

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Discussion A longitudinal study showed, that over a 15-year period post-SCI (n=135), significant gains were realized in work, satisfaction, a reduction in the need for medical services, and improved sitting tolerance (Krause 1992). The greatest gains were related to employment where significant improvements were demonstrated in satisfaction with employment and finances and more individuals were employed (Krause 1992). In another longitudinal study, Krause (1996) showed that after 11 years (n=142) persons with SCI who were unemployed had significantly lower activity levels (F(3, 130)=5.0, p<.01) and high levels of economic dissatisfaction (F(3,118)=3.8, p<.05) than those with SCI who were employed. In addition, having a disability was a significant discriminating factor for gaining employment. In a study completed in France, Ravaud and colleagues (1992) reported that persons with disabilities were significantly less likely to obtain an interview or be hired than their able-bodied counterparts (p<.01). Larger companies were more likely to discriminate against highly qualified individuals, while modest qualifications were less discriminated against in medium and large companies though remained a source of discrimination in small companies. Conclusion There are level 5 evidence studies (2 longitudinal) that show that those persons with SCI that were employed 15 years post-SCI had greater satisfaction with employment and finances while those who were unemployed 11 years post-SCI had lower activity levels and greater economic dissatisfaction. There is level 5 evidence (one cross-sectional study) that persons with disabilities in France experience discrimination related to employment, as they are less likely to obtain an interview or be hired. Employed persons with SCI had greater satisfaction with employment and finances while those unemployed had lower activity levels and higher economic dissatisfaction. Persons with disabilities experience discrimination and are less likely to obtain an interview or be hired. 4.3.3 Leisure and Recreation In the face of catastrophic events such as a SCI, adjustment generally involves engaging in the necessary or important tasks to sustain life. Typically these activities consume available time with leisure and recreational occupations relegated to one’s memory. This, however, is unfortunate as the enjoyment and satisfaction of participating in leisure occupations have positive effects on other aspects of life and should not be disregarded. The studies in leisure and recreation among persons with SCI primarily use cross-sectional research designs. Collectively this research investigates the influence of engaging in leisure and its impact on adjustment to SCI, community integration, and employment. Table 4.8 provides a summary of these studies and the factors related to leisure and recreational engagement of persons with SCI.

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Table 4.8 Factors Relating to Leisure Among Individuals with SCI
Factors identified to have a relationship with leisure among SCI Involvement in leisure activities Impact ( + positive; - negative) + adjustment to SCI + physical independence + mobility 1 + occupation + social integration Characteristics of leisure occupations Leisure Diversity Leisure Intensity Facilitators to leisure participation Social support system Being healthy Being employed or attending school Expectations for leisure participation Adventure activities Crafts Intellectual activities Perceived Barriers to Leisure Participation Health concerns Cost of program Lack of leisure opportunities in the community Intrinsic (Intrapersonal)2 Physical ability3 + subjective well-being + subjective well-being + + - if lack of support + + Study N 178 48 Study reference Loy et al. 2003 Hanson et al. 2001

178 178 178 14 72 178 48

Loy et al. 2003 Loy et al. 2003 Loy et al. 2003 Dattilo et al. 1998 Scelza 2005 Loy et al. 2003 Hanson et al. 2001

- (tetraplegia) -

388

Kennedy & Smith 1990

72 72 14 72 14 72

Scelza 2005 Scelza 2005 Dattilo et al. 1998 Scelza 2005 Dattilo et al. 1998 Scelza 2005

Having a SCI Engaging in sporting activities 45 Tasiemski et al. 2000 Engaging in recreation activities 45 Tasiemski et al. 2000 1 Items include # of hours per week to engage in homemaking, working, school, self improvement, maintenance, recreation and volunteering. 2 Refers to lack of motivation, energy and interest in exercise. 3 Refers to lack or loss of physical balance, mobility and strength.

Discussion Studies suggest that the primary facilitator for leisure involvement is a supportive social network (3 studies, total n = 264). Other facilitators are being healthy and being employed or attending school. The main barrier to leisure participation was lack of physical ability (2 studies, total n= 86) with other barriers noted as health concerns, cost, and lack of opportunity or interest. Participation in leisure occupations were shown to have a positive impact on adjustment to SCI, physical independence, mobility, hours in activities of daily living and social integration. Conclusion Level 5 evidence (several cross-sectional studies) suggests that facilitators for leisure involvement are social support, being healthy and being employed or attending school.

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Facilitators for leisure involvement are social support, being healthy and being employed or attending school. Barriers are lack of physical ability, health concerns, cost, and lack of opportunity or interest. Participation in leisure occupations have a positive impact on adjustment to SCI, physical independence, mobility, hours in activities of daily living and social integration. Limited research has also been reported on the use of 2 technologies to support the engagement in leisure activities. These are a computer video game called GAMEWHEELS and functional electrical stimulation (FES). Each of these is described in turn. Table 4.9 Wheelchair Exercise
Author Year; Country Score Research Design Total Sample Size Methods Population: 10 males, 5 females, age 34.7yrs (male) and 39.6yrs (female), all incomplete injuries at C6-L2. Intervention: Submaximal oxygen consumption test with and without simultaneous use of the GAME system (a video game device). The order in which the trials were administered was randomized. Outcome Measures: HR, ventilation rate (Ve), VO2. 1. Outcome Mean Ve was significantly higher for the GAME group at the 16 and 20 min time points (during exercise); however, there were no significant differences in Ve max values at these time points. Mean VO2 was significantly higher for the GAME group at the 16 and 20 min time points (during exercise). There were significant differences in Ve and VO2 between conditions during transition points (warm-up to exercise).

O’Connor et al. 2001; USA Downs & Black score=12 Prospective Controlled Trial N=15

2.

3.

Discussion A study (n = 15) investigated the effects of the GAMEWHEELS system (an interface between a portable roller system and a computer that is controlled by propulsion of a wheelchair’s wheels on the roller) on physiological responses during and motivators for engaging in fitness and exercise activities when wheeling a wheelchair. Results suggest that metabolic activity was greater and significantly different (specifically, oxygen consumption (p<.05) and ventilation rate (p<.05) when exercising using the GAMEWHEELS than when not. There was no difference in heart rate between the two conditions. The system also allowed individuals to achieve their target exercise training zone faster and to maintain it for the entire session. 87% (13) reported that the system assisted them to work out on a regular basis. Conclusion Level 2 evidence (1 non-randomized controlled study) showed the physiological and motivational benefits of using the GAMEWHEELS system when engaging in wheelchair exercise. Use of the GAMEWHEELS system showed physiological and motivational benefits for engaging in wheelchair exercise.

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Table 4.10 FES Assisted Exercise
Author Year; Country Score Research Design Total Sample Size

Methods

Outcome

Moynahan et al. 1996; USA Downs & Black score=12 Post-test N=5

Population: N=5, age 17-20yrs, LOI T4T11, all complete, at least 1 year postinjury, all ASIA A. Intervention: FES system implanted into the major muscles used for standing (quadriceps, gluteus maximus, gluteus medius, and posterior fibers of the adductor magnus). Sometimes erector spinae, hamstrings, adductor longus, and tibialis anterior were included. Stimulation patterns were conducted every 1-4 weeks. The protocol was changed in order to finetune the timing, intensity and coordination of muscle activity. Subjects wore either hinged, molded ankle-foot orthosis or molded shoe inserts depending on requirement for ankle stability. All subjects underwent an 8-week FES exercise program designed to increase muscle strength and endurance. Outcome Measures: FES usage, adherence, functional skill level and mobility.

1. 2.

3. 4.

FES was used mainly for exercise purposes (51%-84% of total days used) and less for mobility. Even though all subjects had previous brace training, standing balance training was needed before progressing to functional skills training with FES. Eventually, subjects showed a range of proficiency at manoeuvring and short-distance ambulation. The primary factor that motivated FES standing was enjoyment of being able to stand. Most common reason for non-use was not having time during the day, not wanting to wear the device all day and not wearing it in public.

Discussion Home use of FES training was investigated in a 1 year study with 5 adolescents who had paraplegia. Results showed that the FES was primarily used for exercise and standing, both of which were regarded as motivators for use. Other benefits were ability to do more things and a sense of well-being. Barriers were lack of time to use the system and reluctance to wear the FES all day. Conclusion There is level 4 evidence (one uncontrolled study) that suggests that FES is beneficial as a motivator to engage in exercise and standing. Drawbacks included lack of time to use the system and reluctance to wear all day. FES is a motivator to engage in exercise and standing, augments ability to do more things and enhances the sense of well-being. Drawbacks included lack of time to use the system and reluctance to wear all day. 4.4 Quality of Life Spinal cord injury (SCI) is a devastating life situation that occurs suddenly and unexpectedly. After the initial (acute) phase of care, individuals start a long period of rehabilitation that aims at

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returning them to the community and allowing them to resume, as much as possible, daily activities and social roles so that they may ultimately begin to enjoy life again. It might be seen as irrelevant to discuss quality of life (QOL) shortly after SCI, however, being part of the fundamental nature of life, QOL becomes a significant issue after rehabilitation discharge. Some reports suggest that compared to the general population people with SCI might experience a slightly lower QOL (Westgren & Levi 1998) but a substantial number of these individuals regain a good to excellent QOL after a period of time (Post et al. 1998a). As expressed by Albrecht and Devlieger (1999), it may be seen as a paradox that “many people with disabilities report experiencing a good or excellent QOL when to most observers these people seem to live an undesirable daily existence” (p. 977). This situation brings out a fundamental issue in the assessment of QOL – unlike other QOLrelated constructs that are described below, subjective QOL (life satisfaction, well-being) is such an intimate feeling that any process trying to measure QOL from an external observer indubitably remains imperfect. As it is mostly influenced by one’s personal experiences, comparisons with societal values usually brought about by an external point of view, are likely to misjudge one’s QOL. Furthermore, making QOL more difficult to understand, it has been observed that individuals sustaining alterations in health status or a life event such as a SCI, may change their internal standards, their values or their conceptualization of QOL (Spranger 1999). These phenomena might partly explain why it is likely that a difference exists between the external vision of QOL and what is really experienced by people with SCI. 4.4.1 QOL Definitions and Models Although the term “goodness of life” (Baker & Intagliata 1982) seems appropriate to express the overall concept of QOL, its apparent simplicity hides a multidimensional concept that is among the most difficult to define and translate into a functioning and operating reality. Nonetheless, two main conceptualizations of QOL are well-accepted: (1) the subjective approach, whose focal point is the person’s emotional or cognitive assessment of the congruence between his/her life expectations and achievements, usually associated with life satisfaction or well-being and (2) the objective approach, based on one’s characteristics that can be objectively measured by an external appraiser (Dijkers 2003). The latter includes the concept of Health-Related Quality of Life (HRQOL) that focuses mostly on physical and mental health, social and role achievements, and thus it is more oriented toward functional performance than is subjective QOL (Wood-Dauphinee et al. 2002). Several models explaining the overall concepts of QOL and its determinants have been presented in the field of disability with a particular link to the disablement process (WoodDauphinee & Kuchler 1992; Whiteneck 1994; Post et al. 1999; Dijkers 2003). Post and collegues (Post et al. 1999; Post & Noreau 2005) proposed a conceptual model that integrates 1) the dimensions of The International Classification of Functioning, Disability and Health (ICF) (World Health Organization 2001) seen as observable deviations from normal functioning and 2) a subjective dimension based on one’s perception of satisfaction, perceived health and wellbeing. For example, paralysis (Body Function), inability to walk (Activities), level of social support (Environment) and employment restrictions (Participation) can be assessed from an external observer and some of these dimensions will potentially influence QOL. Conversely, perceived health, satisfaction with social participation and general well-being can only be reported by the person him/herself. All these dimensions form the global (superordinate) construct of QOL that include the objective and subjective approach. Dijkers (2003; 2005) proposed a more generic model that integrates different conceptualizations: 1) QOL as subjective well-being, reflecting the congruence between one’s expectations, values and

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achievements, 2) QOL as achievements focusing on one’s accomplishments, performances and statuses and including the concept of HRQOL (health and functioning), and 3) QOL as a utility that compares achievements/statuses with societal norms and standards. These models can help clinicians to differentiate between QOL as subjective well-being and its objective determinants. Needless to say, depending on the conceptualization of QOL that would be valued for a specific research or clinical purpose, the choice of an appropriate measure is a critical issue. Some concerns exist regarding the use of the term HRQOL for the conceptualization of QOL given its emphasis on health status and functioning (Moons 2004) especially given that a shift in QOL may occur after SCI, and therefore, just because people may have significant health problems does not necessarily mean they have poor QOL (Smith et al. 1999). Health status should be considered an important determinant of QOL instead of being regarded as an integral dimension of QOL itself. Consequently, QOL as an outcome seems to be more appropriately defined in terms of life satisfaction and this review will mainly focus on that concept. 4.4.2 Exploring QOL after SCI from a Scientific Perspective An impressive number of studies have addressed Health-related and subjective QOL after SCI. Several reports have attempted to identify the potential determinants of QOL from different perspectives but it remains difficult to compare this substantial bulk of information due to the methodological discrepancy between the studies and the lack of consistency in the assessment of the construct of QOL (well-being, life satisfaction) with different measures. Moreover, most studies focused on a single or limited number of variables as very few studies have been conducted with a conceptual framework that takes into account the spectrum of factors that influence QOL. As a result, these studies predict only a small percentage of the variance in QOL (Dijkers 2005) and therefore give a limited scope of the QOL determinants. 4.4.3 Quantitative Measurement Approach of QOL Determinants To overcome the problem of reduced statistical power in many studies with small sample sizes, common with SCI studies, researchers recommend the use of meta-analyses which consist of combining the results of several studies that address similar research hypotheses (e.g. impact of SCI on QOL). Because of limited rigor of research design and poor validity of measurements in the reviewed studies, Evans et al. (1994) failed to determine whether or not rehabilitative care improves QOL. Unlike an overwhelming number of recent reports, this meta-analysis supported an association between QOL and the level of injury. In his meta-analysis, Dijkers (1997b) focused on determining the relationships between QOL and each dimension of the International Classification of Impairment Disability and Handicap (the disablement process). Results showed that overall, slightly lower mean QOL scores are observed in individuals with a SCI than in people without disability, but the relationship between the level of injury and QOL (mostly paraplegia vs. tetraplegia) was almost non existent or weak at best. Conversely, consistent relationships (r = .30 - .50) were observed between QOL and some aspects of handicap (social integration, occupation). It remains possible that severity of injury indirectly affects QOL through its influence on societal participation (Post et al. 1998; Dijkers 1999). If the level of societal participation valued by a person is not affected because of favourable conditions (e.g. education, appropriate environmental adaptations, social support), it is likely that subjective well-being will not be affected, regardless the severity of injury. The potential predictors of QOL that have been mentioned in studies are summarized in Table 4.11. They were grouped into global dimensions for the purpose of this review and not

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surprisingly, predictors related to community integration/participation are among those most often cited in the literature, which supports their importance to enhance QOL. However, it is not necessarily all dimensions of participation that strongly influence QOL. Mobility, occupation, and community life (including interpersonal relationships) are seen as the most important predictors. Poor health status and the occurrence of secondary impairments are also known to diminish QOL. Interestingly, there is growing interest regarding the impact of the environment on societal participation and QOL. Perceived social support (particularly from a spouse) has been considered in several studies as a major predictor of QOL but it is unclear if this variable is a mediator that will promote the level of community integration/social participation or a direct contributor to QOL. The physical environment also has the potential to influence QOL. Richards et al. (1999) observed that access to the environment (home and transportation) was positively and linearly associated with satisfaction with life. It contributed to the explanatory model predicting life satisfaction even after all the other independent measures were considered. As previously mentioned, few studies have used a conceptual framework in order to account for the spectrum of factors that influence QOL. Even with a strong conceptualization, difficulties still exist in attempting to capture the complete picture of QOL determinants using quantitative research methods. For example, Whiteneck et al. (2004) studied the relative impact of environmental barriers on life satisfaction compared to injury-related variables, demographics and activity/participation limitations. A limited amount of variance in QOL (10%) was explained by the environmental barriers compared to participation (15%) and demographics (11%). Overall, 26% of the variance was explained by all subsets of predictors, meaning that about 75% of the variance is unknown or unexplained by factors measured in such a study. This lack of prediction is probably attributable to methodological difficulties such as using measures that do not fully translate the concepts into good metrics rather than a misidentification of the potential factors that influence QOL. Despite the large number of studies on QOL after SCI that applied a quantitative approach, our objective knowledge of how well-being after SCI develops and what factors have a positive or negative influence on the course of QOL remains limited (Post & Noreau 2005). Further research is needed using an integrative approach with measures that strongly fit distinct constructs as those defined in the ICF or other models explaining the consequences of health, disease and trauma. Table 4.11 Potential Predictors of Subjective QOL
Issues perceived to influence subjective QOL Meta analyses or relationships with the disablement process Demographics Age, time since injury, ethnicity, education, marital status Post et al. 1998; Dijkers 1999; Holicky & Charlifue 1999; McColl et al. 1999; Kennedy & Rogers 2000; Putzke et al. 2001 Post et al. 1998; Westgren & Levi 1998; Hall et al. 1999; Putzke et al. 2001 References Fuhrer et al. 1992; Evans et al. 1994; Dijkers 1997b; Pierce et al. 1999; Whiteneck et al. 2004

Injury-related factors Health-related factors Mobility, perceived health, rehospitalization, secondary impairments (respiratory problems, pressure sores,

Decker & Schulz 1985; Schulz & Decker 1985; Crisp 1992; Fuhrer et al. 1992; Lin et al. 1997; Post et al. 1998;

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Issues perceived to influence subjective QOL spasticity) Pain

References Kemp & Krause 1999; Pierce et al. 1999 Putzke et al. 2002; Anderson & Vogel 2003; Franceschini et al. 2003 Siösteen et al. 1990; Lundqvist & Siösteen 1991; Stensman 1994; Anke et al. 1995; Krause 1997; Post et al. 1998; Vogel et al. 1998; Westgren & Levi 1998; Ville et al. 2001; Bénony et al. 2002

Psychological factors Loneliness, boredom Perceived control on life Krause & Kjorsvig 1992 Decker & Schulz 1985; Schulz & Decker 1985; Crisp 1992; Fuhrer et al. 1992; Krause 1992; Krause 1997; Mcneil et al. 1998; Tate & Forcheimer 1998; Putzke et al. 2002; Franceschini et al. 2003

Community integration/participation Social functioning/integration Decker & Schulz 1985; Schulz & Decker 1985; Krause & Crewe 1987; Siösteen et al. 1990; Lundqvist & Siösteen 1991; Crisp 1992; Clayton & Chubon 1994; Dijkers 1997b; Post et al. 1998; Dijkers 1999; Pierce et al. 1999; Kemp & Ettelson 2001; Ville et al. 2001; May & Warren 2002; Putzke et al. 2002 Krasue 1997; Bénony et al. 2002; Putzke et al. 2003; Franceschini et al. 2003 Schulz & Decker 1985; Fuhrer et al. 1992; Cayton & Chubon 1994; Nosek et al. 1995; Dijkers 1997a; Hansen et al. 1998 Krause & Crewe 1987; Lundqvist & Siösteen 1991; Crisp 1992; Fuhrer et al. 1992; Krause 1992; Krause & Kjorsvig 1992; Dijkers 1997b; Krause 1997; Lin et al. 1997; Pentland et al. 1998; Westgren & Levi 1998; Dijkers 1999; Kemp & Krause 1999; McColl et al. 1999; Ville et al. 2001; Putzke et al. 2002; Franceschini et al. 2003 Decker & Schulz 1985; Schulz & Decker 1985; Crisp 1992; Fuhrer et al. 1992; Rintala et al. 1992; Warren et al. 1996; Dijkers 1997b; Kemp & Krause 1999 Richards et al. 1999; Deconinck 2003 Cushman & Hassett 1992 Gerhart 1991; Krause 1992; Clayton & Chubon 1994; Vogel et al. 1998; Heck & Makuc 2000; Ville et al. 2001 Dijkers 1999; Putzke & Richards 2001

Interpersonal relationships/social interactions

Community access/participation

Occupation/employment status (including satisfaction with), life opportunities

Environmental issues Perceived social support

Accessibility (home/health care)

Preferred living situation

Level of income

Residence (nursing home)

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Average level of QOL after SCI is slightly lower than in people without disability but a substantial number of people with SCI report good or excellent QOL. Severity of injury and other diagnostic factors do not significantly impact QOL. There influence may become significant through restrictions in community integration and social participation. A limited amount of variation in QOL has been explained by quantitative research methods. 4.4.4 Qualitative Research Methods to Understand QOL and its Determinants Because of the difficulty quantitatively capturing complete information on QOL and its determinants, few reports have used qualitative methods and shed light on the issue of QOL when living with SCI (Bach & McDaniel 1994; Hillebrand et al. 2001; Manns & Chad 2001; Whalley Hammell 2004). These studies confirm that several people with SCI enjoy life and have a good or excellent QOL, even those with a severe injury. Overall, QOL is seen as something dynamic and subjective. It is generated by the individual’s personal experiences and changes over the course of life in response to changing priorities and values. The latter is a concept frequently mentioned and corresponds to the response shift theory (Rapkin 2004). Several elements that make life enjoyable do not differ in persons with SCI compared to those without disability. These elements include satisfying interpersonal relationships, financial security, meaningful social roles (including those related to work and productivity) and opportunity to pursue leisure and community services. In general, factors reflecting participation in life situations or reintegration into the community are very influential to QOL. Having control over one’s life, assertiveness and balance between dependence and independence have all been reported as major QOL determinants. Access to various resources (physical, emotional, social) is seen as a necessary foundation to QOL and refers to the overall contribution of the environment. There is an interactive process between correlates of QOL that suggests a complex interrelationship between the domains influencing QOL. Moreover, each domain, taken independently, is insufficient to maintain QOL and rather, it is the interaction between personal attributes, meaningful roles and environmental assets that build an optimal QOL. Albrecht and Devlieger (1999) nicely summarize this perspective by stating that it refers to “the ability of the self to build and manage a balance between the body, mind and spirit in searching for a state of well-being and to maintain an harmonious relationship with the environment” (page 986). Qualitative reports suggest that factors affecting QOL after SCI do not seem to differ from those impacting QOL in people without disability. They are related to life issues such as achieving meaningful social roles, having control over one’s life and maintaining adequate access to the environment 4.4.5 Trials Examining QOL as an Outcome Unlike the concept of HRQOL, which has been the object of an infinite number of clinical trials, there is a paucity of experimental studies that examine QOL as subjective well-being or use this concept as a primary outcome. One reason for this is related to the concept of subjective QOL itself, resulting from subjective feelings where the appraisal is built on the accomplishment of

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valued life dimensions. Therefore, subjective QOL cannot be the primary outcome of a clinical intervention and thus, the aim of a study must be to examine the life dimensions valued by the person (e.g., health status, functional independence, occupation, etc.) and to presume an indirect effect of enhanced life dimensions on QOL. The aforementioned findings suggest that dimensions related to community integration (in particular, active participation and full citizenship) are the most likely to enhance QOL after SCI. Thus, interventions to enhance QOL should pay careful attention to these determinants. In Table 4.12 we present 4 studies which use experimental and quasi-experimental designs to examine changes in QOL after an intervention. Three studies focus on people with SCI while another one involves spouses. Table 4.12 Clinical Trials Examining the Effect of Specific Interventions on QOL
Author Year; Country Score Research Design Total Sample Size Methods Outcome

Martin Ginis et al. 2003; Canada PEDro=5 RCT N=34

Phillips et al. 2001; USA PEDro=4 RCT N=111

Population: 34 subjects (23 men, 11 women), complete-incomplete, LOI: 10±11 years. Treatment: exercise training ( aerobic and resistive) performed in groups of 3-5 people, twice weekly (24 sessions: avg. 15 wks to complete; range 12-22 weeks). Mediators: pain perception, self-efficacy, stress. Outcome Measures: self-concept, depression, subjective well-being. Population: Total n=111 Treatment n=72, Control n=39; acute phase and 1 yr post-discharge. Treatment: Participants randomly assigned into 3 groups (n=36 video, n=36 telephone, n=39 standard care) for education on various SCI issued. Follow-up (1 yr) to monitor QOL. Outcome Measures: Depression (CES-D), HRQOL-QALY (Quality of Well-Being). Population: 36 SCI spouses: 19 treatment subjects, 17 controls, Age: Support group 32.5yrs, Control spouse 38.5yrs, DOI: Support=21 mo, Control= 36 mo. Intervention: Support groups met 7 times (1 h) over a 2-wk period. Controls did not. Program: discussions on previous sessions home task, topic specific performance, assignment of home task, wind down. Outcome Measures: General Health Questionnaire (GHQ), Hospital anxiety and depression rating scale (HAD) and QOL (WHOQOL-BREF). Population: 25 treatment subjects, 25 control subjects. Treatment: Experimental group had five leisure group sessions (1 hr) included: 1) intro and group interaction, 2) importance of leisure, 3) problems faced in leisure participation, 4) strategies to overcome

1. 2.

Exercisers reported less pain, depression, stress and greater perceived QOL and self-concept. Stress and pain mediated exercise induced-changes in QOL.

1.

2.

The standard care group spent an average of 8.0 days/yr in the hospital vs. 5.2 for the telephone and 3.0 for the video group. At 1 yr post-discharge, QWB scores were slightly higher in the intervention groups (video-telephone) (n = only 42% of the initial sample).

1.

Sheija & Manigandan, 2005; India Downs & Black score=16 Prospective Controlled Trial N=36

2.

All values from QOL were significantly improved after the treatment in the support group compared to the control group (physical, psychological, social relation (p<0.0001). Significant reduction in anxiety and depression in the support group.

Daniel & Manigandan 2005; India Downs & Black score=15 Prospective Controlled Trial N=50

1.

Significant improvement in all domains of the LSS and WHO QOL-BREF in the experimental group (except for social relationships) as compared with the control group (p=0.0001).

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Author Year; Country Score Research Design Total Sample Size

Methods

Outcome

them, & 5) revision and summary, along with carrying out an activity suggested by the group members] as intervention while the control group had none. Outcome Measures: leisure (Leisure satisfaction scale), QOL (WHOQOL-BREF)

Discussion Even though reality is more complex, some studies support the straightforward hypothesis that an intervention can modify a particular dimension of life, and the latter will directly influence QOL. For example, Martin Ginis et al. (2003) suggest that the effect of an exercise program on QOL is mediated by modifying pain and stress. Sometimes, weaker designs and less sophisticated analyses (prospective controlled trial) can also be used to suggest the indirect impact of an intervention on QOL, as shown by Daniel and Manigandan (2005). These authors attempt to determine if a leisure intervention program would influence subjects’ attitudes toward leisure, the level of leisure satisfaction and, consequently, QOL. One experiment that we located did not lead to an obvious effect on QOL. In their post-discharge follow-up conducted by telehealth or telephone Philips et al. (2001) found that telehealth lead to a more positive outcome than standard care but this did not translate into better subjective QOL. The aforementioned hypothesis could also be validated with the partners of people with SCI who are impacted by the new life context. A good example is Sheija and Manigandan’s investigation of a spouse support program (2005). They found significant improvements in all domains of QOL and psychological variables while marginal changes were observed in the control group. Overall, only one study (Martin Ginis et al. 2003) provided strong evidence that a specific intervention on life domains will have an impact on QOL. The conclusions from the other studies would have been stronger if secondary analyses had been conducted to demonstrate an association between the changes in an intermediate outcome (depression, anxiety, psychological distress, etc.) and QOL. At present we can only assume that eliciting changes in an individual’s characteristics or life situations would enhance subjective QOL. Conclusion There is Level 1 evidence in 1 RCT study that supports the use of exercise to reduce pain and stress which in turn mediates changes in QOL. There is level 1 evidence from 1 RCTstudy that suggests that telehealth provides better prevention education than telephone or standard care, however, there was little influence on the QOL. There is level 2 evidence from 1 non-RCT study that suggests the positive impact of a 2week leisure educational program (group therapy) on leisure satisfaction and, potentially, QOL. There is level 2 evidence from 1 non-RCT study that suggests the use of group therapy to support spouses of individuals with SCI will decrease the symptoms of depression, anxiety and psychological distress with a potential impact on QOL.

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Overall, there is a paucity of information from clinical trials on the most appropriate interventions favouring subjective QOL in people with SCI and their significant others. QOL can be indirectly enhanced through the use of an exercise program designed to reduce pain and stress. Providing group therapy to spouses of individuals with SCI can decrease their symptoms of depression, anxiety and psychological distress with a potential impact on QOL. 4.4.6 Summary – QOL One of the highlights of this section refers to the inherent difficulty in studying the concept of QOL as an outcome. QOL, being such an intimate feeling and influenced by one’s personal experiences, is difficult but not impossible to study as the primary outcome of an intervention study. Moreover, the theory of response shift suggests that the essence of QOL (values, personal standards, expectations) might change over time, making this concept changeable over the course of life. Nonetheless, some methodological considerations could facilitate the design of proper QOL studies. Firstly, there is a need to identify and define what construct of QOL will be the focus of the study as well as the underlying conceptualization (e.g. subjective vs. objective, general well-being vs. life satisfaction per domain). The proposed measure must fit the selected construct of QOL and must have sound psychometric properties (validity, reliability, responsiveness). Secondly, studies that aim to identify predictors of QOL must use strong conceptual models that will include all the potentially important facets of life (individual characteristics, environmental dimensions and societal involvement, etc.). Again, appropriate measures are a critical issue. Thirdly, in the case of clinical trials designed to enhance QOL, the interventions should be appropriately selected, such that there is a sensical indirect connection between the intervention and QOL. For example, one could exam the influence of placement in a long term care facility versus the return to community living on QOL. The outcome should, therefore, be identified from the dimensions of a conceptual model, such as the ICF model of health and disability (body functions and structures, activities, participation, contextual factors). Finally, there is a necessity to carry out further statistical analyses (multivariate analyses, group differences, path analyses) to provide evidence of the association between the intermediate or mediating factors and QOL. 4.5 Summary – Community Reintegration There is Level 4 evidence from a single post-test study that having contact with a person who has an SCI has a significant impact on attitudes towards disability. There is Level 5 evidence based on a qualitative study that SCI results in a changed social network - some relationships are lost but others improve. There is very limited (Level 5) evidence that people with SCI consider the following factors as the main barriers to community integrations: barriers in the natural environment, transport, help at home, health care and government policy. There is very limited (level 5) evidence from two observational studies that assistive equipment may promote increased activity and participation in and outside of the home.

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There is moderate (Level 2) evidence from one RCT study that a community based system for post discharge monitoring in no more effective in terms of community integration than a hospital based system. There is very limited (Level 5) evidence from one observational study that productivity was correlated to the individuals’ subjective experience of community reintegration. There is very limited (Level 5) evidence from two observational studies that a positive relationship exists between the adequacy of personal assistance and the physical and mental health of those with SCI. There is very limited (Level 5) evidence from two observational studies that people who receive consumer directed personal assistance services are more satisfied with services than those who receive services that are not consumer directed. There is limited (Level 4) evidence from one case series that an independent living follow-up program is more beneficial than no program. There is very limited (Level 5) evidence from one observational study that supported employment assists job placement of some people with SCI. There is very limited (Level 5) evidence from one observational study that individuals with disabilities (SCI, cerebral palsy, multiple sclerosis) did not receive adequate equipment or services on more than half of the occasions in which they were requested. There is level 5 evidence (1 cross sectional study) that suggests that at discharge from a rehabilitation unit there is improvement in self care and mobility that is preserved for 1 year. There is level 5 evidence (1 observational study) suggesting that following a driving training program, persons with tetraplegia who drove tended to be of younger age, have a lower level of SCI, drove prior to injury, able to perform independent transfers, employed and involved in sports. There are several level 5 evidence studies that show the following factors have a positive impact on employment: male, more years since injury, younger age, car driving ability, higher education and professional job prior to the SCI. Many studies also show that having tetraplegia has a negative impact on gaining and maintaining employment. There are level 5 evidence studies (2 longitudinal) that show that those persons with SCI that were employed 15 years post-SCI had greater satisfaction with employment and finances while those who were unemployed 11 years post-SCI had lower activity levels and greater economic dissatisfaction. There is level 5 evidence (one cross-sectional study) that persons with disabilities in France experience discrimination related to employment, as they are less likely to obtain an interview or be hired regardless of qualification or size of company. Level 5 evidence (several cross-sectional studies) suggests that facilitators for leisure involvement are social support, being healthy and being employed or attending school.

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Level 2 evidence (1 non-randomized controlled study) showed the physiological and motivational benefits of using the GAMEWHEELS system when engaging in wheelchair exercise. There is level 4 evidence (one uncontrolled study) that suggests that FES is beneficial as a motivator to engage in exercise and standing. Drawbacks included lack of time to use the system and reluctance to wear all day. There is Level 1 evidence in 1 RCT study that supports the use of exercise to reduce pain and stress which in turn mediates changes in QOL. There is level 1 evidence from 1 RCTstudy that suggests that telehealth provides better prevention education than telephone or standard care, however, there was little influence on the QOL. There is level 2 evidence from 1 non-RCT study that suggests the positive impact of a 2week leisure educational program (group therapy) on leisure satisfaction and, potentially, QOL. There is level 2 evidence from 1 non-RCT study that suggests the use of group therapy to support spouses of individuals with SCI will decrease the symptoms of depression, anxiety and psychological distress with a potential impact on QOL.

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CHAPTER FIVE
Upper Limb Rehabilitation Following Spinal Cord Injury
Sandra Connolly, BHScOT, OT Reg (Ont.) JoAnne Aubut, BA Robert W Teasell MD FRCPC Tal Jarus, PhD, OTR

Key Points Neuromuscular stimulation-assisted exercise following a spinal cord injury is effective in improving muscle strength, preventing injury and increasing independence in all phases of rehabilitation. Augmented feedback does not improve motor function of the upper extremity in SCI rehabilitation patients. Intrathecal baclofen may be an effective intervention for upper extremity hypertonia of spinal cord origin. Afferent inputs in the form of sensory stimulation associated with repetitive movement and peripheral nerve stimulation may induce beneficial cortical neuroplasticity. Restorative therapy interventions need to be associated with meaningful change in functional motor performance and incorporate technology that is available in the clinic and at home. The use of concomitant auricular and electrical acupuncture therapies when implemented early in acute spinal cord injured persons may contribute to neurologic and functional recoveries in spinal cord injured individuals with ASIA A and B. There is clinical and intuitive support for the use of splinting for the prevention of joint problems and promotion of function for the tetraplegic hand. However, there is very little research evidence to validate its overall effectiveness. Shoulder exercise and stretching protocol reduces post SCI shoulder pain intensity. Acupuncture and Trager therapy may reduce post-SCI upper limb pain. Prevention of upper limb injury and subsequent pain is critical. Reconstructive surgery appears to improve pinch, grip and elbow extension functions that improve both ADL performance and quality of life in tetraplegia. The use of neuroprostheses appears to have a positive impact on pinch and grip strength and ADL functions in C5-C6 complete tetraplegia, however, access to the devices are limited and continue to be expensive in use.

Table of Contents
5.1 Introduction ......................................................................................................................5-1 5.2 Acute Phase of Rehabilitation ........................................................................................5-2 5.2.1 Exercise and Strengthening............................................................................................5-3 5.3 Augmented Feedback on Motor Functions ...................................................................5-6 5.4 Pharmacological Interventions.......................................................................................5-9 5.5 Restorative Strategies ...................................................................................................5-11 5.5.1 Plasticity of Motor Systems ...........................................................................................5-11 5.5.2 Complimentary Alternative Therapies (CAM) ...............................................................5-13 5.5.3 Splinting of the Hand.....................................................................................................5-14 5.6 Sub Acute Phase of Rehabilitation ..............................................................................5-16 5.6.1 Upper Limb Injuries.......................................................................................................5-16 5.6.1.1 Shoulder Injuries ........................................................................................................5-17 5.6.1.2 Elbow/Wrist and Hand Injuries...................................................................................5-18 5.7 Reconstructive Surgery ................................................................................................5-22 5.7.1 Hand .............................................................................................................................5-22 5.7.2 Elbow Extension ...........................................................................................................5-29 5.7.2.1 Elbow Extension (Biceps to Triceps) .........................................................................5-30 5.7.3 Multiple Reconstructions...............................................................................................5-31 5.8 Neuroprostheses ...........................................................................................................5-35 5.8.1 Types of Neuroprostheses............................................................................................5-36 5.8.1.1 Freehand System.......................................................................................................5-36 5.8.1.2 HandMaster-NMS-1 ...................................................................................................5-42 5.8.1.3 Bionic Glove...............................................................................................................5-43 5.8.1.4 ETHZ-ParaCare System ............................................................................................5-44 5.8.2 Other Surface or Percutaneous Neuroprosthesis Systems ..........................................5-45 5.8.2.1 NEC-FES System ......................................................................................................5-45 5.8.2.2 Neuroprosthesis developed by Rebersek and Vodovik (1973)..................................5-45 5.8.2.3 Belgrade Grasping-Reaching System (BGS).............................................................5-46 5.8.3 Reported Benefits of Neuroprosthesis Use...................................................................5-46 5.8.4 Clinical Results of Neuroprosthesis Use.......................................................................5-46 5.8.5 Challenges in Neuroprosthesis Use..............................................................................5-46 5.9 Summary.........................................................................................................................5-48 References..............................................................................................................................5-50
This review has been prepared based on the scientific and professional information available in 2005. The SCIRE information (print, CD or web site www.icord.org/scire) is provided for informational and educational purposes only. If you have or suspect you have a health problem, you should consult your health care provider. The SCIRE editors, contributors and supporting partners shall not be liable for any damages, claims, liabilities, costs or obligations arising from the use or misuse of this material. Connolly S, Aubut J, Teasell RW, Jarus T (2006). Upper Limb Rehabilitation Following Spinal Cord Injury. In: Eng JJ, Teasell RW, Miller WC, Wolfe DL, Townson AF, Aubut J, Abramson C, Hsieh JTC, Connolly S, editors. Spinal Cord Injury Rehabilitation Evidence. Vancouver, p 5.1-5.58. www.icord.org/scire

Upper Limb Rehabilitation Following Spinal Cord Injury
5.1 Introduction Raineteau and Schwab (2001) defined a spinal cord injury as a lesion within the spinal cord that results in the disruption of nerve fibre bundles that convey ascending sensory and descending motor information. A spinal cord injury (SCI) at the cervical level results in tetraplegia, the loss of hand and upper limb function with impairment or loss of motor and/or sensory function. In incomplete spinal cord injuries, some neural transmissions can still pass through the spinal cord but it is often fragmentary or distorted which leads to additional neurological complications such as chronic pain or spasticity. Tetraplegia results in impairment of function in the arms as well as in the trunk, legs and pelvic organs. Individuals with tetraplegia rely on the use of their hands and upper limbs in order to complete basic activities of daily living such as self-feeding, dressing, bathing and toileting. Mobility needs such as transfers from surface to surface, transitional movements such as rolling, bridging and sit to lying down, crutch walking and wheeled mobility are also completed by using their arms (Snoek et al. 2004). The level at which the injury or lesion occurs and the completeness of the lesion (incomplete or complete) indicate the level of independence of the person (Ditunno1999). The Paralyzed Veterans of America (PVA) have published a clinical practice guideline (CPG), “Outcomes Following Traumatic Spinal Cord Injury: Clinical Practice Guidelines for Health Care Professionals,” that outlines the expected skills and outcomes that a person is expected to acquire and achieve at each significant level of injury (Consortium for Spinal Cord Medicine 1999). As medical care of the spinal cord injured person has improved, life expectancy now approaches the rest of the population. Secondary complications from SCI and aging are ongoing challenges and include pain and upper limb musculoskeletal injuries (Sipski and Richards 2006). Hanson and Franklin (1976) compared sexual function to three other impairments in patients with SCI. 75.7% of the subjects gave the highest priority to upper extremity function. Snoek et al. (2004) surveyed the needs of patients with SCI and found a high impact and high priority for improvement in hand function in tetraplegics comparable to that for bladder and bowel dysfunction. Given the above, the initial care, management, rehabilitation and prevention of injuries in the upper limb of tetraplegics are of great importance in maximizing and maintaining independence. According to Murphy and Chuinard (1998), management and care of the upper limb can be divided into three phases: the acute, the sub acute and the reconstructive phase. The aim of the first two phases is to: prevent complications; to achieve optimal functioning within the limits of the neurological deficit; and to create optimal conditions for the reconstructive phase (Bedbrook 1981; Keith et al. 1991; Curtin 1994; Harvey 1996). In the latter phase, various surgical options and functional electrical stimulation (FES) are available to improve positioning and stabilization of the arm as well as key and palmar grasp function (Waters et al. 1996; Triolo et al. 1996; Johnstone et al. 1988; Snoek et al. 2000; Peckham et al. 2001). In the new clinical practice guidelines by the Consortium for Spinal Cord Medicine (2005) emphasizes prevention of upper limb injuries of tetraplegic individuals in maintaining independence.

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Although, there is no overall consensus regarding the management of the tetraplegic upper limb, Hummel et al. (2005), Snoek et al. (2005) and the Consortium for Spinal Cord Medicine (2005) provide excellent discussions and recommendations. There is agreement that restoration of hand function is an important goal in rehabilitation. It is also worth noting that there are very few upper extremity tests that accurately evaluate upper limb function in this population (van Truijl et al. 2002). Curtin (1994) and Krajnik and Bridle (1992) noted a great inconsistency in evaluation and documentation of the tetraplegic upper limb between therapists. The main focus in rehabilitation of the spinal cord injured person is compensation of functional loss and using those parts of the sensorimotor system, which are still intact (van Truijl et al. 2002). Research findings regarding neuroplasticity and neurological recovery of the spinal cord also include current rehabilitation practices that should focus on strategies to restore function lost after SCI. Several studies have explored increased hand function as a result of reconstructive surgery and/or neuroprothesis. Although these and many other treatment options exist, and have proven to improve the overall functioning and functional independence of the person with tetraplegia, clinical practice has shown that suitable candidates for reconstructive surgery or FES interventions often do not accept the treatment that is offered (Snoek et al. 2004). According to Moberg (1975), over 60% of the tetraplegic population could benefit from reconstructive surgery and it continues to be widely advocated (Snoek et al. 2004). Reconstructive surgeries such as muscle/tendon transpositions of the intact arm or hand muscles are designed to substitute for lost motor function (van Truijl et al. 2002). Despite this, controversy still exists among clinicians as to whether or not to perform reconstructive surgeries and the benefits of reconstructive surgery have not been clarified with good quality randomized clinical trials (Harvey et al. 2001). Gorman et al. (1997) deduced that 11% of the tetraplegic population could be candidates for an implanted FES device (Freehand System). Most implanted FES devices are usually combined with augmentative and substitutional reconstructive surgery (Keith et al. 1996). Using the framework proposed by Murphy and Chuinard (1998), this chapter will be divided into the following sections: acute phase of rehabilitation, sub acute phase of rehabilitation and reconstructive phase. 5.2 Acute Phase of Rehabilitation Rehabilitation and management of the person with a spinal cord injury requires an interdisciplinary team approach during the acute phase of rehabilitation. The level and classification of the injury is determined and the goals of maintaining range of motion (ROM), improving strength, managing tone, spasticity, and the prevention of secondary complications in order to achieve the person’s maximum functional ability for independent transfers, activities of daily living and mobility are developed (Haisma et al. 2006; Sipski and Richards 2006; Drolet et al. 1999). Clinicians must be knowledgeable about the change in physical capacity based on level of injury as a prerequisite to developing optimal rehabilitation programs and for setting realistic individual rehabilitation goals.

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5.2.1 Exercise and Strengthening In the acute phase of rehabilitation, the person with a spinal cord injury has a reduced physical capacity because of muscle weakness, loss of autonomic control below the level of injury, reduced activity and subsequent changes in metabolic and vascular function (Haisma et al. 2006). The inability to reach one’s maximum potential will result in an increased risk of medical and secondary complications and has been correlated to a reduced level of functioning and quality of life. One of the important goals of rehabilitation is to reverse the debilitative cycle of reduced physical capacity that leads to reduced activity and functioning (Haisma et al. 2006). With shorter hospital lengths of stay, spinal cord injured person have less training opportunities. It is important to determine whether people with SCI can maintain their levels of physical capacity after discharge. There are very few evidence-based analyses of the effectiveness of specific exercise therapies (Sipski and Richards 2006). Most research has only focused on one component of physical capacity (e.g., peak oxygen uptake [VO2 peak] or muscle strength, or respiratory function). Many physical factors have been associated with optimal functional independence individual post-SCI and muscle strength is identified as an important contributor to functional independence (Drolet et al. 1999). Studies by Noreau et al. (1993), Marciello et al. (1995) and Durand et al. (1996) all noted a correlation between the level of the lesion, performance in functional abilities in relationship to peak oxygen intake and level of muscle strength. These associations were significant in individuals with tetraplegia especially in areas of sitting balance, spasticity of the lower limb, hand-grip strength, wrist extensor strength and global upper extremity strength. These functional areas have also been related to Functional Independence Measure (FIM) motor and self-care scores. It was also identified that upper extremity strength must be adequate to support the body weight during transfers and lower limb strength for walking. Optimal recovery of muscle strength following a spinal cord injury is an essential objective of functional rehabilitation of individuals with a SCI (Drolet et al. 1999). Changes in motor function observed six months after an injury may be partially explained by collateral sprouting within the spinal cord (Mange et al. 1990). Changes between 2 to 8 months may be related to peripheral nerve sprouting and muscle fiber hypertrophy after partial denervation (Mange et al. 1990; Yang et al. 1990). Natural muscle strength recovery may occur up to two years post injury, with the recovery rate being more important for the first six months as measured by manual muscle testing (Ditunno et al. 1992; Mange et al. 1992; Waters et al. 1993). Muscle strength gains have been attributed to two different mechanisms in healthy subjects. In healthy subjects, short-term gains (2-4 weeks) might be explained by improved capacity to recruit motor units (neural adaptation) and gains observed after 4 weeks have been attributed to morphological changes within the contractile tissue inducing muscle fiber hypertrophy (Sale 1988). Additional studies regarding cardiovascular and exercise interventions will be discussed in another chapter. Table 5.1 Exercise and Strengthening
Author Year; Country Score Research Design Total Sample Size Needham-Shrophire et al. 1997;USA/CA Pedro=8 RCT Methods Population: age 18-45yrs, gender m=31, f=3, tetraplegia, time since injurymean=3yrs. Treatment: Subjects randomly assigned to 1. Outcome No significant difference was found at the 4-week evaluation between Groups 1 and 2 (p=0.22) or between Groups 2 and 3 (p=0.07).

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Author Year; Country Score Research Design Total Sample Size Initial N=43; Final N=32

Methods one of three groups: Group 1 – received 8 wks of neuromuscular stimulation (NMS) assisted arm ergometry exercise Group 2 – received 4 wks of NMS assisted exercise, then 4 wks of voluntary arm crank exercise Group 3 (control group) - voluntarily exercise for 8 wks without the application on NMS. Outcome Measures: Manual muscle test. Population: age19-65 yrs; C4-L1; ASIA AD; 1-24 yrs duration Treatment: Experimental group (EX) participated in progressive exercise training twice weekly for 9 months-each session offered on alternative days lasing 90-120 minutes. Outcome Measures: Perceived stress scale, muscle strength, depression, physical self-concept pain, perceived health and Q of L were assessed 2.

Outcome Subjects in Group 1 had a higher proportion of muscles improving one or more muscle grades after 4 weeks of NMS cycling compared with Group 3 (p<0.003). Following the second 4 weeks of training, a significant difference was found between Groups 1 and 3 (p<0.0005) and between Groups 2 and 3 (p<0.03). No statistically difference was found between Groups1 and 2 (p=0.15). Overall 11 in the ex group (exercise adherence 82.5%) and 13 in the control group completed the study No sign differences were noted between the two groups at baseline Following training, EX gr. had significant increases in sub maximal arm ergometry power output (81%; p<0.05) and significant increases in upper body muscle strength (19-34%; p<0.05) EX gr. reported less pain, stress and depression after training + scored higher than CON in indices of satisfaction with physical function, level of perceived health + overall quality of life (p<0.05) Age was related to the PO peak and handheld dynamometry (HHD) score (p<0.05), the older the subject the more improvement in either of these measures was significantly less than it was in younger subjects. Men had greater PO peak, VO2peak and HHD score than women did (p<0.05), thus improvement in men was greater than women. In tetraplegia subjects the PO peak, VO2peak, muscle strength and % of forced vital capacity (FVC) was lower (p<0.05) than it was in paraplegics but tetraplegics improved more in muscle strength and % of forced expiratory flow (FEV1). Those with a complete lesion had greater HHD score and lower % of FVC than those with incomplete lesions (p<0.05). Strength values at admittance were inversely repeated to strengthen changes during rehab (Pearson correlation coefficients ranging from .47 (p=.001 shoulder flexors) to -.73 (p<.001 shoulder adductors). For those with paraplegia the range was from -.48 (p=0.049 shoulder

3.

4. 1. 2. 3.

Hicks et al. 2003; Canada Downs & Black score=20 PEDro=7 RCT Initial N=34; Final N=11

4.

Haisma et al. 2006; Netherlands Downs & Black score=13 Cohort Initial N=186; Final N=42

Population: Age: approx 40 yrs, Gender: 75% male, Level of Injury: both para and tetraplegia; Injury completeness: approx 67.5% complete injuries; Time since injury: approx 105 days Treatment: No treatment provided Outcome Measures: Power output (PO) peak, VO2 peak, strength of upper extremity, respiratory function

1.

2.

3.

4.

Drolet et al. 1999; CA Downs & Black score=15 Pre-post Initial N=40; Final N=31

Population: Gender: m=27, f=4; Age: approx 29.5yrs; ASIA: A-D; length of stay: approx 4.5 months; time since injury: approx 2 months Treatment: Rehab included PT, OT and physical conditioning. There were 4 1hr sessions of each intervention Outcome Measures: Meaning muscle

1.

2.

5-4

Author Year; Country Score Research Design Total Sample Size

Methods strength was assessed for 6 muscle groups 4 times. Muscle strength changes during & after functional rehab

Outcome abductors to -.72 (p=.001 elbow flexors) compared to those with tetraplegia, the correlation coefficients ranged from -.28 (p=.345 elbow extensors) to -.68 (p=.010 shoulder adductors). Patterns of change in muscle strength from admittance to the 15 month follow up differed between the 2 groups. Differences in strength have been observed for: elbow flexors (p=.001) and shoulder extensors (p=0.04) All subjects showed improvement in one or more of their manual muscle score with the most dramatic occurring in the tricep muscle group (average increase 1.1 +/- 0.2 for L triceps, 0.7 +/- 0.1 for R) Results show NMS in combination with resistive exercise can be used safely and assists in the strengthening of voluntary contractions

3. 4. Population: Gender m=10, f=1, age 1845yrs, >1yr post injury, level of injury C4C7, neurologically stable Treatment: Testing of hybrid device, 8 wks of NMS assisted exercise with training sessions 3x/wk Outcome Measures: Manual muscle test scores biceps, triceps, wrist flexors and extensors. 1.

Cameron et al. 1998; USA Downs & Black score=9 Case Series N=11

2.

Discussion The five studies presented address the long-term change of upper limb strength after the spinal cord injured person has returned to community living. Needham-Shophire et al. (1997) found that Neuromuscular stimulation (NMS)-assisted exercise ergometry alone and in combination with voluntary arm crank exercise was effective for strengthening of the upper limb for SCI injured individuals well after injury (mean time since injury 3 years). Hicks et al. (2003) demonstrated all study participants had progressive increases in muscle strength in each of the muscle groups tested and that the change scores were significant from the control group except for the left anterior deltoid. Study participants self-reported decreases in stress, pain, depression, enhanced physical self-concept and overall quality of life. Drolet et al. (1999) conducted one of the first longitudinal studies published in muscle strength changes in individuals with SCI during rehabilitation. Significant improvement of muscle strength during rehabilitation for individuals with both paraplegia and tetraplegia was noted. Significant improvements were noted at the three-month post discharge evaluation period with the tetraplegia group in the four muscle groups (elbow flexors and extensors and shoulder flexors and extensors) and then began to plateau. One year later elbow flexors showed significant improvement in both paraplegia and tetraplegia groups and shoulder extension showed significant gains only on individuals with paraplegia. Large variability was noted indicating the recovery of strength maybe influenced by a variety of individual factors such as level and severity of injury, associated health conditions, age, gender, motivation and physical condition before SCI. Improvements in strength realized in rehabilitation continue to be maintained or improved when the person with a SCI returned to community living.

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Haisma et al. (2006) found positive changes in the different components of physical capacity both during and after inpatient rehabilitation. SCI subjects continued to improve and this study illustrates the importance of regularly assessing the physical capacity of people with SCI after discharge. It is important to create conditions (education, exercise facilities) that facilitate further improvements (Haisma et al. 2006). Cameron et al. (1998) also reported improvements in upper limb strengths in combination with neuromuscular stimulation. Haisma et al. (2006) and Sipski and Richards (2006) recommended further research in this area: • Further research is needed to document benefits of exercise interventions post-SCI including optimal methods for strengthening muscles, merits of endurance versus strength training, range of motion, gait, ADL, and transfer training. • Due to impact of body composition, age, concomitant medical problems and our limited knowledge of recovery post SCI, research needs to be performed through well-designed multicentre trials. Longitudinal studies are needed to gain more insight into the changes that occur after inpatient rehabilitation and the factors which influence these changes. Exercise and strengthening of the upper limb in both the acute and subacute phase of rehabilitation are important in promoting independence and prevention of injury.

• •

Conclusions For exercise and strengthening of the SCI individual following injury: There is level 1 evidence based on one RCT that physical capacity continues to improve after 1- year post discharge. There is level 2 evidence based on one pre/post study that neuromuscular stimulationassisted ergometry alone and in conjunction with voluntary arm crank exercise was an effective strengthening intervention for chronically injured individuals. There is level 2 evidence based on one study that muscle strength continues to improve up to 15 months post hospital discharge for both tetraplegic and paraplegic individuals. There is level 4 evidence based on one study that neuromuscular stimulation-assisted exercise improves muscle strength over conventional therapy. Neuromuscular stimulation-assisted exercise following a spinal cord injury is effective in improving muscle strength, preventing injury and increasing independence in all phases of rehabilitation. 5.3 Augmented Feedback on Motor Functions Several studies have addressed the use of augmented feedback such as biofeedback with spinal cord injured populations. Van Dijk et al. (2005) conducted a systematic review of RCTs on the effect of augmented feedback on motor function of the affected upper extremity in

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rehabilitation patients. Much of the information about augmented feedback comes from the motor learning literature where it has been noted that feedback combined with practice is a potent variable for affecting motor skill learning (Newell 1991; Schmidt and Lee 1999). There are two types of performance-related information or feedback. The first type of feedback, task intrinsic or inherent feedback, is sensory-perceptual information and is a natural part of performing a skill. The second type of feedback is augmented feedback or information-based extrinsic or artificial feedback. Augmented feedback refers to enhancing task intrinsic feedback with an external source (Schmidt et al. 1999; Magill 2001), such as a therapist or device (biofeedback or timer) (van Dijk et al. 2005). It has been suggested that augmented feedback may have practical implications for rehabilitation therapy since re-acquisition of motor skills is an important part of functional motor recovery (Winstein 1991; Kilduski and Rice 2003; Jarus 1994; Jarus and Ratzon 2005). The ability to use intrinsic feedback to guide performance is impaired in patients with cognitive and perceptual impairments (Flinn and Radomski 2002). In persons who are compromised by neurological sensory impairments, augmented feedback is important (Sabari 2001). van Dijk et al. (2005) systematic review found three randomized clinical control trials which studied augmentative feedback in the SCI population (Klose et al. 1993; Klose et al. 1990 and Kohlmeyer et al.1996). In our literature search we were able to find an additional two other studies with lower level of evidence that studied augmented feedback applications. Table 5.2 Augmented Feedback on Motor Functions
Author Year; Country Score Research Design Total Sample Size Methods Population: Gender m=40, f=5, age mean=39yrs, injury level C4 –C6, complete & incomplete injuries, Treatment: Extremities were randomly assigned to 1 of 4 treatment groups: 1. conventional strengthening; 2. electrical stimulation; 3. biofeedback and electrical stimulation; 4. biofeedback. Participation ranged from 5 to 6 weeks post SCI Outcome Measures: manual muscle testscoring and ADL performance 1. Outcome Comparison of Groups (Increment or Decrement or No Change): no relationship between treatment group and observed change; no treatment produced a significantly higher proportion of individuals that improved relative to the proportion showing no change or a decrement; no change between treatment groups. Influence of Initial Muscle Grade: a correlation between the initial muscle grade and increment in muscle grade was seen at the end of treatment; poorer initial muscle grades, more likely to see a larger increment in muscle grade as a result of treatment. Conclusion-biofeedback and electrical stimulation both alone + together did not prove to be more effective than standard therapy for wrist extensor recovery during the acute phase of rehabilitation A great deal of variance between participants in most measures due to low numbers of subjects, no significant differences was found between the Control and Intervention groups.

Kohlmeyer et al. 1996; USA PEDro=10 RCT Initial N=60; Final N=45

2.

3.

Popovic et al. 2005; Canada PEDro=6 RCT N=21

Population: Age: 25-70; ASIA A-D incomplete; Time Since Injury: 15-243 days; acute/subacute; tetraplegic Treatment: The control group received conventional Occupational Therapy; Intervention group received Functional Electrical Therapy and conventional Occupational Therapy

1.

5-7

Author Year; Country Score Research Design Total Sample Size

Methods Outcome Measures: Functional Independence Measure (FIM); Spinal Cord Independence Measure (SCIM); Rehabilitation Engineering Laboratory Hand Function Test (REL Test); Consumer Perceptions. Population: Age 18 to 35 yrs, Gender m=24, f=4, level of injury C5-C7, at least 1yr post injury Treatment: Both groups received 45 mins of aggressive exercise therapy 3/wk for 12 weeks along with 30 min of neuromuscular stimulation to assist with upper extremity muscle strength. EX group also received 12 wks of 30 min EMG biofeedback 3/wk. Outcome Measures: Manual muscle test, functional activities score Population: Age 18-45 yrs, level of injury C4-C6, incomplete injury, at least 1yr post injury Treatment: All received 3days/wk of therapy in 2 consecutive eight week treatment blocks. Treatment blocks were as follows; Group 1: Biofeedback followed by supervised physical therapy exercise (PET) Group 2: Biofeedback followed by neuromuscular stimulation (NMS) Group 3: NMS followed by PET Group 4: 16 weeks PET Outcome Measures: Manual muscle test assessed the biceps, triceps, wrist flexors and wrist extensors. Self care measures looking at feeding, hygiene and dressing. Mobility measure and a muscle electrical activity were also measured Population: Gender m=81, f=19, injury level C2-C6, age 17-63yrs, time since injury 1-29.7yrs. Treatment: EMG biofeedback treatment sessions. Outcome Measures: EMG scores.

Outcome

1.

Klose et al. 1993; USA PEDro=5 RCT Initial N=31; Final N=28

2.

Scores after training indicated no significant differences for the muscle test score and functional activities score between groups. Analysis of the repeated measures factor showed a significant change (p<0.05) for the manual muscle test (F=25.17, df=2, 52) and functional activities score (F=8, 86, df=2, 52). No statistically significant differences were noted between the groups. Differences were noted for the repeated measures of mobility, selfcare, and the left arm muscle test scores (p<0.05). The repeated measures factor was statistically significant in all of the analyses looking at measures of physical function (p<0.01) but not in those that compared EMG values.

1. 2.

3.

Klose et al. 1990; USA PEDro=3 RCT Initial N=43; Final N=39

1.

Brucker & Bulaeva 1996; USA Downs & Black score=18 Pre-post N=100

2.

3.

T-test analysis of the differences before and after initial biofeedback treatment an increase of 19.21% of normal EMG scores for right triceps and increase of 19.59% of normal EMG scores from the left triceps from one biofeedback treatment session, significant (p<.001). T-test analysis of the difference from before initial biofeedback treatments to after additional treatments, increase in percentage of normal EMG scores of 41.55% right triceps and 38.31% left triceps, significant (p<.001). Increases in percentage of normal EMG scores after initial biofeedback treatment to after additional biofeedback treatment 22.3% right triceps and 18.72% for left triceps, significant (p<.001). Correlation coefficient for manual muscle test score and EMG pretest before initial treatment was r=.569 for

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Author Year; Country Score Research Design Total Sample Size

Methods

Outcome right triceps and r=.437 for left triceps, significant (p<.001). Increases in percentage of normal EMG before, after, and after additional treatments was significant in right and left triceps regardless of initial manual muscle test.

4.

Discussion All of the studies concluded that there was no firm evidence of the effectiveness of the use of augmented feedback to improve arm function in rehabilitation. van Dijk et al. (2005) in their systematic review recommended the following be considered in future research in this area: • • future studies need to focus on content, form and timing of the augmented feedback to clarify its importance in rehabilitation studies should recognize the difference between performance and learning effects concerning reacquisition of motor skills by re-examining the study population after a follow up period

Conclusion There is level 1 evidence (from 2 RCTs) that augmented feedback is not effective in improving upper limb function in tetraplegia. Augmented feedback does not improve motor function of the upper extremity in SCI rehabilitation patients.

5.4 Pharmacological Interventions Cervical injuries of the spinal cord frequently lead to hypertonia characterized by disabling spasticity and dystonia involving the upper and lower limb. Spasticity has been defined by Lance (1980) as “a velocity exaggerated increase in the tonic stretch reflexes (muscle tone) resulting from hyperactivity of the stretch reflex.” The EU-SPASM Thematic Network or Consortium (Support Network for the Assembly of Database for Spasticity Measurement) has presented an updated definition of spasticity that reflects a recent research findings and current clinical interpretations. Spasticity has been re-defined as “disordered sensori-motor control, resulting from an upper motor neurone lesion, presenting as intermittent or sustained involuntary activation of muscles” (Pandyan et al. 2005).

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Table 5.3 Pharmacological Interventions
Author Year; Country Score Research Design Total Sample Size Methods Population: age 25-64yrs, injury level C4C7, ASIA A-D, length of time since injury 1.2-24yrs. Treatment: Intrathecal baclofen. Outcome Measures: Ashworth Scale; Spasm Frequency Scale; Reflex Scale 1. 2. Outcome Significant decline in UE hypertonia during 12 month follow up period. Average baseline Ashworth score was 2.4 ± 1.1 (SD) compared to 1.8 ± 1.0 (SD) at 12 months (P<0.0001, Friedman). The average spasm score decreased from 2.3 ± 1.6 (SD) to 0.5 ± 0.9 (SD), not significant at P=0.2503 (Friedman test). The difference was significant (P=0.0012 Wilcoxon signed rank test). UE reflexes, average baseline reflex score was 2.3 ± 0.2 (SD) compared to 0.9± 0.2 (SD) at 12 months (P<0.0001 Friedman). Dosage requirements increased during the 12-month follow-up period, statistically significant (P<0.0001, Friedman). Statistically significant declines in upper extremity spasm scores (1.8 points, p=0.012), reflex scores (1.4 points, P<0.0001) and Ashworth scores (0.6 points, P<0.0001) for the 1-year follow-up period.

3.

Burns & Meythaler 2001; USA Downs & Black score=16 Case Series N=14

4.

5.

6.

Discussion The management of severe cases of hypertonia can be challenging as it can be refractory to oral medications. Many studies have shown that intrathecal delivery of balcofen has been effective for refractory hypertonia in the lower extremity. Baclofen, 4-amino-3 (p-chlorophenyl) butyric acid works by binding to the inhibitory presynaptic GABA-B receptors in the spinal cord (Meythaler et al. 1999). Intrathecal delivery of the drug facilitates achievement of therapeutic levels in the cerebral spinal fluid (CSF) while minimizing systemic side effects (drowsiness, confusion). Burns and Meythaler (2001) is the only study published which deals with hypertonia involving the upper extremity post-SCI. Further discussion regarding the management of hypertonia can be found in the spasticity chapter. Burns and Meythaler (2001) showed statistically significant decrease in Ashworth (tone) and reflex scores in upper extremity hypertonia due to pathology at the level of the spinal cord. Conclusion There is level 4 evidence that intrathecal baclofen may be an effective treatment for upper extremity hypertonia of spinal cord origin. Intrathecal baclofen may be an effective intervention for upper extremity hypertonia of spinal cord origin.

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5.5 Restorative Strategies 5.5.1 Plasticity of Motor Systems It has been reported that 55% of all spinal cord injured persons are classified as having complete injuries. Through the use of magnetic resonance imaging (MRI) and histopathology indicates that approximately 65% of the traumatic injuries initially classified as ‘neurologically complete’ (absence of sensory and motor function in lowest sacral segment) show some tissue and axonal sparing across the lesion (Bunge et al. 1997). It is now accepted that the CNS is capable of substantial reorganization, especially in incomplete SCI because cortical, sub cortical and much of the local spinal cord circuitry remains largely intact and still partially interconnected by unlesioned fibres (Raineteau et al. 2001). Information may still pass through the level of the lesion on spared fiber tracts but the information maybe fragmented or distorted (Beekhuizen et al. 2005). Functional recovery can occur for several years after injury in incomplete spinal cord injury, with the degree of recovery dependent upon the reorganization of circuits that have been spared by the lesion (Green et al. 1999). Cortical reorganization occurs after SCI with evidence that the sensorimotor cortex may play a role in the recovery of function in individuals with SCI (Green et al. 1999). Results of neuroimaging and neurophysiological techniques (functional magnetic resonance imaging (fMRI), transcranial magnetic stimulation (TMS) and positron emission tomography (PET) demonstrate that changes occur in the cortex following damage to the spinal cord with expansion of cortical areas corresponding to muscles spared after SCI into the cortical areas previously associated with control of muscle reinnervated at spinal cord levels below the level of the lesion (Raineteau et al. 2001; Bruehlmeier et al. 1998; Cohen et al. 1991; Levy et al. 1990). In ISCI, reorganization might occur at two levels; in pre-existing circuits by modifications of synaptic strength (synaptic plasticity) or by new circuits through sprouting or anatomical reorganization, including growth of axonal branches and dendrites (anatomical plasticity) (Raineteau et al. 2001). Laboratory work is currently explaining and researching cortical reorganization, cortical plasticity, sub cortical plasticity, plasticity at the red nucleus, plasticity and spontaneous adaptation of the central pattern generators (CPG) and plasticity of unlesioned descending pathways. The strengthening and weakening of synapses, axonal and dendritic sprouting can occur at different levels of motor system in response to spinal cord lesions, in the cortex, the brainstem, and the spinal descending pathways and in the intraspinal circuits. All interact with each other; therefore it is difficult to interpret functional recovery processes. A spinal cord injury interrupts distinct descending fibre populations. The overall complexity of an incomplete spinal cord injury resides first in the organization of descending spinal tracts. Most of the descending systems terminate on spinal interneurons, but some direct excitatory or inhibitory connections to motor neurons also exist. Different tracts are involved in specific functions. For example, lesions of the cortical and rubrospinal systems lead to more severe and longer lasting deficits for movement of the distal extremities and lesions of the reticulo and vestibulospinal systems affect movements of proximal and axial muscles. Functional outcomes of given spinal cord lesions therefore depends on type of fibres that are interrupted (Raineteau et al. 2001). Functional reorganization is based on two mechanisms; synaptic plasticity in pre-existing circuits and sprouting and anatomical reorganization that leads to the formation of new circuits. The study of animal models provides further understanding of rehabilitation treatments and development of new therapeutic approaches for people with spinal cord injury (Raineteau et al. 2001).

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Two studies were found that tested the use of massed practice, a form of constraint therapy, and repetitive transcranial magnetic stimulation (rTMS) in changing the cortex. Table 4: Restorative Strategies
Author Year; Country Score Research Design Total Sample Size Methods Population: Age: range 22-63 yrs; Gender: m=9, f=1; ASIA score: C N=4, D N=6; Level of injury: C5-C7: time since injury: 12 to 154 mths Treatment: Subjects participated in 2h of massed practice (MP) therapy 5/wk for 3 wks or MP+median nerve somatosensory stimulation (SS). Massed practice training focused on continuous repetitions of the following: gross upper extremity movement, grip, and grip with rotation, pinch and pinch with rotation. Tasks in each block were performed for 25 min before moving to the next category. Outcome Measures: Maximal pinch grip force, Wolf motor function test timed task scores, Jebson hand function test scores, stimulus intensity required to elicit motor threshold response in muscles, and motor evoked potentials amplitude. 1. 2. 3. Outcome Pinch grip scores: differences were noted in the MP+SS group (Z=-2.023, p<0.05) only. The MP+SS group also showed greater increase in pinch grip strength than the MP group (U=2.0, p<0.05). Upper extremity Functional tests: the Pre/post Wolf Motor Function Test timed scores in the MP+SS group showed a difference (Z=-2.023, p<0.05). No statistical differences were noted for the MP group. Timed test scores between the 2 groups were also found to be statistically different (U=1.0, p<0.05). Jebsen test scores: pre and posttest scores were different for the MP+SS group (Z=-2.023, p<0.05). The MP+SS group showed greater improvement than the MP group (U=3.0, p<0.05). Cortical Excitability: No significant differences were noted between the 2 groups. No difference between patients when looking at the assessments done after baseline and after sham intervention. The level of intracortical inhibition was reduced to 37.5 ± 8.0% of pretreatment levels during the week of therapeutic treatment (p<0.05) and returned to 90.2 ± 15% of pretreatment levels during the follow-up period. This was linked to improvements in clinical measures of both motor and pinprick of 4-10% during treatment week. (p<0.05). Subjects also improved perceptual threshold to electrical stimulation of the skin and peg board test scores (p<0.05)

Beekhuizen and FieldFote 2005; USA PEDro=8 RCT N=10

4. 5.

6. Population: gender m=3, f=1, age 4154yrs, time since injury 1.25-8yrs, lesion level C5, ASIA-D Treatment: 5 days of sham repetitive transcranial magnetic stimulation (rTMS) followed by 5 days of therapeutic stimulation (rTMS) Outcome Measures: electrophysiological, clinical - sensory + motor function (ASIA) & Functional - 9 Hole Peg Board 1. 2.

Belci et al. 2004; UK Downs & Black score=13 Prospective Controlled Trail N=4

3.

4.

Discussion Beekhuisen et al. (2005) suggested that massed practice or constraint-induced therapy promotes cortical reorganization that may be an effective rehabilitative tool for improving strength and function in individuals with cervical spinal cord injury. Improvement may be further enhanced by the addition of somatosensory stimulation. Belci et al. 2004 observed clinical changes consistent with the concept that reduced corticospinal inhibition can facilitate functional recovery. Recovery involved increased ASIA

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sensory and motor scores, improved response to cutaneous electrical stimulation over the thenar muscles and possibly improved hand/finger function. This preliminary study demonstrated rTMS treatment in patients with chronic stable incomplete spinal cord injury can produce reductions in corticospinal inhibition detectable using electrophysiological techniques. Additional research studies with appropriate controls are needed to confirm the overall effectiveness of the intervention. There is lack of studies evaluating the efficacy of restorative strategies. In order for these therapies to be successful in everyday clinical practice, the therapy interventions need to be associated with meaningful changes in functional motor performance and incorporate techniques that are available in the clinic and at home (Beekhuizen et al. 2005). Conclusion There is level 1 evidence from one RCT that showed that massed practice (repetitive activity) and somatosensory stimulation (median nerve stimulation) demonstrated significant improvement in grip and pinch strength required for functional activity use. There is level 2 evidence from a before/after study that showed that rTMs treatment in individuals with chronic stable ISCI may produce reductions in corticospinal inhibition that resulted in clinical and functional changes for several weeks after treatment. Afferent inputs in the form of sensory stimulation associated with repetitive movement and peripheral nerve stimulation may induce beneficial cortical neuroplasticity. Restorative therapy interventions need to be associated with meaningful change in functional motor performance and incorporate technology that is available in the clinic and at home. 5.5.2 Complimentary Alternative Therapies (CAM) Acupuncture is an ancient Chinese therapy practiced for more than 2500 years to cure disease and relieve pain (Lee et al. 1990). There are 361 identified acupoints that have been formed into a network of 14 channels called the meridians. Acupuncture therapy has been shown to be effective in improving functional outcomes in hemiplegic stroke patients and in paraplegic spinal cord injured patients (Cheng et al. 1998). In electrical acupuncture therapy, electrical stimulation is provided directly to the acupoint areas. It has been speculated that acupuncture therapy through the correct acupoints and meridians in the acute spinal cord injury episode will assist in the minimization of posttraumatic cord shrinkage and sparing of the ventral horn neurons (Politis et al. 1990; Ran et al. 1992; Tsay 1974; Wu 1990). Table 5.5 Complimentary Alternative Therapies (CAM)
Author Year; Country Score Research Design Total Sample Size Wong et al. 2003; Taiwan PEDro=5 RCT N=100 Methods Population: Age mean=35, gender m=80, f=20, ASIA A-B, tetraplegia (37)/quadriplegia (63). Time since injury: acute, admission to ER after injury Treatment: Acupuncture was administered to the treatment group via 4 x 5 cm 1. Outcome Acupuncture group - sensory, motor + FIM scores improved significantly day of D/C + 1yr after injury (p<0.05). Control group - only motor score significant improvement at 1yr post injury F/U p=0.023

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Author Year; Country Score Research Design Total Sample Size

Methods adhesive surface electrodes at the acupoints of bilateral Hou Has (S13) and Shen Mo (B62). Frequency was set at 75 hz with a pulse duration of 200 usec and the magnitude of stimulation was set at 10 mV Outcome Measures: ASIA (sensory + motor), FIM, before + after therapy 2.

Outcome Comparison of ASIA + FIM scores of both groups not at admission; D/C + 1yr post significant improvement ASIA + FIM in acupuncture vs. control p<0.05 More patients in acupuncture group improved to ASIA grade B + C or better at D/C + 1yr post p<0.05

3.

Discussion With acupuncture thin metal needles are inserted into specific body sites and slowly twisted manually or stimulated electrically. The uncomfortable pain sensation or de qi, a prerequisite for effective acupuncture therapy, is induced by needle manipulation (Wong et al. 2003). The randomized control trial by Wong et al. (2003), studied the use of electrical acupuncture therapy through adhesive surface electrodes and concomitant auricular acupuncture therapy in improving the neurologic or functional recovery in acute traumatic spinal cord injury patients. The study demonstrated that in the acupuncture group all sensory, motor and FIM scores improved significantly when examined on the day of discharge from hospital and one year after injury (p<0.05). The control group (auricular acupuncture) demonstrated only significant improvement in motor score at one-year post injury follow up (p=0.023). At discharge and at one year post injury follow up, the acupuncture group revealed significant improvement in all ASIA and FIM scores when compared to the control group (p<0.05). An inherent bias may have been introduced into this study as the reviewer who assessed the participants was not blinded to the group assignment. Conclusion There is level 2 evidence from one RCT that showed that the use of concomitant auricular and electrical acupuncture therapy may improve the neurological and functional recovery of acutely injured spinal cord individuals. The use of concomitant auricular and electrical acupuncture therapies when implemented early in acute spinal cord injured persons may contribute to neurologic and functional recoveries in spinal cord injured individuals with ASIA A and B.

5.5.3 Splinting of the Hand Splinting of the hand in the management of tetraplegia is a well-accepted therapy intervention and has been an accepted practice for many years in the management of SCI especially in the acute phase of injury (Curtin1994; Krajnik and Bridle1992). The therapeutic goals of splinting are immobilization, protection and support of the joints of the wrist and hand, prevention of joint malalignment, prevention and reduction of soft tissue shortening and contractures, prevention of soft tissue overstretch, counteracting hypertrophic scars, support of weak muscles, improvement of function and pain relief (Paternostro-Sluga and Stieger 2004; Curtin1994; Krajnik and Bridle 1992). There are four most common static hand splints for tetraplegic

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patients; resting pan or paddle splints, wrist extension splints (Futuro-type splint, long opponens splint and dorsal cock-up splint and spiral splint), short hand splints and tenodesis splints (Curtin 1994). Table 5.6 Splinting of the Hand
Author Year; Country Score Level Total Sample Size Methods Population: Age 18 to 42 yrs, gender m=12, f=1, time since injury 6–8wks Treatment: EX gr. was given long or short orthosis to be worn at night (8hrs) as soon as the subject could tolerate it. Outcome Measure: pinch strength and functional activity use DiPasquale-Lehnerz 1994; USA Pedro=4 RCT Initial N=13; Final N=9 1. Outcome No significant differences were noted between the 2 groups-all subjects demonstrated improvement in hand function and pinch strength. At 8 weeks the 13 subjects showed improvement in their performance on the checkers subtest (F=10.32, df=1, 11, p<0.01), simulated feeding subtest (F=7.58, df=1, 11, p<0.01), and the large light object subtest (F=5.49, df=1, 11, p<0.01). At the 12-week marker, improvement could be seen on the card subtest (F=3.94, df=2, 14, p<0.05). An increase in pinch strength was noted at 8 weeks for all subjects (F=4.41, df=1,11, p<0.05) and at 12 weeks 9 remaining subjects (F=4.46, df=2,14, p<0.05)

2.

3. 4.

Discussion Even though splinting and orthotic fabrication is an accepted practice, there is minimal research data on the effectiveness of this intervention (DiPasquale-Lehnerz 1994; Krajnik and Bridle 1992), although there are numerous anecdotal descriptions of orthotic devices and rationales for orthotic intervention (DiPasquale-Lehnerz 1994). Curtin (1994) and Krajnik and Bridle (1992) also found formal assessments were often not done due to; a lack of time and staff shortages; inconsistent documentation; absence of standardized tests available for spinal cord injured patients; limited funding to purchase equipment; and/or patient declined to participate in formal assessments due to boredom and frustration. Krajnik and Bridle (1992) noted that therapists considered observation of the patient when involved in a functional activity as the most informative assessment although this was not an objective means of documenting a patient’s status and progress. There appears to be a variety of splints made for similar purposes because there is little research as to what splint is best for the level and stage of SCI (Krajnik and Bridle 1992). In Paternostro-Sluga and Stieger’s (2004) review, the therapeutic aims of splinting and the choice of splint depend on the disease and the individual functional problem resulting from the impairment. These authors also concluded that there is insufficient evidence from clinical trials on splinting strategies in CP or spinal cord injury patients. The studies also referred to research looking at hand splints for clients with an acquired brain injury or stroke (Rose and Shah 1987; McPherson et al. 1982). In the only study which met criteria for our review, by DiPasquale-Lehnerz (1994) noted that there was no significant improvement in hand function as it related to passive range of motion, strength of prehension or coordination in subjects with C6 tetraplegia who wore a thumb

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opponens orthoses during sleep as compared to those subjects with C6 tetraplegia who did not wear such an orthosis. The study did show over time a significant improvement of hand function especially pinch strength, and functional use (turning cards, picking up small objects, simulated feeding and holding onto light cans) for those wearing the splint. There are several published surveys that addressed the use of splints in the spinal cord population with the majority of splints being functional use splints (i.e., feeding splint, writing splint, typing splint or an application for an assistive device) (Krajnik and Bridle 1992; Garber and Gregoria 1990). More research is needed in this area. Conclusion There is level 2 evidence based on one RCT that wearing a thumb opponens splint will improve pinch strength and functional use of the hand. There is clinical and intuitive support for the use of splinting for the prevention of joint problems and promotion of function for the tetraplegic hand. However, there is very little research evidence to validate its overall effectiveness. 5.6 Sub Acute Phase of Rehabilitation 5.6.1 Upper Limb Injuries A spinal cord injured individual is forced to rely on their upper extremities for their weight bearing activities such as transfers, mobility needs and activities of daily living (ADLs) using limbs that were designed to place hands in space (Dalyan et al. 1999; Dyson-Hudson et al. 2004; Consortium of Spinal Cord Medicine, 2005). Repeated use of the upper limb for weight bearing activities such as manual wheelchair propulsion, transfers, raised ischial pressure reliefs (weight shifts) and reaching from a seated position in the wheelchair in environments designed for nondisabled individuals places a great deal of stress on the bones, joints and soft tissues of the shoulder complex. This places the structures of the upper limb at significant risk for overuse and subsequent injury (Dyson-Hudson et al. 2004). Pain in the early post injury period is typically due to increased demands on anatomically weakened muscles or muscle weakness induced because of deconditioning. Upper limb pain is known to interfere with a wide range of functional activities, transfers, ambulation, pressure relief, self-care (Curtis et al. 1995, Dalyan et al. 1999); many individuals report alternation/cessation of activities critical to functional independence (Pentland and Twomey 1994; Sie et al. 1992). Shoulder pain may be functionally and economically equivalent to a higher level of lesion (Salisbury et al. 2003). Dalyan et al. (1999) reported that of individuals with upper limb pain, 26% needed additional help with functional activities and 28% reported limitations of independence. Subbarao et al. (1994) and Gerhart et al. (1993) reported that individuals with SCI reported that their dependence in personal care assistants fluctuated with upper limb pain and was a major reason for functional decline. The Consortium of Spinal Cord Medicine (2005) has written clinical practice guidelines “Preservation of Upper Limb Function Following Spinal Cord Injury: A Clinical Practice Guideline for Health Care Professionals,” as a way to address upper limb problems.

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5.6.1.1 Shoulder Injuries Upper limb pain and injury are highly prevalent in people with SCI and consequences are significant. The Consortium of Spinal Cord Medicine (2005) and Dyson-Hudson and Kirshblum (2004) reported through surveys and cross-sectional studies that shoulder pain in chronic spinal cord injured persons are common in both paraplegia and tetraplegia at a prevalence of 30-73%. In the acute phase after SCI, shoulder pain is reported in approximately 75% of patients (Silfverskiold and Waters 1991; Waring and Maynard 1991), and 33% to 63% of patients in the chronic phase (>6 months) experience shoulder pain (Nepomuceno et al. 1979; Sie et al. 1992; Silfverskiold and Waters 1991). Curtis et al. (1995), Nichols et al. (1979) and Pentland and Twomey (1991) reported in cross sectional studies that 60-100% of long-term wheelchair users experience shoulder pain. Subbardo et al. (1994) and Sie et al. (1992) reported that there is a high prevalence of shoulder pain during the first year after injury, and in individuals 15-20 years post injury. Pain experienced above the injury level during the first 3-6 months after injury is different than the pain experienced 1 year or more after injury (Apple 2001). Pain above the level of injury in chronically injured person assumes the character of overuse syndromes (Apple 2001). Injury involving the shoulder, elbow, wrist and hand are seen at an earlier age in spinal cord injured individuals than in the general population because of the stresses of weight bearing and mobility that are added to the normal use of the upper limb (Pentland and Twomney 1996). Individuals who are older at the time of injury may experience functional changes earlier than people who are injured at a younger age (Thompson 1999). It is also very difficult to determine whether shoulder pain is a function of duration of SCI or simply a part of the normal aging process (Neer and Walsh 1977). The wide variability in these numbers is most likely a reflection of the heterogeneity of participant populations between the studies with respect to duration of injury, age, neurologic level and severity of injury, as well as body mass index. Small sample size, selection bias and variations in participant populations across the different studies with respect to duration of injury, age, gender and neurological level and severity of injury make it difficult to assess the true prevalence of shoulder pain in individuals with shoulder pain (Pentland and Twomey 1991). The incidence of shoulder pain in acute tetraplegia (<6 months post injury) has been reported to range from 51% to 78% (Salisbury et al. 2003). Nichols et al. (1979) was one of the first groups to report an association between chronic SCI and shoulder pain coining the term “wheelchair user’s shoulder. “ Due to the prevalence of shoulder pain, Curtis et al. (1995) developed a Wheelchair Users’ Shoulder Pain Index (WUSPI) that measures the severity of pain for 14 functional activities.
The following are the many identified risk factors for the development of injury and pain in the upper limb. • • • The shoulder is the most common joint above the level of injury where pain complaints are reported with persons with paralysis (tetraplegia or paraplegia) (Apple 2001). The shoulder is not well designed to handle the higher intra-articular pressures required for both weight bearing and mobility (Apple 2001). Partial innervation and impaired balance of shoulder, scapular and thoracolumbar muscles place individuals with tetraplegia at a higher risk for developing shoulder pain especially during weight-bearing upper limb activities such as wheelchair propulsion, transfers, and pressure reliefs. Due to differences in trunk postural control, differences may also occur between individuals with high paraplegia (T2-T7) and low paraplegia (T8-T12). Individuals with C1-C4 motor levels of injury are also at risk for shoulder pain SCI severity also may be associated with shoulder pain (Dyson-Hudson and Kirshblum 2004).

• • •

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• • • • • • •

Lack of use of immobilization of the shoulder girdle muscles can limit their active joint movement and lead to muscle shortening and shoulder capsule tightness. The development of pain is associated with decreased shoulder ROM Weakness and paralysis in these muscles can lead to increased reliance on the trapezius, which can result in overuse and pain in this muscle. Shoulder pain can occur from nerve root injury or radicular pain with dysesthesias or phantom sensations People of certain age groups, those with higher cervical lesions and those with shorter lengths of bed rest may be at a greater risk Gender may be associated with shoulder pain in individuals with SCI (Pentland and Twomey 1991). Body mass index (BMI) also may play a role in shoulder injuries in manual wheelchair using individuals with SCI because it directly relates to the amount of physical strain experienced during ADLs in these individuals (Boninger et al. 2001; Jensen et al. 1996). Shoulder pain is more common in individuals with tetraplegia and complete injuries and in women and duration of injury, older age, and higher BMI all may be risk factors for developing shoulder pain and/or abnormalities in persons with SCI (Dyson-Hudson and Kirshblum 2004).

5.6.1.2 Elbow/Wrist and Hand Injuries The prevalence of elbow pain and injury has been reported to be between 5-16% (Consortium of Spinal Cord Medicine, 2005); Sie et al. (1992) found 15% and 16% rates of pain localized in the elbow region in persons with tetraplegia and paraplegia. Dalyan et al. (1999) in their study found 35% complained of elbow pain. The prevalence of carpal tunnel syndrome is reported to be between 40-66% (Consortium of Spinal Cord Medicine 2005). There are four studies done by Aljure et al. 1985; Gellman et al. 1988; Schroer et al. 1996, and Sie et al. 1992 that found an association between length of time since injury and prevalence of carpal tunnel syndrome. Some studies also found median nerve damage without clinical symptoms. The most significant activities causing pain in the wrist and hand were propelling a wheelchair and doing transfers (Subbarao et al. 1994). Table 5.7 Shoulder Treatment Interventions
Author Year; Country Score Research Design Total Sample Size Methods Population: Gender: m=18, f=6, age: 2869yrs, time since injury: 5-33 yrs, SCI; length of shoulder pain: 4mths-22yrs. Treatment: Subjects received either acupuncture treatments (sessions lasted 20 to 30 min) or Trager Psychophysical Integration - sessions lasted approx 45 min. Consisted for both table work and mentastic exercises. Outcome Measures: Intake questionnaire (demographics and medical history), Weekly log, Wheelchair users shoulder pain index (WUSPI), Numeric rating scale, Verbal rating scale (VRS), Range of Motion (ROM). 1. Outcome There was a significant effect of time for both treatments on performance corrected (PC)-WUSPI (Acupuncture p<0.001 and Trager p=0.001). Overall a reduction of the PC-WUSPI could be seen when looking at the data from the beginning of treatment to the end for both groups (p<0.05) There was a significant effect of time for both acupuncture and Trager groups for average pain & most severe pain (p<0.01, p<0.001 respectively), for the least severe pain the acupuncture group showed a significant reduction (p<0.01) compared to the Trager group.

2.

Dyson-Hudson et al. 2001; USA PEDro=7 RCT N=21

3.

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Author Year; Country Score Research Design Total Sample Size

Methods 4. Population: age19-65 yrs; TSCI (C4-L1); ASIA A-D; 1-24 yrs duration Treatment: Experimental group participated in a progressive exercise training twice weekly for 9 months-each session offered on alternative days lasing 90-120 minutes. Outcome Measures: Perceived stress scale, muscle strength, depression, physical self-concept pain, perceived health and Q of L were assessed Population: Gender: m=35, f=7, age: mean=35yrs, duration of wheelchair use: mean=24yrs, Injury level: cervical to lumbar, mixed etiology Treatment: Both groups completed the Wheelchair Users Shoulder Pain Index (WUSPI) q2mos x 6mos. The experimental group attended a 60min educational session where they were instructed in 5 shoulder exercises. Outcome Measures: Self report questionnaire (demographic and medical info), Wheelchair User's Shoulder Pain Index (WUSPI), and a visual analog scale (VAS) used to rate intensity of pain. 1.

Outcome Verbal response scores- there was a statistically significant treatment effect for both groups (p=0.001). EX group reported less pain, stress and depression after training + scored higher than CON in indices of satisfaction with physical function, level of perceived health + overall quality of life (p<0.05). Following training, EX gr. had significant increases in sub maximal arm ergometry power output (81%; p<0.05) and significant increases in upper body muscle strength (19-34%; p<0.05) There were no significant differences between control and experimental group in age, years of wheelchair use or activity levels. When looking at the effect of exercise of intervention on performance corrected (PC) WUSPI, a 2 factor repeated measures ANOVA showed a significant effect of time only (p=0.048).

Hicks et al. 2003; Canada PEDro=6 RCT Initial N=32; Final N=24

2.

1.

2.

Curtis et al. 1999; USA PEDro=5 RCT N=42

Discussion Management of established upper limb pain is very difficult and thus prevention is critical. Evidence-based best practice standards have not been established for the medical, rehabilitative or surgical treatment of upper limb injuries in people with spinal cord injury. In addition, there is little consensus among health-care providers on the best treatment practices for upper limb injuries in the general population. In general, musculoskeletal upper limb injuries in the SCI population are managed in a similar fashion as the unimpaired population. Outcome studies of surgical treatment in SCI also very limited. Two small studies report the outcome of rotator cuff repair – one showing relatively poor results (Goldstein et al. 1997) and another study showing relatively good outcomes (Robinson et al. 1993). Both studies recommend non-surgical approaches prior to surgical intervention. One randomized control trial found that supervised exercise produced results similar to arthroscopic surgery for patients with impingement syndrome (Brox et al. 1993), however; this study was not on SCI patients. Exercise has been shown to reduce pain in a randomized control trial in which subtypes of pain were not reported (Hicks et al. 2003). Two studies found an association between restricted ROM and pain, reduced activity and/or injury (Ballinger et al. 2000; Waring and Maynard 1991). A study incorporating stretching into an exercise program for individuals who use manual wheelchairs found stretching exercises were associated with decreased reported pain intensity (Curtis et al. 1999).

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One study demonstrated that acupuncture was no more effective than Trager Treatment in the treatment of shoulder pain (Dyson-Hudson et al. 2001). There are several studies that address the use of complimentary or alternative medicine (CAM) with the spinal cord population, which is used at similar rates to the general population. It was reported that the most common reason CAM was used, was for dissatisfaction with conventional medicine for treatment of chronic pain (Nayak et al. 2001). The only CAM technique evaluated in the SCI population is acupuncture although studies do not provide conclusive evidence of effectiveness (Nayak et al. 2001; DysonHudson et al. 2001; Rapson et al. 2003). Psychological interventions among non-SCI individuals with chronic pain are popular and it has been suggested that selected approaches may be useful for those with SCI (Consortium of Spinal Cord Medicine 2005). Cognitive-behavioural strategies have been found to produce changes in pain experience, increase positive cognitive coping and appraisal skills and reduce pain behaviours (Morley et al. 1999). There are mixed results for the use of relaxation training for relief of chronic pain (Carroll and Seers1998), which may also have secondary beneficial effects on muscle tension and emotional distress (Astin et al. 2002; Luebbert et al. 2001). Cognitive-behavioral interventions have not been subjected to controlled trials as to their effectiveness in the SCI population (Wegener et al. 2001). As identified in the Consortium of Spinal Cord Medicine (2005) document, modification of task performance based on ergonomic analysis has been proven to reduce the incidence of upper limb pain and cumulative trauma disorders of the upper limb in various work settings (Carson 1994; Hoyt 1984; Chatterjee 1992; McKenzie et al. 1985). It is suggested that these same interventions can be used to prevent pain and injury in SCI. Although the number of studies linking activities of individual with SCI to injury may be small, the ergonomics literature provides a strong basis for evidence-based practice.
The Consortium of Spinal Cord Medicine (2005) Clinical Practice Guideline Preservation of Upper Limb Function published the following recommendations regarding the upper limb; • • • • • Both the spinal cord injured person and the clinician need to be educated about the prevalence of upper limb pain and injury and the potential impact of pain and possible means of prevention Routinely assess the patient’s function, ergonomics, equipment and level of pain as part of periodic health review Assessment of risk factors, changes in medical status, new medical problems, changes in weight Reduce the number of non level transfers per day Assess work related activities Re-evaluate current exercise program (strengthening, stretching, conditioning)

Dyson-Hudson et al. (2001) in a randomized controlled trial compared acupuncture treatment to Trager Psychosocial Integration performed by a certified Trager practitioner. The authors noted that trager therapy is a form of bodywork and movement re-education to induce relaxation and encourage the patient to identify and correct painful patterns. The theory is that chronically contracted muscles reduced by stress led to pain (Dyson-Hudson et al. 2001). There was a significant effect over time for both treatment groups in reducing shoulder pain, but there was no difference between the two groups. Curtis et al. (1999) in a randomized control trial and Hicks et al. (2003) studied the effectiveness of a six-month exercise and stretching protocol on shoulder pain experienced by wheelchair users. The data supported the effectiveness of this exercise and stretching protocol

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in decreasing the intensity of shoulder pain that was interfering with functional activity of wheelchair users. Further Research The Consortium of Spinal Cord Medicine (2005), Sipski and Richards (2006), Campbell and Koris (1996), Dalyan et al. (1999), and Nichols et al. (1979), have identified the following as important areas of further research in the upper limb:

• Research to validate and support the adoption of a standardized classification scheme with accompanying diagnostic procedures and criteria. • Research trials could include both primary prevention and treatment of acute and chronic pain. • Determine the best methods to treat existing painful shoulder lesions and prevent others so that these individuals are as pain free and independent as possible. • Further study is needed to elucidate the mechanisms of pain in this group and to establish why some patients who have pain early in rehabilitation continue to have pain at discharge and others do not. • Multicentre RCT of intervention are also needed to reduce the severity and impact of different subtypes of SCI pain. • Possible links between pain during rehabilitation and pain in long-term SCI. • Detailed investigation of the biomechanics of activities commonly performed by people with tetraplegia to enhance understanding of the stresses placed on the shoulder and the mechanical causes of shoulder pain. • Causes of shoulder pain in the acutely injured individual compared to the chronic spinal cord injured person. • Implementation of upper limb pain prevention and management programs for persons with SCI- acute and ongoing patient education about basic biomechanical principles on avoiding impingement and overuse • Managing the early signs of strain and overuse and knowledge of several alternative techniques of ADL. • Education and training in endurance and balanced strengthening of muscles acting around the shoulder and optimizing posture to achieve a normal alignment of shoulder, head, and the spine are critical for avoidance of injuries. • Ergonomically designed environmental changes and wheelchair, home and work modifications

• Further clinical and biomechanical research to improve the preventative measures and treatment methods of
upper limb pain in SCI persons in order for them to maintain optimal functional status.

Conclusions There is level 1 evidence based on two RCTs that a shoulder exercise and stretching protocol reduces the intensity of shoulder pain post SCI. There is level 2 evidence that general acupuncture is no more effective than Trager therapy in reducing post-SCI upper limb pain. Shoulder exercise and stretching protocol reduces post SCI shoulder pain intensity. Acupuncture and Trager therapy may reduce post-SCI upper limb pain. Prevention of upper limb injury and subsequent pain is critical.

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5.7 Reconstructive Surgery 5.7.1 Hand The loss of upper limb function especially the use of the hand is one of the most significant and devastating losses an individual can experience. Tetraplegia is responsible for many problems in daily living, mostly related to the recovery and/or preservation of independence for the tetraplegic individual (Welraeds et al. 2003). In the study by Hanson and Franklin (1976) showed recovery of hand function was preferred to that of the bladder, bowel or even sexual function among tetraplegics. In a survey of tetraplegic patients, 75% responded that hand function was very important for their independence in activities of daily living (ADL) and to increase their quality of life (Snoek et al. 2004). Reconstructive surgery is one option to attempt to improve the function of the hand and upper limb in persons with tetraplegia. Functionally, the benefit of reconstructive surgery may be evident as improved ability to write, complete catheterizations, dress, self-feed, drive, lift objects, button, turn dials, propel their wheelchair, catch objects overhead, turn in bed and swim are only some of the activities that become possible after surgery (Rabischong et al. 1993). Surgery has been reported to improve quality of life for those people who had little or no upper limb function (Freehafer et al. 1984). As aptly stated by Sterling Bunnell, one of the preeminent surgeons when describing improvements of hand and upper limb function as a result of surgery, “When you have nothing, a little is a lot.” Despite the many reported studies, over 40 documented studies, hand reconstructive surgery is not common practice in many spinal units and its importance in improving hand function still remains controversial (Forner-Cordero et al. 2003). Guttmann (1976), McSweeney (1969) and Bedbrook (1969) believed that only a small percentage of tetraplegics (5%) benefit from hand surgery because they re-adjust the function of their arm and hands if properly rehabilitated, while other authors like Moberg (1975) state that 75% of tetraplegics can obtain benefit from hand surgery. Reconstructive surgery and tendon transfers are generally performed following an identifiable pattern based on the level of injury and results depend on the patient’s residual motor and sensory function as identified in each group (Freehafer et al. 1984). In 1978, the International Classification for Surgery of the Hand in Tetraplegia was developed at the International Conference held in Edinburgh and modified in 1984. The classification takes into account the residual motor strength below the elbow, considering that only the muscles graded 4 or 5 according to the Medical Research Council Scale (MRCS) are adequate for muscle transfer, as well as the sensibility in thumb and index. The sensibility was evaluated by the two-point discrimination test in the thumb and the index. If it is lower than 10mm the classification belongs to the group Cutaneous (Cu-) and if it is higher than 10mm and the patient needs visual help it is classified in the group Ocular (O-). Table 8: Modified International Classification for Surgery of the Hand in Tetraplegia
0 1 2 3 4 5 Motor Weak or absent Brachioradialis (BR) ≤ grade 3 BR (≥ grade 4) BR, ECRL BR, ECRL, ECRB BR, ECRL, ECRB, PT BR, ECRL, ECRB, PT, FCR O2 1 3 Sensory Cu1 1 1 4 4 Total 3 1 2 7 4

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Sensory Motor Total OCu6 BR, ECRL, ECRB, PT, FCR, Finger Extensors 7 BR, ECRL, ECRB, PT, FCR, Finger Extensors, Thumb Extensors 1 1 BR, ECRL, ECRB, PT, FCR, Finger Extensors, Thumb Extensors, 8 1 1 Finger Flexors 9 Lacks intrinsics only 1 1 Total 7 13 20 O-: Two-point discrimination in the thumb > 10mm. Cu-: Two-point discrimination in the thumb < 10mm. ECRL: Extensor Carpi Radialis Longus ECRB: Extensor Carpi Radialis Brevis PT: Pronator Teres FCR: Flexor Carpi Radialis The listing of a muscle means that it is functional (grade 4 or better). (McDowell CL, Moberg EA, House JH. The Second International Conference on Surgical Rehabilitation of the Upper Limb in Traumatic Quadriplegia. J Hand Surg 1986; 11A: 604-608.)

Candidates for reconstructive surgery are carefully selected and are followed by a rehabilitation team that includes an orthopedic surgeon, rehabilitation physiatrist, and therapist over a significant period of time. The identified criteria for selection are as follows: • • • • At least one year post injury Completed a comprehensive rehabilitation program Neurologically stable Psychologically adjusted to their injury

The measure of outcomes following reconstructive surgery continues to be debated in the literature. Many of the reported studies on surgical outcomes are older, are case series evaluations and lack the rigor of randomized control trials, and have subjective outcomes based on reported client satisfaction. In addition, there is little consensus in the literature on the assessment instruments and tools to be used in this population as their reliability, validity and responsiveness have not been adequately proven. The methodology appears to be a major failing of the various scales and the absence of clear conceptual models forming the basis of their scales. Also, the scales or instruments have been deemed to be too insensitive to document the small but meaningful functional gains made by tetraplegics after functional surgery (Fattal 2004). Many authors state that comparing the post surgical condition is the best way to evaluate results (Freehafer et al. 1984). There have been several articles published that discuss the use of the ICF conceptual framework as a way to interpret hand function outcomes following tendon transfer surgery for tetraplegia (Sinnott et al. 2004; Bryden et al. 2005). The reconstructions of upper limb to obtain functions of pinch and grasp often require multiple procedure and are also individualized to each person. The reconstructions performed are also dependent on what motor muscles/tendons are present and strong enough for transfer. The most commonly performed surgeries for reconstructive pinch are: Key-Pinch Grip: Brachioradialis (BR) to Extensor Carpi Radialis Longus (ECRL), Flexor Pollicis Longus (FPL) split tenodesis. The IP joint of the thumb may need to be stabilized to prevent excessive IP flexion. Key-Pinch Grip with or without Hook Grip: Brachioradialis (BR) to Flexor Pollicis Longus (FPL) with or without Flexor Digitorum Profundus (FDP) tenodesis or Brachioradialis (BR) to Extensor Carpi Radialis Longus (ECRL).

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Key-Pinch Grip and Hook Grip: Brachioradialis (BR) or Pronator Teres (PT) to Flexor Pollicis Longus (FPL) and BR or Extensor Carpi Radialis Longus (ECRL) to Flexor Digitorum Profundus (FDP). Additional procedures to increase thumb pinch and thumb opposition may also be completed. Table 9: Reconstructive Surgery: Pinch Studies
Author Year; Country Score Research Design Total Sample Size Methods Population: Gender: m=13 , f=2; Age: range 20-47 yrs; Injury to operation: range 8 months-18 yrs; Operation to follow-up: range 8-48 months; Treatment: Surgery Outcome Measures: Pinch strength; ADL reports. 1. Outcome Release of the BR and suture to the FPL. In 16/17 hands , fixation of the IP joint of the thumb was obtained with a Moberg screw. 11/17 patients lacked active thumb extension had tenodesis of the thumb extensors to the MCP to prevent excessive flexion of the MCP joint. 2. EPL and EPB were secured to the dorsum of the MC. 6/11 patients did not require tenodesis had sufficient strength in the EPL to extend the thumb. 3. 2/6 EIP was transferred to EPL for active extension. 4. Satisfactory finger flexion present 10 hands. In seven hands: intertendinous suture of all FDP tendons 4 patients who had active flexion in the ulnar profundi of small and ring finger, but could not flex index finger; 5. Transfer of PT to all FDP tendons in 2 patients; transfer of ECRL to all FDP tendons in 1 patient; transfer of FCU to all FDP tendons one patient. 6. Preoperative lateral pinch ranged from 0- 0.15 lbs post operative lateral pinch ranged from 2.2-4 (depending on elbow and wrist position) 7. Residual motor function in triceps (fair plus)(11 patients) and pinch strength; lateral pinch 5.1 lbs, strength fair or less (6patients) 2.0 lbs pinch. 8. 87% (13/15) reported significant improvement; 4 patients wanted stronger pinch; 9. 80% (12/15) could name 4 ADL activities that they were able to perform. 10. 13% (2/15) were dissatisfied. 11. 20% (3/15) reported discomfort tip of thumb. (Follow-up 1-10yrs (average 3.5yrs) 1. All patients reported a significant increase in independent hand function in relation to ADL's, no patient reported hand function was worse after surgery 2. Technique provided a reliable and

Waters et al. 1985; USA Downs &Black score=12 Case Series N=15

House et al. 1992; USA Downs & Black score=11 Case Series N=18

Population: Gender-m=14, f=4, level of injury-C5-C6, Age-16-29yrs, time to surgery-16mths to 12/13 yrs Treatment: Carpal-metacarpal fusion was performed; along with extensor pollicis longus tenodesis and motor transfer to flexor pollicis longus.

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Author Year; Country Score Research Design Total Sample Size

Methods Outcome measures: function of the hand, subjective pain scale, & level of satisfaction with surgery and rehabilitation Population: Gender m=103, f=30, age 858yrs, tetraplegia, follow-up 3-24mths. Treatment: Extrinsic hand reconstruction with intrinsic balancing procedures vs. extrinsic reconstructions without intrinsic balancing procedures Outcome Measures: Pre and postoperative assessments of grip strength (on the second position of the Jamar dynamometer) and a patient questionnaire evaluating 31 activities of daily living

Outcome reproducible key pinch All patients had significant improvement in functional activities of daily living and highly satisfied with results of surgery All patients had preoperative grip strength of 0. At an average follow-up period of 31 months, the average final grip strength was 69N (7kg) and the ADL improvement score averaged 35.5 Patients who underwent an intrinsic procedure had a statistically stronger grip (72N) than patients who did not undergo an intrinsic procedure (p=0.026). OCU group 5 patients with an intrinsic procedure had a statistically stronger grip than patients without an intrinsic procedure (p=0.028). With the exception of OCU group 7 in which 8 patients did not undergo an intrinsic procedure due to their ability to balance tension between the extensors and flexors, all other OCU groups with an intrinsic reconstruction showed stronger grip than patients without an intrinsic reconstruction. ADL improvements scores were higher but not statistically significant for those with intrinsic rebalancing versus those without rebalancing. There was significant difference between the hands treated by FDS lasso and those treated by intrinsic tenodesis when patients were stratified by OCU level. There was also no significant difference in grip strength results between the FDS lasso versus the intrinsic tenodesis procedures when stratified by both OCU level and type of extrinsic reconstruction, both surgical techniques were effective in improving strength and ADL.

3.

1.

2.

3.

4. McCarthy et al. 1997; USA Downs & Black score=10 Pre-post N=135 5.

6.

7.

Summary Table 5.10 Pinch Studies
Author N 15 patients (17 procedures) Intervention BR to FPL (lateral pinch) with thumb IP joint stabilization (16 hands) 11 patients also had EPL tenodesis and EPB to metacarpal joint; 2/17 patients EIP to EPL procedure CMC fusion EPL tenodesis Main Outcome(s) +ve lateral pinch strength in all test positions +ve ADL functions +ve direct correlation between pinch strength and amount of residual triceps and wrist extensor strength +ve pinch strength +ve ADL and functional use

Waters et al. 1985

House et al. 1992

18 patients (21 procedures)

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Intervention BR 0r ECRL or ECRI to FPL As indicated: stabilization of thumb IP joint and Zancolli Lasso procedure 135 patients Extrinsic reconstruction with Intrinsic (183 procedures) Balancing vs. without Intrinsic McCarthy et al. 1997 Balancing FDS Lasso vs. Intrinsic Tenodesis for Intrinsic Balancing + positive outcome, = no difference, - negative outcome

Author

N

Main Outcome(s)

+ve grip strength with intrinsic balancing = ADL and functional use = grip strength = ADL and functional use

Pinch and Grasp (Key-Pinch and Hook Grip) The most commonly performed surgeries to obtain key-pinch and hook grip are; Wrist Extension: If the person does not have adequate wrist extension, Brachioradialis (BR) to Extensor Carpi Radialis Brevis (ECRB) is performed prior to any surgery for pinch reconstruction. Key-Pinch and Hook Grip: Extensor Carpi Radialis Longus (ECRL) to Flexor Digitorum Profundus (FDP). This is a synergistic transfer in which dorsiflexion of the wrist potentiates the effects of the transfer. The amplitude of excursion provides strong flexion of the fingers into the palm. Brachioradialis (BR) is also transferred to Flexor Pollicis Longus (FPL). The aim of these transfers is to provide mass finger flexion for grasp and independent thumb flexion for key-pinch against the side of the middle phalanx of the index finger. Adjustment of tension in these transfers is also completed (Lamb and Chan 1983). Table 5.11 Reconstructive Surgery: Pinch and Grip Studies
Author Year; Country Score Research Design Total Sample Size Meiners et al. 2002; Germany Downs & Black score=10 Case Series Initial N=24; Final N=22 Methods Population: Gender f=3, m=21, age 2157yrs, time since injury 9-59months Methodology: Surgery Outcome Measures: ADL questionnaire, Satisfaction Survey, Key grip and lateral force grip Population: Age: 19-60 yrs Age at injury: 15-46 yrs; Injury to operation: 1-17 yrs; Follow-up post op: 1-17 yrs ; Gender: 17 m, 7 f; Level of injury; 3 in group III, 11 in group IV, 7 in group V, 4 in group VI. Intervention: surgery Outcome Measures: Not specified Kelly et al. 1985; USA Downs & Black score=9 Case Series N=24 Outcome No statistical findings reported. 1. Operative interventions on the tetraplegic hand brings gains in cylindrical and lateral grip and improvement in ADL 2. Subjective acceptance is high 3. Complication rate is high 4. Long duration of treatment 1. 7 extremities had had post deltoid to triceps transfer before opponensplasty; 24 patients, 11 (46%) had bilateral opponensplasty. 2. 35 opponensplasties were done. 22 flexor tendon transfers were done for voluntary grasp and then opponensplasty. 3. 14 patients (22 extremities) evaluated. 4. Subjects reported that they would have the operation again (95% of the extremities) and had improved function (91%). 5. One patient reported that function was unchanged; 1 was dissatisfied. Overall value of key pinch 35 extremities was 1.47 +/- 1.29 kg (mean +/- SD).

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Author Year; Country Score Research Design Total Sample Size

Methods 6.

Outcome Grasp measured in 20 extremities; 2.81 +/- 2.89 kg (mean +/-SD) (range trace to 10kg). 7. Palmar pinch; 9 of 20 extremities (45%) achieved palmar pinch (1.04 +/1.02 kg; mean +/- SD) (range 0.20-3.0 kg). Palmar pinch achieved in 17% of the extremities in group III, 71% in group IV, and 33% in group V. No statistical results reported. 1. Self assessment questionnaire results indicated: power decreased since surgery in all patients. No statistical results reported. 1. All reported they would have surgery again. 2. Key pinch strength in non-op limbs was 1.0 ± 1.3 kg, in surgically treated arms it was 1.2 ± 1.1 kg. 3. Minnesota rate of manipulation: nonoperative limbs were 1 min 29 secs ± 15 secs, post operative limbs was 2 min 56 secs ± 1 min 56 secs. No statistical results reported 1. 6 of 8 subjects were evaluated. Subjects indicated they were pleased with the surgery. 2. Hand function tests indicated an improvement (16-49% improvement). 5 of 6 subjects showed key grip strength remained constant. No statistical results reported-8 pts interviewed, 5 completed questionnaire. 1. Conclusion-transfer of brachioradialis tendon provides key pinch and grip of sufficient quality to improve the activities of daily living in patients with loss of flexion of the thumb and fingers 1. Strength: key-pinch strength average of 17.2 kPa (5-50 kPa); grasp strength average 18.8 kPa (3-45 kPa). 2. No relation found between the activities of daily living test and the key=pinch strength (P=O.7976) or grasp strength (P=0.6948). 3. Modification of ADL questionnaire; excellent (3) 21.4%; good (7) 50.0%; fair (2) 14.3 %; poor (2) 14.3%. Scores ranged from 54-122 points. No statistical analysis reported 1. Passive range of motion of the elbow and wrist remained unchanged post surgery. Functional active flexion of the fingers was gained in 10 of 11 subjects. 2. Improved performance of ADLs was reported.

Rieser & Waters 1986; USA Downs & Black score=8 Case Series N=23

Lo et al. 1998; CA Downs & Black score=7 Case Series N=9

Population: Age: mean=23.6yrs; age at time of surgery: mean=29.8yrs, time from injury to operation 6.2 yr, follow-up time of this study: 7.4 yrs Intervention: Surgery Outcome Measures: Not specified Population: at least 1 yr post injury, C5-6 spared quadriplegia Intervention: Surgery Outcome Measures: not specified

Colyer & Kappelman 1981; USA Downs & Black score=7 Case Series N=8

Population: Age: 16-36yrs, time post injury: 4mths-18yrs Intervention: Surgery Outcome measures: Not specified

Faillia et al. 1990; USA Downs & Black score =6 Case Reports N=8

Population: age 9-58yrs, tetraplegia Treatment: Surgery Outcome Measures: key pinch, grip strength, function in ADL

Forner-Cordero et al. 2003; Spain Downs & Black score=5 Retrospective Follow-up Initial N=15; Final N=14

Population: age at first operation 2062yrs, level of injury C4-C7, time from injury to operation 15-239 months. Treatment: Surgical reconstruction. Outcome Measures: Increased hand movement and strength; improvement in ADL; patient's satisfaction, fulfillment of patient's expectations, surgical complications. Population: age at time of surgery 20-47 yrs. Intervention: Surgery. Outcome Measures: Not specified

Gansel et al. 1990; USA Downs & Black score=4 Case Series N=19

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Summary Table 5.12 Pinch and Grip Studies
Author N 22 patients (23 hands) Intervention FCR to FDP ECRL to FDP Main Outcome(s) +ve lateral and cylindrical grip +ve satisfaction with surgery +ve ADL and functional use

Meiners et al. 2002

Kelly et al. 1985

24 patients (57 procedures)

Reiser and Waters 1986

9 patients (10 procedures)

7/24 also had PD to Triceps Opponensplasty- FDS to APB Flexor tendon transfers: BR (also used PT, FCR, ECRL, FCU, PL) to FDP 22/35 Flexor tendon transfer BR to FDP (also used PT, FCR, ECRL) Tenodesis of FPL, thumb IP joint stabilization 6/9 MP joint tenodesis of extensor tendons of thumb 2/9 BR to wrist extensor 7/9 tenodesis of EPL and EPB

+ve satisfaction with surgery +ve ADL functional use +ve key-pinch, palmar pinch and grip strength

-ve result, bowstringing of FPL across MP joint -ve grasp and lateral pinch strength +ve satisfaction with surgery +ve key-pinch and grip strength +ve ADL functional use +ve improved pinch strength -ve finger flexion +ve ADL and functional use +ve key-pinch and grip strength +ve ADL and functional use

Lo et al. 1998

8 patients (12 procedures)

ERCL to FDP and BR to FPL

Colyer and Kappleman 1981

6 patients (8 hands)

FPL tenodesis 2 also had ECRL to FDP BR to FDP or FPL BR or ECRL to FPL PD to Triceps BR to ECRB Tenodesis of FPL APL to CMC joint or arthrodesis of CMC joint BR or ECRL or PT to EDC and EPL or tenodesis of extensor tendons BR or ECRL or ECRB to FPL PT or ECRL or BR to FDP Zancolli Lasso of FDS 11/11 PT to FDP 10/11 BR to FPL 1/11 BR to FDS

Faillia et al. 1990

8 patients (9 hands)

Forner-Cordero et al. 2003

15 patients (20 limbs)

+ve key-pinch strength +ve grip strength = ADL and functional use +ve patient satisfaction -ve patient expectation

Gansel et al. 1990

11 patients

+ve finger flexion +ve key-pinch strength +ve ADL functional use

+ positive outcome, = no difference, - negative outcome

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5.7.2 Elbow Extension The most commonly performed surgery for elbow extension is using the posterior third of the deltoid (PD) to motor the triceps. This converts the transferred portion of the deltoid into a two joint muscle but causes no functional loss at the shoulder (Moberg 1975). Table 13: Reconstructive Surgery: Elbow Extension Studies (Posterior Deltoid to Triceps)
Author Year; Country Score Research Design Total Sample Size Methods Population: age-mean 33.6yrs, level of lesion-C6, time since injury 28-173 months, time prior to sugery-34.5yrs, time since surgery-46.1 months Treatment: The arm and forearm were locked in position and a force transducer was used to assess the torque output isometrically. The muscle was tested at 6 different lengths with the shoulder abducted at 900 Outcome Measures: Maximal torque and absolute values. 1. Outcome The muscle was tested at 6 different lengths (130, 110, 90, 70, 45 and O degrees of elbow flexion) with the shoulder abducted at 90. 2. When compared, the absolute values (dimension of torque) were significantly different between groups (0.00001<p<0.002. 3. The expression of this relation (% of maximum values) revealed significant statistical differences (p<0.002) at 90 and 70 degree of elbow flexion; peak torque was at 130 degrees in experimental group and 110 degrees in control group with a plateau between 110 and 70 degrees. 4. Length-tension relationship was fairly similar among control group, but great differences in experimental group. 1. Straight Arm Raising-statistically significant decrease in maximal shoulder abduction (mean 57 SEM 12 before, 14 SEM 6 after surgery) 2. Shoulder flexion increased after deltoid-to-triceps transfer by 42% (mean 113 SEM 11), remained significantly lower (121 SEM 12) than control group (P<0.0001) 3. Hand-to-nape-of-neck-movement-no significant improvements were noted after surgery 4. Conclusion-peaks of shoulder and elbow flexion speed are almost normal, indicating the importance of restoring elbow extension torque for improving the whole kinematic picture of the upper limb 1. FIM scores: both groups scored identically 2. Mobility: no significant differences were noted (p=0.256, and p=0.432 3. Questionnaire: answered only by the treatment group-clients gave positive response to the questions. No statistical results reported: No statistically significant differences between pre and post operative stages. 1. Activities that were noted as improved

Rabischong et al. 1993; France Downs & Black score=16 Prospective Controlled Trial N=12

Remy-Neris et al. 2003; France Downs & Black score=13 Pre-post N=17

Population: gender m=11, f=5, age mean 27yrs, ASIA score 16-20 Treatment: Surgery. Control group members sat on a chair, while the tetraplegics sat in a wheelchair. All were asked to perform 2 movements; a straight arm lateral and maximal raising and return Outcome Measures: Straight Arm Raising & Hand-to-nape-of-neck movement

Dunkerley 2000; UK Downs & Black score=13 Case-Control Initial N=15; Final N=11 Lacey et al. 1986; USA Downs & Black score=7 Case Series N=10

Population: Age: 23-38yrs; Time since injury: 5-16 yrs; Age at time of injury: 18-27 yrs. Treatment: Surgery. Outcome Measures: Questionnaire; FIM; 10 m push and the figure of 8 push Population: Level of injury: C6 or C7; time since injury: average 24 mths, time to operation: approx 32 months Treatment: Surgery

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Author Year; Country Score Research Design Total Sample Size

Methods Outcome Measures: Not specified Population: Time since injury: average 10242 mths, 64.1 mths to surgery. Treatment: Surgery Outcome Measures: ADLs, use of wheelchair

Outcome were: the overhead use of the arms, use of arms while lying supine and eating. No statistical analysis reported. 1. 15 of 18 reported function improvement after surgery, 13 felt they gained an increase in independence. 2. Functional improvements and grooming was noted. 3. Improvements were noted in subject’s ability to relieve ischial pressure from their wheelchair, writing improved, and driving in a small percentage was positively affected.

Raczka et al. 1984; USA Downs & Black score=4 Case Series Initial N=22; Final N=18

Summary Table 5.14 Elbow Extension (Posterior Deltoid to Triceps)
Author Rabischong et al. 1993 Remy-Neris et al. 2003 N Gr 1- 8 pts/11 elbows Gr 2-control 9 R hand (female) 5 pts 17 limbs 5 elbows, 6 controls 10 pts/16 procedures 18pts/19transfers Intervention PD to triceps PD to triceps Main Outcome(s) = initial tension pt transfer at time of surgery is important for torque output + ve ADL and functional use + ve straight arm raise +ve speed of movement = surgical/control gr: FIM (adapted) 13 items =surgical/control gr: W/C propulsion 8m&10 m push +ve elbow function indicated on questionnaire +ve satisfaction with surgery +ve ADL and functional use +ve elbow extension strength +ve ADL and functional use

Dunkerley 2000

PD to triceps

Lacey et al. 1986 Raczka et al. 1984

PD to triceps PD to triceps

+ positive outcome, = no difference, - negative outcome

5.7.2.1 Elbow Extension (Biceps to Triceps) A biceps to triceps transfer can be used to create elbow extension in patients who have active supinator and brachialis muscles to provide for the lost functions of the transferred biceps (Kuz et al. 1999). Table 5.15 Reconstructive Surgery: Elbow Extension Studies (Biceps to Triceps Transfer)
Author Year; Country Score Research Design Total Sample Size Kuz et al. 1999; USA Downs & Black score=7 Case Series N=3 Methods Population: Tetraplegic Treatment: Surgery Outcome Measures: Not specifed Outcome No statistical results reported: 1. subjects indicated they were satisfied with the surgery. 2. Activities that required precision hand placement had improved. 3. Elimination of the need for some adaptive aids was possible post surgery.

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Summary Table 5.16 Reconstructive Surgery: Elbow Extension Studies (Biceps to Triceps Transfer)
Author Kuz et al. 1999 N 3 patients 4 elbows Intervention Biceps to Triceps Main Outcome(s) +ve elbow extension +ve functional improvements through ability to place the hand in space +ve satisfaction with surgery

+ positive outcome, = no difference, - negative outcome

5.7.3 Multiple Reconstructions The following studies report results from multiple procedures to reconstruct the upper limb. Table 5.17 Reconstructive Surgery: Multiple Reconstructions
Author Year; Country Score Research Design Total Sample Size Methods Population: Age: mean age 42.9 years; Mean time since injury: 20.5 years; Mean time since surgery: 15.1 years; 22/24 right handed; Level of Injury: 01: 6 hands; 02: 3 hands; 03: 5 hands; 0Cu2: 2 hands; 0Cu3: 6 hands; 0Cu4: 17 hands; 0Cu5: 8 hands; 0Cu6: 1 hand; Tetraplegia Treatment: surgery Outcome Measures: Lamb and Chan questionnaire with additional 10 Burwood questions; Swanson sphygmomanometer (hook grip); Preston Pinch Meter (key pinch); Quadriplegic index of Function (QIF); Digital Analyzer (key and grip pinch) 1. Outcome Elbow Extension: bilateral surgery 9/11 subjects; Hook Grip; 17 right hands (av. Grip 46.2 mm Hg in 1991; improved slightly, not statistical significant (p=0.30)) Left hand: 15 hands: significant increase (p=<0.001), av. 28.7 mmHg to 53.2 mmHg; no statistical significance between right and left hook grip as measured by SGM and DA in 2001 (p=0.93 and p=0.97). Key Pinch: av. key pinch 20 right thumbs in 1991 25.8 N and decreased in time to av. 13.9 N (significant decrease p=<0.001); average pinch strength 18 left thumbs decreased from 17.7 to 8.8 N (significant decrease p=<0.001). Average pinch strength measured by DA, increase in key pinch when compared to 1991, significant for both right (p=0.01) and left (p=0.01) thumbs. Active Transfer Vs. Tenodeses: hook grip: active transfers 2x strength of tenodeses in 1991 (p=0.05) and 2001 (p=0.03). Pinch grip: similar to 1991 data (p=<0.001), 2001 data does not follow trend. 2001 DA data did not reach significance (p=0.06); Longitudinal Comparison: hook grip strength 25 hands with active transfers significant increase 42.1 to 60.2 mm Hg (p=<0.001) and pinch grip increase from 24.0 to 38.4 N in 31 thumbs that had active transfers using 2001 DA data (p=0.03). Hook strength obtained from a tenodesis in 7 hands did not weaken over time (p=0.05) but pinch strength in 7 thumbs significantly increased (p=<0.001) using 2001 DA data.

2.

Rothwell et al. 2003; New Zealand Downs & Black score=20 Case Series Initial N=29; Final N=24

3.

4.

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Author Year; Country Score Research Design Total Sample Size

Methods 5.

Outcome Questionnaire results; Lamb and Chan activity measure: showed perceived improvement of functional activities significantly lower in 2001 (p=<0.001). QIF scores of current functional independence was significantly better (p=0.004). Additional Burwood questionnaire showed levels of satisfaction, perceived expectation, gratification and opportunity enhancement were maintained over time (p=0.281). Elbow Function: 10/16 elbows (10 patients): full extension; 2/16 elbows 20 degree flexion contracture; 4/16 15 degrees of extension lag. All 10 patients considered the procedure beneficial. Hand Function: 48 hands (assessed only 27 patients). 5 rated as excellent; 28 rated good; 11 rated as fair; 4 graded as poor. No patient had any impairment of hand function after operation. ADL: 29 patients assessed. No one considered their functional capability deteriorated after operation. Most significant improvement in basic activities such as washing, eating and using the toilet, hold glasses and cups, wash limbs and brush hair, turn on taps, improve bladder compression, insertion of suppositories, change from complete reliance on other for selfcare, more mobile, 7 able to drive a car. Improvement in UL function facilitated development of personal interests. No statistical analysis providedgestural ability improved in more than 80% of the patients and functional gain was important in more than half. 43 procedures; Atypical procedures (2) good: 2; Moberg procedures (18) good: 17; poor: 1; Deltoid/triceps (12) good: 7; fair 3; poor 2; Additional procedures (11) good: 7; fair: 3; poor: 1. Subjective Assessment: obtained for 86% of the patients, av. Follow up of 37 months (range 5-86 months); 70% reported good or excellent results; 22% fair; 8% poor. Simultaneous surgery for key-grip and hook grip strength 96% good or excellent results. Objective Results: over 70% of patients, av. follow up of 32 months;

Population: Age: 21-59 years (av. 29 years); Gender: 38 male; 3 female; Complete injuries. Av. Follow up after operation: 6 months- 25 years; Tetraplegia Treatment: Surgery Outcome Measures: Elbow strength; Hand function (assessment checklist developed); ADL (developed checklist)

1.

2.

Lamb & Chan 1983; UK Downs & Black score=14 Case Series N=41

3.

Walreads et al. 2003; Belgium Downs & Black score=12 Case Series N=25

Population: Age at time of injury-mean 30yrs, age at time of operation-mean37yrs, time between injury and surgery 7-356 months, injury level C5-C8 Treatment: Upper limb surgery Outcome measures: Functional testing.

1.

2.

Mohammed et al. 1992 New Zealand Downs & Black score=12 Case Series N=57

Population: Age: av. age at first operation 27 years (5-55 years); Gender: 51 males, 6 females; Level of Injury: 00:4; 01: 6; 02: 4; 03: 6; 0X: 3; Cu3: 6; Cu 4: 24; Cu 5: 10; Cu 6: 3; Cu X: 3; Tetraplegia Treatment: Surgery Outcome Measures: Subject assessment of ADL by questionnaire; Objective assessment of key pinch (Preston Pinch Meter); Hook-grip strength (modified

1.

2. 3.

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Author Year; Country Score Research Design Total Sample Size

Methods Sphygmomanometer); Elbow extension: MRC grading system

Outcome Key Pinch 52/68 cases (76%); av. strength was 2.1 kg. Hook grip measured in 42/58 cases (72%), thumb included av. strength was 42 mmHg; thumb excluded 29 mmHg. Elbow extension measured in 71% of patients, obtained grade 3 or 4 strength. One hundred forty two transfers were performed on 68 subjects. No upper limbs were made worse. Four remained unimproved, all others that had tendon transfers improved.

4. Population: age at time of surgery 1561yrs, time since injury to surgery 1-17yrs, tetraplegics, Treatment: Surgical reconstruction Outcome Measures: Comparison of the post surgical with the pre surgical condition Population: Age: born between 19181962; Gender: 7 female, 36 male; Level of Injury: 0:1 9 pts; 0:2 2 pts; 0Cu:1 4 pts; 0Cu:2 13 pts; 0Cu:3 9 pts; 0Cu:4 5 pts; 0Cu:6 1 pt. re-examined 1-14 yrs after the last operation. Treatment: Surgery Outcome Measures: Questionnaire of 55 ADL tasks; opinion of the effect of surgery to perform these ADL tasks; elbow extension (evaluation of extension deficit or holding a sand bag in hand); key grip pinch (Preston Pinch Guage); finger flexion (Martin Vigorimeter) 1. 2. 3. 1.

Freehafer et al. 1984; USA Downs & Black score=12 Case Series N=68

Ejeskar & Dahllof 1988; Sweden Downs & Black score=11 Case Series N=43

Freehafer 1998; USA Downs & Black score=10 Case Series N=285

Population: Neurological levels C5-C8. Treatment: Surgical reconstruction. Outcome Measures: Not specified

Hentz et al. 1983; USA Downs & Black score=4 Case Series Initial N=30; Final N=23

Population: level of injury OCu 1,2,3 Treatment: Reconstruction of key grip and active elbow extension. Outcome Measures: interview and/or questionnaire (self-care, communication, mobility), objective measurements - pre + post op strength, ROM wrist + elbow extension, strength of key pinch, range of passive wrist flexion + functional testing

Elbow Extension: 30 elbows in 23 patients; (23/30 with free tendon graft;7/30 Castro-Sierra and LopezPita method); 5/23 with free tendon graft 1/23 full ext.; 8/23 lack ext. against gravity of max. 60; 10/23 lack even more ext.; 6/7 ext. deficit greater than 60. 2. Key Grip: 50 hands/40 patients; Strength 0-3.5 kg (av. 0.7 kg); 15 case had minimum of 1.0 kg. 3. Finger Flexion: 14 hand/13 patients (ECRL to profundi II-V); grip 0-0.27 kP (av. 0.13 kP); 5/14 minimum strength 1.0 kg. 4. 4 patients reported no improvement (1 severe spasticity, 2 BR muscle transferred to wrist; 1 operation on weaker hand); 4/43 could not state how much they had improved, 35/43 average improved capacity to perform 23/55 ADL tasks; 3/43 patients a functional deterioration. 1. Opponens transfers were done 180 times; transfers for finger flexion-161 times; posterior deltoid transfers-59 times; transfers for wrist extension-17 times. 2. 13 out of 285 stated that they were no better, and no patient said they were worse. No statistically significant findings reported Subjective client reports.

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Summary Table 5.18 Multiple Reconstructions
Author Rothwell et al. 2003 N 24 patients (48 reconstructions) Intervention BR to FPL or BR and tenodesis FPL ECRL to FDP PD to Triceps PD to Triceps Biceps to Triceps Hand Grip: ECRL to FDP BR to FPL Key-Pinch: FPL tenodesis or FPL tenodesis plus ECRL to FDP Other: EPB to ECU, FCR to FDS, APB to EDM PD to Triceps ECRL to FDS BR to FDS PD to Triceps Key-Pinch: BR or PT to ECRL; FPL tenodesis and IP stabilization Hook Grip: BR or ECRL to FDP Variation of all procedures PD to Triceps Tenodesis FPL, thumb IP joint stabilization ECRL to Profundus iv Opponens transfer: 180 times Transfers to finger flexors: 161 times PD to Triceps: 59 times Transfers for wrist extension: 17 times PD to Triceps or Biceps to Triceps FPL tenodesis BR to ECRB EPL and EPB tenodesis Main Outcome(s) +ve key-pinch and hook grip +ve ADL and functional use

Lamb and Chan 1983

41 patients (57 reconstructions)

+ve elbow extension and function -ve elbow extension (biceps to triceps) +ve hook grip and key pinch and ADL and functional use

Walreads et al. 2003

25 patients (43 procedures)

+ve elbow extension +ve key grip and grasp +ve ADL and functional use + hook grip strength +ve ADL and functional use +ve key-pinch and grip strength +ve elbow extension +ve ADL and functional use -ve elbow extension +ve key-grip and finger flexion +ve ADL and functional use

Mohammed et al. 1992

57 patients (97 transfers)

Freehafer et al. 1984

68 patients (142 transfers) 43 patients (94 transfers)

Ejeskar and Dahllof 1988

Freehafer 1998

285 patients (417 transfers)

Review of surgical procedures and recommendations.

Hentz et al. 1983

30 patients (40 limbs)

+ve satisfaction with surgery +ve pinch and grip strength

+ positive outcome, = no difference, - negative outcome

Discussion In reviewing the identified studies as a whole, the operative interventions on the tetraplegic hand and upper limb bring definite gains in pinch force, cylindrical grasp, and the ability to reach above shoulder height that result in an improvement in ADL function and quality of life for the individual with tetraplegia. Despite the level of evidence (grade 4) the subjective acceptance among patients who have had reconstructive surgery is high. One of the reported downsides of surgery is the high complication rate (infection, torn attachments) and the extended period of time post surgery for rehabilitation and increased need for personal care (Meiners et al. 2002).

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Many Spinal Cord Injury Centres do not offer or have access to reconstructive surgery or neuroprothesis interventions. It is also debated whether the overall cost of surgery or use of neuroprostheses is more beneficial to the client, as the client has to relearn new movement strategies in order to perform activities of daily living (ADL) (van Truijl et al. 2002). Conclusion There is level 4 evidence from multiple studies that support the use of reconstructive surgery for the tetraplegic upper limb for the improvement of ADL and quality of life. Reconstructive surgery appears to improve pinch, grip and elbow extension functions that improve both ADL performance and quality of life in tetraplegia.

5.8 Neuroprostheses A neuroprostheses for grasping is a device designed to improve or restore the grasping, holding and reaching functions in individuals with stroke and SCI (Baker et al. (1993); Cornwall et al. 2004). The neuroprostheses applies functional electrical stimulation (FES) in which paralyzed muscles are electrically stimulated to produce movement (Shimada et al. 1996A). The FES uses bursts of short electrical pulses (pulse widths 0-250 mSec and pulse amplitude 0-150 mA) to generate muscle contraction by stimulating motoneurons or reflex pathways. The key element for achieving synergistic activity of muscles that results with reaching and grasping is the appropriate sequencing of bursts of electrical pulses. For continuous contraction of the arm and hand muscles (tetranization), a FES system has to deliver at least 16 stimulation pulses per second to elicit action potentials (AP) in the motor nerve, causing the corresponding muscles to contract. FES enables the patients with high spinal cord injury to reconstruct grasp movements such as palmar and lateral grasps of the upper extremity (Shimada et al. 2003). The palmar grasp is used to hold bigger and heavier objects such as cans and bottles and the lateral grasp is used to hold smaller and thinner objects such as keys, paper and CDs (Popovic et al. 2002). It has been reported to be useful in improving ADL functions (Shimada et al. 1996A; Popovic et al. 2001). FES is also applied to generate elbow extension by stimulating the triceps brachii in combination with voluntary biceps contraction used to augment reaching (Grill and Peckham 1998; Popovic et al. 1998). Elbow and shoulder FES systems have not been developed into practical clinical devices. The motor nerves can be stimulated using surface (transcutaneous), percutananeous or implanted electrodes (Mortimer 1981). Transcutaneous stimulation is performed with selfadhesive or non-adhesive electrodes that are placed on the subject’s skin in the vicinity of the motor point of the muscle that needs to be stimulated (Baker et al. 1993; Mortimer et al. 1981). Percutaneous and fully implanted electrodes are placed close to the entry point of the motor nerve to the muscle which should be stimulated, either epimysial or intramuscular (Cameron et al. 1997; Hoshimiya and Handa 1989). Individuals with C5-C7 complete SCI and with no major degree of motoneuron or nerve root damage of the stimulated muscles benefit the most from neuroprosthesis. The use of an implanted FES system can only be applied once the patient reaches stable neurological status, which usually occurs two or more years post SCI. The use of surface FES systems can be introduced during the early rehabilitation period, as the patient does not have to be neurologically stable. 5-35

Gorman et al. (1997) and Cornwall and Hausman (2004) have presented guidelines for patient selection for consideration of for an implantable neuroprosthesis. They are as follows: • Anatomic: Stable tetraplegia with C5 or C6 motor level with international classification motor scores of 0, 1, 2 or an impairment scale level of A, B, C (ASIA) • Physiologic: Presence of adequate ROM in joints of the shoulder, arm, forearm, wrist and hand • Medical: Free of overwhelming medical problems • Psychosocial factors: Sufficient motivation to learn its use and use it • Adequate caregiver and/or family support • One year post injury, plateau of functional recovery. • Need for sufficient vision to provide visual feedback during training and use sufficient cognitive ability Contraindications to neuroprothesis use include: • Cardiac disease • Arrhythmias • Pace makers • Chronic systemic infections • Diabetes • Immune disease 5.8.1 Types of Neuroprostheses There are several existing neuroprostheses and these include implanted FES systems such as the Freehand System and the NEC FESMate System and surface stimulation electrode systems such as the Handmaster NMS-1, Bionic Glove, ETHZ-ParaCare Neuroprosthesis and systems developed by Rebersek and Vodonik and Popovic et al. 5.8.1.1 Freehand System The Freehand System from Cleveland, OH, USA is an implantable neuroprothesis intended to restore hand function in C5 and C6 level tetraplegics. The Freehand system can stimulate eight different muscles in order to produce a useful grip and key pinch in tetraplegic individuals. It is the only FDA approved (1997) implantable upper extremity neuroprothesis. The system consists of a surgically implanted receiver/stimulator unit and electrodes with an external controller and power supply/microprocessor. It was first implanted in 1986 (Cornwall and Hausman 2004). The NeuroControl Freehand System consists of an active receiver/stimulator that is placed in the chest wall and has eight leads that come from the receiver/stimulator and pass under the skin to a connector site in the upper arm. At this point they are joined to epimyseal electrode leads that are passed under the skin from the forearm and hand. Power and control signals from the unit are passed through the skin to the receiver/stimulator from a skin-mounted coil. The patient controls the device by movement of the opposite shoulder that uses a skin surface mounted position detector. The lateral grasp is generated by first flexing the fingers to provide opposition, which is followed by thumb flexion. Palmar grasp is generated by first forming the opposition between the thumb and palm, followed by simultaneous flexion of both the thumb and fingers. Stimulating the flexor digitorum superficialis and profundus muscles performs finger flexion and finger extension is obtained by stimulating the extensor communis digitorum. Stimulation of the thumb thenar’s muscle or median nerve produces thumb flexion. Hand opening and closure strength are proportional to the distance moved by the shoulder. Both

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palmar and lateral grasps are possible by pressing a button on the shoulder controller. Taylor et al. (2002) and Keith et al. (1996) reported that most clients with require several surgical procedures are needed for each client for optimal use of the device. The most common surgeries performed are brachioradialis to extensor carpi radialis for voluntary wrist extension and posterior deltoid to triceps for elbow extension (Taylor et al. 2002; Keith et al. 1996). The 1st generation of the Freehand System is no longer available from NeuroControl Corporation. There are devices still available on a selective basis in several centres (Cornwall et al. 2004). Table 5.19 Freehand System
Author Year; Country Score Research Design Total Sample Size Methods Population: Gender m=26, f=8; Age: 1353 yrs; Age at implantation: 16-57yrs; Tetraplegia; One year post survey, including 6 months of home use Treatment: Implemented with a hand neuroprosthesis that provides grasp and release Outcome Measures: Functional Evaluations: standardized test of grasp and release, measurements of pinch strength and range of motion & satisfaction survey 1. Outcome General Satisfaction: 87% were positive agree or strongly agree, 97% would recommend neuroprosthesis to others, 90% were satisfied with neuroprosthesis, 90% stated neuroprosthesis was reliable, 87% would have surgery again, 80% felt the neuroprosthesis met their expectations, & 77% would pay for the neuroprosthesis if they had the money Life Impact: 88% responses were positive for life impact; 90% stated neuroprosthesis improved their quality of life; 87% positive impact on their life (90% reported did not make a negative impact); 83% provided a benefit ADL; 87% responses regarding changes in ADL were positive; 93% participants could perform ADL easier; 93% could perform ADL such as painting and shaving; 90% had increased confidence when performing ADL; 83% could perform ADL more normally; 73% could perform ADL faster Independence: 81% of responses were positive; 87% reported they were able to function more independently; 83% used less adaptive equipment; 87% required less assistance from others; 67% felt more comfortable out in the community alone Occupation: 57% of responses to occupation questions were positive Appearance: 87% felt their hand appearance was unchanged or improved Usage: used prosthesis median of 5.5 days/week - ranged from 15 participants (44%) who donned the neuroprosthesis 7 days per week to 5 participants (15%) who used it less than 1 day/week; 24/34 participants (71%) used it 4 or more days/week; range of usage C4/C5, C5/C5, C6/C6 levels was the same (0 to 7 days/week) C5/C6 group - used it

2.

Wuolle et al. 1999; USA Downs & Black score=22 Case Series Initial N=42; Final N=30

3.

4. 5. 6.

5-37

Author Year; Country Score Research Design Total Sample Size

Methods

Outcome most regularly 4 to 7 days/week with most participants 8/10 reporting daily use Activities: most frequently reported activities included eating, drinking, shaving, brushing teeth, brushing hair, writing, operating a computer, playing games Quality of Life: 18/34 positive comments; 1/34 responded neutrally; 1/34 responded negatively Improvements: Additional stimulus channels, an implanted command source, smaller, lighter external control unit - easier to don, improve hand and arm function, make device operable if user is confined to bed When the neuroprosthesis was activated all participants increased their pinch force in lateral pinch (p<0.001) and some increased their pinch force in palmar grasp (p<0.001). 98% of participants moved at least 1 object with the neuroprosthesis (p<0.001) and 37 improved by moving at least 3 more objects (p<0.001). Disability was reduced in 49 of 50 participants as measured by the ADL abilities or ADL assessment tools.

7.

8. 9.

Peckham et al. 2001; USA/UK/Australia Downs & Black score=16 Cohort Initial N=51; Final N=50

Participants: gender m=42, f=9, age at implant 16-57yrs, level of injury C5=C6, time from injury 4.6yrs (median), follow-up3-13.9yrs Treatment: Participants were trained to use the neuroprosthesis and to use it for functional activities. Once they were satisfied with their ability to perform daily activities or when they reached a plateau in proficiency then rehab was complete. Outcome Measures: Pinch strength, active ROM, Grasp-Release Test, Activities of Daily Living (ADL) Abilities Test, ADL Assessment Test, user satisfaction survey. Population: Age: 31-48 Gender: m=7: f=1; Level: C4-6 Time Since Injury: 43-430 months; Time Since Surgery: 8-53 months Treatment: Interviews- reviewing use of Neuro Control Freehand System Outcome Measures: Amount of Care & The System

1.

2.

3.

Taylor et al. 2001; UK 2001 Downs & Black score=16 Case Series Initial N=9; Final N=8

No statistical results reported 1. Care-all users had come from outside agencies (mean 11.5 h a day, range 324 hrs); 4 users had additional care from family members (mean 3.4 h a day, range 2-5 hrs); no users claimed that care given by family members had decreased 2. System-donning external components 5-10 min; most users reported no significant problems fitting the external equipment; 2 users had problems locating the coil; 3 locating the shoulder controller; 1 had persistent problems maintaining the position through the day d/t the adhesive tape used becoming detached (4 reported this as an occasional problem); 4 users had problems with skin allergy to the tape or double sided adhesive rings; 2 users reported that the system made transfers more difficult; 3 users never stopped using the system d/t system failure; some problems with equipment reliability; no change in paid caregiver time; 6 users felt more

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Author Year; Country Score Research Design Total Sample Size

Methods

Outcome confident when using the system; 7 felt their quality of life had improved Variation in elbow moment across subjects significantly greater than the variance within subjects (ANOVA p< 0.001). 10/11 elbows tested elbow moment generated by triceps stimulation at different elbow angles, elbow moment weakest with elbow in more extended position (30 degrees flexion) and peaked with elbow at 90 flexion, significant ANOVA p<0.001. Elbow moment generated by triceps stimulation at 90 and 120 degrees elbow flexion was significantly greater than elbow moment produced by tendon transfer (ANOVA p<0.05), no difference between elbow extension methods at 30 degrees elbow flexion. Triceps stimulation and posterior deltoid together provided a greater elbow moment than each method separately, difference significant at each elbow position p<0.05, except at 90 degrees. Quantitative workspace assessment done on 5 arms, more successful with triceps stimulation, significant for each subject, chi square p<.05). Average acquisition time with triceps stimulation less than without stimulation 4/5 arms (3.2-6.4 seconds) and significant in 3/5 arms (unpaired ttest p<0.01) and not for one p=0.076. 7/9 use Freehand System daily Provided an active grip of some strength which allowed many functional activities Increase in self confidence Over 80% of their selected ADL goals - user preferred to be independent with their Freehand system than use previous method or have activity performed by caregiver Pinch force ranged from 8 to 25 N, with stimulation and greater than tenodesis grasp alone; all demonstrated functional grasp patterns and were able to manipulate at least 3 more objects with the neuroprosthesis; had increased independence and were able to use the neuroprosthesis at home on a regular basis; the implanted stimulator proved to be safe and reliable.

Population: Level of injury C5-C6. Treatment: Epimysial or intramuscular electrodes were implanted on the triceps. Following surgery standard stimulation exercise regimens were followed. Outcome Measures: elbow extension moments at different elbow positions, performance in controllable workspace experiments, comparison to an alternative method of providing elbow extension in these individuals (posterior deltoid to triceps tendon transfer) Memberg et al. 2003; USA Downs & Black score=14 Case Series N=22

1.

2.

3.

4.

5.

6.

Hobby et al. 2001; UK Downs & Black score=14 Cohort N=9

Population: Tetraplegia; Age:16-55 Treatment: The patients, using an external stimulator, built up the muscles strength in the hand and forearm, to ensure the muscles were in good condition at the time of surgery Outcome Measures: Grip Strength, ADL

1. 2. 3. 4.

Kilgore et al. 1997; USA Downs & Black score=13 Case Series N=5

Population: Age: 28-57 years; Time from injury to insertion of implant: 2 years 2 months to 9 years; Clinically complete at C5 or C6; Chronicity: 2 years 2 months to 9 years Treatment: Implanted neuroprosthesis. Outcome Measures: Grasp force; GraspRelease Test; Tests of ADL (functional independence); Usage Survey

1.

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Author Year; Country Score Research Design Total Sample Size

Methods Population: age-16-18yrs, level CC6, >1yr post injury. Treatment: Surgery Outcome Measures: Grasp Release Test & ADL Test before and after implementation of the implanted FES hand system 1.

Outcome 40 electrodes implanted, 37 continued to work, all implant stimulators have functioned without problems with follow up ranging between 16 and 25 months 2. Grasp Release Test-lateral pinch and palmar grasp forces - Wilcoxon test, FES forces were significantly greater than tenodesis forces for both grasps (P=0.043) 1. Grasp release test results: increase in the types of tasks that subjects could perform (pre n=1.4) and post implantation (n= 5.1 p=0.011). 2. One year post implantation the types of tasks performed was 5.5 p=0.027, without the system it was 1.2 (p=0.028). 3. Number of repetitions increased post implantation from 12.7 to 37.4 (p=0.028) and with out the implant post-implantation (20.2, p=0.046). 4. At one year number of repetitions was increase to 50.5, p=0.046 with the system and without 24.3, p=0.28. 1. No predicted difference between electrodes in intrinsic and extrinsic muscles (P=0.93) 2. Significant differences were predicted between exit sites (P=0.016) + across muscle groups (P=0.047) 3. Survival likelihoods poorer for electrodes exiting dorsally 4. At 90 days after implant survivals probabilities of the finger + thumb extensors + thumb abductors (P=0.8) were smaller than that of thumb adductor + flexor muscle groups (P>0.9) No statistical analysis was complete. 1. Passive elbow extension was within normal limits. 2. With stimulated triceps subjects attained full elbow extension; without it full range was not met

Mulcahey et al. 1997; USA Downs & Black score=13 Pre-post N=5

Taylor et al. 2002; UK Downs & Black score=12 Case Series N=9

Population: age-mean 38.4yrs, gender m=7, f=1, level-C4-C6, time since injurymean 10.1 yrs. Treatment: no-it was assessment of the Freehand System Outcome Measures: Grasp Release Test, Grip Strength, Activities of Daily Living, Sensory ability (static 2 pt discrimination)

Smith et al. 1994; USA Downs & Black score=12 Case Series N=5

Population: age-13-19yrs, gender m=5, level of injury C5-C6, # of mths in study 1238, time since injury 3-72mths Treatment: Intramuscular electrodes were implanted in the upper extremity muscles Outcome measures: The Breslow Test - a non-parametric linear rank test used to compare survival chances across subgroups 95% confidence limit used to reject the null hypothesis

Bryden et al. 2000; USA Downs & Black socre=12 Case Series N=4

Smith et al. 1996; USA Downs & Black score=11 Case Series N=5

Population: Age 23-48yrs, level of injuryC5-C6 Treatment: Participants were implanted with an upper extremity neuroprothesis including a triceps’ electrode to provide stimulated elbow extension. Participants exercised triceps 4-6 hr/session using a programmed electrical stimulation exercise regimen that includes breaks. Participants exercised either nightly or every other night-whatever was best for maintaining an optimal amount of strength Outcome Measures: 5 overhead reaching tasks, amount of assistance required to complete the task & survey of home use. Population: age-13-19yrs, gender m=3, f=2, level of injury C5, time since injury 3 – 72mths. Treatment: FNS vs. Tenodesis

FNS vs. Tenodesis 1. With FNS and tenodesis each case of improved performance in later sessions was significantly better as

5-40

Author Year; Country Score Research Design Total Sample Size

Methods Outcome Measures: CWRU Hand System (Case Western Reserve University), Grasp and Release Test

Outcome compared to the initial session. (p<0.05). The average grasp forces with FNS increased; the range was from 8.9N (SD+5.2) to 22.5N (SD+8.6) and the palmar grasp forces increases from 2.1N (SD+2.9) to 11.1N (SD+6.0). No statistical results are reported. No perioperative complications reported. Subjects began Freehand System use between 2 = 5 days after implantation Muscle Strength-no subject gained significant strength in any key muscle on their freehand limb Pinch Force-with Freehand System each subject realized significant improvement in pinch force Upper Extremity Capacity-first 11 questions - no difference with or without Freehand-last set of questions Freehand System improved scores Quadriplegic Index of Function-all subjects increased their level of independence Freehand System Open-ended Questions-all subjects would repeat implantation

2.

Mulcahey et al. 2004; USA Downs & Black score=6 Case Series N=4

Population: Age-13-16years, tetraplegia, injury to surgery 4-16 weeks. Treatment: The following muscles were implanted with intramuscular electrodes: Extensor digitorum profundus, extensor pollicis longus, flexor pollicis longus, adductor pollicis, and opponens pollicis for each subject. Outcome Measures: Muscle StrengthPinch Force & Hand Function, Performance of ADL, Satisfaction with + without the Freehand System (COPM), Upper Extremity Capacity, Quadriplegic Index of Function

1. 2. 3. 4. 5. 6.

7. 8.

SummaryTable5. 20 Implanted Neuroprostheses (Freehand System and CWRU)
Author N Intervention Main Outcome(s) +ve satisfaction (87%) +ve life impact (90%) +ve ADL (87%) +ve independence (81%) +ve occupation (74%) +ve appearance +ve usage (5.5 d/week median) +ve activities +ve QOL +ve lateral pinch +ve palmar grasp +ve Grasp Release Test +ve satisfaction = no change in ability and long term stability and function = no change in level of personal care assistance -ve system failure +ve ADL and functional use

Wuolle et al. 1999

34

Implanted Freehand System and 31 had adjunctive surgeries

Peckham et al. 2001

51 implanted (50 evaluated)

Implanted Neuroprosthesis and adjunctive surgeries

Taylor et al. 2001

8

Implantation of Freehand System 5/11 Implanted Freehand System 6/11 CWRU 6/11 tendon transfer surgery for elbow extension 4 arms triceps electrode 11 triceps electrodes/10 UL

Memberg et al. 2003

10

+ve elbow extension +ve workspace assessment

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Author

N

Intervention

Hobby et al. 2001

9

Implanted Freehand System and adjunctive surgeries

Taylor et al. 2002

9

Implantation of Freehand System Implanted Neuroprosthesis and adjunctive surgeries Implanted Freehand System and adjunctive surgeries Implanted Neuroprosthesis Implantation of Freehand System with electrode to triceps Implanted Neuroprosthesis

Kilgore et al. 1997 Mulcahey et al. 1997 Smith et al. 1994 Bryden et al. 2000 Smith et al. 1996

5 5 5 4 (5 limbs) 5

Mulcahey et al. 2004

4

Implanted Freehand System

Main Outcome(s) +ve ADL and functional use (80%) +ve lateral grasp +ve palmar grasp +ve 5 finger grasp -ve several electrode failures; stimulator failure; medical complications 7/9 use device daily +ve Grasp Release Test +ve Grip Strength +ve ADL Assessment +ve pinch force +ve grasp strength +ve Grasp Release Test +ve ADL and functional use +ve Grasp Release Test +ve ADL and functional use -ve electrode failure +ve elbow function (strength, ROM) +ve ADL and functional use +ve unilateral grasp and release abilities with FNS = UE strength +ve ADL: QIF scores +ve Satisfaction: COPM +ve lateral and palmar pinch = UE capacity: UEC

+ positive outcome, = no difference, - negative outcome

5.8.1.2 HandMaster-NMS-1 The Handmaster developed by Nathan et al., and produced by Neuromuscular Electrical Stimulator Systems, Ra’anana, Israel. It has been FDA approved for use with stroke patients. It is predominantly used as an exercise tool for stroke subjects and is commercially available in a limited number of countries (Popovic et al. 2001). The Handmaster has three surface stimulation channels used to generate grasping function in tetraplegic and stroke subjects. One channel is used to stimulate extensor digitorum communis muscle at the volar side of the forearm. The second channel stimulates the flexor digitorium superficialis and profundus muscles. The third stimulation channel generates thumb opposition. The system is controlled with a push button that triggers the hand opening and closing functions. The system is easy to don and doff. However, it does have some limitations in its design. The system is limited by not enough sufficient flexibility to vary the position of the electrodes for stimulation of the finger flexors for grasp; it is a stiff orthosis that fixes the wrist joint angle and prevents full supination of the forearm (Popovic et al. 2001). Table 5. 21 Handmaster-NMS-1
Author Year; Country Score Research Design Total Sample Size Alon & McBride 2003 USA Downs & Black score=12 Case Series N=7 Methods Population: Gender m=7, level of injury C5-C6, 6mths post injury Treatment: Subjects practiced with the neuroprothesis daily to regain grasp, hold, and release ability and to restore selected functions of 1 of the 2 paralyzed hands. Outcome No statistical results reported. 1. All were 100% successful in using the handmaster in the studied ADL and grasp (hold and release) tasks. 2. Improvements were noted in strength (.57 ± 98N to 16.5 ± 4.4N, finger linear

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Author Year; Country Score Research Design Total Sample Size

Methods Subjects were observed 2 to 3 times weekly for 3 wee Outcome Measures: Hand function was evaluated by a series of upper limb measures: 3 ADL tasks, 3 hand impairment measures, 2 grasp and release tests. Population: Gender: m=8, f=2; Age range: 20 to 65; Level of injury: C4 to C6; Classification: 3-Cu n=3, 1-O n=5, 2-O n=1, 0-O n=1; Fitted hand: Right n=6, Left n=4 Treatment: Training for use of Handmaster Outcome Measures: not specified

Outcome motion (0.0cm to 8.4 ± 3.2cm) and Fugi-Meyer scores (p<0.05)

Snoek et al. 2000; Netherlands Downs & Black score=8 Case Series Initial N=10; Final N=4

No statistical results were reported. 1. 6 people left the study for various reasons (>50%). Over all the 4 remaining were able to perform several tasks with the Handmaster that they were not able to without it ( e.g.: 3/4 were able to put the splint on independently)

Summary Table 5. 22: Handmaster-NMS-1
Author Alon and McBride 2003 Snoek et al. 2000 N 7 Intervention NESS Handmaster Main Outcome(s) +ve ADL use +ve Grasp Release Test +ve grip strength = finger motion -ve poor compliance, only 4 completed the training period

10 patients Handmaster (7 at end) + positive outcome, = no difference, - negative outcome

5.8.1.3 Bionic Glove Developed by Prochazka and colleagues at the University of Alberta the Bionic Glove improves hand function in people with SCI. This device uses three channels of electrical stimulation to stimulate finger flexors, extensors and thumb flexors. The control signal comes from a wrist position tranducer mounted in the garment. The actual functioning of the device can be described as greatly augmenting tenodesis (Prochazka et al. 1997; Popovic et al. 2005). The Bionic Glove is designed to enhance the tenodesis grasp in subjects that have a voluntary control over the wrist (flexion and extension). Stimulates finger flexors and extensors during tenodesis grasp, enhances strength of grasp. The Bionic Glove is available at the University of Alberta, Alberta, Canada and used primarily for clinical evaluation. A modified version of this device will be called Tetron (Popovic et al. 2002). Overall acceptance rate for long-term use is reported in 30% of potential users. Functions of power grasp and handling of big objects were significally improved (Popovic et al. 2002). There have been several identified concerns with the device that include damage to the stimulator located on the forearm that is frequently damaged through accidental contact during functional activities and the transducer mechanism is delicate and has to be replaced frequently (Popovic et al. 2001). Table 5.23 Bionic Glove
Author Year; Country Score Level Total Sample Size Popovic et al. 1999; Methods Population: 12 people with SCI at C5-7 1. Outcome QIF: mean was 19.0 +/- 6.5 at the

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Author Year; Country Score Level Total Sample Size Yugoslavia Downs & Black score=13 Case Series N=12

Methods who had used the device 6 months or more Age: 26.5 +/- 8.3 years (18-38 yr) 10 complete; 1 central cord; 1 BrownSequard Time post injury; 2+ years: 7; 1+ year: 3; 6 months+: 1; 3 months: 1 Treatment: Taught how to use the device Outcome Measures Quadriplegia Index of Function; Functional Independence Measure; Upper Extremity Function Test; Goniometric Measurements

Outcome beginning; at the end 28.4 +/- 5.2, improvement of 49.5%. FIM: 63.8 +/- 10.4 at the beginning; 79.0 +/- 8.9 after 6 months. When 3 clients excluded who had 120 points on FIM scores were beginning 44.4 +/13.5 and 64.8 +/- 16.6 after 6 months (increase of 20.4 points/46%). Functional task completion: 6 subjects continued to use the device. Average was .745 or 75% of the functions were performed better after 6 months of use. 6/12 (50%) did not continue to use the device C6-C7 individuals may find the device beneficial enough to use it as an assistive device. Technical improvements specifically cosmetics, positioning of the electrodes, donning/doffing. Best candidates are individuals with complete C6-C7 tetraplegia; FIM score between 25-50 (up to 75), QIF between 0-13 (up to 27), are motivated to use it, can demonstrate efficient grasp. Mean peak force of tenodesis grasp in the nine subjects increased from 2.6 N ± 3.8 N (passive) to 11.3 N ± 7.4 N (glove active), significant than Fp (P= 0.0064, t-test), and significant at end of 5th grasp 6.8 N ± 4.2 N, P= 0.0064, Mann-Whitney rank sum test. Most manual tasks improved significantly with the use of the glove

2.

3.

4. 5. 6.

Prochazka et al. 1997; Canada Downs & Black score=12 Case Series N=9

Population: Gender m=8, f=1, age-2242yrs, level of injury-C6-C7, time post injury-16mths-22yrs. Treatment: Use of bionic glove Outcome Measures: Mean peak force of tenodesis grasp, qualitative ratings of manual tasks.

1.

2.

Summary Table 5.24 Bionic Glove
Author Popovic et al. 1999 Prochazka et al. 1997 N 12 9 Intervention Bionic Glove Bionic Glove Main Outcome(s) +ve QIF +ve FIM +ve UE Function Test +ve grasp +ve compliance (60%)

+ positive outcome,= no difference, - negative outcome

5.8.1.4 ETHZ-ParaCare System The ETHZ-Para Care System was developed collaboratively between ParaCare, the University Hospital Zurich, the Rehabilitation Engineering Group at Swiss Federal Institute of Technology Zurich and Compex SA, Switzerland. The system was designed to improve grasping and walking function in SCI and stroke patients. Surface stimulation FES system is programmable, 4 stimulation channels, can be interfaced with any sensor or sensory system. The system provides both palmar and lateral grasps. The device has some reported disadvantage that includes a lengthy time to don and doff the device (7-10 minutes) and it is not commercially available. The next generation of the device will be called the Compex Motion (Popovic et al. 2001; Popovic et al. 2005). The Compex Motion device is currently available in clinical trials 5-44

with approximately 80 units available. The Compex Motion stimulator was designed to serve as a hardware platform for the development of diverse FES systems that apply transcutaneous (surface) stimulation technology. One of the main designs in this system is that it is easily programmable (Popovic et al. 2005). Table 5.25 ETHZ ParaCare and Compex Motion Systems
Author Year; Country Score Research Design Total Sample Size Methods Population: gender m=9, f=2, age 1570yrs, level of injury C5-C7, ASIA A-D, FES applied 1-67 mths post injury Treatment: FES was carried out with a stationary stimulation system and 2 portable systems (ETHZ-Paracare FES system, and Complex Motion) Outcome Measures: videos of functional tasks: hand function tests, self-designed functional tests, f/u query-assessment of muscle strength Outcome No statistical results. Case Reports. 1. Cervical SCI patients can benefit from transcutaneous FES of hand muscles during rehabilitation with respect to muscle strengthening, facilitation of voluntary muscle activity and improvements of ADL functions 2. Surface FES system is more flexible in its application and does not need surgical procedures 3. High flexibility in electrode placement, stimulation programmes, and FES control devices is required in order to adapt the system to individual needs

Mangold et al. 2005; Switzerland Downs & Black socre=10 Case Series N=11

Summary Table 5.26: ETHZ ParaCare and Compex Motion Systems
Author Mangold et al. 2005 N 11 Intervention ETHZ-ParaCare FES System and Compex Motion Main Outcome(s) +ve Training Programme +ve Functional exercises in therapy = ADL function in rehab centre -ve ADL use at home

+ positive outcome, = no difference, - negative outcome

5.8.2 Other Surface or Percutaneous Neuroprosthesis Systems 5.8.2.1 NEC-FES System The Sendai FES team in corporation with NEC Inc. 1994 developed the NEC-FES System. The system is to restore both grasping and walking abilities. It is an implanted FES system with 16 stimulation channels. It is used almost exclusively for research purposes and is not available outside Japan. 5.8.2.2 Neuroprosthesis developed by Rebersek and Vodovik (1973) This is one of the first FES systems developed for grasping three decades ago. The device has three stimulation channels (2 stimulation electrodes per channel) that are used to generate the grasping function by stimulating finger flexors and extensors and thumb flexors. The user can control the stimulation intensity via different sensory interfaces such as EMG sensor, sliding resistor and pressure sensors. The main reported disadvantages of the system are the long donning and doffing times and the selectivity of stimulation is low. This device is not commercially available (Popovic et al. 2001).

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5.8.2.3 Belgrade Grasping-Reaching System (BGS) The BGS as proposed by Popovic et al. (1998) is a neuroprosthesis device designed for grasping and it also provides a reaching function. The device has four stimulation channels (three for generating grasping function and fourth to stimulate triceps brachii muscle for elbow extension). The grasping function is controlled via a push button that triggers hand opening and closing. The motion of grasp is performed in three phases; prehension that forms the correct aperature of the hand, a relaxation phase that allows the hand to get into good contact with the object and closure of the hand by opposing either the palm and the thumb or side of index finger and thumb. The act of hand release is completed in two stages; opening of the hand and resting. Measuring the subject’s shoulder velocity with a goniometer and then generating a synergistic elbow motion by stimulation of the triceps brachii muscle achieves the reaching function of the upper limb. It is reported that the BGS system requires more time to place electrodes compared to Handmaster system, and it is not commercially available (Popovic et al. 2002). 5.8.3 Reported Benefits of Neuroprosthesis Use There have been many documented and reported benefits of neuroprosthesis use with the spinal cord injured person. The training required to use the device leads to short and long-term changes within the central nervous system (Popovic et al. 2002). A neuroprosthesis can be used as a neurorehabilitation system that promotes recovery and better hand function in incomplete SCI and stroke subjects or as a permanent orthotic device for complete cervical lesion SCI subjects to augment the grasp and manipulation functions required for typical ADLs. 5.8.4 Clinical Results of Neuroprosthesis Use The following are the reported clinical results of neuroprosthesis use; • Clinical trials show improvement in grasping functions in stroke and SCI subjects • FES technology facilitates a comfortable and secure grasp that allows the individual to hold and manipulate various objects • All except the Bionic Glove were able to facilitate both palmar (power) grasp and lateral (fine) grasp • The Handmaster-NMS-1, the BGS system, and the ETHZ-ParaCare neuroprostheses have been applied successfully as rehabilitation tools to restore grasping function in SCI individuals instead of being used as permanent orthotic systems • To control the neuroprosthesis, subjects are using either an on-off type of switch or have to apply simple analog sensors to generate desired control commands • There is a delay of 1-2 seconds from time command is issued and moment that grasp is executed which restricts the speed that an individual can grasp and release objects • Neuroprosthesis for grasping can only be used for slower grasping tasks • The most widely used and accepted neuroprostheses for grasping are the Freehand System and the Handmaster-NMS-1 and all of the other neuroprostheses mentioned are mainly used in experimental trials for research purposes 5.8.5 Challenges in Neuroprosthesis Use There are several reported challenges in neuroprosthesis use: • There is a general perception within the clinical community that neuroprosthesis technology is not fully matured and the application of its use is labour intensive

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• • • • • • • • • • • • • • • • • • •

Patients and families have over expectations from assistive systems as aspirations and results do not match Acceptance of the device depends on the specific needs of the client Complicated by variety of age and lifestyle factors represented in patients with UE paralysis Complacent (feel comfortable, safe and happy with home and workplace adaptation and with attendant care) Waiting for cure (refuse any other intervention) Afraid of technology Degree of cognitive interaction they require – high levels of attention to their neuroprosthesis may interfere with social interaction Impact in clinical applications is limited Reasons for poor acceptance is can be technical, cultural and psychological FES technology requires intensive maintenance and skilled technician Found to be effective in hospitals with strong engineering support Attempts to simplify neuroprosthesis systems and reduce the system’s donning and doffing time resulted in less technical support needed but the devices then failed to address the needs of a wider population Inadequate reliability of use (breakage of wires, electrode failure, accidental damage) The grasping functions are robotic quality of stimulated motions and in order to design a more dexterous hand motion it would require a more complicated system Overall cosmetics of the device Implanted neuroprosthesis require additional surgery and it is recommended that tendon transfers be performed to augment the system Extensive training is required to learn how to use the device, which is expensive in terms of staffing and resources Efforts to increase reliability of system components, data on long-term reliability not yet available Simple systems for powered tenodesis grip for individual with lesions at C6 or lower have not been fully explored in deference to volitional tendon transfer surgery (Popovic et al. 2002; Triolo et al. 1996)

Discussion The use of neuroprosthesis whether implanted or surface electrodes appear to benefit persons with C5-C7 level tetraplegia. The studies consistently demonstrate improvements in pinch (lateral and palmar), grip strength, and ADL functioning and general satisfaction with the use of the device, although the study subject numbers are relatively small. Ongoing compliancy and use of the devices on a long-term basis continue to be problematic. Reasons for discontinuing the use of the device are with length of time and the amount of assistance required to don and doff the device, and if using the device can provide enough of a difference in overall level of functioning. The studies also consistently report both mechanical/electrode failure and adverse medical complications. Many of the devices are only available in specialized rehabilitation centres where access to rehabilitation engineering is available. In addition, many of the devices continue to be only available in clinical trials. The overall cost to use the device continues to be great when factors such as cost of the device, the extensive training period required and staff to support the programme.

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Conclusion There is level 4 evidence from multiple studies that support the use of neuroprostheses for persons with C5-C6 complete tetraplegia in the improvement of pinch and grip strength and ADL functioning. However, many devices are only available in clinical trials in specialized rehabilitation centres and the overall cost of the device continues to be expensive. The use of neuroprostheses appears to have a positive impact on pinch and grip strength and ADL functions in C5-C6 complete tetraplegia, however, access to the devices are limited and continue to be expensive in use.

5.9 Summary The treatment and management of the upper limb in persons with a spinal cord injury can be rewarding yet very challenging. Secondary complications related to repetitive strain injury, pain and hypertonicity in addition to aging presents numerous challenges for both the injured individual and the clinician. In reviewing the critical evidence of treatment interventions it was surprising that there was few studies on the effectiveness of traditional interventions such as strengthening, exercise, splinting and management of hypertonicity. The majority of research for the upper limb has been focused on reconstructive surgery and the use of neuroprosthesis. Advancements in understanding the mechanisms related to spinal cord injury has led to restorative treatment interventions especially in the management of the incomplete SCI person. This chapter outlined the importance in the prevention of upper limb dysfunction and the impact of an injury in one’s overall level of basic independence in the areas of self-care and mobility. Further research and consensus is needed in how we assess and document upper limb function especially hand function in an effort to establish objective, reliable and measurable outcomes. Other areas for further research have been identified throughout the chapter. There is level 1 evidence based on one RCT that physical capacity continues to improve after 1- year post discharge. There is level 2 evidence based on one pre/post study that neuromuscular stimulationassisted ergometry alone and in conjunction with voluntary arm crank exercise was an effective strengthening intervention for chronically injured individuals. There is level 2 evidence based on one study that muscle strength continues to improve up to 15 months post hospital discharge for both tetraplegic and paraplegic individuals. There is level 4 evidence based on one study that neuromuscular stimulation-assisted exercise improves muscle strength over conventional therapy. There is level 1 evidence (from 2 RCTs) that augmented feedback is not effective in improving upper limb function in tetraplegia. There is level 4 evidence that intrathecal baclofen may be an effective treatment for upper extremity hypertonia of spinal cord origin.

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There is level 1 evidence from one RCT that showed that massed practice (repetitive activity) and somatosensory stimulation (median nerve stimulation) demonstrated significant improvement in grip and pinch strength required for functional activity use. There is level 2 evidence from a before/after study that showed that rTMs treatment in individuals with chronic stable ISCI may produce reductions in corticospinal inhibition that resulted in clinical and functional changes for several weeks after treatment. There is level 2 evidence from one RCT that showed that the use of concomitant auricular and electrical acupuncture therapy may improve the neurological and functional recovery of acutely injured spinal cord individuals. There is level 2 evidence based on one RCT that wearing a thumb opponens splint will improve pinch strength and functional use of the hand. There is level 1 evidence based on two RCTs that a shoulder exercise and stretching protocol reduces the intensity of shoulder pain post SCI. There is level 2 evidence that general acupuncture is no more effective than Trager therapy in reducing post-SCI upper limb pain. There is level 4 evidence from multiple studies that support the use of reconstructive surgery for the tetraplegic upper limb for the improvement of ADL and quality of life. There is level 4 evidence from multiple studies that support the use of neuroprostheses for persons with C5-C6 complete tetraplegia in the improvement of pinch and grip strength and ADL functioning. However, many devices are only available in clinical trials in specialized rehabilitation centres and the overall cost of the device continues to be expensive.

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Schmidt RA, Lee TD. Motor control and learning: a behavioral emphasis. 3rd Edn. Champaign, IL: Human Kinetics, 1999. Schroer W, Lacey S, Frost FS, Keith MW. Carpal instability in the weight-bearing upper extremity. Journal of Bone and Joint Surgery 1996; 78:1838-43. Shimada Y, Chida S, Matsunaga T, Misawa A, Ito H, Sakuraba T, Sato M, Kazutoshi H, Itoi E. Grasping power by means of functional electrical stimulation in a case of C6 complete tetraplegia. Tohoku J. Exp. Med. 2003;201:91-96. Shimada Y, Sato K, Abe E, Kagaya H, Ebata K, Oba M, Sato M. Clinical experience of functional electrical stimulation in complete paraplegia. Spinal Cord 1996a;34:615-619. Sie IH, Waters RL, Adkins RH, Gellman H. Upper extremity pain in the post rehabilitation spinal cord injured patient. Arch Phys Med Rehabil 1992; 73:44-47. Silfverskiold J, Waters RL. Shoulder pain and functional disability in spinal cord injury. Clin Orthop. 1991; 272:141-145. Sinnott KA, Dunn JA, Rothwell AG. Use of the ICF conceptual framework to interpret hand function outcomes following tendon transfer surgery for tetraplegia. Spinal Cord 2004; 42:396-400. Sipski ML, Richards JS. Spinal cord injury rehabilitation: State of science. Am J Phys Med Rehabil 2006; 85:310-342. Smith BT, Betz RR, Mulcahey MJ, Triolo RJ. Reliability of percutaneous intramuscular electrodes for upper extremity functional neuromuscular stimulation in adolescents with C5 tetraplegia. Arch Phys Med Rehabil 1994; 75: September, 939-945. Smith BT, Mulcahey MJ, Betz RR. Quantitative comparison of grasp and release abilities with and without functional neuromuscular stimulation in adolescents with tetraplegia. Paraplegia 1996; 34: 16-23. Snoek GJ, Ijzerman MJ, FACG in ‘t Groen, Stoffers TS, Zilvold G. Use of the NESS Handmaster to restore hand function in tetraplegia: clinical experiences in 10 patients. Spinal Cord 2000; 38: 244-249. Snoek GJ, Ijzerman MJ, Hermens HJ, Biering-Sorensen F. Survey of the needs of patients with spinal cord injury: impact and priority for improvement in hand function in tetraplegics. Spinal Cord 2004; 42; 526-532. Snoek GJ, Ijzerman J, Post MW, Stiggelbout AM, Roach MJ, Zilvold G. Choice-based evaluation for the improvement of upper-extremity function compared with other impairments in tetraplegia. Arch Phys Med Rehabil 2005; 86: August, 1623-1630. Subbarao JV, Klopfstein J, Turpin R. Prevalence and impact of wrist and shoulder pain in patients with spinal cord injury. J Spinal Cord Med. 1994;18(1):9-13. Taylor P, Esnouf J, Hobby J. Pattern of use and user satisfaction of Neuro Control Freehand system. Spinal Cord 2001; 39: 156-160. Taylor P, Esnouf J, Hobby J. The functional impact of the freehand system on tetrapleic hand function. clinical results. Spinal Cord 2002; 40:560-566. Thompson L. Functional changes in persons aging with spinal cord injury. Assistive Technology II 1999: 123-9. Triolo R, Nathan R, Handa Y, Keith M, Betz RR, Carroll S, Kantor C. Challenges to clinical deployment of upper limb neuroprostheses. Rehabil Res Dev 1996; 33: 111-122. Tsay RC. Textbook of Chinese acupuncture medicine: general introduction to acupuncture. Wappinger Falls, Association of Chinese Medicine and East-West Medical Centre, 1974; 1:40-52. Van Dijik H, Jannink JA, Hermens HJ. Effect of Augmented feedback on motor functions of the affected upper extremity in rehabilitation patients: a systematic review of randomized controlled trials. J Rehabil Med 2005; 37: 202-211. Van Tuijl JH, Janssen-Potten YJM, Seelen HAM. Evaluation of upper extremity motor function tests in tetraplegia. Spinal Cord 2002; 40: 51-64. 5-57

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CHAPTER SIX
Lower Limb Rehabilitation Following Spinal Cord Injury
Tania Lam, PhD, PT Dalton L Wolfe, PhD Jane TC Hsieh, MSc Maura W Whittaker, PT Janice J Eng, BSc (PT/OT), PhD

Key Points Patterned Electrical Stimulation (PES) programs are beneficial in preventing and restoring lower limb muscle atrophy as well as improving lower limb muscle strength and endurance. Functional Electrical Stimulation (FES)-assisted exercise programs are beneficial in preventing and restoring lower limb muscle atrophy as well as improving lower limb muscle strength and endurance. For patients less than 6 months post-SCI, body weight supported treadmill training has equivalent effects on gait outcomes to conventional rehabilitation consisting of overground mobility practice. Body weight-support gait training strategies can improve gait outcomes in chronic, incomplete SCI, but no body weight-support strategy (overground, treadmill, with FES) is more effective. There is little evidence that any pharmacological agent is significantly beneficial in directly improving ambulation in individuals with SCI. FES-assisted walking can enable walking or enhance walking speed in incomplete SCI or complete (T4-T11) SCI. Regular use of FES in gait training or activities of daily living can lead to improvement in walking even when the stimulator is not in use. There is limited evidence that bracing alone does not enable significant gains in functional ambulation for people with complete SCI. The advantages of bracing appear largely restricted to the general health and well-being benefits related to practice of standing and the ability to ambulate short-distances in the home or indoor settings. The benefits of bracing-alone on functional ambulation are primarily with people with incomplete spinal lesions. There is limited evidence that a combined approach of bracing and FES results in additional benefit to functional ambulation in paraplegic patients with complete SCI. Locomotor training programs are beneficial in improving lower limb muscle strength although in acute SCI similar strength benefits can be obtained with conventional rehabilitation. The real benefit of locomotor training on muscle strength may be realized when it is combined with conventional therapy. This should be further explored in acute, incomplete SCI where better functional outcomes may be realized with the combination of therapies.

Table of Contents
6.1 Introduction ......................................................................................................................6-1 6.2 Electrical Stimulation to Enhance Lower Limb Muscle Function........................................6-2 6.2.1 Patterned Electrical Stimulation (PES) ...........................................................................6-2 6.2.2 Functional Electrical Stimulation .....................................................................................6-4 6.3 Gait Retraining to Achieve Functional Measures of Overground Ambulatory Capacity ............................................................................................................................6-7 6.3.1 Body-weight supported treadmill training (BWSTT) ........................................................6-8 6.3.1.1 BWSTT in Acute/Sub-acute SCI ..................................................................................6-8 6.3.1.2 BWSTT in Chronic SCI ..............................................................................................6-10 6.3.2 Special Case Report: Spinal Cord Stimulation Combined with BWSTT .......................6-12 6.3.3 Pharmacological Interventions......................................................................................6-12 6.3.4 Functional Electrical Stimulation (FES).........................................................................6-15 6.3.5 Orthoses/Braces ...........................................................................................................6-18 6.3.5.1 Bracing alone in SCI ..................................................................................................6-18 6.3.5.2 Bracing Combined with FES in SCI ...........................................................................6-22 6.3.6 Enhancing Strength Following Locomotor Training ......................................................6-24 6.4 Summary...........................................................................................................................6-26 References..............................................................................................................................6-29

This review has been prepared based on the scientific and professional information available in 2005. The SCIRE information (print, CD or web site www.icord.org/scire) is provided for informational and educational purposes only. If you have or suspect you have a health problem, you should consult your health care provider. The SCIRE editors, contributors and supporting partners shall not be liable for any damages, claims, liabilities, costs or obligations arising from the use or misuse of this material. Lam T, Wolfe DL, Hsieh JTC, Whittaker M, Eng JJ (2006). Lower Limb Rehabilitation Following Spinal Cord Injury. In: Eng JJ, Teasell RW, Miller WC, Wolfe DL, Townson AF, Aubut J, Abramson C, Hsieh JTC, Connolly S, editors. Spinal Cord Injury Rehabilitation Evidence. Vancouver, p 6.1-6.34. www.icord.org/scire

Lower Limb Rehabilitation Following Spinal Cord Injury
6.1 Introduction The rehabilitation of lower extremity function after spinal cord injury has generally focused on the recovery of mobility. In individuals with paraplegia, the recovery of trunk stability and walking function are cited as the highest priorities after sexual and bladder/bowel function. Among people with tetraplegia, the return of arm/hand function is by far the greatest concern, but trunk stability and walking movement do appear among their priorities (Anderson 2004). Indeed, the basic capacity to stand upright and interact with others at eye-level is an important ability that many able-bodied individuals take for granted. Improvements in emergency and acute medical care for spinal cord injury have translated into improved survival rates in people who suffer such trauma (Frankel et al. 1998; O'Connor 2005). Concomitant with this change is also the finding that there is a trend towards less severe lesions, increasing the number of incomplete spinal cord injuries (Tator et al. 1993). The chance that a person can be ambulatory following a spinal cord injury is greatly increased when the severity of the spinal lesion is less (Burns et al. 1997; Curt & Dietz 1997). Thus, with the trend towards increased survival rates and decreased lesion severity, there is an increasing need for ambulatory rehabilitation treatments to maximize function and mobility for people with spinal cord injury. Conventional rehabilitation strategies for enhancing lower limb function after spinal cord injury have focused on range of motion and stretching, active exercises, electrical stimulation to strengthen functioning musculature, and functional training in daily mobility tasks (e.g. transferring, bed mobility, sitting). After SCI, it is well established that muscles experience deconditioning, especially those denervated following complete SCI. The most visible effect of deconditioning is muscle atrophy, characterized by a reduction in size of individual muscle fibers (Castro et al. 1999a; Castro et al. 1999b). Deconditioning is also associated with a complex cascade of biochemical events and alterations over time in muscle composition such as changes to muscle fiber type (Stewart et al. 2004; Round et al. 1993). Functionally, these changes are manifest as loss of strength and endurance of muscular contractions and have been targets for various interventions. Muscular contractions have the added potential of improving the well known loss of bone density following SCI. It should be noted that there might be additional benefits to enhancing muscle structure and function in addition to the immediate functional consequences of enhancing strength and endurance. For example, Anderson (2004) noted that future treatments developed for chronic SCI may require the reversal of muscle atrophy in order for benefits of the treatment to be detectable. Others have noted the potential health benefits (e.g., reduction in secondary conditions) that may be associated with reducing muscle atrophy and enhancing muscular strength and endurance (Shields & Dudley-Javoroski 2006). Various rehabilitation techniques have been focused on reducing or reversing these detrimental changes to the muscles of the lower limb following SCI. Standing and overground ambulation training are also important components of conventional rehabilitation using various bracing and assistive devices such as walkers (O'Sullivan & Schmitz 1994; Somers 1992). In the last several years, we have also seen exciting advances in technology applications for facilitating or augmenting gait rehabilitation strategies, such as

6-1

robotic devices for treadmill gait retraining (Colombo et al. 2001; Hesse et al. 2004) and the introduction of microstimulators for activating paralyzed muscles (Weber et al. 2004). 6.2 Electrical Stimulation to Enhance Lower Limb Muscle Function A variety of electrical stimulation techniques have been employed to enhance lower limb muscle structure and function in people with SCI. These typically involve delivering a series of electrical pulse trains to the muscle (or nerve supplying the muscle) over time such that it simulates the “normal” exercise experience. Specific stimulation parameters (i.e., pulse width, train duration, between train interval, method of application) and other exercise-related variables (i.e., frequency, duration, intensity, program length) may each be varied to attain an optimal training stimulus. Given the number and variety of these factors, it is not surprising that there is considerable heterogeneity among the specific electrical stimulation interventions that have been investigated to date. In the present review we focus on two strategies: patterned electrical stimulation (PES) and functional electrical stimulation (FES). Whereas both methods typically employ cyclical patterns of electrical stimulation that simulate natural muscular activity, FES is directed towards the attainment of purposeful movement such as cycling or walking. PES, on the other hand, is focused on producing muscle contractions that may be used to generate muscle force such as in an isometric condition. In some applications, PES techniques have been used as a training stimulus to prepare muscles for a subsequent FES training condition (e.g., Kern et al. 2005; Hjeltnes & Lannem 1990). In situations where increased muscle torque and endurance are primary goals to improve function, for example in the quadriceps in an incomplete SCI, the outcomes of these experimental studies have direct clinical relevance. 6.2.1 Patterned Electrical Stimulation (PES) Table 6.1 PES Studies Examining Muscle Function and Morphology
Author Year; Country Score Research Design Total Sample Size Methods Population: 26 subjects within 15 weeks SCI, traumatic, motor complete, thoracic or cervical SCI, mean ages from 25.0 to 28.2 years, 67.5-80% males. Treatment: Random assignment to 3-6 months of 1. FES-assisted cycle ergometry (n=8), 30 min, 3X/week; 2. PES-assisted isometric exercise group (n=8) (same muscle groups as FES group) for 1 hr, 5X/week and 3. control group (n=9) with no stimulation. Outcome Measures: lean body mass lower lim . Population: 7 men with complete SCI (ASIA class A), C5-T10, ≥ 6 weeks postinjury, ages 21-43. Treatment: PES exercise to unilateral ankle plantarflexion (untrained leg served as a control). Four 4 min exercise bouts, 5 days/week for 1.87-3.05 years. Outcome Measures: Stimulated ankle torque and soleus twitch profiles at baseline and every 6 months up to 3 years. 1. 2. Outcome Lean body mass increased with FES-cycling at all regions and declined for control and PES group. With respect to total body lean mass, lower limb lean mass and gluteal lean mass, controls lost an average of 6.1%, 10.1%, 12.4% after 3 months and 9.5%, 21.4%, 26.8% after 6 months.

Baldi et al. 1998; USA PEDro=5 RCT N=26

Shields et al. 2006; USA Downs & Black score=17 Prospective Controlled Trial N=7

Compared to the untrained side, stimulated limb had: 1. ↑ strength (↑ peak stimulated ankle torque and higher torque-time integrals (p<0.05). 2. More resistant to fatigue (↑muscle fatigue indexes), (p<0.05). 3. Increased twitch difference (indicative of force generating capacity) (p<0.05), especially with successive stimulation trains. 4. Greater trabecular bone mineral

6-2

Author Year; Country Score Research Design Total Sample Size

Methods

Outcome density at some sites but not others.

Hjeltnes & Lannem 1990; Norway Downs & Black score=11 Pre-post N=4

Kayaga et al. 1996; Japan Downs & Black score=9 Pre-post N=5

Population: 4 subjects with SCI; Frankel A (3 chronic T7-T12; 1 with recent injury at T5); age range 20-36; 3 females, 1 male; 3 months-5 years post-injury. Treatment: PES, 4 weeks, 2x/day, 510mins, isokinetic resistance to quadriceps muscles followed by 4 weeks, 30 min, 2X/day, 4-5X/day of integrated training of rising and standing. Outcome Measures: Knee extension torque, thigh circumference, creatine kinase collected monthly. Population: 5 male patients, complete paraplegia (T5-L2), 19 to 68 years of age, 3-60 months post-injury. Treatment: Subcutaneous PES to various lower limb nerves and muscles for 6 months. Applied at 10 min, 3X/day and gradually increased to 60 min, 3X/day at 10 weeks. Outcome Measures: Muscle crosssectional area (CT scan), manual muscle test, stimulated muscle torque.

1.

2.

No group statistics done. At least 2 subjects had ↑ knee extension torque, ↑ muscular endurance, ↑ thigh circumference, ↑ elevated CK (indicator of muscle injury) on occasion. The more acute subject stopped training due to muscle spasms. One subject progressed to the planned stage of FNS-assisted ambulation training. No group statistical analysis performed, limited by heterogeneity across subjects. All cross-sectional muscle areas except gluteus maximus increased (p<0.05 to <0.001). Muscle torques generally increased after PES. Manual muscle tests generally increased (p<0.001) for muscles initially assessed as poor-minus or greater.

1. 2. 3. 4.

Discussion In general, all studies reviewed involving PES produced beneficial results on muscle functions such as strength and endurance or muscle structure such as increased muscle size (i.e., reduced muscle atrophy). The study with the strongest design was conducted by Shields and Dudley-Javorski (2006), who employed an experimental non-RCT design to examine the effect of long-term (up to 3 years) PES exercise to unilateral ankle plantarflexor muscles with the untrained leg serving as a control. This study examined 7 ASIA class A males with relatively recent injuries (~6 weeks post-injury). Peak stimulated ankle torque (i.e, non-voluntary) was found to be significantly greater in the stimulated leg as compared to the untrained leg. Trained limbs also generated significantly higher torque-time integrals than untrained limbs (p<0.05). Pre-post study designs of PES-assisted exercise also found increased stimulated muscle forces or torques following training although the subjects involved in these studies were generally more chronic (Kagaya et al. 1996; Hjeltnes & Lannem 1990). In addition, Bajd et al. (1999) showed increases in voluntary and stimulated isometric knee joint torques in 4 of 7 subjects with incomplete SCI (2 months to 8 years post-injury) with a 5th subject showing an increase in the stimulated response only. In addition to enhancing muscle bulk, most interventions are focused on improving muscle function, most notably strength and endurance, but also contractile speed and muscle fatigue. PES-assisted exercise, in particular, has been studied and shown to benefit the property of strength in the lower limb. All but one (i.e., Bajd et al. 1999) of the studies assessing outcome measures associated with strength evaluated this in individuals with complete or motor complete SCI (Shields & Dudley-Javoroski 2006; Kagaya et al. 1996; Hjeltnes & Lannem 1990).

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Shields and Dudley-Javorski (2006), also demonstrated a beneficial effect with their protocol of PES-assisted exercise to the plantarflexors in more recently injured individuals with ASIA A SCI. Conclusion There is level 2 evidence that a program of PES-assisted isometric exercise reduces the degree of lower limb muscle atrophy in individuals with recent (~10 weeks post-injury) motor complete SCI, but not to the same extent as a comparable program of FESassisted cycling exercise. There is level 4 evidence that programs of PES-assisted exercise partially reverses the lower limb muscle atrophy found in individuals with long-standing (>1 year post-injury) motor complete SCI. There is level 2 evidence that a program of PES-assisted exercise increases lower limb strength and muscular endurance.

PES programs are beneficial in preventing and restoring lower limb muscle atrophy as well as improving lower limb muscle strength and endurance.

6.2.2 Functional Electrical Stimulation Table 6.2 FES Studies Examining Muscle function and Morphology
Author Year; Country Score Research Design Total Sample Size Methods Population: 26 subjects within 15 weeks SCI, traumatic, motor complete, thoracic or cervical SCI, mean ages from 25.0 to 28.2 years, 67.5-80% males. Treatment: Random assignment to 3-6 months of 1. FES-assisted cycle ergometry (n=8), 30 min, 3X/week; 2. PES-assisted isometric exercise group (n=8) (same muscle groups as FES group) for 1 hr, 5X/week and 3. control group (n=9) with no stimulation. Outcome Measures: lower limb lean body mass. Population: 9 subjects (1 female, 8 males), aged 20-49, complete traumatic conus cauda equina lesions, at least .8 years post-injury. Treatment: Progressive PES to FES program for quadriceps to FES-assisted standing (n=4 trained ≥ 2.4 years); untrained controls (n=5). Outcome Measures: Muscle biopsy of vastus lateralis (mean fiber diameter, % area covered by muscle fibers, adipocytes, connective tissue). 1. 2. Outcome Lean body mass increased with FES-cycling at all regions and declined for control and PES group. Controls lost an average of 6.1%, 10.1%, 12.4% after 3 months and 9.5%, 21.4%, 26.8% after 6 months in total body lean mass, lower limb lean mass and gluteal lean mass, respectively.

Baldi et al. 1998; USA PEDro=5 RCT N=26

1.

Kern et al. 2005; Austria Downs & Black score=14 Pre-post N=9

2.

Overall mean fiber diameter of trained group was increased vs untrained group (p<0.001) and also had similar values to normal sedentary adults. Proportion of total cross-sectional area covered by muscle fibers increased with training whereas the area covered by adipocytes and connective tissue significantly decreased.

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Author Year; Country Score Research Design Total Sample Size

Methods Population: 6 tetraplegic, 4 paraplegic, complete, aged 27-45, 5 sedentary controls, age 30-39. Treatment: 18-month FES-assisted cycling ergometry (First training period: 30 min, 3X/week, 1 year; Second training period:1X/week, 6 months). Outcome Measures: Muscle morphology and protein measurement (type IV collagen, total collagen, muscle proteins). 1.

Outcome Total collagen content (as indicated by hydroxyproline concentration) was increased with first training period (p=0.05) and second training period (p=0.05) and even more so compared to able-bodied controls. No difference in Type IV collagen content between groups. This result combined with the changes seen with the other muscle proteins suggest accelerated type IV collagen turnover in skeletal muscle. ↑ Work output as training progressed (p=0.019). More fatigue-resistant: ↓ force decrement during quadriceps fatiguing stimulations (p=0.012). No change in contractile speed (using maximal rate of rise force), ↓ mean ½ Rt (p=0.014) and the degree of fusion diminished (p=0.006). ↓ Force responses at low stimulation frequencies. No change in thigh circumference. ↑ cross-sectional area including: rectus femoris, sartorius, adductor magnus-hamstrings, vastus lateralis, vastus medialisintermedius (all p ≤ .025). No change in cross-sectional area of adductor longus and gracilis muscles. No correlations between total number of sessions and magnitude of muscle hypertrophy. There were significant increases in the muscle/adipose tissue ratio (p<0.05), muscle tissue in the thigh and leg (p<0.05) but no changes in the adipose tissue. Total work performed increased (p<0.05) after training. Paralysed vastus lateralis muscle was altered with ↑ type IIA fibres, ↓ type IIX fibres ↓ MHC IIx and ↑ MHC IIA (p<0.05). Total mean fibre cross-sectional area increase of 129%, ↑ crosssectional area of type IIA and IIX fibres (p<0.05). ↑ Number of capillaries surrounding each fibre (p<0.05). ↑ Citrate synthase and hexokinase activity (p<0.05).

Koskinen et al. 2000; Finland Downs & Black score=14 Pre-post N=15

2.

Gerrits et al. 2000; UK Downs & Black score=16 Pre-post N=7

Scremin et al. 1999; USA Downs & Black score=16 Pre-post N=13

Population: 7 male subjects with motorcomplete spinal lesions, aged 28-61, (5 ASIA A, 2 ASIA B), C5-T8, from 1-27 years post-injury. Treatment: FES leg cycle ergometry training, 3 - 30 minutes sessions/week for 6 weeks. Outcome Measures: Thigh girth, work output, contractile speed and fatigue resistance characteristics, including half relaxation time (½ Rt) and degree of fusion of electrically stimulated isometric contractions. Population: 13 males, ASIA class A, aged 24-46, C5-L1, 2-19 years post-injury. Treatment: A 3-phase, FES-assisted cycle ergometry exercise program leading to FES-induced cycling for 30 minutes. Average program was 2.3X/week for 52.8 weeks. Outcome Measures: CT-scan of legs to assess muscle cross-sectional area and proportion of muscle and adipose tissue collected (pre-test, midpoint and post-test).

1. 2. 3.

4. 5. 1.

2. 3.

Crameri et al. 2002; Denmark Downs & Black score=14 Pre-post N=6

Population: 6 subjects with complete paraplegia (T4-T12) at least 8 years postinjury, 5 males, 1 female, age 28-43. Treatment: FES leg cycle ergometry training, 3 - 30 min/week for 10 weeks. Outcome Measures: Incremental exercise leg test to muscle fatigue (total work output), histological assessment, myosin heavy chain (contractile protein) (MHC), citrate synthase (a mitochondrial enzyme) and hexokinase (enzyme needed to produce muscle glycogen).

1. 2.

3.

4. 5.

6-5

Discussion In general, all studies reviewed involving FES produced beneficial results on muscle functions such as strength and endurance or muscle structure such as increased muscle size (i.e., reduced muscle atrophy). FES may have additional benefits over PES alone. In particular, the study by Baldi et al. (1998) should be highlighted as it was the only randomized, controlled trial (n=26) which compared FES (cycle ergometry exercise), PES (isometric exercise) and an untrained control group. These investigators assessed lean body mass in 3 distinct body areas (i.e., total body, lower limb, gluteal) as a marker of muscle atrophy in recently injured (˜10 weeks) individuals with motor complete SCI. Their results demonstrate that the FES-assisted cycling program is effective in reducing atrophy and resulted in relative increases in lean body mass in all areas after 3 and 6 months of participation. The PES-assisted isometric exercise group also reduced muscle atrophy but had intermediate results between FES and no treatment (their control group actually loss lean mass). Reversal of muscle atrophy also appears feasible in more longstanding complete or motorcomplete SCI (i.e, > 2 years post-injury) SCI as shown by increases in muscle cross-sectional area and the muscle/adipose tissue ratio using FES-cycling (Crameri et al. 2002; Scremin et al. 1999). However, controlled trials in chronic SCI are lacking. Note that PES is often used to strengthen the atrophied muscles to some extent prior to FES (Kern et al. 2005) and in some cases, FES is not possible unless PES is first used. Kern et al. (2005) used a progressive PES - FES program for quadriceps building eventually leading to FES-assisted standing in people with longstanding complete cauda equina injuries (>1.2 years post-injury). These investigators demonstrated increases to the overall mean fiber diameter and the proportion of total cross-sectional area covered by muscle fibers with training as compared to an untrained group. However, the feasibility of providing life-long stimulation therapy to subjects with denervation injuries is uncertain. There was one null finding associated with muscle atrophy in that Gerrits et al. (2000) employed a relatively shorter program of 6 weeks of FES-assisted cycling exercise in people with longstanding motor complete SCI (> 1 year post-injury) and found no change in muscle size. These non-significant results might be due to the measure of thigh circumference which may not have been sufficiently sensitive to change, especially with the short intervention period and the absence of a control group for comparison purposes. In addition to improving muscle properties, FES-cycling can improve work output and endurance (Crameri et al. 2002; Gerrits et al. 2000). For example, Gerrits et al. (2000) used a short (6 weeks) pre-post trial of FES-assisted cycling intervention in people with motor complete SCI and found an increase resistance to fatigue in the quadriceps muscle and greater work output. Some mechanistic investigations have been conducted which help to explain some of these adaptations to muscle morphology and function with ongoing electrical stimulation exercise programs. For example, using FES-assisted cycling, Koskinen et al. (2000) demonstrated an increase in total collagen content as well as up- and down-regulation of proteins consistent with muscle-building activity. Others have noted an adaptive response to FES-assisted cycling exercise that serves to limit or alter the shift in the oxidative properties or fibre type composition of muscles that typically occurs following SCI (Crameri et al. 2002)

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Conclusion There is level 2 evidence that a program of FES-assisted cycling exercise prevents and reverses lower limb muscle atrophy in individuals with recent (~10 weeks post-injury) motor complete SCI and to a greater extent than PES. There is level 4 evidence that programs of FES partially reverses the lower limb muscle atrophy found in individuals with long-standing (>1 year post-injury) motor complete SCI. There is level 4 evidence that a program of FES-assisted cycle exercise increases lower limb muscular endurance. FES-assisted exercise programs are beneficial in preventing and restoring lower limb muscle atrophy as well as improving lower limb muscle strength and endurance.

6.3 Gait Retraining to Achieve Functional Measures of Overground Ambulatory Capacity There are several approaches to measure overground functional ambulation, as opposed to neurophysiological or biomechanical measures of gait. These include objective measures of walking speed or distance, or the use of qualitative functional scales or categories to describe ambulatory capacity. Walking speed is typically calculated from the time required for the subject to walk over 10 m (10-m walk test, or 10MWT). Walking speed has also been calculated by measuring the total distance traversed over a 2-minute period (Field-Fote 2001; Field-Fote et al. 2005). Walking endurance is typically assessed by measuring the total distance traversed within 6 minutes (6-minute walk test, or 6MWT). This test was developed to assess fitness capacity in patients with cardiopulmonary illnesses, but is now also often used to assess walking endurance in patients with spinal cord injury e.g. (Hornby et al. 2005; Thomas & Gorassini 2005; Wirz et al. 2005; Dobkin et al. 2006). Recently, both the 10MWT and the 6MWT have been shown to be valid and reliable measures for assessing walking function in ambulatory individuals with SCI (Van Hedel et al. 2005). Ambulatory capacity may also be qualitatively described by the type of ambulatory aid used during overground walking. The Walking Index for Spinal Cord Injury (WISCI) (Ditunno et al. 2000) and its current revision (the WISCI-II) (Dittuno & Dittuno 2001) is a 20-point scale that measures the level of assistance and type of ambulatory aid required to walk 10-m. A score of 0 corresponds to an inability to stand or walk with assistance while the maximum score of 20 is given when the subject can ambulate 10m without any personal or physical assistance (Dittuno & Dittuno 2001). This measure has been shown to be a valid measure of ambulatory capacity in patients with SCI (Ditunno et al. 2000). There are other functional ambulatory scales in use by various investigators to describe walking capacity in people with SCI. The Wernig Scale of Ambulatory Capacity (Wernig et al. 1995; Wernig et al. 1998; Hicks et al. 2005; Effing et al. 2006) classifies people according to the amount and type of assistance required to walk 5 steps, with classification levels ranging from no walking capability to free walking for more than 5 steps. The Garrett Scale of Walking classifies subjects according to their functional ambulatory status, ranging from a physiological walker (hospital ambulation) to unlimited community ambulator (Scivoletto et al. 2000; Protas et al. 2001).

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6.3.1 Body-weight Supported Treadmill Training (BWSTT) It has been more than a decade now since it was first demonstrated that body-weight supported treadmill training (BWSTT) in animals can enhance locomotor activity after spinal cord transection (Barbeau & Rossignol 1987; Edgerton et al. 1991). In this approach, partial body weight support is provided by a harness suspended from the ceiling or a frame while limb stepping movements are assisted by a moving treadmill belt. Since then, BWSTT strategies has been introduced as a promising approach to improve ambulatory function in people with spinal cord injury (Barbeau & Blunt 1991). This area of research has raised much excitement and interest among rehabilitation specialists and neuroscientists. In this review, we focus on the BWSTT intervention studies that report functional ambulation outcome measures (such as walking speed). These studies tend to focus on individuals with incomplete SCI lesions. There are a few studies reporting the effects of treadmill training on the locomotor pattern in people with complete SCI lesions (Dietz et al. 1994; Dietz et al. 1995; Wernig et al. 1995; Dietz et al. 1998; Wirz et al. 2001; Dietz & Muller 2004; Grasso et al. 2004). While there is modulation of muscle (EMG) activity during body weight support treadmillassisted stepping in individuals with complete SCI lesions, there has not been any evidence for functional ambulatory gains in this sub-population. In people with incomplete SCI, much motor recovery already occurs within the first 2 months post-injury; the rate of further recovery then decelerates over the next 3 to 6 months (Burns & Ditunno 2001). However, it is possible for motor function to continue to improve up to 2 years post-injury. For ease of interpretation, the studies reviewed in this section separate those that investigated subjects <6 months post-injury (“acute/sub-acute”) from those that studied subjects who were >6 months post-injury (“chronic”). In studies that used both types of subjects, the results were divided by subject chronicity. In addition, only results from studies with more than 3 subjects of a given chronicity were included. Therefore, some studies that investigated both chronic and acute SCI subjects may appear only in Table 6.4 because they had >3 chronic subjects, but <3 acute subjects (e.g. Thomas & Gorassini 2005). 6.3.1.1 BWSTT in Acute/Sub-acute SCI Table 6.3 Studies Using BWSTT in Acute/sub-acute SCI (<6 months post-injury)
Author Year; Country Score Research Design Total Sample Size Methods Population: 117 men and women (completed study), age 16-69 years, ASIA B-D; up to 8 weeks post-injury. Treatments: BWSTT (manual) vs. conventional rehabilitation with overground mobility training. BWSTT group also practiced overground walking. Gait training was 5X/week, 9-12 weeks, 30-45 min/session. Follow-up at 3 and 6 months post-training. Outcome measures: primary: Locomotor Scale of the Functional Independence Measure (ASIA B & C, n=108), walking speed (ASIA C & D, n=72); secondary: 6MWT, WISCI. Population: Study 1: 0-4.5 months post injury. Study 2: 2-30 weeks post-injury. 1. Outcome No difference in Functional Independence Measure Locomotor Scale (ASIA B & C) or walking speed (ASIA C & D) between groups. ASIA C & D subjects in both groups improved walking function. No improvement in walking function in the ASIA B subjects with either intervention, except in subjects who improved to ASIA C within 8 weeks after injury.

2.

Dobkin et al. 2006; USA PEDro=7 RCT N=117

Wernig et al. 1995; Germany

1.

Study 1 (BWSTT): 7 initially nonambulatory tetraplegic subjects

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Author Year; Country Score Research Design Total Sample Size Downs & Black score=9 Case Control N=97

Methods Treatment: Study 1: BWSTT (manual, no parameters presented) (n=12). Study 2: BWSTT (n=45), 2-22 weeks versus conventional rehab (n=40) (historical controls). Outcome measures: Wernig Scale of Ambulatory Capacity.

Outcome progressed to walk with assistance or with rollator. Five subjects progressed from walking with aids to walking independently. Study 2: Of the non-ambulatory subjects, 33/36 progressed to walking with aids or independently after BWSTT, but only 12/24 improved to functional walking with conventional rehab. 29/37 initially non-ambulatory subjects improved to walking with aids. Follow-up (6 months to 6 years post-training): 15 subjects showed continued improvement, 26 had no change in ambulatory status

2.

Wernig et al. 1998; Germany Downs & Black score=12 Pre-post N=41

Population: 41 subjects, incomplete, 3-16 weeks post-injury. Treatment: BWSTT (manual). 30-60 min, 5X/week, 3-22 weeks. Outcome measures: Wernig Scale of Ambulatory Capacity.

1. 2.

Discussion For acute/sub-acute (< 6 months) incomplete SCI, there were 3 studies (n>3) reporting the effects of locomotor training in subjects with using functional measures of ambulatory capacity (Table 6.3). The general finding across these studies is that BWSTT with manual assistance beginning during the acute/sub-acute post-injury period provides improvements in ambulatory capacity in people with incomplete SCI. The studies of Wernig (Wernig et al. 1995; Wernig et al. 1998) showed that 87% (87/98) of their incomplete SCI subjects achieved improvements in functional ambulation with BWSTT in the acute phases of injury. The lack of ambulatory change in 13 subjects may be related to severe flaccid paralysis, high cervical lesion, or proprioceptive disturbances (Wernig et al. 1995). Although lower levels of study design (non-randomized, non-blinded) suggest that BWSTT in acute/sub-acute SCI yields better outcomes than conventional rehabilitation (Wernig et al. 1995), there exists strong evidence from a single-blind RCT (Dobkin et al. 2006) (n=146) that there are no differences in effects between BWSTT and overground mobility practice (standard of care) in incomplete SCI during inpatient rehabilitation for walking speed or distance. In both groups, improvements in walking function were particularly notable in subjects with ASIA C (92%) or D (100%). Among the subjects who were initially classified as ASIA B, those who improved to ASIA C within 8 weeks post-injury showed improved walking function. In addition, subjects who entered the trial earlier (< 4 weeks post-injury) had faster walking speeds and endurance post-training. This was particularly the case for subjects who improved in their ASIA classification within 4 to 6 weeks post-injury. The fact that both subjects in both treatment groups were provided with task-specific locomotor training (on a treadmill or overground) may account for the lack of any difference in functional outcomes observed (Dietz 2006). Both groups experienced similar durations of body loading during therapy, either as a function of practicing standing or walking between parallel bars or ambulatory aids overground, or practicing upright locomotion with body weight support and a treadmill (Dobkin et al. 2006). In the older study that reported improved outcomes with BWSTT compared to conventional rehabilitation (Wernig et al. 1995), the ‘conventional’ rehabilitation was not well defined. The disparate results between these two sets of data may be accounted for by the shift in recent years towards more intensive and task-specific rehabilitation therapy.

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Conclusion There is level 2 evidence using historical controls that BWSTT is effective in improving ambulatory function. However, stronger evidence from one level 1RCT demonstrates that BWSTT has equivalent effects to conventional rehabilitation consisting of overground mobility practice for gait outcomes in acute/sub-acute SCI. For patients less than 6 months post-SCI, body weight supported treadmill training has equivalent effects on gait outcomes to conventional rehabilitation consisting of overground mobility practice. 6.3.1.2 BWSTT in Chronic SCI Table 6.4 Studies Using BWSTT in Chronic SCI (>1 year post-injury)
Author Year; Country Score Level Total Sample Size Methods Population: 27 men and women, age 2164 years, incomplete, C3-T10. Treatment: Randomized to 4 gait training strategies, 45-50 min, 5X/week, 12 weeks: 1) BWSTT (manual leg movement) (n=7); 2) BWSTT+FES (common peroneal nerve) (n=7); 3) overground body weight support walking+FES (n=7); 4) Lokomat (robotic gait device with body weight support) (n=6). Outcome measures: walking speed and distance, step length, step symmetry. Population: 44 subjects with para and tetraplegia. BWSTT (manual leg movement). Treatment: Study 1: 30-60 min, 5X/week, 3-20 weeks. Study 2: 29/44 subjects of study 1 compared with 24 chronic subjects who underwent conventional rehab (historical controls). Outcome measures: Wernig Walking Capacity Scale. Population: 14 men and women, age 2053 years, ASIA B (n=2) & C (n=12), C4-L1. Treatment: BWSTT (robotic). Up to 45 min, 3X/week, 144 sessions (12 months). Outcome measures: Walking Capacity Scale (Wernig). Population: 20 men and women, age 1664 years (mean 40, SD 14), ASIA C (n=9) & D (n=11), C3-L1. Treatment: BWSTT (robotic). Up to 45 min, 3-5X/week, 8 weeks. Outcome measures: WISCI II, 10MWT, 6MWT. Population: 19 men and women, mean age 31.7 (SD 9.4) years, ASIA C, paraand tetraplegia. 1. Outcome No difference in outcome between groups, but a trend towards better improvement in groups who received FES (groups 2 & 3). Subjects with slower initial walking speed (< 0.1 m/s) had greater percent increase in walking speed compared to those with faster initial walking speeds. Study 1: 25/33 initially nonambulatory could walk after BWSTT. At 6 months post-training, 18/21 ambulatory patients maintained abilities. Study 2: 14/18 initially nonambulatory subjects could walk after BWSTT, compared with only 1/14 in the conventional rehab group. 6/14 subjects improved in walking capacity, but only 3 maintained improvements at 8 months posttraining. 3/10 initially non-ambulatory subjects could walk (with assistance) post-training. No statistical change in WISCI II. Among initially-ambulatory subjects, there was an overall significant increase in 10MWT and 6MWT. Significant increase in walking speed (median: 77%).

Field-Fote et al. 2005; USA PEDro=6 RCT N= 27

2.

1.

Wernig et al. 1995; Germany Downs & Black score=9 Case Control N=68

2.

1.

Hicks et al. 2005; Canada Downs & Black score=18 Pre-post N=14 Wirz et al. 2005; Switzerland Downs & Black score=17 Pre-post N=20 Field-Fote 2001; USA Downs & Black score=15 Pre-post

2. 1. 2.

1.

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Author Year; Country Score Level Total Sample Size N=19

Methods Treatment: BWSTT + common peroneal nerve FES. Up to 90 min, 3X/week, 12 weeks. Outcome measures: gait speed. Population: 14 men and women, age 1850 years, ASIA C, C4-T7. Treatment: BWSTT + common peroneal nerve FES. Up to 90 min, 3X/week, 12 weeks. Outcome measures: overground gait speed. Population: 6 men and women, age 29-78 (mean 54.4, SD 14.8) years, ASIA C (n=4) & D (n=2), C5-L1. Treatment: BWSTT (manual). Up to 60 min, 3-5X/week, 10-23 weeks. Outcome measures: 10MWT, 6MWT, WISCI II. Population: 35 men and women, age 1970, C4-T12. Treatment: BWSTT (manual). 30-60 min, 5X/week, 8-20 weeks. Outcome measures: Wernig Walking Capacity Scale.

Outcome

1.

Field-Fote & Tepavac 2002; USA Downs & Black score=13 Pre-post N=14 Thomas & Gorassini 2005; Canada Downs & Black score=12 Pre-post N=6

All subjects showed increase in walking speed (ranging from 0.01 to 0.2 m/s increase). Subjects with slower walking speeds showed the greater % improvement. Significant improvement in WISCI II score, 6MWT, and 10MWT and improvements correlated with the increase in corticospinal connectivity. 20/25 initially non-ambulatory improved to walking with aids. 2/10 ambulatory patients improved functional class, but all improved speed and endurance. At follow-up (0.5-6.5 years later) all ambulatory patients remained ambulatory, with changes only in functional class.

1.

1. 2. 3.

Wernig et al. 1998; Germany Downs & Black score=12 Pre-post N=35

Discussion Across 8 studies, there was a total of 158 chronic incomplete subjects (C3-L1) enrolled in some form of body-weight supported gait retraining therapy. Gait retraining strategies were typically performed with a treadmill and the assistance of therapists or the Lokomat, which is a robotic gait device. The training protocols ranged from 30 to 90 minutes per day, occurred 3 to 5 times/week and lasted for 8 weeks to 12 months. All studies (and 82% of all subjects) reported overall improvements in functional walking ability. Subjects with initially-slower walking speeds (< 0.10 m/s walking speed) tend to make the most improvements in locomotor function. Subjects with initially high walking capacity (> 0.10 m/s gait speed) or severely impaired, initially non-ambulatory subjects tend to show little improvement after gait retraining (Wernig et al. 1995; Wernig et al. 1998). Note that a large percent improvement from an initially low walking speed can be a result of the mathematics. Of greater clinical utility is an understanding of how gains in walking speed translate to everyday function. For people with paraplegia, it has been suggested that an overground walking speed of at least 0.9 m/s is necessary for community ambulation (Cerny et al. 1980). None of the studies showed attainment of walking speeds greater than 0.5 m/s. Nevertheless, even modest gains in walking speed after treadmill training have been reported to translate into meaningful enhancements in daily function (Field-Fote et al. 2005). BWSTT with FES of the common peroneal nerve results in improvements in overground walking speed in chronic incomplete SCI (Field-Fote 2001; Field-Fote & Tepavac 2002). However, there is only a non-significant trend for better outcomes when electrical stimulation was combined with

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treadmill or overground body weight support gait training in chronic SCI subjects compared with locomotor training alone (Field-Fote et al. 2005). Conclusion There is Level 4 evidence from pre-test/post-test studies that BWSTT is effective for improving ambulatory function in people with chronic, incomplete SCI. There is Level 1 evidence from 1 RCT that different strategies for implementing body weight support gait retraining all yield similar ambulatory outcomes in people with chronic, incomplete SCI. It is recommended that therapists may choose a body weight support gait retraining strategy based on available resources (Field-Fote et al. 2005). Body weight-support gait training strategies can improve gait outcomes in chronic, incomplete SCI, but no body weight-support strategy (overground, treadmill, with FES) is more effective.

6.3.2 Special Case Report: Spinal Cord Stimulation Combined with BWSTT There are 2 published reports (Herman et al. 2002; Carhart et al. 2004) describing the effects of epidural spinal cord stimulation combined with gait training in a single subject (male with incomplete tetraplegia, 43 years old, injury level C5-C6, ASIA C, 3.5 years post-injury). The subject first underwent 12 weeks of BWSTT that resulted in some significant improvements in treadmill gait parameters although overground ambulation remained limited. Subsequently, the subject underwent surgical implantation of an epidural stimulation system placed over the T10T12 vertebral level. BWSTT and overground gait training in combination with epidural stimulation commenced after surgical healing. The combination of epidural spinal cord stimulation with gait training resulted in a substantial improvement in treadmill gait parameters as well as in overground ambulation. The subject reported a decreased sense of effort, a doubling in walking speed, and increased walking endurance when assisted by spinal cord stimulation. This was associated with improved community and indoor functional ambulation. Obviously, controlled trials of this specific intervention are required before spinal cord stimulation combined with locomotor training can be recommended as a useful rehabilitation strategy. Nevertheless, this special case report highlights one of the innovative and exciting possibilities of technology. 6.3.3 Pharmacological Interventions Drugs such as clonidine (a noradrenergic agonist), cyproheptadine (a serotonergic antagonist), baclofen (GABA agonist), GM-1 ganglioside and 4-aminopyridine have been used in association with attempts to improve ambulation in individuals with SCI. The results from animal studies indicate that such drugs may act on the receptors in the spinal cord which facilitate interaction with a locomotor central pattern generator (spinal circuits which produce coordinated locomotor movement) (Barbeau et al. 1990; Chau et al. 1995; Rosssignol et al. 1996). Although not conclusive, there is some evidence that similar “central pattern generator” circuits exist in humans (Calancie et al. 1994; Illis 1995; Bussel et al. 1988; Bussel et al.1996a, 1996b) and provide the rationale for clinical use of these drugs.

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Table 6.5 Studies of Pharmacological Interventions for Enhancing Locomotion in SCI
Author Year; Country Score Research Design Total Sample Size Methods Population: SCI, chronic, ambulatory (ASIA D). Treatment: Double-blind, placebocontrolled, crossover design: 4Aminopyridine (4-AP): 1 week of uptitration prior to 2 weeks of 10 mg 4x/day stable dosing of 4-AP (n=15) versus Placebo (n=14) and then switch conditions. Outcome measures: Isometric muscle force, gait analysis. Population: chronic, incomplete. Treatment: Double-blind, placebocontrolled, crossover design: 4 weeks of 15-45 mg, immediate-release 4Aminopyridine capsules or Placebo. 2 week washout between conditions. Outcome measure: walking speed. Population: chronic paraplegia, complete and incomplete. Treatment: Double-blind, placebocontrolled, crossover design: Two periods of 4 weeks of medication (Clonidine or Placebo, randomly assigned) separated by a 2 week washout period. Outcome measures: Kinematic measures during body weight support gait, spasticity, adverse effects. 1. Outcome Some positive effects for both placebo and 4-AP treatment when compared to baseline, but no changes between groups were not significant.

Deforge et al. 2004; Canada PEDro=10 RCT N=29

1.

Van der Bruggen et al. 2001; Netherlands PEDro=10 RCT N=20

No significant differences were found between groups, period, cross over design, or treatment effects.

1.

2.

Stewart et al. 1991; Canada PEDro=8 RCT N=9

3.

Walker & Harris 1993; USA PEDro=8 RCT N=9

Wainberg 1990; Canada PEDro=7 RCT N=15

Remy-Neris et al. 1999; France Downs & Black score=15 Pre-post N=11

Population: Chronic. Treatment: Double-blind, placebocontrolled crossover study design: Intravenous GM-1 ganglioside (Sygen®), 6 days per week. 6 month physical therapy preceding 4 months of trial. Outcome measures: Motor Score Walking distance and velocity. Population: spastic paraparesis of spinal origin, motor incomplete. Treatment: Randomized, double-blind cross-over design: Oral Cyproheptadine (n=8) or placebo tablets (n=7) over 3 weeks (1 week each at 2mg, 4mg and 8mg 5x/day) with a 1 week washout in between. Outcome measures: Kinematic and leg muscle activity (EMG) during gait, spasm severity, spasticity diary. Population: sub-acute to chronic (0.5-16 years post injury). Treatment: Intrathecal Clonidine 60μg test dose (n=11) followed by 3 doses (15 to 90 μg) and a placebo injection (n=4). Outcome measures: Ashworth spasticity

1.

1/3 ambulatory patients had marked improvement in locomotor function resulting from Clonidine compared to Placebo. Spasticity (#Improvement/deterioration/nochange resulting from Clonidine): Ankle reflexes 5/2/2, Knee reflexes 5/0/2, spasticity visual analog scale 6/1/2, Daily spasms 2/0/2, Daily clonus 4/0/1. Side effects of clonidine (8/9 patients): dry eyes and mouth, lethargy, mild hypotension and constipation. Irrespective of treatment order, GM-1 resulted in ↑motor scores, walking distance, ↑ walking velocity.

1. 2.

1.

2.

Descriptive results only. Compared to control, Cyproheptadine resulted in 1) gait changes (↓ forward trunk flexion but no change in EMG,↑ walking speed, ↓ %stance time,↓ %double support duration; 2) ↓ spasticity: all subjects reported a decrease in the severity and frequency of involuntary movements. Only 5/8 ambulatory subjects could stand up and walk after 60 ug clonidine dose (2 showed improvements). One subject showed ↑ overground speed (P>0.03), ↑ stride length

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Author Year; Country Score Research Design Total Sample Size

Methods scores, H-reflex, ambulation parameters, flexion reflexes. 3. Population: male, chronic, 6 tetraplegics, 3 paraplegics. Treatment: 4-Aminopyridine (single 10mg immediate-release capsule). Comparison of means at baseline and at intervals over 24-hour follow-up. Outcome measures: Ambulation parameters. Population: chronic, incomplete, traumatic. Treatment: 3 different oral tablets in order of convenience: Clonidine (≤0.25 mg/day) or Cyproheptadine (≤24 mg/day) or Baclofen (≤80mg/day): each drug trial had incremental increase to maximum dose and stable dosing over 3 weeks followed by incremental decrease from maximum dose and washout over 2 weeks. Outcome measures: Surface EMG and kinematic gait analysis during treadmill walking. No statistical analysis. 1.

Outcome (P>0.0009) but not cycle duration and higher doses impaired gait. ↓ Ashworth score in all subjects. No change seen in H-reflex. Flexion reflex not enhanced with low doses. Improvements in gait velocity (↑ by 36% from 24.1 ± 16.5 m/min to 32.7 ± 22.9 m/min; (p ≤ 0.04); in stride length (↑ from 0.9 ± 0.3 meters to 1.0 ± 0.3 meters, p≤ 0.02); ↑ cadence and gait cycle duration, but not significant. Gait changes began 6 hours after drug administered and persisted the 24 hour follow-up. 7/12 subjects had evaluations of all 3 drugs; adverse effects for 4/5 subjects prevented completion of all conditions. The greatest effects in more severely disabled subjects. Cyprohyeptadine resulted in↓need for assistance, ↑ in maximum treadmill speed and ↓ clonus. Clonidine resulted in ↑maximal treadmill speed and a generally more upright posture. Baclofen resulted in minor changes in walking. Maximal treadmill speed increases and other changes were often retained following washout of drugs.

Segal & Brunneman; 1998; USA Downs & Black score=14 Pre-post N=9

2. 1.

2.

Norman et al. 1998; Canada Downs & Black score=13 Pre-post N=12

Discussion The interactions of these pharmacological interventions are complex and appear to affect walking ability and spasticity to varying effects. The studies on clonidine (oral or intrathecal), cyproheptadine and baclofen demonstrate improvements in various aspects of gait (i.e. walking speed, posture, spasticity), but no improvements led to significant functional improvements in walking. Norman et al. (1998) found the greatest improvements in more severely disabled subjects and in many cases, the drug effects were retained following washout of drugs. Bradycardia and hypotension, common side-effects of oral clonidine can be ameliorated with intrathecal injection of clonidine (150-450µg) (Filos et. al. 1994). The combined effect of different drugs has not been well explored. One very small study (not tabled due to its small sample size of 2 subjects) (Fung et al. 1990) showed that a combination of Clonidine, Cyproheptadine and treadmill training improved SCI locomotion in 2 subjects. Conflicting evidence exists on the use of GM-1 ganglioside for neurologic recovery for walking in SCI. The small RCT conducted by Walker and Harris in 1993 (N=9) concluded that the use of GM-1 ganglioside improved motor scores, walking distance and walking speed in chronic SCI subjects. A recent large scale multicenter RCT (n=760) (Geisler et al 2001) suggested that although GM-1 treatment may have accelerated initial SCI recovery (at 8 weeks), it did not improve the final extent of recovery (26 weeks). However, walking ability was not assessed given the subjects who ranged from ASIA A to D. 6-14

The effects of immediate release, 4-aminopyridine capsules on ambulation are conflicting with 2 RCTs suggesting no benefit (vander Bruggen et al. 2001, n=20; Deforge et al. 2004, n=15). However, the van der Bruggen et al. (2001) hypothesis was not directed solely at exploring the effects on walking and therefore the heterogenous nature of the subject groups may have confounded the ambulation results. Furthermore, differences in intervention (i.e. 10mg single dose, 15-45mg/day over 4 weeks in the Deforge et al. study versus 10mg 4X/day for 8 days in the Van der Bruggen et al study and the lack of consistent clinically relevant outcome measures complicates the interpretation of the available evidence. Conclusion In summary, level 1 evidence describes limited and indirect improvements in aspects of walking (i.e. spasticity, speed and posture) but do not translate into significant functional walking gains as a result of clonidine and cyproheptadine. Limited and non-functional improvements in walking as a result of baclofen are only supported by level 4 evidence. Conflicting evidence provides little guidance with respect to the use of GM-1 and 4aminopyridine for the improvement of ambulation in spinal cord injury. Scientifically robust studies with consistent clinically relevant outcome measures are needed for pharmacological intervention studies of ambulation after spinal cord injury.

There is little evidence that any pharmacological agent is significantly beneficial in directly improving ambulation in individuals with SCI.

6.3.4 Functional Electrical Stimulation (FES) The idea of compensating for paralyzed function using electrical stimulation was introduced as early as the 1960s (Liberson et al. 1961). Functional electrical stimulation of the common peroneal nerve was found to be effective in assisting foot clearance during the swing phase (Liberson et al. 1961). There has also been a report of attempts to stimulate the ankle plantarflexor muscles to assist push-off at the end of stance and enhance the initiation of the swing phase in subjects with incomplete SCI (Bajd et al. 1999). Approaches that focus on swing phase activity are more suitable for less severely disabled individuals who have adequate balance to support their stance leg during gait. There are also more complex systems that involve several channels of stimulation that support proper extension as well as foot clearance during swing (e.g. Sigmedics 2000). These are more suitable for patients who require assistance in standing as well as gait, such as those with neurologically complete SCI. FES systems such as the Parastep or ALT-2 provide stimulation of thigh extensor muscles (quadriceps, gluteal muscles) to support extension and standing, as well as stimulation of the common peroneal nerve to assist with swing phase movements. FES may also be combined with bracing to counter trunk and hip instability (Solomonow et al. 1997a). One of the limitations of surface FES is possible skin irritation, discomfort under the electrodes, or difficulties with proper positioning of the electrodes. With improvements in electronics technology, FES systems are becoming smaller and more amenable for everyday use. In addition, some patients have opted for implanted FES systems that may be inserted without surgery. These systems offer a more precise delivery of stimulation, enabling greater muscle selectivity, and the ability to access deeper muscles, such as the hip flexors (Kobetic et al.

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1997). Percutaneous electrodes, which are inserted through the skin with a hypodermic needle, offer one possibility to circumvent complications with surface electrodes (Marsolais & Kobetic 1986; Kobetic et al. 1997). However, there may be complications due to infection or irritation at the site of insertion, and electrode movement or breakage (Agarwal et al. 2003). More recently, there was a case study reporting positive effects with a BION microstimulator in an incomplete tetraplegic subject with drop-foot (Weber et al. 2004). Thus, preliminary reports of the use of such innovative FES technology are promising, but further study is warranted to determine the long-term stability and efficacy of such implanted systems. Table 6.6 Studies Using Functional Electrical Stimulation to Improve Locomotor Function
Author Year; Country Score Research Design Total Sample Size Methods Population: 15 men and women, age 1647 years, T3-T11, Frankel A, B (n=1), and C (n=1), 6-240 months post-injury (some same subjects as Gallien et al. (1995). Treatment: Surface FES: Parastep® 6 channels (bilateral common peroneal nerve, quadriceps, glutei/lumbar muscles), mean of 20 sessions. Outcome measures: ambulatory status, walking distance and speed (with FES). Population: 14 (but only 10 subjects analyzed), age 25-49 years, C3-L1, incomplete, 1.8-19.1 years post-injury. Treatment: Surface FES: bilateral or unilateral common peroneal nerve, home use as much as possible ~1 year (26 and 56 weeks), 2 subjects also had bilateral quadriceps. Outcome measures: temporal gait measures. Population: 16 men and women, mean age 28.4 (SD 6.6) years, T4-T11, complete, 0.7-9.0 years post-injury. Treatment: Surface FES: Parastep®I: 6 channels (bilateral common peroneal nerve, quadriceps, glutei). 3X/week, 32 sessions (once subjects had sufficient strength to stand). Outcome measures: walking distance and speed (with FES). Population: 6 men and women, age 20-40 years, C3-L1, Frankel C & D, 2 to 18 years post-injury. Treatment: Surface FES: quadriceps, hip abductors, hamstrings, erector spinae, common peroneal nerve, home program >30 min, 5X/week, 3 months. Outcome measures: walking speed, stride length, cadence. 1. Outcome 13 subjects completed training. All could ambulate independently with the Parastep system after ~14 sessions. The mean walking distance without a rest was 52.8 m (SD 69 m; range: 1-350 m). The mean speed was 0.15 m/s (SD 0.14 m/s; range: 0.03-0.4 m/s). 5/10 patients with a 3 year follow-up continued to use the system at home. Mean increase of 0.10 m/s in walking speed (over the first year of FES-use (measured with and without FES).

Brissot et al. 2000; France Downs & Black score=17 Post-test N=15

2.

1.

Ladouceur & Barbeau; 2000a; Canada Downs & Black score=16 Pre-post N=14

1.

Klose et al. 1997; USA Downs & Black score=15 Pre-post N=16

Most subjects improved endurance and gait speed. Longest distance walked with FES was between 12 to 1707 m (mean: 334 m; SD 402 m).

1. 2.

Granat et al. 1993; Scotland Downs & Black score=14 Pre-post N=6

Significant mean increase in stride length, but not speed or cadence. 3 to 4 subjects had significant individual increases in gait speed, stride length and cadence.

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Author Year; Country Score Research Design Total Sample Size

Methods Population: 14 (but only 10 subjects analyzed), age 25-49 years, C3-L1, incomplete, 1.8-19.1 years post-injury (same subjects as in Ladouceur & Barbeau 2000a). Treatment: Surface FES: bilateral or unilateral common peroneal nerve, 2 subjects also had bilateral quadriceps, home use as much as possible ~1 year. Outcome measures: temporal gait measures. Population: 31, mean age 36 (SD 2) years, injury level above lumbar levels, incomplete, mean 6 (SD 1) years postinjury, 4 centres. Treatment: Surface FES: common peroneal nerve; some subjects also received FES to hamstrings, quadriceps, gluteus medius, duration of FES ranged from 3 months to over 3 years. Outcome measures: walking speed, stride length, cycle time. Population: 13 men and women, age 1742 years, T4-T10, complete, 5-240 months post-injury. Treatment: Surface FES: Parastep®: 6 channels (bilateral common peroneal nerve, quadriceps, glutei). Outcome measures: walking distance and speed (with FES). Population: age 20-44 years, C2-T10, incomplete, 2.5-10 years post-injury. Treatment: Surface, percutaneous, or implanted FES of common peroneal nerve, and sometimes quadriceps, glutei, and psoas. Outcome measures: speed, gait parameters 1.

Outcome All subjects showed an improvement in functional mobility. 7/14 subjects showed improvement based on type of ambulatory device. When walking with FES, 13/14 subjects improved gait speed. Ambulatory improvements were still evident when the FES was turned off during walking in12/14 subjects, suggesting a training, or carryover, effect with long-term FES-use. Overall improvement in gait speed which persisted even when subjects walked without FES. Mean increase in speed was 0.14 m/s (SE: 0.03 m/s) (although mixed stroke and SCI results). Greatest % improvements particularly for the initially slow walkers.

Ladouceur & Barbeau 2000b; Canada Downs & Black score=14 Pre-post N=14

2.

1. 2.

Wieler et al. 1999; Canada Downs & Black score=13 Pre-post N=31

1.

Gallien et al. 1995; France Downs & Black score=6 Post-test N=13

2.

Independent ambulatory distances 2 to 350m (mean 73.25 m, SD 102 m) and speed 0.2 to 0.6 m/s (mean: 0.2 m/s, SD 0.1 m/s). Poorer performances were observed in more chronic subjects. All subjects improved gait speed when FES was on (mean change was 4 m/min), particularly significant for more disabled subjects.

1.

Stein et al. 1993; Canada Downs & Black score=6 Pre-post N=10

Discussion To date, there are no randomized controlled or blinded assessments of the efficacy of any form of FES to improve mobility after SCI. Results from the experimental pre-test/post-test studies reviewed here show that almost all the participants showed improvements in gait parameters (walking speed or distance) when FES was used. This is not surprising, given that the FES could compensate for weakened or paralyzed muscle function during gait. Of greater interest is the finding of carryover effects after FES training. After completion of an FES-training program, improvements in gait function persisted even when the stimulator was turned off (Wieler et al. 1999; Ladouceur & Barbeau 2000; Johnston et al. 2003). This suggests that neuroplastic changes may have taken place in response to regular use of FES during walking. Indeed, it has been shown in non-disabled human subjects that the combination of treadmill walking and FES led to an acute increase in corticospinal excitability that persists even after the cessation of FES

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(Kido Thompson & Stein 2004). Improved muscle strength and conditioning after regular use of FES could also contribute to carryover effects in walking function (Granat et al. 1993). Although laboratory studies advocate the efficacy of FES systems for improving ambulatory function in patients with SCI, the effectiveness of any technology is only as good as its acceptance by the intended users. Wieler et al (Wieler et al. 1999) reported that the majority of their subjects found they could use the FES device easily on a regular basis and that they walked better with the FES. Those who reported difficulties reported problems with finding the proper stimulation site or technical difficulties with the leads, switches, or electrodes. There have also been reports of musculoskeletal complications such as ankle sprain, calcaneum fracture, back pain, or falls with FES use (Gallien et al. 1995; Brissot et al. 2000). Some of these complications may have been associated with commencement of upright exercise (gait) after a period of being non-ambulatory. Anecdotal reports found in several studies suggest that most subjects mainly use FES indoors or at home, for short distance walking, to prevent complications due to prolonged immobilization, and to enhance physical fitness rather than functional community ambulation (Gallien et al. 1995; Klose et al. 1997; Brissot et al. 2000). Subjects who do use FES outdoors for community ambulation tend to be the less severely impaired (Granat et al. 1993; Brissot et al. 2000). The functional benefits derived from FES are also quite variable. For instance, Stein et al. (Stein et al. 1993) report that most subjects showed a modest improvement in gait speed (average: 4 m/min), which was more significant for the more severely disabled subjects. Higher-functioning subjects felt that this small benefit in gait speed did not warrant the daily use of FES. In contrast, (Ladouceur & Barbeau 2000) reported that there was a tendency for the subjects with initially faster gait speed to have greater absolute improvements. Thus, outcomes from FES-use also seem to be quite variable in terms of walking speed (Stein et al. 1993; Ladouceur & Barbeau 2000) or distance (Klose et al. 1997). Conclusion There is Level 4 evidence that FES-assisted walking can enhance walking speed and distance in complete and incomplete SCI. There is also Level 4 evidence from 3 independent laboratories that regular use of FES in gait training or activities of daily living leads to persistent improvement in walking function that is observed even when the stimulator is not in use.

FES-assisted walking can enable walking or enhance walking speed in incomplete SCI or complete (T4-T11) SCI. Regular use of FES in gait training or activities of daily living can lead to improvement in walking even when the stimulator is not in use.

6.3.5 Orthoses/Braces 6.3.5.1 Bracing alone in SCI There are several available devices used for bracing the legs in order to support standing and walking function, particularly for people with complete SCI. These range from single-joint bracing (e.g. ankle-foot orthosis), usually for individuals with low, incomplete spinal lesions, to whole-leg/long-leg braces that extend from the lower back to the ankle. Among the most common long-leg braces studied in the literature are the purely mechanical Parawalker (Rose 6-18

1979) or the Reciprocating Gait Orthosis (RGO) (Douglas et al. 1983). These devices may also be combined with FES to augment gait function and efficiency (Nene and Patrick 1990; Yang et al. 1996; Marsolais et al. 2000). These devices must be used with a walking aid (e.g. crutches or walker) for functional ambulation. Table 6.7 Studies of Bracing Interventions in SCI
Author Year; Country Score Research Design Total Sample Size Methods Population: 10 men and women, mean age 37 years (SD 8.4), T9-T12, motor complete, 4-19 years post-injury. 1 Treatment: Walkabout Orthosis (WO ) vs. Isocentric Reciprocal Gait Orthosis (IRGO2): training with first orthosis 2-3 hours, 2-3X/week for 6-8 weeks, followed by 3-month home trial period. 2-month wash-out period (no orthosis) followed by other orthosis. Outcome measures: functional skills (e.g., curbs, stairs, donning/doffing, sit-stand), Functional Independence Measure, gait speed over flat and inclined surfaces. 1. Outcome No differences between orthoses re: donning/doffing (“independent”), stairs and curbs (“stand-by” or “minimal”), or level gait (“independent” or “stand-by”). Tendency for better performance with IRGO for flat walking, ramp walking, and stairs. Faster gait with IRGO on flat (mean IRGO=0.34 m/s ± 0.18, mean WO=0.14 m/s ± 0.12; p=.002) and on inclined surfaces. IRGO allowed more independent gait; WO easier to go from sit-stand and stand-sit. Neither orthosis enabled subjects to be fully independent in the key skills necessary for functional ambulation after 8 weeks of training. The orthosis enabled all subjects to independently ambulate with canes. All 3 subjects increased gait speed from 0.13, 0.22, 0.37 m/s to 0.20, 0.35, 0.43 m/s, respectively. 11/24 patients had stopped using RGO at 1-year follow-up, but there was no difference between the RGO-users and RGO-non-users in terms of gait speed, stair climbing, or use of ambulatory aid. However, the RGO-users achieved a higher functional ambulatory capacity (Garrett Scale) than non-users. RGO-users achieved home ambulation with limitations or home ambulation (Level 2-3) while nonusers achieved hospital ambulation or home ambulation with limitations (Level 1-2). No one reached community ambulation levels.

2.

Harvey et al. 1997; Australia Downs & Black score=17 Post-test N=10

3.

Nakazawa et al. 2004; Japan Downs & Black score=14 Pre-post N=3

Scivoletto et al. 2000; Italy Downs & Black score=14 Post-test N=24

Population: 3 men, age 22 to 28 years, T8 -T12, complete (ASIA A), 8-12 months post-injury. Treatment: Weight bearing control orthosis (WCBO), a long-brace reciprocating gait orthosis: training occurred 1 hour, 5X/week for 12 weeks. Outcome measures: walking speed. Population: 24 men and women, mean age 33.6 years (SD 3.2), T1-T12, complete (ASIA A), mean 5.3 years (SD 2.1) postinjury. Treatment: RGO: training provided and then subjects given braces for home-use for 1 year. Outcome measures: gait speed, going up and down stairs, use of walker or crutches, Garrett Score (out of 6; 6 = community ambulation with no limitations; 1=hospital ambulation).

1. 2.

1.

2.

3.

1
2

Similar model to the MSH-KAFO Successor model to the RGO (uses a central pivot bar and tie rod arrangement instead of crossed-cable to couple hip flexion/extension). The IRGO is thought to be less fatiguing for subjects compared to RGO Winchester et al. (1993).

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Author Year; Country Score Research Design Total Sample Size

Methods Population: 5 men, age 26-36 years, T5L1, 4 complete (Frankel A) and 1 incomplete (Frankel C), 8.4-70 months post-injury. Treatment: Medially-placed Single-axis Hip joint with long-leg hip-Knee-Ankle-Foot Orthosis (MSH-KAFO). Patients were trained to stand and walk using device daily for 2 weeks, followed by an exercise program 1-2 times/week. Outcome measures: walking speed and distance. Population: multicentre, 74 men and women, mean age 27 years, T1-T12, complete (Frankel A & B), mean 37 years post-injury. Treatment: Orthoses: RGO (n=53), Advanced RGO (RGO with links between mechanical hip joints and hip and knee joints) (n=17), and Hip Guidance Orthosis (HGO) (n=4). Individual treatment included practice at don/doff device and functional mobility. Follow-up at hospital discharge and 6 months later. Outcome measures: Garrett Score, ability to climb up and down 12 steps. Population: 22 men and women, age 21 to 44 years, T3-T12. Treatment: Hip Guidance Orthosis (HGO), also known as Parawalker combined with crutches vs. Reciprocating Gait Orthosis (RGO) combined with rollator walker. Groups matched for age and level of injury. Practice period followed by 4 month home use before being switched to the second orthosis. Outcome measures: walking speed, cadence, stride length. 1. 2. 3.

Outcome 4 of 5 were able to stand without crutches with MSH-KAFO (1 subject needed parallel bars). 3/5 could climb stairs with crutches and rail. Donning and doffing brace took only 3-4 minutes. After 3-10 months of therapy, gait speed improved from 0.05-0.2 m/s to 0.17-0.63 m/s) and walking distance ranged from 300 to 4000 m. At discharge, 28 patients could climb stairs (13 with crutches, 15 with a walker). The ability to climb stairs or Garret score at discharge was associated with continued orthosis-use. 31 patients achieved functional gait (Garrett = 2-5) and 9 achieved community ambulation (Garrett=45). 19 used orthosis only for exercise (Garrett=1).

Saitoh et al. 1996; Japan Downs & Black score=10 Pre-post N=5

1. 2.

Franceschini et al. 1997; Italy Downs & Black score=12 Post-test N=74

1. 2. 3.

Whittle et al. 1991; UK Downs & Black score=12 Post-test N=22

4.

No significant differences between the orthoses in terms of gait speed, cadence, and stride length. Mean walking speed with either orthosis was 0.24 m/s. The HGO was much quicker to put on and to take off. The RGO was quicker on most of the other ergonomic tests, but this was significant only for standing up and climbing up a curb. At the end of the trial 12 subjects chose to keep the RGO, 4 the HGO, and 6 kept neither. The rollator prescribed for use with the RGO may have influenced subjects’ preference to keep the RGO system.

Discussion The level 4 (primarily pre-test/post-test studies) reviewed here indicate that these devices facilitate the ability of people with sub-acute (as low as 4 months post-injury) or chronic complete paraplegia to rise from sitting to standing independently and to achieve some modest gains in ambulation (Thoumie et al. 1995; Saitoh et al. 1996; Harvey et al. 1997; Scivoletto et al. 2000). In general, however, the use of any of the braces investigated in these studies did not greatly enhance the ability of complete paraplegic subjects to be fully independent for functional community ambulation (Hong et al. 1990; Harvey et al. 1997; Scivoletto et al. 2000), although community ambulation was reported in some subjects in one study (Franceschini et al. 1997).

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Maximum walking speeds achieved with orthosis-use range from 0.14 to 0.63 m/s, which is 13 to 57% of the optimal speed (1.1 m/s) required for successful community ambulation (Robinett & Vondran 1988). In a few studies, some subjects demonstrated the ability to climb up and down stairs with the assistance of crutches or walker (Whittle et al. 1991; Franceschini et al. 1997; Harvey et al. 1997). Thus, the greatest benefit derived from orthosis/brace-use is from enhanced home or indoor mobility, for general exercise and health benefits, and psychological benefits from attaining upright posture and standing (Mikelberg & Reid 1981; Hong et al. 1990; Sykes et al. 1996). The successful use of orthoses/braces is also dependent on other more individual and practical factors. It has been recommended that orthoses or braces are best for people who are wellmotivated, with complete SCI at T9 or below or incomplete SCI at any level, with good postural control and good level of fitness (Hong et al. 1990; Thoumie et al. 1995; Franceschini et al. 1997). Medical problems such as limited thoraco-lumbar mobility or mechanical back pain, or any musculoskeletal problems that make standing upright uncomfortable tend to interfere with successful use of these orthoses/braces (Harvey et al. 1997; Middleton et al. 1997). The ability for a patient to don/doff the orthosis without difficulty and relatively quickly (e.g. <5 minutes) also appears to enhance the probability of their acceptance (Mikelberg & Reid 1981; Hong et al. 1990; Thoumie et al. 1995; Saitoh et al. 1996; Franceschini et al. 1997; Harvey et al. 1997; Scivoletto et al. 2000). Frequent reports of technical problems (e.g. mechanical breakdown at the hinges, improper fitting) across many studies (Mikelberg & Reid 1981; Whittle et al. 1991; Thoumie et al. 1995; Harvey et al. 1997; Scivoletto et al. 2000) suggest that appropriate technical support of these mechanical devices is necessary to enhance ongoing use of these braces (Whittle et al. 1991). Overall, it appears that most subjects feel that the difficulties and inconvenience encountered with orthoses/braces and the modest increase in function do not warrant their acceptance for regular, daily use in functional activities (Mikelberg & Reid 1981; Hong et al. 1990; Sykes et al. 1996; Harvey et al. 1997). It has been suggested that the therapeutic benefits of orthosis-use (e.g. health benefits from standing practice) should be stressed to patients rather than setting forth an expectation that they will enhance functional ambulation and be a replacement for wheelchair-use (Franceschini et al. 1997). However, it must be noted that for people with incomplete SCI, bracing (AFO-use) alone during walking can enhance gait speed and endurance compared to walking without an AFO (Kim et al. 2004). Conclusion None of the studies investigating the efficacy of brace/orthotic devices for upright support and mobility are randomized or blinded, but that is in part due to the ethical dilemma of providing safe and appropriate bracing and the fact that participants will be able to distinguish which device they received. There is weak evidence from post-test studies that bracing alone results in significant gains in functional ambulation for people with complete SCI. Only 2 studies reported pre-test/post-test results (total n = 8) that the use of long-leg braces could enhance gait speed and endurance in people with complete SCI.

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There is limited evidence that bracing alone does not enable significant gains in functional ambulation for people with complete SCI. The advantages of bracing appear largely restricted to the general health and well-being benefits related to practice of standing and the ability to ambulate short-distances in the home or indoor settings. The benefits of bracing-alone on functional ambulation are primarily with people with incomplete spinal lesions.

6.3.5.2 Bracing Combined with FES in SCI Energy expenditure of walking facilitated by bracing alone in spinal cord injury is extremely high and contributes to its low use. Hybrid systems combine conventional bracing with FES to activate large lower extremity muscles in the hopes of improving the gait pattern and reduce upper extremity exertion. The additional FES is used to improve trunk and hip stability and to facilitate forward progression. Table 6.8 Studies of Bracing Interventions combined with FES in SCI
Author Year; Country Score Research Design Total Sample Size Methods Population: 26 men and women, age 2053 years, C8-T11, complete, 9-144 months post-injury. Treatment: RGO-II orthosis: long-leg brace with reciprocal hip joint combined with FES to the quadriceps and hamstrings. 4-6 weeks of gait training with orthosis alone followed by RGO-II+FES (hybrid) program (total program time: 2-5 months inpatients, 3-14 months outpatients). Outcome measures: walking distance and speed with RGO and with RGO+FES. 1. Outcome 21/26 completed the training program, 19 were able to stand up alone. Following program, walking distance ranged from 200-1400 m with hybrid orthosis, 150-400 m with RGO II. Maximal walking speed with the hybrid orthosis (mean 0.32 m/s; SD 0.02; range 0.21-0.45 m/s) was not significantly different from that with orthosis alone (mean 0.29 m/s; SD 0.03; range 0.22-0.41 m/s). A two-month follow-up study revealed that, out of 15 patients using the hybrid orthosis, 11 were home users. After training, 57 patients could walk at least 180 m (19 could walk >450 m). 77% of patients could walk independently on different surfaces (grass, ramps, curbs).

Thoumie et al. 1995; France Downs & Black score=19 Pre-post N=26

2.

3.

Solomonow et al. 1997b; USA Downs & Black score=12 Post-test N=70

Marsolais et al. 2000; USA Downs & Black score=11 Pre-post N=6

Population: 70 men and women, age 16 to 50+, C6-T12, 1-10+ years post-injury. Treatment: RGO +/- FES. Orthosis-use and gait training of 1-3 hours, 3X/week for 6 weeks. In patients with injury level above T10, FES was added (bilateral quadriceps and hamstrings) with up to 6 more weeks of gait training. Outcome measures: walking ability, 180m walk. Population: 6 men and women, age 22-50 years, C7-T12, severity not reported, 2.520.6 years post-injury. Treatment: Case-Western Reserve University Hybrid Gait Orthosis: IRGO combined with FES to various muscles (combination of 8-16 muscles). Outcome measures: walking speed and distance.

1.

1.

Subjects who were unable to use RGO alone could ambulate with hybrid system. 3 subjects (all paraplegics) who were previously ambulatory with either RGO or FES alone showed improvement in walking distance with the hybrid system (from 3-90 m to 200-350 m).

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Author Year; Country Score Research Design Total Sample Size

Methods 2. Population: 3 subjects, age 28-42 years, C6 -T8 (tetraplegic incomplete, paraplegics complete), 3-15 years post-injury. Treatment: RGO ± FES. RGO with and without FES to common peroneal nerve stimulation. Outcome measures: walking speed, stride length. Population: 5 subjects, age 24-37 years, C2 -T6 (2 tetraplegics ASIA A & C, 3 paraplegics ASIA A & B), 8-14 years postinjury. Treatment: RGO and FES. 20-40 weeks of RGO use at home followed by hybrid system (RGO combined with FES. bilaterally to quadriceps and hamstrings). Outcome measures: RGO pedometer measured number of steps over 18 months. 1.

Outcome 2 of the subjects were capable of stair-climbing with the hybrid system. Use of the RGO with FES was associated with modest (nonsignificant) increase in walking speed and stride length compared with RGO with no FES. When subjects walked with the RGO+FES, average walking speed was 13% faster and stride length was 5% longer. Number of steps taken per week varied between 306 and 1879 steps (=99-845 m/week). Use of the RGO was low and no increase in use or function after hybrid system supplied. 1 subject (ASIA C) was already a community ambulator and showed most frequent use of RGO but across all subjects, RGO-use was variable, intermittent and generally poor.

Yang et al. 1996; UK Downs & Black score=11 Pre-post N=3

2. 3. 1. 2. 3.

Sykes et al. 1996; UK Downs & Black score=13 Observational N=5

Discussion There does not seem to be much further benefit of combining FES with orthosis-use in terms of maximal walking speed (Thoumie et al. 1995; Sykes et al. 1996; Yang et al. 1996), although greater walking distance may be achieved (Thoumie et al. 1995; Marsolais et al. 2000). Biomechanical studies (not included in the summary tables if they did not have a training period) provide some insight into the relative benefits of FES versus bracing. One study that has compared FES-alone with bracing-alone found that FES provides a particular advantage in facilitating sit-to-stand movements and donning the system in young (<18 years old) patients with chronic motor complete SCI (Bonaroti et al. 1999). However, mobility (e.g. walking, stairs) once standing was achieved was not found to be different between FES and bracing. In incomplete SCI, FES-use was found to result in greater benefits in terms of walking speed while bracing alone (with an AFO) was found to be particularly advantageous for improving walking distance (Kim et al. 2004). However, the combination of AFO with FES provided improved gait benefits than either device used alone (Kim et al. 2004). Conclusion There is Level 4 evidence that a combined approach of bracing and FES results in additional benefit to functional ambulation in paraplegic patients with complete SCI. However, in subjects who are achieve little benefit from bracing alone, the addition of FES appears to help improve standing or short-distance walking function (Marsolais et al. 2000). In incomplete SCI, however, there is some indication that a combination of bracing and FES provides greater ambulatory function than either approach alone (Kim et al. 2004).

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There is limited evidence that a combined approach of bracing and FES results in additional benefit to functional ambulation in paraplegic patients with complete SCI.

6.3.6 Enhancing Strength Following Locomotor Training Much research is focused on the development of effective therapies directed at enhancing locomotion. Typically, as noted earlier in this chapter, the majority of these investigations focus on individuals with incomplete SCI and also predominately employ ambulation-related outcome measures. However, some investigators have also examined the effect of locomotor training on enhancing lower limb strength as a secondary measure, or in other cases have examined the relationship between changes in lower limb strength and walking ability. For the most part, these therapies include a form of body-weight supported treadmill training (also termed Laufband Therapy). In these therapies, the patient’s limb movements may also be assisted by any (or a combination) of the following: therapist, appropriately timed stimulation (i.e., FES) or a robotically controlled servo-mechanism (Wernig et al. 1995; Wernig et al. 1998; Field-Fote 2001; Hornby et al. 2005; Wirz et al. 2005). In other locomotor studies involving strength measures, locomotor training consisted of overground walking assisted by FES (Johnston et al. 2003; Granat et al. 1993) or a combination of this with treadmill and biofeedback training (Petrofsky 2001). In the present section, the outcomes associated with the strength benefits of these studies will be presented. Table 6.9 Locomotor Training Studies Examining strength Measures
Author Year; Country Score Level Total Sample Size Methods Population: 10 male patients with incomplete SCI, paraplegia T3-T12, aged 22-30, asymmetrical impairment with Trendelenburg gait; could walk without an assistive device. Treatment: The control group (n=5) had 2hour daily conventional physical therapy, including 30 min biofeedback of more affected gluteus medius for 2 months. Experimental treatment (n=5) had same program and used a portable home biofeedback device. Outcome Measures: Muscle strength (isometric strain gauge transducer) and gait analysis. Population: 153 patients overall, 89 (44 chronic, 45 acute) locomotor training, 64 (24 chronic, 40 acute) control. Treatment: Body-weight supported treadmill locomotor training (BWSTT) (Laufband therapy) vs conventional rehabilitation. Specific parameters for each were not described or appeared to vary within and between groups. Outcome Measures: Manual muscle testing, walking function and neurological examination pre and post training. 1. Outcome Gains in strength (in quadriceps, gluteus medius and hamstring) were seen for both groups but were greater for the experimental group than controls (p<0.05). After 2 months of therapy the reduction in Trendelenburg gait was greater for the experimental group than for the control group (p<0.01) and the experimental group showed almost normal gait.

Petrofsky 2001; USA Downs & Black score=12 Prospective Controlled Trial N=10

2.

1.

Wernig et al. 1995; Germany Downs & Black score=9 Case Control N=153

2. 3.

6 /20 chronic individuals initially “nearly paralysed” gained bilateral muscle strength (↑ manual muscle testing) For acute patients, no differences in strength gains between BWSTT and conventional rehab. Authors noted that locomotor gains had little correlation with strength gains.

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Author Year; Country Score Level Total Sample Size

Methods Population: 19 subjects, 13 men and 6 men, mean age 31.7 (ASIA class C), > 1 year post-injury, asymmetrical lower extremity function. Treatment: Body weight-supported treadmill walking with peroneal nerve FES of the weaker limb for 1.5 hours, 3X/week, 3 months. Outcome Measures: Lower extremity motor score (LEMS), Gait outcomes. Population: 6 incomplete SCI (3 males, 3 females), aged 20-40, 2-18 years post injury, C4 to L1, 3 Frankel C, 3 Frankel D. Treatment: FES-assisted locomotor training to quadriceps, hip abductors, hamstrings, erector spinae, common peroneal nerve, minimum 30 min, 5 days/week. Outcome Measures: Manual muscle tests, maximum voluntary contraction (MVC), upright motor control, spasticity, balance and gait outcomes. Population: 3 adolescents (age 12-17), incomplete SCI, 1-3 years post-injury, 1 male, 2 females, all ASIA C, C6, C7 and L2 injury levels. Treatment: 1 year percutaneaous intramuscular FES system preceded by 4 week stimulated exercise and FES gait training period. Outcome Measures: Manual muscle test scores, gait outcomes. Population: 2 males, 1 female, ASIA C, 5 weeks/ 6 weeks/ 18 months post-injury. Treatment: Therapist and Roboticassisted, body-weight-supported treadmill training (parameters varied between subjects). Outcome Measures: Lower extremity motor scores (LEMS), functional mobility outcomes. Population: 76 SCI patients (35 chronic, 41 acute), strength data reported for 25 chronic only who returned to clinic for follow-up. Treatment: Body-weight supported treadmill locomotor training (Laufband therapy). 1-2X/day for 30 minutes, 5 days/week for 8-20 weeks. Outcome Measures: Voluntary muscle scores and walking function. 1.

Outcome LEMS had median increases of 3 points in both the FES-assisted leg and the non-stimulated leg (p<.005). ↑ASIA lower limb motor scores in 15 of 19 incomplete SCI (ASIA C) (p<.005).

Field-Fote 2001; USA Downs & Black score=15 Pre-post N=19

2.

1. 2.

Granat et al. 1993; UK Downs & Black score=14 Pre-post N=6

↑ strength (↑ hip flexors and knee extensor manual muscle test, p<0.05). ↑ strength as indicated by increased quadriceps torque with MVC (p<0.05).

1. 2.

Johnston et al. 2003; USA Downs & Black score=14 Pre-post N=3

No group statistics. ↑ Voluntary strength for all subjects in 12/13 stimulated muscles by ~1 manual muscle grade. The greatest gains were in hip extension and hip abduction.

1. 2.

Hornby et al. 2005; USA Downs & Black score=12 Pre-post N=3

No group statistics ↑ ASIA lower limb motor scores in 2/3 subjects in acute phase (5 & 6 weeks) which cannot be separated from natural recovery. No changes seen in 3rd person initiated at 18 months. No group statistics. All subjects showed increases in cumulative muscle scores (i.e., 8 muscles summed) indicative of increased strength.

1.

Wernig et al. 1998; Germany Downs & Black score=12 Pre-post N=76

Discussion Measures of strength were employed as a secondary outcome measure to the primary outcome of ambulation. In general, investigators have noted significant increases of lower limb strength 6-25

following locomotor training – despite variations between training protocols and specific methods employed. Outcome measures have included manual muscle testing of individual lower limb muscles in incomplete SCI or summated scores of several muscles (Granat et al. 1993; Wernig et al. 1995; Wernig et al. 1998; Field-Fote 2001; Johnston et al. 2003; Hornby et al. 2005; Wirz et al. 2005). Most recent studies have adhered to ASIA international guidelines for the manual muscle testing (Field-Fote 2001; Hornby et al. 2005; Wirz et al. 2005). Others have employed muscle torque measurements by employing strain gauge transducers (Granat et al. 1993; Petrofsky 2001;). All investigators have reported increases in lower limb muscle strength in individuals with chronic SCI. However, several investigators have noted that enhanced walking capability did not necessarily demonstrate parallel increases in strength (Wernig et al. 1995; Wernig et al. 1998; Field-Fote 2001; Wirz et al. 2005). Furthermore, the clinical relevance of the small strength gains following locomotor training is questionable when considering the duration and complexity of the intervention (Field-Fote 2001). However, there is weak evidence (from 1 study, n = 3) that significant improvements in muscle strength may be realized when locomotor training is combined with conventional therapy (Hornby et al. 2005). Detecting group differences in strength gains during the acute phase may be more challenging given the natural recovery. Wernig et al. (1995) found no differences between those provided locomotor training versus those treated conventionally in muscle strength gains. However, specific subject characteristics were inadequately described other than stating that body-weight supported treadmill training was initiated within a few weeks (i.e., 2-20 weeks, median 7 weeks) following injury. There was also a lack of standardized assessment, further confounding the findings. Conclusion There is level 4 evidence that most forms of locomotor training (i.e., including body weight supported treadmill training with various assists and FES-assisted overland training) increase lower limb muscle strength in chronic SCI as indicated by overall increases in total lower extremity motor scores. There is level 3 evidence that body weight supported treadmill training is not significantly different than conventional rehabilitation therapy in enhancing lower limb muscle strength in acute SCI, although these studies are confounded by the natural recovery that may take place in the acute period.

Locomotor training programs are beneficial in improving lower limb muscle strength although in acute SCI similar strength benefits can be obtained with conventional rehabilitation. The real benefit of locomotor training on muscle strength may be realized when it is combined with conventional therapy. This should be further explored in acute, incomplete SCI where better functional outcomes may be realized with the combination of therapies.

6.4 Summary There is level 2 evidence that a program of PES-assisted isometric exercise reduces the degree of lower limb muscle atrophy in individuals with recent (~10 weeks post-injury)

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motor complete SCI, but not to the same extent as a comparable program of FESassisted cycling exercise. There is level 4 evidence that programs of PES-assisted exercise partially reverses the lower limb muscle atrophy found in individuals with long-standing (>1 year post-injury) motor complete SCI. There is level 2 evidence that a program of PES-assisted exercise increases lower limb strength and muscular endurance. There is level 2 evidence that a program of FES-assisted cycling exercise prevents and reverses lower limb muscle atrophy in individuals with recent (~10 weeks post-injury) motor complete SCI and to a greater extent than PES. There is level 4 evidence that programs of FES partially reverses the lower limb muscle atrophy found in individuals with long-standing (>1 year post-injury) motor complete SCI. There is level 4 evidence that a program of FES-assisted cycle exercise increases lower limb muscular endurance. There is level 2 evidence using historical controls that BWSTT is effective in improving ambulatory function. However, stronger evidence from one level 1RCT demonstrates that BWSTT has equivalent effects to conventional rehabilitation consisting of overground mobility practice for gait outcomes in acute/sub-acute SCI. There is Level 4 evidence from pre-test/post-test studies that BWSTT is effective for improving ambulatory function in people with chronic, incomplete SCI. There is Level 1 evidence from 1 RCT that different strategies for implementing body weight support gait retraining all yield similar ambulatory outcomes in people with chronic, incomplete SCI. It is recommended that therapists may choose a body weight support gait retraining strategy based on available resources (Field-Fote et al. 2005). In summary, level 1 evidence describes limited and indirect improvements in aspects of walking (i.e. spasticity, speed and posture) but do not translate into significant functional walking gains as a result of clonidine and cyproheptadine. Limited and non-functional improvements in walking as a result of baclofen are only supported by level 4 evidence. Conflicting evidence provides little guidance with respect to the use of GM-1 and 4aminopyridine for the improvement of ambulation in spinal cord injury. Scientifically robust studies with consistent clinically relevant outcome measures are needed for pharmacological intervention studies of ambulation after spinal cord injury. There is Level 4 evidence that FES-assisted walking can enhance walking speed and distance in complete and incomplete SCI. There is also Level 4 evidence from 3 independent laboratories that regular use of FES in gait training or activities of daily living leads to persistent improvement in walking function that is observed even when the stimulator is not in use. None of the studies investigating the efficacy of brace/orthotic devices for upright support and mobility are randomized or blinded, but that is in part due to the ethical dilemma of providing safe and appropriate bracing and the fact that participants will be able to distinguish which device they received. There is weak evidence from post-test studies that bracing alone results in significant gains in functional ambulation for people with complete SCI. Only 2 studies reported pre-test/post-test results (total n = 8) that the use of long-leg braces could enhance gait speed and endurance in people with complete SCI.

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There is Level 4 evidence that a combined approach of bracing and FES results in additional benefit to functional ambulation in paraplegic patients with complete SCI. However, in subjects who are achieve little benefit from bracing alone, the addition of FES appears to help improve standing or short-distance walking function (Marsolais et al. 2000). In incomplete SCI, however, there is some indication that a combination of bracing and FES provides greater ambulatory function than either approach alone (Kim et al. 2004). There is level 4 evidence that most forms of locomotor training (i.e., including body weight supported treadmill training with various assists and FES-assisted overland training) increase lower limb muscle strength in chronic SCI as indicated by overall increases in total lower extremity motor scores. There is level 3 evidence that body weight supported treadmill training is not significantly different than conventional rehabilitation therapy in enhancing lower limb muscle strength in acute SCI, although these studies are confounded by the natural recovery that may take place in the acute period.

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CHAPTER SEVEN
Cardiovascular Health and Exercise Following Spinal Cord Injury
Darren ER Warburton, PhD Shannon Sproule, PT Andrei Krassioukov, MD, PhD Janice J Eng, BSc (OT/PT), PhD

Key Points There is limited evidence that BWSTT can improve indicators of cardiovascular health in individuals with complete and incomplete SCI. Tetraplegics and paraplegics can improve their cardiovascular fitness and physical work capacity through aerobic exercise training which are of moderate intensity, performed 20-60 min day, at least three times per week for a minimum of six to eight weeks. Resistance training at a moderate intensity at least two days per week also appears to be appropriate for the rehabilitation of persons with SCI. It remains to be determined the optimal exercise intervention for improving cardiovascular fitness. Interventions that involve FES training a minimum of 3 days per week for 2 months can improve muscular endurance, oxidative metabolism, exercise tolerance, and cardiovascular fitness. Aerobic and FES exercise training may lead to clinically significant improvements in glucose homeostasis in persons with SCI. Preliminary evidence indicates that a minimum of 30 min of moderate intensity training on 3 days per week is required to achieve and/or maintain the benefits from exercise training. Aerobic and FES exercise training may lead to improvements in lipid lipoprotein profile that are clinically relevant for the at risk SCI population. The optimal training program for changes in lipid lipoprotein profile remains to be determined. However, a minimal aerobic exercise intensity of 70% of heart rate reserve on most days of the week appears to be a good general recommendation for improving lipid lipoprotein profile in persons with SCI.

Table of Contents
7.1 Introduction ......................................................................................................................7-1 7.2 The Risk for Cardiovascular Disease in Persons with SCI ..........................................7-2 7.3 Physical Inactivity and the Risk for Cardiovascular Disease in Persons with SCI....7-3 7.4 Exercise Rehabilitation and Cardiovascular Fitness ...................................................7-3 7.4.1 Treadmill Training ...........................................................................................................7-4 7.4.2 Arm, Mixed Arm and Wheelchair Ergometry...................................................................7-6 7.5 Functional Electrical Stimulation (FES).........................................................................7-9 7.5.1 FES Leg Cycle Ergometry ..............................................................................................7-9 7.5.2 Hybrid FES (Combined Leg and Arm Ergometry).........................................................7-11 7.5.3 Other Electrically-Assisted Training Programs .............................................................7-12 7.6 Glucose Homeostasis ...................................................................................................7-14 7.7 Lipid Lipoprotein Profiles .............................................................................................7-17 7.8 Summary.........................................................................................................................7-19 References..............................................................................................................................7-23

This review has been prepared based on the scientific and professional information available in 2005. The SCIRE information (print, CD or web site www.icord.org/scire) is provided for informational and educational purposes only. If you have or suspect you have a health problem, you should consult your health care provider. The SCIRE editors, contributors and supporting partners shall not be liable for any damages, claims, liabilities, costs or obligations arising from the use or misuse of this material. Warburton DER, Sproule S, Krassioukov A, Eng JJ (2006). Cardiovascular Health and Exercise Following Spinal Cord Injury. In: Eng JJ, Teasell RW, Miller WC, Wolfe DL, Townson AF, Aubut J, Abramson C, Hsieh JTC, Connolly S, editors. Spinal Cord Injury Rehabilitation Evidence. Vancouver, p 7.1-7.28. www.icord.org/scire

Cardiovascular Health and Exercise Following Spinal Cord Injury
7.1 Introduction Persons with SCI currently have an increased life expectancy owing to improvements in medical treatment (Bauman et al. 1992a). The majority of all SCI (80%) occur in individuals who are under 30 years of age (ICORD 2003). Therefore, persons with SCI will be susceptible to the same chronic conditions across the lifespan as able-bodied persons. In fact, cardiovascular disease (CVD) is the leading cause of death in both able-bodied individuals (Health Canada 1999) and persons with SCI (Bauman et al. 1992a, Whiteneck et al. 1992). In the general population, it is estimated that approximately one in four Canadians has some form of CVD. However, there appears to be an earlier onset of CVD and/or and increased prevalence of CVD in individuals with SCI in comparison to the general population (Yekutiel et al. 1989, Whiteneck et al. 1992, DeVivo et al. 1993, Bauman et al. 1999b). The prevalence of asymptomatic CVD has been shown to be between 60-70% in persons with SCI (Bauman et al. 1993, Bauman et al. 1994). This is an alarming statistic, which places a significant burden upon the patient, his/her family and society as a whole. Physical inactivity is a major independent risk factor for CVD and premature mortality (Blair & Brodney 1999, Booth et al. 2000, Katzmarzyk et al. 2000). As reviewed later, persons with SCI are commonly inactive and exhibit low levels of cardiovascular fitness (Hoffman 1986). Also, it appears that the ordinary activities of daily living are not adequate to maintain cardiovascular fitness in persons with SCI (Hoffman 1986). Extremely low levels of physical activity and fitness (as a result of wheelchair dependency) may explain directly the increased risk for CVD in individuals with SCI. Moreover, a reduction in cardiovascular fitness may also lead to a vicious cycle of further decline, which results in a reduction in functional capacity and the ability to live an independent lifestyle. The current chapter summarizes briefly the literature regarding the risk for CVD in persons with SCI. This chapter also evaluates critically the level of evidence regarding the effectiveness of varied forms of exercise rehabilitation in increasing cardiovascular fitness and attenuating the risk for CVD in persons with SCI. Table 7.1 contains a definition of the commonly used terms and/or abbreviations in this chapter (Warburton et al. 2006a). Table 7.1 Description of Commonly Used Terms
Term Spinal Cord Injury (SCI) Cardiovascular Disease (CVD) Physical Activity Exercise Aerobic Training Heart Rate Reserve Definition • Refers to persons who have sustained a spinal cord injury. • Refers to diseases affecting the circulatory system (i.e., heart and/or blood vessels) including acute myocardial infarction, coronary artery disease, arteriosclerosis, heart valve disease, heart failure, high blood pressure, peripheral vascular dysfunction, congenital heart disease, stroke, and arrhythmias. • Refers to all leisure and non-leisure body movements resulting in an increased energy output from the resting condition. • Refers to structured and repetitive physical activity designed to maintain or improve physical fitness. • Refers to an exercise program that incorporates activities that are rhythmic in nature, using large muscle groups at moderate intensities for 3 to 5 days per week. • Refers to the difference between maximal heart rate (HRmax; predicted or determined

7-1

Term (HRR) • • • • •

MET Moderate Intensity Exercise Current General Exercise Recommendation Activities of Daily Living (ADLs) Cardiovascular (Aerobic) Fitness Maximal Aerobic Power (VO2max) Health-related Physical Fitness Quality of Life

Definition directly) and resting HR. The %HRR formula takes into account resting and maximal HR to provide an appropriate target HR (or range) for training. Training Heart Rate = [(HRmax – HRrest) x 40-85%] + HRrest Refers to an estimate of resting metabolic rate while sitting quietly. 1 MET = 3.5 mL·kg-1·min-1 or 1 kcal·kg-1·h-1 Exercise performed at relative intensities of 40-59% HRR, approximately 4-6 METs, or 55-69% of HRmax. Moderate intensity exercise for 20-60 min day on most days of the week.

• Refers to the activities in which one engages during daily life. • Refers to the ability to transport and utilize oxygen during prolonged, strenuous exercise or work. It reflects the combined efficiency of the lungs, heart, vascular system and exercising muscles in the transport and utilization of oxygen. • The maximum amount of oxygen that can be transported and utilized by the working muscles. Also, known as maximal oxygen consumption. • Involves the components of physical fitness that are related to health status including cardiovascular fitness, musculoskeletal fitness, body composition and metabolism. • Refers to an overall satisfaction and happiness with life, and includes the facets of physiological, emotional, functional and spiritual well-being.

7.2 The Risk for Cardiovascular Disease in Persons with SCI The majority of CVD events are the result of atherosclerosis (i.e., narrowing and hardening of the arteries) (Grey et al. 2003). Persons with SCI appear to be particularly susceptible to the development of atherosclerotic disease (Bravo et al. 2004). Researchers have revealed that persons with SCI exhibit a series of risk factors for atherosclerotic disease and thus CVD (as shown in Table 7.2). A healthy endothelium (interior lining of blood vessels) is essential for the protection against atherosclerosis (Anderson 2003). Relatively limited data exists regarding the vascular health of individuals with SCI (de Groot et al. 2005). However, the majority (if not all) of the risk factors for CVD in persons with SCI will have a significant negative impact upon endothelial function. As such, it would appear that vascular dysfunction is also a central step in the development of CVD in persons with SCI. Table 7.2 Risk Factors for Cardiovascular Disease in Persons with SCI
• Risk Factor Abnormal lipoprotein profiles Literature Support Brenes et al. 1986, Dearwater et al. 1986, Bauman et al. 1992b, Krum et al. 1992, Maki et al. 1995, Dallmeijer et al. 1997, Bauman et al. 1998, Bauman et al. 1999a, Bauman et al. 1999b Myllynen et al. 1987, Bauman & Spungen 2001 Bauman et al. 1999c, Spungen et al. 2003 Wecht et al. 2000, Wecht et al. 2003, de Groot et al. 2005 Miranda & Hassouna 2000 Vaidyanathan et al. 1998, Kahn 1999, Roussi et al. 1999, Kahn et al. 2001, Frost et al. 2005, Lee et al. 2005 Bauman et al. 2001 Claus-Walker & Halstead 1982b, Bauman & Spungen 2000

• • • • • • •

Abnormal glucose homeostasis Increased relative adiposity, elevated body fat and/or reduced lean body mass Reduced peripheral vascular function and/or endothelial dysfunction Increased risk for deep vein thrombosis Abnormal haemostatic and inflammatory markers Excessive homocysteine Depressed endogenous anabolic hormone levels (e.g. serum testosterone and growth hormone)

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• • •

Risk Factor Increased activation of the renin-angiotensinaldosterone system Hypertension Reduced aerobic fitness

Literature Support Claus-Walker & Halstead 1982a Lee et al. 2006 Hoffman 1986

7.3 Physical Inactivity and the Risk for Cardiovascular Disease in Persons with SCI The separation of the autonomic nervous system from the superior brain centres after injury results in a series of changes that markedly affect the cardiovascular health of persons with SCI (Bravo et al. 2004). Adrenergic dysfunction, poor diet, and physical inactivity are thought to play key roles in the elevated risk for CVD in SCI. Physical inactivity is prevalent amongst persons with SCI. In fact, persons with SCI often lead relatively sedentary lives leading to marked deconditioning (Jacobs & Nash 2004). In the general population, deconditioning has been associated with a pronounced reduction in cardiovascular fitness (Warburton et al. 2006a) and an increase in the risk for CVD and premature mortality (Warburton & Mathur 2004). Not only is physical inactivity a major independent risk factor for CVD and premature mortality (Warburton et al. 2006a), it also plays a key role in the development of the majority of the other commonly observed risk factors for CVD in persons with SCI. For instance, cross-sectional investigations have shown that the extreme inactivity (associated with SCI) is related to lower HDL cholesterol levels (Brenes et al. 1986, Dearwater et al. 1986, Shetty et al. 1992, Schmid et al. 2000, Manns et al. 2005), elevated LDL cholesterol (Schmid et al. 2000), triglyceride (Schmid et al. 2000, Manns et al. 2005), and total cholesterol levels (Schmid et al. 2000), abnormal glucose homeostasis (Myllynen et al. 1987, Elder et al. 2004, Manns et al. 2005), increased adiposity (Elder et al. 2004, Manns et al. 2005), and excessive reductions in aerobic fitness (Eriksson et al. 1988, Schmid et al. 2000, Manns et al. 2005). It is important to note, that SCI presents additional risk for CVD above that seen in able-bodied individuals owing to the marked decrease in physical activity and injury-related changes in metabolic function (Bravo et al. 2004). The major abnormalities observed in SCI are reduced physical activity/fitness, abnormal glucose homeostasis, and deteriorated lipid lipoprotein profiles. Based on the available literature, it is clear that effective exercise interventions are required to slow the progression of multiple risk factors for CVD and other chronic diseases (e.g. obesity, type 2 diabetes) in persons with SCI. 7.4 Exercise Rehabilitation and Cardiovascular Fitness Exercise rehabilitation has been shown to be an effective means of attenuating or reversing chronic disease in persons with SCI. Similar to the general able-bodied population (Warburton et al. 2006a), habitual physical activity (beyond activities of daily living) can lead to numerous health benefits that significantly reduce the risk for multiple chronic conditions (in particular CVD) and premature mortality in persons with SCI. Although research is increasingly evaluating the health benefits of physical activity in persons with SCI, this body of information is relatively low in comparison to the general population and other clinical conditions (such as chronic heart failure) (Warburton et al. 2006a).

7-3

The research conducted within the field of SCI has examined predominantly the effects of aerobic exercise and/or functional electrical stimulation (FES) training. In the following sections we will review the literature regarding to the effects of varied exercise interventions on the risk for CVD in persons with SCI. Particular attention will be given to the changes in cardiovascular fitness, glucose metabolism, and lipid lipoprotein profiles that occur after training interventions in persons with SCI. Aerobic fitness is a strong predictor of multiple chronic diseases, the capacity for activities of daily living, and premature mortality in the general population (Warburton et al. 2006a). Moreover, exercise training commonly results in significant improvements in aerobic fitness (i.e., VO2max) in the general population (Warburton et al. 2006a, 2006b). There is increasing evidence illustrating the important association between the risk for chronic disease (in particular CVD) and cardiovascular fitness in persons with SCI. Recent work has also revealed the importance of maintaining high levels of health-related physical fitness for the capacity of performing activities of daily living in able-bodied and disabled populations (including persons with SCI) (Sloan et al. 1994, Warburton et al. 2006a). Moreover, aerobic fitness (and other components of health-related physical fitness) have been positively associated with the gainful employment of paraplegics (Noreau & Shephard 1992). Both tetraplegic and paraplegic persons appear to benefit from regimented exercise interventions that improve health-related physical fitness. We found at total of 41 studies in our search of the literature for investigations evaluating cardiovascular fitness before and after an exercise intervention. This included investigations related to treadmill training (2 studies; n = 14), arm exercise (20 studies; n = 278), and FES (18 studies; n = 233) training. 7.4.1 Treadmill Training Body-weight supported treadmill training (BWSTT) is an exercise protocol that has been used to potentially affect a number of domains, including motor recovery, bone density, cardiovascular fitness, respiratory function as well as quality of life. Traditional BWSTT requires participants to step on a treadmill while supporting some of their body weight on two parallel bars. Significant resources are often required with BWSTT as the majority of individuals will require one or two assistants to manually move the limbs forward. Limited data exists regarding the changes in cardiovascular fitness and health that occur with BWSTT (Table 7.3). Table 7.3 Effects of Bdy-weight Sported Treadmill Training on Cardiovascular Fitness and Health
Author Year; Country Score Research Design Total Sample Size Methods Population: 6 participants (4 male, 2 female), ASIA A and B, C4-T12, mean age 37.7 yrs, mean 6.7 years post-injury, motor complete. Treatment: Body weight supported treadmill training, 15 min/day (3 bouts of 5 min), 3 days/week for 4 months. Outcome Measures: BP, HR, HR variability, BP variability, arterial diameters and mean blood velocities, and arterial blood flow. Outcome 1. No changes in femoral or carotid artery cross sectional area, blood flow, or resistance post-training 2. An improvement in femoral artery compliance. 3. No change in resting BP, mean arterial blood pressure, resting HR or HR and blood pressure variability after training. 4. 3/6 patients had changes in HR and blood pressure variability reflective of increased vagal predominance.

Ditor et al. 2005a; Canada Downs & Black score=14 Pre-post N=6

7-4

Author Year; Country Score Research Design Total Sample Size

Methods Population : 8 participants (6 males, 2 females), ASIA B-C, C4-C5, incomplete, mean age 27.6 yrs, mean 9.6 years postinjury. Treatment: Progressive, body weightsupported treadmill training, 3 day/week for 6 months. Outcome Measures: HR and BP variability, LF/HR ratio (low to high frequency heart spectrum and is indicative of balanced sympathetic/parasympathetic tone and reduced risk for cardiovascularrelated mortality).

Outcome 1. Significant decrease in resting HR (10.0%) after training. 2. No changes in resting systolic, diastolic, or mean arterial BP after training. 3. Significant reduction in the resting LF/HF ratio after training. 4. There were no significant effects of training on HR and/or blood pressure variability during an orthostatic challenge (60° head up tilt).

Ditor et al. 2005b; Canada Downs & Black score=14 Pre-post N=8

Discussion The two level 4 papers are by the same Canadian research group (Ditor et al. 2005a, Ditor et al. 2005b). They reported that BWSTT did not have substantial group effects on HR and blood pressure in motor complete subjects, but did reveal a significant reduction in resting HR in the study with incomplete tetraplegics. There is also evidence that improvements in HR and blood pressure variability may occur after BWSTT in incomplete SCI and a subset of participants with complete SCI. These changes reflected an increased predominance of the parasympathetic nervous system control of HR and blood pressure. The changes in HR variability are indicative that beneficial changes in cardiac autonomic balance can occur in SCI. This research group also revealed the potential for improvements in vascular health (e.g. arterial compliance) after BWSTT in individuals with motor-complete SCI. There was no indication of the effects of BWSTT on VO2peak. In both papers, two trainers assisted the participants with the gait cycle, while a third trainer assisted with weight shifting, balance and overall safety. The mechanisms responsible for the improvement in markers of cardiovascular health and regulation in individuals with incomplete SCI remain to be determined. Both weight-bearing and the passive movement of the limbs may contribute to the improvement in cardiovascular health in these studies. Conclusion There is Level 4 evidence that BWSTT can reduce resting heart rate in individuals with incomplete, but not complete SCI injuries. There is Level 4 evidence that BWSTT can result in improvements in cardiac autonomic balance in persons with incomplete tetraplegia. There is Level 4 evidence that BWSTT can result in improvements in cardiac autonomic balance in a subset of individuals with motor-complete SCI who respond to ambulation with moderate to large increases in heart rate. There is Level 4 evidence that BWSTT can improve arterial compliance in individuals with motor-complete SCI.

There is limited evidence that BWSTT can improve indicators of cardiovascular health in individuals with complete and incomplete SCI.

7-5

7.4.2 Arm, Mixed Arm and Wheelchair Ergometry Given the motor loss of the lower limbs, upper extremity exercise is a logical choice. Improving cardiovascular fitness can be challenging using the smaller mass of the arms especially when muscle fatigue can often occur before endurance training targets are met. From our search, we found one level 1, five level 2, and fourteen level 4 studies. Given the large number of studies which have looked at upper extremity exercise, we have tabled only those studies which included an SCI control group. Table 7.4 Effects of Arm, Mixed Arm, and Wheelchair Ergometry Training on Cardiovascular Fitness and Health
Author Year; Country Score Research Design Total Sample Size Methods Arm Ergometry Population: 4 male, 2 female, C5-L1, ASIA A (n=1), B (n=1), C (n=4), mean age 36 yrs. Treatment: Interval training (3 min exercise of arm cranking, boxing, push ups and ball throwing followed by 2 minutes rest for 1 hour), 1h/day, 3 days/wk for 8 weeks. Randomized to low intensity (5060% HRR) or high intensity (70-80% HRR) group. Outcome Measures: VO2peak, maximal power output. Population: 24 men with spinal lesions: 8 spina bifida, 16 traumatic, ages 17-42 yrs. Treatment: Random assignment to 1) control or 1 of 3 arm ergometry programs 2 days/week for 24 weeks: 1) high-intensity long duration (40 min at 70% of VO2peak) exercise training, 2) high-intensity short duration (20 min at 70% of VO2peak) exercise training, and 3) low-intensity short duration (20 min at 50% of VO2peak) training. Outcome Measures: cardiac output, HR, VO2peak, power output, stroke volume. Participants: 14 sedentary, disabled males (n=9 exercise group, n=5 control group), ages 20-39. Treatment: 16 week arm ergometry aerobic training at 50-70% of VO2peak for 20-40 min/day, 3 days/week. Outcome Measures: BP, HR, power output, VO2peak, resting left ventricular dimensions, cardiac function. Outcome

de Groot et al. 2003; Netherlands PEDro=7 RCT N=6

1. Training resulted in a significant improvement in VO2peak and peak power output in the entire group. 2. The changes in VO2peak were significantly greater in the high intensity (59%) versus low intensity group (17%).

Davis et al. 1991; Canada PEDro=4 RCT N=24

1. Training increased VO2peak in the 3 arm ergometry groups (about 21%). 2. Significant increases in submaximal stroke volume and cardiac output with training in the high intensity long and the low intensity long training groups. 3. In contrast, the low intensity short duration training and control groups exhibited small, but non-significant decrements in SV. 1. Training was associated with a significant improvement in VO2peak (31%) and HR (-9.5%) 2. During isometric handgrip exercise, ↓rate pressure product (20%), ↑stroke volume (12-16%) 3. No changes in echocardiographic responses at rest or during isometric handgrip exercise.

Davis et al. 1987; Canada PEDro=4 RCT N=14

7-6

Author Year; Country Score Research Design Total Sample Size Hjeltnes & WallbergHenriksson 1998; Norway Downs & Black score=16 Prospective Controlled Trial N=27

Methods Population: 27 participants: Exercise group: 10 tetraplegia, C6-8, 7 ASIA A & 3 ASIA B, 99 days post-injury; Control: 10 paraplegia, T7-11, all ASIA A. Treatment: Exercise group: standard rehabilitation + Arm ergometry, 30 min/day, 3 day/week for a 12-16 week period; Control: standard rehabilitation. Outcome Measures: power output, cardiac function, HR, VO2, systolic blood pressure, lactate levels, muscular strength, ability to perform activities of daily living. Mixed Arm and Other Exercise Population: 34 participants (18 tetraplegic and 16 paraplegic), ASIA A-D, C4-L1, ages 19-65 yrs. Treatment: The exercise group: 90-120 min/day, 2 days/wk for 9 months of aerobic (arm ergometry, 15-30 mins, at ~70% VO2max) and whole-body, circuit resistance exercise (wall pulley, free and machine weights) components. Control group: bimonthly education session on topics including exercise physiology, osteoporosis, and relaxation. Outcome Measures: muscular strength, power output, HR, quality of life ratings. Wheelchair Ergometry Population: low-intensity group n=6, C5T7, moderate-intensity group n=5, C5-T9. Treatment: Wheelchair ergometry 20 min/day, 3 days/week for 8 weeks. The low-intensity group trained at 50-60% max HR reserve (HRR); Moderate intensity group trained at 70-80% max HRR. Outcome Measures: HR, power output, blood lactate, VO2max, Rating of Perceived Exertion (RPE), lipid profiles.

Outcome 1. Peak workload increased (45%) significantly, while VO2peak did not change in the tetraplegics after training. 2. Peak workload (45.5%) and VO2peak (27.7) increased significantly in the paraplegics after standard rehabilitation. 3. No change in peak HR, systolic BP, submaximal exercise stroke volume or cardiac output in either SCI group.

Hicks et al. 2003; Canada PEDro=5 RCT N=23

1. Power output increased by 118% and 45% after training in the tetraplegic and paraplegic groups, respectively. 2. There were progressive increases in strength over the 9 months of training (ranging from 19-34%). 3. There was a significant decline in the HR to power output ratio (an indicator of improved aerobic fitness) after training.

Hooker & Wells 1989; USA Downs & Black score=9 Prospective Controlled Trial N=8

1. Neither group had changes in maximal HR, maximal power output, maximal blood lactate, or VO2max. The mean change in VO2max was 10 and 24%, respectively, for the low-intensity and high-intensity training groups. 2. The moderate-intensity group had significantly lower post-training submaximal HR, lactate, and RPE but no changes in oxygen consumption. 3. 70% maximal HRR appears to be the beneficial training threshold.

Discussion The reported improvements in aerobic capacity after aerobic arm training in SCI are approximately 20-30%; however, it is not uncommon for improvements in excess of 50%. For instance, researchers (DiCarlo 1988) revealed a 99% improvement in VO2max after aerobic arm cycle training. The majority of aerobic training investigations have evaluated the effectiveness of moderate (40-59% HRR or 55-69% of maximum HR) to vigorous (60-84% HRR or 70-89% of maximum HR) intensity exercise. These studies have used arm ergometry, wheelchair ergometry, and swimming based interventions (Jacobs & Nash 2004). Based on the current level of literature, it appears that moderate intensity exercise performed 20-60 min per day, at least 3 days per week 7-7

for a minimum of 6 weeks is effective for improving cardiovascular fitness in persons with SCI. Therefore, the general recommendations provided by Health Canada, the Canadian Society for Exercise Physiology, and the American College of Sports Medicine are appropriate for improving the cardiovascular fitness of persons with SCI. It is important to note that an exercise intensity threshold of 70% maximal HRR has been advocated for the attainment of training benefits when a minimal training duration (20 min) is the standard (Hooker& Wells 1989, Tordi et al. 2001, Bizzarini et al. 2005). It is also important to note that improvements in exercise capacity and functional status may occur after training without significant improvements in VO2peak, particularly in tetraplegic patients (Hjeltnes & Wallberg-Henriksson 1998). Questions remain regarding the primary mechanisms of importance for improvements in aerobic fitness after training. It is unclear whether central (heart and lung) or peripheral (skeletal muscle) adaptations are of key importance. Improvements have been observed in peripheral muscle function. For instance, investigators have shown intrinsic cellular adaptations that facilitate oxidative metabolism (level 4) (Stewart et al. 2004). Only limited investigations, however, have shown an improvement in cardiac function after aerobic exercise training. It could therefore be argued that peripheral adaptations are of primary importance to the improvement in aerobic capacity after aerobic exercise interventions. However, this statement is somewhat misleading as the majority of investigations have not directly evaluated cardiac output during maximal/peak exercise. This is owing to the fact that the assessment of maximal cardiac output during exercise is one of the most difficult and expensive procedures in clinical exercise physiology (Warburton et al. 1999a, 1999b). When exercise measures of cardiac function have been taken, improvements in central function have been observed (Davis et al. 1987). Further research examining the primary mechanism(s) of importance for the improved cardiovascular fitness and exercise capacity seen in SCI after aerobic exercise training is warranted. Less is known about the effects of resistance training on cardiovascular fitness. However, as reviewed by Jacobs and Nash (2004) the incorporation of resistance training into the treatment of persons with SCI appears to be essential. In fact, muscle weakness and dysfunction are key determinants of pain and functional status in persons with SCI. Investigators have evaluated the effects of resistance training on cardiovascular fitness in persons with SCI. For instance, hydraulic resistance training has also been shown to lead to significant improvements in VO2max (Cooney & Walker 1986). Furthermore, circuit resistance training has resulted in increases in VO2peak, time to fatigue, peak power output, and musculoskeletal fitness (Jacobs et al. 2001). The general health guidelines for resistance training appear to be appropriate for the rehabilitation of persons with SCI. This includes 1-2 sets of 8-10 different resistance exercises with large muscle groups for 8-12 repetitions (moderate intensity), on 2-4 days per week (Warburton et al. 2006b). Circuit weight training is also likely appropriate as it provides a significant stress to the cardiovascular and musculoskeletal systems. Conclusion There is Level 1 evidence that arm exercise at a moderate to vigorous intensity (50-80% HRR), 3 days/week for at least 2 months improves cardiovascular fitness. There is Level 1 evidence that high intensity (70-80% HRR) exercise leads to greater improvements in peak power and VO2peak than low intensity (50-60% HRR) exercise. There is Level 1 evidence that aerobic exercise training is effective in improving exercise capacity/tolerance in persons with SCI.

7-8

It is uncertain whether aerobic training can improve cardiac function in persons with SCI. Based on the changes observed in VO2max and findings from able-bodied individuals, a consensus was derived stating that aerobic training may be effective in improving the ability to extract oxygen at the periphery in persons with SCI. Tetraplegics and paraplegics can improve their cardiovascular fitness and physical work capacity through aerobic exercise training which are of moderate intensity, performed 20-60 min day, at least three times per week for a minimum of six to eight weeks. Resistance training at a moderate intensity at least two days per week also appears to be appropriate for the rehabilitation of persons with SCI. It remains to be determined the optimal exercise intervention for improving cardiovascular fitness.

7.5 Functional Electrical Stimulation (FES) Computer-assisted FES during leg cycling has been shown to be an important and practical means of exercising a relatively large muscle mass in persons with SCI (Hooker et al. 1992). These devices also permit the activation of the skeletal muscle pump during leg cycling. For these reasons, FES training has been widely advocated as an effective treatment strategy for SCI. It is important to note, that the physiological responses to FES training appear to be distinct from arm ergometry training. For instance, arm exercise has been shown to lead to faster VO2 kinetics (at a constant workload), greater changes in HR, and lower post-exercise blood lactates than FES leg cycling (Barstow et al. 2000). 7.5.1 FES Leg Cycle Ergometry Table 7.5 Effects of Functional Electrical Stimulation on Cardiovascular Fitness
Author Year; Country Score Research Design Total Sample Size Methods Population: 6 tetraplegia at C6, 4 paraplegia at T4, all complete, ages 2745 yrs, 3-23 yrs post-injury. Treatment: One-year exercise training using an FES cycle ergometer (30 min/day, 3 days/week). Outcome Measures: VO2max, total work output, blood lactate, muscle properties. Population : 16 male, 3 females (7 paraplegics T4-T10, 12 tetraplegics C4C7), ages 19-47 yrs, 2-17yrs post-injury. Treatment: Phase I: quadriceps stimulation with dynamic knee extensions against increasing resistance, 3 days/week for 4 weeks. Phase II: leg-cycle FES, 15-30 mins/day, 3 days/week for 12 weeks. Outcome Measures: HR, work, BP, and VO2peak. Population: 17 males, 1 female, 10 tetraplegia (C5-C7), 8 paraplegia (T4-T11), 7 incomplete, mean age 30.6 yrs, mean 1. 2. 3. Outcome 4 fold increase in total work output and 12% increase in thigh muscle mass over the training program. VO2max increased 17.5% (6 months) and 19.2% (12 months). Shift towards more fatigue resistant contractile proteins, which was accompanied by a doubling of citric synthase activity. Most participants showed an increase in strength and endurance. The average resistance increased by 50.4%. VO2peak increased non-significantly (14.9%) after training.

Mohr et al. 1997; Denmark Downs & Black score=14 Pre-post N=10

1.

Ragnarsson et al. 1988; USA Downs & Black score=14 Pre-post N=19

2.

Hooker et al. 1992; USA Downs & Black score=13 Pre-post

1.

Increase in power output (45%), VO2peak (23%), cardiac output (13%), HR (11%), and a reduction in total

7-9

Author Year; Country Score Research Design Total Sample Size N=18

Methods 6.1yrs post-injury. Treatment: FES leg cycle training 10-30 min/day, 2-3 days/week for 12-16 weeks. Outcome Measures: VO2peak, power output, cardiac output, stroke volume, total peripheral resistance, and HR.

Outcome peripheral resistance (-14%) during peak FES leg cycle. No changes in stroke volume (6%), mean arterial BP (-5%), or arteriovenous oxygen difference (+10%). No differences during peak arm cranking exercise for any of the cardiovascular variables – therefore no carry-over effect from leg training. The isometric-trained leg showed significantly larger mean increases in force, increase in type 1 fibres, fibre cross-sectional area, capillaryto-fibre ratio, citrate synthase activity and relative oxygenation after static training in comparison to baseline and the dynamically trained leg. These changes reflect the importance of load in the amount of adaptation to FES. VO2peak increased (70%) during FES leg cycling, but not during arm cycling. Increase in lean body mass (3.0%) and a decrease in body fat (6.4%). Increase in muscle cross-sectional area (21.3%). Training significantly increased VO2peak (10.9%), peak work rate (46.5%), and peak oxygen pulse (12.6%). HR was unaffected both at rest or peak exercise. ↑resting HR and systolic blood pressure in the tetraplegics, while ↓systolic, diastolic and mean arterial BP in the paraplegics after training. ↓exercise power output after training in both groups. In both groups, ↓submaximal exercise HR and blood pressure and ↑ stroke volume after training. After training, submaximal cardiac output increased significantly in the paraplegic group. ↑work output (300%) over training. No change HR and systolic BP. ↑common femoral artery diameter (8%), no change common carotid artery diameter. Blood flow to the paralyzed limbs was increased.

2.

3.

Crameri et al. 2004; Denmark Downs & Black score=12 Pre-post N=6

Population: all paraplegic, complete, C6T7, ages 26-54yrs, 3-21yrs post-injury. Treatment: FES training 45 min/day, 3 days/week, for 10 weeks. One leg: dynamic cycle ergometry involved bilateral quadriceps and hamstring stimulation; Contralateral leg: isometric contractions. Outcome Measures: muscle biopsies, capillary-to-fibre ratio, muscle proteins, and oxygenation. Population: 5 males, complete chronic lesions, 2 C5, 2 C6, 1 C7; 4 ASIA A, 1 ASIA A/B, mean age 35yrs, mean 10.2yrs post-injury. Treatment: 8 weeks of FES leg cycling, 7X/week. Outcome Measures: DXA (Body composition), VO2peak. Population: 9 males, 2 tetraplegia, 7 paraplegia, all ASIA A, mean age 34.4yrs, mean 10.1yrs post-injury. Treatment: FES leg cycle exercise, 30 min (minimum of 24 sessions, 3X/week). Outcome Measures: work rate, VO2peak, oxygen pulse. Population: 6 paraplegics (5 complete), 7 tetraplegics (all incomplete), C4-C7 and T4-T10, mean age 30.5yrs, mean 8yrs post-injury. Treatment: FES leg cycle, 3X/week for about 12 weeks. Outcome Measures: BP, power output, HR, VO2peak, stroke volume, and cardiac output.

1.

2. 1. 2. 3. 1.

Hjeltnes et al. 1997; Norway Downs & Black score=12 Pre-post N=5

Barstow et al. 1996; USA Downs & Black score=12 Pre-post N=9

2. 1.

Faghri et al. 1992a; USA Downs & Black score=12 Pre-post N=13

2. 3. 4.

Gerrits et al. 2001; Netherlands Downs & Black score=11 Pre-post N=9

Population: C4-C6 and T4-T8, ASIA A (5), B (3) and C (1), ages 26-61yrs, 1-27yrs post-injury. Treatment: FES leg cycle ergometry, 30min/day, 3day/wk for 6 weeks. Outcome Measures: BP, end-diastolic velocity, HR.

1. 2. 3.

7-10

7.5.2 Hybrid FES (Combined Leg and Arm Ergometry) Table 7.6 Effects of Hybrid FES Training on Cardiovascular Fitness and Health
Author Year; Country Score Research Design Total Sample Size Methods Population: 9 males, 1 female, T1-T12, 9 complete, mean age 39.2yrs, 1-20yrs post-injury. Treatment: simultaneous FES cycle ergometry and voluntary arm ergometry, 30 mins/day, 2-3 days/wk for 4 weeks. Outcome Measures: VO2peak, blood flow and vascular resistance, and echo Doppler (diameter and flow-mediated dilation (FMD) after 13 min of ischemia). Population: all male, C4-T10, 4 paraplegia, 2 tetraplegia, ages 23-41yrs, 5-24yrs post-injury. Treatment: Phase I: FES leg cycle, 3 days/week for 6 weeks. Phase II: FES leg cycle with simultaneous, voluntary arm ergometry, 3 days/week for 6 weeks. Phase III: 8 weeks of detraining inactivity. Outcome Measures: VO2peak, submaximal and maximal HR. Population: all male, complete ASIA A, C5-6 to T12-L1, mean 35.6yrs, mean 9.7yrs post-injury. Treatment: 3 phases of exercise training (FES-Leg cycle ergometry): Phase I progressive FES-Leg Cycle Exercise (FESLCE) to 30 min of exercise; Phase II approximately 35 sessions of FES-LCE, and Phase III approximately 41 sessions (30 min each) of combined FES-LCE and arm ergometry. Outcome Measures: VO2peak and submaximal physiological parameters (VO2, HR, blood lactate). Population: 7male, 1 female, 7 paraplegia, 1 tetraplegia, mean age 32yrs, mean 13yrs post-injury. Treatment: 2 phase program. Phase I: FES leg cycle for 6 weeks, 3 days/week. Phase II: FES leg cycle plus simultaneous, voluntary arm ergometry for a 6 week period. Outcome Measures: VO2peak, HR, workload, peak lactate. Population: 7 male and 4 female, C4-C6 and T2-T6, complete motor lesions, ages 18-54yrs, 6-132 months post-injury. Treatment: 3 phase program over 13-28 weeks. Phase I: quadriceps stimulation for knee extension. Phase II: FES leg cycle with 0-1 kp resistance. Phase III: loaded FES leg cycle, 3 days/week for 3 weeks. 1. Outcome Training resulted in increased thigh resting (43.5%) and peak blood flow (17.1%), decreased thigh resting vascular resistance (31.8%), and increased common femoral artery diameter in the stimulated thigh tissue. Forearm and calf arterial parameters and FMD, in both superficial femoral and brachial artery, did not change. After training, there was an increase in maximal workload (6.8%), VO2peak (6.1%), and resistance to fatigue. ↑VO2peak (81.7%) and workload with FES leg cycle. 8 week detraining period, peak workload returned to baseline levels; however VO2peak was still higher than baseline.

Thijssen et al. 2005; Netherlands Downs & Black score=14 Pre-post N=10

2. 3. 1. 2.

Gurney et al. 1998; USA Downs & Black score=12 Pre-post N=6

1.

Mutton et al. 1997; USA Downs & Black score=12 Pre-post N=11

2.

In response to FES-LCE training both VO2peak and peak work rate during graded FES leg exercise (but not graded arm ergometry) testing improved with training. As a result of the hybrid exercise training, VO2peak (13%) and peak power output (28%) were significantly increased during graded hybrid testing, but not during graded arm or graded FES leg testing alone.

1. 2. 3. 4. 1. 2.

Krauss et al. 1993; USA Downs & Black score=12 Pre-post N=8

After Phase 1, ↑arm ergometer VO2peak (21.9%) and FES leg ergometer VO2peak (62.7%). After Phase 2, the hybrid exercise VO2peak increased 13.7%. Peak HR only increased with training in FES leg ergometry. There were no significant changes in peak lactate with training. Resting measures of VO2, HR, and oxygen pulse did not significantly change with training. There were significant increases in endurance time (288%), VO2peak (95.9%) and HR (16.8%), and decreases in diastolic blood pressure (31.5%) with training.

Pollack et al. 1989; USA Downs & Black score=11 Pre-post N=11

7-11

Author Year; Country Score Research Design Total Sample Size

Methods Outcome Measures: BP, HR, oxygen consumption. 3.

Outcome There was a non-significant increase (59.7%) in oxygen pulse with training.

7.5.3 Other Electrically-Assisted Training Programs Table 7.7 Effects of Other Electrically Assisted Training Programs on Cardiovascular Fitness and Health
Author Year; Country Score Research Design Total Sample Size Wheeler et al. 2002; Canada Downs & Black score=17 Pre-post N=6 Methods Population: C7-T12, 5 ASIA A, 1 ASIA C, mean age, 42.5yrs, mean 13.8yrs post-injury. Treatment: FES (quadriceps) with arm rowing 30 min/day, 3 days/week, for 12 weeks at 70-75% of VO2peak. Outcome Measures: VO2peak, rowing distance, and peak oxygen pulse. Population: all male, complete ASIA A, C5-T10, mean age 35.6yrs, mean 13.4yrs post-injury. Treatment: Home-based electrical stimulation (4 sets of 10 dynamic knee extensions with 3 mins rest between, increasing resistance with weight), 2X/week for 18 weeks. Outcome Measures: Doppler echo ultrasound (blood velocity and flow, femoral artery diameter), muscle fatigue, and muscle mass. Population: all paraplegia, no other details given. Treatment: 3 hours per week for 14 weeks with the Reciprocating Gait Orthosis. Outcome Measures: muscle hypertrophy, cholesterol, LDL, cardiac output, and stroke volume. Population: SCI: 3 male, 3 female, T4L2, all complete ASIA A/B, mean age 43 yrs, mean 14.5yrs post-injury; Controls: 8 able-bodied individuals (4 male, 4 female), mean age 41yrs. Treatment: Unilateral surface stimulation of the quadricep, tibial anterior and gastrocnemius muscles, 30 min/day, daily for 4 weeks (isometric training, as the leg was fixed in a sitting position with a knee angle of ~90°) Outcome Measures: leg circumference, total limb volume, resting mean red blood cell velocity and vessel diameter and blood pressure. 1. Outcome Training resulted in significant increases in rowing distance (25%), VO2peak (11.2%), and peak oxygen pulse (11.4%).

1.

Sabatier et al. 2006; USA Downs & Black score=15 Pre-post N=5

2. 3.

Training resulted in significant increases in weight lifted and muscle mass, and a decrease in muscle fatigue (-60%). There was no change in femoral artery diameter with training. Resting, reactive hyperaemia, and exercise blood flow did not change significantly with training.

1. 2.

Solomonow et al. 1997; USA Downs & Black score=13 Pre-post N=70

There was a non-significant increase in cardiac output (7.1%) and stroke volume (5.0%) after training. There was a significant increase in knee extensor torque (78.2%). There was an increase in arterial compliance and a decrease in the flow-mediated dilation response in the femoral artery of the trained leg, with no changes in these vascular parameters in the femoral artery of the untrained leg, the carotid artery, and the brachial artery. There were no significant trainingrelated changes in resting vessel diameter, blood flow or shear rate in the femoral, carotid, and brachial arteries. No significant training-related changes occurred in blood pressure or leg volumes.

1.

de Groot et al. 2005; Netherlands Downs & Black score=10 Pre-post N=6

2.

3. 4.

7-12

Discussion There is a growing body of literature indicating that FES exercise training is effective in improving cardiovascular health, peak power output, and exercise tolerance/capacity in persons with SCI (Table 7.5). This research generally employs a cycling motion, although rowing and bipedal ambulation have also been evaluated. It appears that moderate-to-vigorous intensity FES training (relative to baseline capacity) is effective to improve cardiovascular fitness in persons with SCI. The majority of the investigations are pre-post designs (level 4) with investigations reporting marked changes in VO2max or VO2peak after FES training. Similar to aerobic training, 20-40% changes in aerobic capacity are often observed after FES training. However, it is not uncommon for improvements in excess of 70% (Table 7.5). For instance, researchers (Faghri et al. 1992) found a 260% increase in VO2peak after FES training. Investigations with FES training have also shown an improvement in musculoskeletal fitness and health. Similar to arm exercise training, limited investigations have shown an improvement in cardiac function after FES training. A recent investigation has also revealed that the degree of muscular adaptation that can be achieved via FES exercise is dependent upon the load that is applied to the paralyzed muscle (Crameri et al. 2004). Researchers have also revealed that hybrid exercise training (FES-leg cycling combined with arm ergometry) may elicit greater changes in peak work rates and VO2max/VO2peak than FESleg cycling exercise alone (Krauss et al. 1993, Mutton et al. 1997). Moreover, it appears that the physiological adaptations to combined FES-leg cycling and arm ergometry training are maintained partially following 8 weeks of detraining (Gurney et al. 1998). Furthermore, other interventions (Table 7.7) that make use of FES training have also been shown to improve the exercise capacity and cardiovascular health status of persons with SCI. A series of intrinsic muscle adaptations can also occur after FES training that enhance the ability for oxidative metabolism at the cellular level, which in turn facilitate improved endurance, exercise tolerance and functional capacity. Key intrinsic muscle adaptations that have been observed include an increase in the proportion of type 1 fibres, an enhancement in crosssectional fibre area, an increase in capillary-to-fibre ratio, a shift towards more fatigue resistant contractile proteins, and an increase in citrate synthase activity. Given the recently established importance of musculoskeletal fitness for health and functional status (Warburton et al. 2001a, 2001b, Warburton et al. 2006b), further research is clearly warranted with persons with SCI. Randomized, controlled exercise interventions (both arm and/or FES training) that evaluate concurrent changes in musculoskeletal fitness and health status are particularly needed. Conclusion There is Level 4 evidence FES training for a minimum of 3 days per week for 2 months can improve muscular endurance, oxidative metabolism, exercise tolerance, and cardiovascular fitness. There is Level 4 evidence that FES training is effective in improving exercise cardiac function in persons with SCI. Based on the changes observed in VO2max and findings from able-bodied individuals a consensus (Level 5; Expert Opinion) was derived stating that aerobic training is effective in improving the ability to extract oxygen at the periphery in persons with SCI.

7-13

Interventions that involve FES training a minimum of 3 days per week for 2 months can improve muscular endurance, oxidative metabolism, exercise tolerance, and cardiovascular fitness.

7.6 Glucose Homeostasis Glucose intolerance and decreased insulin sensitivity are independent risk factors for CVD (Hurley & Hagberg 1998). Abnormal glucose homeostasis is associated with deteriorated lipidlipoprotein profiles and an increased risk for the development of hypertension and type 2 diabetes (Hurley & Hagberg 1998, Warburton et al. 2001a, 2001b). It is well-established that habitual physical activity is an effective primary preventative strategy against insulin resistance and Type 2 diabetes in the general population (Warburton et al. 2006a). Although comparatively less information is available for SCI, it appears that exercise training programs are effective in improving glucose homeostasis (Hjeltnes et al. 1998, Chilibeck et al. 1999, de Groot et al. 2003, Phillips et al. 2004, Mahoney et al. 2005). Table 7.8 Glucose Homeostasis
Oral Glucose Tolerance Test (OGTT) Insulin Sensitivity Blood Glucose Blood Insulin Glucose Transporters (GLUT-4) Glycogen Synthase Hexokinase Citrate Synthase Phosphofructokinase • Involves the ingestion of glucose and the subsequent serial blood analysis of glucose levels to determine the rate of blood glucose removal. Common test used in the diagnosis of diabetes. • Refers to the sensitivity of target cells (muscle, hepatic cells and adipose) to insulin. • Refers to blood levels of glucose (a simple sugar, carbohydrate). High fasting blood glucose levels reflects pre-diabetic or diabetic conditions. • Refers to blood levels of insulin (a hormone that regulates carbohydrate metabolism). • Glucose transporters are important membrane proteins that facilitate the transport of glucose through the cellular membrane. GLUT4 is an insulin-regulated glucose transporter located in adipose and muscle tissues. • Enzyme involved in the synthesis of glycogen from glucose. • An enzyme that acts during carbohydrate metabolism. In the first step of glycolysis, hexokinase phosphorylates (transfers phosphate from ATP) glucose to prepare it for subsequent breakdown for use in energy production. • Citrate synthase is an important enzyme in the Citric Acid Cycle (Krebs cycle). • Phosphofructokinase (PFK) is an important regulatory enzyme of glycolysis.

Table 7.9 Effects of Exercise Training on Glucose Metabolism in Persons with SCI
Author Year; Country Score Research Design Total Sample Size de Groot et al. 2003; Netherlands PEDro=7 RCT N=6 Methods Population: 4 male, 2 female, C5-L1, ASIA A (n=1), B (n=1), and C (n=4), mean age 36yrs, mean 116 days post-injury. Treatment: Randomized to low intensity (50-60% HRR) or high intensity (70-80% HRR) arm ergometry. 20 min/day, 3 days/week for 8 weeks. Outcome Measures: VO2peak, insulin Outcome 1. There was a significant difference in insulin sensitivity between groups, with a non-significant decline in the high intensity group and a significant improvement in the low intensity group with training. 2. A significant positive correlation between VO2peak and insulin

7-14

Author Year; Country Score Research Design Total Sample Size

Methods sensitivity, blood glucose. Population: 5 males, complete SCI, C5T10, ASIA grade A, mean age 35.6yrs, mean 13.4yrs post-injury. Treatment: Home-based neuromuscular electric stimulation-induced resistance exercise training, 2 days/week for 12 weeks. Outcome Measures: quadriceps femoris muscle cross-sectional area, plasma glucose, insulin.

Outcome sensitivity (r=0.68, p=0.02) was found for the group as a whole. 1. Quadriceps femoris muscle crosssectional area increased in both thighs (~37%) after training. 2. All participants had normal fasting glucose levels before and after training. 3. There were no significant changes in blood glucose or insulin with training. However, there was a trend towards reduced plasma glucose levels (p=0.074). 4. There was a progressive increase in muscular strength over the 12 week program. 1. After training, insulin-mediated glucose disposal was increased by 33%. There was an associated 2.1 fold increase in insulin-stimulated glucose transport activity. 2. Training led to marked increases in protein expression of GLUT4 (glucose transporter) (378%), glycogen synthase (526%), and hexokinase II (204%) in the vastus lateralis muscle. 3. Hexokinase II activity increased 25% after training. 4. A small increase in percentage type I muscle fibres and signs of transformation from type IIb to IIa muscle fibres were noted in 4/5 participants. 1. Decrease in the external supported proportion of body weight and increase in session length and walking velocity. 2. Reduction in the area under the curve for glucose (-15%) and insulin (-33%). 3. The oxidation of exogenous (ingested) glucose and endogenous (liver) glucose increased (68% and 36.8%, respectively) after training. 4. Training resulted in increased muscle glycogen, GLUT-4 content (glucose transporter) (126%), and hexokinase II enzyme activity (49%). 1. There were significantly lower (14.3%) 2h OGTT glucose levels after 8 weeks of training. 2. Glucose utilization was higher for all 3 participants and insulin sensitivity was higher for 2 of the 3 participants during post-training 2h clamp test.

Mahoney et al. 2005; USA Downs & Black score=17 Pre-post N=5

Hjeltnes et al. 1998; Sweden Downs & Black score=13 Pre-post N=5

Population: 5 males, C5-C7, all complete ASIA A, mean age 35yrs, mean 10yrs postinjury. Treatment: Electrically stimulated leg cycling exercise, 7 days/week for 8 weeks. Outcome Measures: peripheral insulin sensitivity, whole body glucose utilization, glucose transport, phosphofructokinase, citrate synthase, hexokinase, glycogen synthase, blood glucose, plasma insulin.

Phillips et al. 2004; Canada Downs & Black score=12 Pre-post N=9

Population : 8 male, 1 female, incomplete ASIA C, C4-T12, mean 8.1yrs post-injury. Treatment: Body-weight supported treadmill walking, 3 days/week for 6 months. Outcome Measures: whole-body dualenergy X-ray absorptiometry, GLUT4 protein abundance, hexokinase activity, oral glucose tolerance tests, glucose oxidation, CO2 breath analysis.

Jeon et al. 2002; Canada Downs & Black score=11 Pre-post N=7

Population: 5 male, 2 female, motor complete, C5-T10, ages 30-53yrs, 3-40yrs post-injury. Treatment: FES leg cycle training, 30 min/day, 3 day/week for 8 weeks. Outcome Measures: oral glucose tolerance test (OGTT), glucose and insulin

7-15

Author Year; Country Score Research Design Total Sample Size

Methods levels, glucose utilization, insulin sensitivity and levels. Population : 8 male, 2 female, 6 tetraplegia, 4 paraplegia, C6-T4, mean age 35yrs, mean 12yrs post-injury. Treatment: FES cycling, 30 min/day, 3 day/wk for 12 months. 7 participants completed an additional 6 months (at 1 day/week). Outcome Measures: insulin-stimulated glucose uptake, oral glucose tolerance test (OGTT), GLUT 4 glucose transporter protein.

Outcome

Mohr et al. 2001; Denmark Downs & Black score=10 Pre-post N=10

Chilibeck et al. 1999; Canada Downs & Black score=10 Pre-post N=5

Population: 4 male, 1 female, motor complete C5-T8, ages 31-50yrs, 3-25yrs post-injury. Treatment: FES leg cycle ergometry training, 30 min/day, 3 day/week for 8 weeks. Outcome Measures: glucose transporters (GLUT-4, GLUT-1), oral glucose tolerance test, citrate synthase.

1. Insulin-stimulated glucose uptake rates increased after intensive training. 2. With the reduction in training, insulin sensitivity decreased to a similar level as before training. GLUT 4 increased by 105% after intense training and decreased again with the training reduction. The participants had impaired glucose tolerance before and after training, and neither glucose tolerance nor insulin responses to OGTT were significantly altered by training. 1. Training resulted in increases in GLUT-1 (52%) and GLUT-4 (72%). 2. There was a training-induced increase in citrate synthase activity (56%) and an improvement in the insulin sensitivity index as determined from oral glucose tolerance test.

Discussion The majority of the data is from experimental non-randomized controlled trials. A search of the literature revealed 7 investigations (n = 47). This included 1 randomized controlled trial (RCT) and 6 experimental non-randomized controlled trials. The RCT involved the randomization to two different forms of exercise, and as such an exercise condition served as the control. The majority (5) of these trials examined the effectiveness of FES training in comparison to aerobic training (2 investigations). Similar to other studies in the field of SCI research, this area of investigation is limited by the lack of quality RCT. Moreover, the majority of the research relates to the effects of FES training. Limited work has been conducted using aerobic and/or resistance exercise training. As a whole, however, these studies are consistent and reveal several important findings. For instance, the improvements in glucose homeostasis may be the result of increased lean body mass (which leads to enhancd insulin sensitivity), and increased expression of GLUT4, glycogen synthase, and hexokinase in exercised muscle. Consistent with findings in able-bodied individuals (Warburton et al. 2001a, 2001b), the improvement in glucose homeostasis after exercise interventions (such as aerobic training or FES) does not appear to be solely related to decreases in body adiposity and/or increases in VO2max. This is due to the fact that significant improvements in glucose homeostasis can occur with minor changes in body composition and/or aerobic fitness. It is also important to note that there appears to be a minimal volume of exercise required for improvements in glucose homeostasis. For instance, Mohr et al. (2001) revealed that a reduction of FES training was not sufficient to maintain the beneficial changes in insulin sensitivity and GLUT4 protein observed during a 3 day/week FES training program.

7-16

Conclusion There is Level 4 evidence that aerobic exercise training programs (performed 30 min/day, 3 day per week for 6 weeks or more) are effective in improving glucose homeostasis in persons with SCI. There is Level 4 evidence that FES training programs (performed 30 min/day, 3 day per week for 6 weeks or more) are effective in improving glucose homeostasis in persons with SCI. There is Level 4 evidence that the changes in glucose homeostasis after aerobic or FES training are clinically significant for the prevention and/or treatment of type 2 diabetes. Aerobic and FES exercise training may lead to clinically significant improvements in glucose homeostasis in persons with SCI. Preliminary evidence indicates that a minimum of 30 min of moderate intensity training on 3 days per week is required to achieve and/or maintain the benefits from exercise training.

7.7 Lipid Lipoprotein Profiles Abnormal lipid-lipoprotein profiles have been associated with an increased risk for CVD (Hurley & Hagberg 1998, Warburton et al. 2001a, 2001b, Warburton et al. 2006a, 2006b). Routine physical activity has been shown to enhance lipid lipoprotein profiles, e.g., reduced triglycerides (TG), greater levels of high-density lipoprotein (HDL) cholesterol and lower low/high density lipoprotein ratios (LDL/HDL) (Brenes et al. 1986, Tell & Vellar 1988, DuRant et al. 1993, Taimela et al. 1994, O'Connor et al. 1995, Halle et al. 1996, Berg et al. 1997, Warburton et al. 2001a, 2001b) in the general population (Warburton et al. 2006a). Although limited, similar findings have been observed in persons with SCI (Table 7.9). The following table describe the common measurements of lipid profiles. Table 7.10 Lipid Lipoprotein Profiles
Low-density lipoprotein (LDL) • Lipid protein complex that transports cholesterol from the liver to other tissues within the body. LDL is often referred to as the “bad” cholesterol. LDL levels above 160 mg/dL (4.1 mmol/L) are considered to be high. • Lipid protein complex that transports cholesterol from the tissues to the liver for excretion and re-utilization. HDL is often referred to as the “good” cholesterol. HDL levels of <40 mg/dL (<1.03 mmol/L) are associated with an increased risk for CVD. • Total amount of all cholesterol in the blood (↑TC related to ↑risk for CVD) • High energy fatty acids which form much of the fat stored by the body

High-density lipoprotein (HDL) Total cholesterol (TC) Triglycerides (TG)

Table 7.11 Effects of Exercise Training on Lipid Lipoprotein Profiles in Persons with SCI
Author Year; Country Score Research Design Total Sample Size de Groot et al. 2003; Netherlands PEDro=7 RCT N=6 Methods Population: 4 male, 2 female, C5-L1, ASIA A (n=1), B (n=1), and C (n=4), mean age 36yrs, mean 116 days post-injury. Treatment: Randomized to low intensity (50-60% HRR) or high intensity (70-80% Outcome 1. The TC/HDL and triglycerides decreased significantly more in the high intensity versus the low intensity group.

7-17

Author Year; Country Score Research Design Total Sample Size

Methods HRR) arm ergometry. 20 min/day, 3 days/week for 8 weeks. Outcome Measures: lipid profiles including total cholesterol (TC), HDL, LDL, triglycerides (TG). Population: 5 SCI: lesion below T10, mean age 32 years; 7 AB controls: mean age 31 years. Treatment: Arm ergometry, 30 min/day (at 60-65% VO2peak), 3 day/week for 12 wks. Outcome Measures: VO2peak, peak HR, peak workload, TC, triglycerides, HDL. Population: all paraplegia, no other details given. Treatment: 3 hours per week for 14 weeks with the Reciprocating Gait Orthosis. Outcome Measures: cholesterol, LDL, HDL Population: 5 males, complete lesions T6L1, mean age 37.8yrs, mean 4.8yrs postinjury. Treatment: Circuit resistance training, 3 days/week for 12 weeks, with resistive load of 50-60% 1RM. Outcome Measures: VO2peak, time to fatigue, TC, triglycerides, HDL, LDL. Population: 8 male, 1 female, incomplete lesions ASIA C, C4-T12, mean 8.1yrs postinjury. Treatment: Body weight-supported treadmill training, 3 day/week for 6 months. Outcome Measures: ambulatory capacity (Wernig Walking Scale), cholesterol, HDL, LDL, triglycerides Population: low-intensity group: n=6, 3 male, 3 female, C5-T10, ages 26-36yrs, 3months-19yrs post-injury; moderateintensity group: n=5, 3 male, 2 female, C5T9, ages 23-30yrs, 2-19yrs post-injury. Treatment: Two SCI groups performed wheelchair ergometry 20 min/day, 3 days/week for 8 weeks. The low-intensity group trained at 50-60% max HRR and the moderate intensity group trained at 70-80% max HRR. Outcome Measures: total cholesterol (TC), triglycerides, HDL, LDL.

Outcome

El-Sayed et al. 2005; UK Downs & Black score=13 Pre-post N=12

1. There was a significant increase in peak workload (10.1%) and VO2peak (8.6%). 2. Training did not alter TC or triglycerides. 3. Training improved HDL. 1. There were significant reductions in total cholesterol, LDL, LDL/HDL, and TC/HDL in 8 patients with initially high total cholesterol levels (>200 mg/dL). 2. 20 patients with initially normal cholesterol levels did not exhibit a statistically significant change in total cholesterol, HDL, or LDL levels. 1. There were significant increases in VO2peak, time to fatigue and peak power output after training. 2. There were significant decreases in LDL, LDL/HDL and TC/HDL after training. 1. Treadmill velocity and session length increased by 135% and 55%, respectively, while amount of externally supported weight decreased as the result of training. 2. Functional locomotor capacity improved in 4 subjects. 3. There were significant reductions in TC (-11.2%), LDL (-12.9%) and total cholesterol/HDL (-19.8%). 1. Blood lipid levels remained unaltered in the low-intensity group, while the moderate-intensity group exhibited significant increases in HDL and decreases in triglycerides, LDL, and the TC/HDL ratio. 2. It appears that 70% maximal HRR was the threshold intensity needed to elicit training benefits in SCI persons.

Solomonow et al. 1997; USA Downs & Black score=13 Pre-post Initial N=70; Final N=33

Nash et al. 2001; USA Downs & Black score=11 Pre-post N=5

Stewart et al. 2004; Canada Downs & Black score=10 Pre-post N=9

Hooker & Wells 1989; USA Downs & Black score=9 Prospective Controlled Trial N=8

Discussion The information regarding the effects of exercise training on lipid lipoprotein profile is derived from one level 1 study, 1 level 2 and several level 4 studies (N = 105). The majority (6) of the investigations examined a form of aerobic training (either arm ergometry or assisted-treadmill 7-18

walking). The other investigation examined the effects of reciprocating gait orthosis powered with electrical muscle stimulation. These findings generally support the importance of exercise in the reduction of atherogenic lipid lipoprotein profiles and the reduction of the risk for CVD in persons with SCI. It appears that a minimal threshold of training exists for changes in lipoprotein profile. For instance, a few authors reported that 70% of maximal HRR is the threshold necessary to achieve significant improvements in lipid lipoprotein profiles. Future research is warranted, however, to quantify the effects of varying forms of exercise (including aerobic exercise, resistance exercise, and FES) on lipid lipoprotein profiles in persons with SCI. Conclusion There is Level 4 evidence to suggest that aerobic exercise training programs (performed at a moderate to vigorous intensity 20-30 min/day, 3 days per week for 8 weeks) are effective in improving the lipid lipoprotein profiles of persons with SCI. Preliminary evidence (Level 4) also indicates that FES training (3 hours/week, for 14 weeks) may improve lipid lipoprotein profiles in SCI.

Aerobic and FES exercise training may lead to improvements in lipid lipoprotein profile that are clinically relevant for the at risk SCI population. The optimal training program for changes in lipid lipoprotein profile remains to be determined. However, a minimal aerobic exercise intensity of 70% of heart rate reserve on most days of the week appears to be a good general recommendation for improving lipid lipoprotein profile in persons with SCI. 7.8 Summary There is a growing body of evidence to suggest that persons with SCI are at an increased risk for CVD. The evidence is summarized for the management of the risk of cardiovascular disease with aerobic exercise training (Table 7.12) and with FES (Table 7.13). Table 7.12 Management of the Risk for Cardiovascular Disease in Persons with SCI through Aerobic Exercise Training Interventions
Risk Factor Strength of Evidence Literature Support Gass et al. 1980, DiCarlo et al. 1983, DiCarlo 1988, Hjeltnes & WallbergHenriksson 1998, Jacobs et al. 2002, Sutbeyaz et al. 2005 Gass et al. 1980, DiCarlo et al. 1983, Cooney & Walker 1986, DiCarlo 1988, Jacobs et al. 2002, de Groot et al. 2003, El-Sayed et al. 2004, Sutbeyaz et al. 2005. Davis et al. 1987, Davis et al. 1991

Cardiovascular Fitness

• Increased exercise tolerance

Level 1

• Increased VO2max

Level 1

• Increased cardiac output

Level 4

7-19

Risk Factor • Reduced submaximal exercise heart rate • Increased maximal heart rate • Increased stroke volume • Decreased total peripheral resistance

Strength of Evidence Level 4 Level 4 Level 4 Level 4

Literature Support DiCarlo 1988 Sutbeyaz et al. 2005 Davis et al. 1987, Davis et al. 1991 Davis et al. 1987, Davis et al. 1991 Cooney & Walker 1986, DiCarlo 1988, Hjeltnes & Wallberg-Henriksson 1998, Jacobs et al. 2002, de Groot et al. 2003, Hicks et al. 2003, Sutbeyaz et al. 2005 Stewart et al. 2004 Hooker & Wells 1989, Nash et al. 2001, El-Sayed & Younesian 2005 Hooker & Wells 1989, Nash et al. 2001, de Groot et al. 2003, Stewart et al. 2004 de Groot et al. 2003 Hooker & Wells 1989, de Groot et al. 2003, Stewart et al. 2004 de Groot et al. 2003

• Increased power output

Level 1

• Intrinsic cellular adaptations that facilitate oxidative metabolism • Increased HDL cholesterol Lipid Lipoprotein Profile • Reduced LDL cholesterol • Reduced triglycerides • Reduced total cholesterol Glucose Homeostasis • Increased insulin sensitivity, decreased insulin resistance, and/or improved glucose tolerance.

Level 4 Level 4 Level 4 Level 4 Level 4 Level 4

Table 7.13 Management of the Risk for Cardiovascular Disease in Persons with SCI through Functional Electrical Stimulation Training Interventions
Risk Factor Strength of Evidence Level 4 Literature Support Pollack et al. 1989, Hooker et al. 1992, Barstow et al. 1996, Mohr et al. 1997, Wheeler et al. 2002, Thijssen et al. 2005 Pollack et al. 1989, Hooker et al. 1992, Barstow et al. 1996, Hjeltnes et al. 1997, Mohr et al. 1997, Wheeler et al. 2002, Thijssen et al. 2005 Hooker et al. 1992 Faghri et al. 1992 Faghri et al. 1992 Faghri et al. 1992 Faghri et al. 1992, Hooker et al. 1992, Thijssen et al. 2005 Andersen et al. 1996, Mohr et al. 1997, Crameri et al. 2002, Crameri et al. 2004 Solomonow et al. 1997 Solomonow et al. 1997 Jeon et al. 2002

• Increased exercise tolerance

• Increased VO2max Cardiovascular Fitness • • • • Increased cardiac output Reduced submaximal exercise heart rate Increased stroke volume Decreased total peripheral/vascular resistance

Level 4 Level 4 Level 4 Level 4 Level 4 Level 4 Level 4 Level 4 Level 4 Level 4

• Increased power output • Intrinsic cellular adaptations that facilitate oxidative metabolism Lipid Lipoprotein Profile Glucose Homeostasis • Reduced LDL cholesterol • Reduced total cholesterol • Increased insulin sensitivity, decreased insulin resistance, and/or improved glucose tolerance.

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Marked physical inactivity appears to play a central role in this increased risk. Accordingly, exercise interventions are effective in leading to significant reductions in the risk for CVD and multiple comorbidities (such as type 2 diabetes, hypertension, obesity). Both exercise and FES training are effective in attenuating and/or reversing abnormalities in glucose homeostasis, lipid lipoprotein profiles, and cardiovascular fitness in persons with SCI. Future well-designed randomized controlled trials are required to firmly establish the primary mechanisms by which exercise interventions elicit these beneficial changes in health status. There is Level 4 evidence that BWSTT can reduce resting heart rate in individuals with incomplete, but not complete SCI injuries. There is Level 4 evidence that BWSTT can result in improvements in cardiac autonomic balance in persons with incomplete tetraplegia. There is Level 4 evidence that BWSTT can result in improvements in cardiac autonomic balance in a subset of individuals with motor-complete SCI who respond to ambulation with moderate to large increases in heart rate. There is Level 4 evidence that BWSTT can improve arterial compliance in individuals with motor-complete SCI. There is Level 1 evidence that arm exercise at a moderate to vigorous intensity (50-80% HRR), 3 days/week for at least 2 months improves cardiovascular fitness. There is Level 1 evidence that high intensity (70-80% HRR) exercise leads to greater improvements in peak power and VO2peak than low intensity (50-60% HRR) exercise. There is Level 1 evidence that aerobic exercise training is effective in improving exercise capacity/tolerance in persons with SCI. It is uncertain whether aerobic training can improve cardiac function in persons with SCI. Based on the changes observed in VO2max and findings from able-bodied individuals, a consensus was derived stating that aerobic training may be effective in improving the ability to extract oxygen at the periphery in persons with SCI. There is Level 4 evidence FES training for a minimum of 3 days per week for 2 months can improve muscular endurance, oxidative metabolism, exercise tolerance, and cardiovascular fitness. There is Level 4 evidence that FES training is effective in improving exercise cardiac function in persons with SCI. Based on the changes observed in VO2max and findings from able-bodied individuals a consensus (Level 5; Expert Opinion) was derived stating that aerobic training is effective in improving the ability to extract oxygen at the periphery in persons with SCI. There is Level 4 evidence that aerobic exercise training programs (performed 30 min/day, 3 day per week for 6 weeks or more) are effective in improving glucose homeostasis in persons with SCI.

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There is Level 4 evidence that FES training programs (performed 30 min/day, 3 day per week for 6 weeks or more) are effective in improving glucose homeostasis in persons with SCI. There is Level 4 evidence that the changes in glucose homeostasis after aerobic or FES training are clinically significant for the prevention and/or treatment of type 2 diabetes. There is Level 4 evidence to suggest that aerobic exercise training programs (performed at a moderate to vigorous intensity 20-30 min/day, 3 days per week for 8 weeks) are effective in improving the lipid lipoprotein profiles of persons with SCI. Preliminary evidence (Level 4) also indicates that FES training (3 hours/week, for 14 weeks) may improve lipid lipoprotein profiles in SCI.

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Jacobs PL, Mahoney ET, Nash MS, Green BA. Circuit resistance training in persons with complete paraplegia. J Rehabil Res Dev 2002;39(1):21-8. Jacobs PL, Nash MS, Rusinowski JW. Circuit training provides cardiorespiratory and strength benefits in persons with paraplegia. Med Sci Sports Exerc 2001;33(5):711-7. Jacobs PL, Nash MS. Exercise recommendations for individuals with spinal cord injury. Sports Med 2004;34(11):727-51. Jeon JY, Weiss CB, Steadward RD, Ryan E, Burnham RS, Bell G, et al. Improved glucose tolerance and insulin sensitivity after electrical stimulation-assisted cycling in people with spinal cord injury. Spinal Cord 2002;40(3):110-7. Kahn N, Sinha A, Bauman W. Impaired platelet prostacyclin receptor activity: a monozygotic twin study discordant for spinal cord injury. Clin Physiol 2001;21(1):60-6. Kahn NN. Platelet-stimulated thrombin and PDGF are normalized by insulin and Ca2+ channel blockers. Am J Physiol 1999;276(5 Pt 1):E856-62. Katzmarzyk PT, Gledhill N, Shephard RJ. The economic burden of physical inactivity in Canada. CMAJ 2000;163(11):1435-40. Krauss JC, Robergs RA, Depaepe JL, Kopriva LM, Aisenbury JA, Anderson MA, et al. Effects of electrical stimulation and upper body training after spinal cord injury. Med Sci Sports Exerc 1993;25(9):1054-61. Krum H, Howes LG, Brown DJ, Ungar G, Moore P, McNeil JJ, et al. Risk factors for cardiovascular disease in chronic spinal cord injury patients. Paraplegia 1992;30(6):381-8. Lee MY, Myers J, Abella J, Froelicher VF, Perkash I, Kiratli BJ. Homocysteine and hypertension in persons with spinal cord injury. Spinal Cord 2006;44(8):474-9. Lee MY, Myers J, Hayes A, Madan S, Froelicher VF, Perkash I, et al. C-reactive protein, metabolic syndrome, and insulin resistance in individuals with spinal cord injury. J Spinal Cord Med 2005;28(1):20-5. Mahoney ET, Bickel CS, Elder C, Black C, Slade JM, Apple D, Jr., et al. Changes in skeletal muscle size and glucose tolerance with electrically stimulated resistance training in subjects with chronic spinal cord injury. Arch Phys Med Rehabil 2005;86(7):1502-4. Maki KC, Briones ER, Langbein WE, Inman-Felton A, Nemchausky B, Welch M, et al. Associations between serum lipids and indicators of adiposity in men with spinal cord injury. Paraplegia 1995;33(2):102-9. Manns PJ, McCubbin JA, Williams DP. Fitness, inflammation, and the metabolic syndrome in men with paraplegia. Arch Phys Med Rehabil 2005;86(6):1176-81. Miranda AR, Hassouna HI. Mechanisms of thrombosis in spinal cord injury. Hematol Oncol Clin North Am 2000;14(2):401-16. Mohr T, Andersen JL, Biering-Sorensen F, Galbo H, Bangsbo J, Wagner A, et al. Long-term adaptation to electrically induced cycle training in severe spinal cord injured individuals. Spinal Cord 1997;35(1):1-16. Mohr T, Dela F, Handberg A, Biering-Sorensen F, Galbo H, Kjaer M. Insulin action and longterm electrically induced training in individuals with spinal cord injuries. Med Sci Sports Exerc 2001;33(8):1247-52. Mutton DL, Scremin AM, Barstow TJ, Scott MD, Kunkel CF, Cagle TG. Physiologic responses during functional electrical stimulation leg cycling and hybrid exercise in spinal cord injured subjects. Arch Phys Med Rehabil 1997;78(7):712-8. Myllynen P, Koivisto VA, Nikkila EA. Glucose intolerance and insulin resistance accompany immobilization. Acta Med Scand 1987;222(1):75-81. Nash MS, Jacobs PL, Mendez AJ, Goldberg RB. Circuit resistance training improves the atherogenic lipid profiles of persons with chronic paraplegia. J Spinal Cord Med 2001;24(1):2-9.

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CHAPTER EIGHT
Respiratory Management Following Spinal Cord Injury
A William Sheel, PhD W Darlene Reid, BMR (PT), PhD Andrea F Townson, MD FRCPC Najib Ayas, MD FRCPC, MPH

Key Points For exercise training to improve respiratory function the training intensity must be relatively high (70-80% of maximum heart rate) performed three times per week for six weeks Ideal training regimes have not been identified. There is limited evidence that inspiratory muscle training improves respiratory muscle strength or endurance in people with SCI. The use of bronchodilators should be considered in subjects with tetraplegia who demonstrate an element of obstructive airway impairment. The effects of other medications commonly used in the management of SCI such as baclofen and oxybutynin should be considered when reviewing airway hyperreactivity in subjects with tetraplegia The short-term use of oxandrolone should be considered to improve pulmonary function in subjects with tetraplegia. Progressive ventilator free breathing protocol should be considered for ventilator dependent subjects with tetraplegia who are appropriate for ventilator weaning. Resistance and endurance training should be considered in subjects who are candidates for ventilator weaning. Case by case consideration should be given to tracheostomy decannulation in subjects with SCI. The indications and criteria for tracheostomy decannulation have not been established in SCI. Abdominal binding can be used to achieve immediate improvements in respiratory function, but long term effects have not been established. Chest wall vibration may improve pulmonary function while the vibration is applied, but carry-over effects when the vibration is not in use has not been evaluated. There is limited evidence that immersion to shoulder-deep 33-34° Celsius water may improve pulmonary function, but carry-over effects following immersion has not been evaluated. Patients with SCI have a high prevalence of obstructive sleep apnea, and therapy may improve quality of life and other outcomes. Therefore, we recommend vigilance for suggestive signs and symptoms (e.g., snoring, obesity, witnessed apneas, daytime sleepiness) and further testing in patients with suggestive symptoms/signs (with overnight oximetry or polysomnography). There is limited evidence that suggests that improving inspiratory and expiratory muscle force is important to maximize expiratory flow during cough. Cough effectiveness can be enhanced by a variety of methods including manual assistance by a caregiver and/or electrical stimulation triggered by the person with SCI. Hand-held expiratory pressure devices may enhance secretion removal in people with SCI.

Table of Contents
8.1 Introduction ......................................................................................................................8-1 8.2 Exercise Training .............................................................................................................8-3 8.3 Inspiratory Muscle Training ............................................................................................8-6 8.4 Pharmaceutical Interventions.......................................................................................8-10 8.4.1 Airway Hyperresponsiveness and Bronchodilators.......................................................8-10 8.4.2 Anabolic Agents ............................................................................................................8-14 8.4.3 Other pharmaceuticals..................................................................................................8-15 8.5 Assistive Devices...........................................................................................................8-15 8.5.1 Mechanical Ventilation and Weaning Protocols............................................................8-15 8.5.2 Other methods of ventilation .........................................................................................8-17 8.5.3 Tracheostomy Decannulation .......................................................................................8-17 8.5.4 Girdle/abdominal Binder ...............................................................................................8-18 8.5.5 Vibration........................................................................................................................8-19 8.5.6 Immersion .....................................................................................................................8-20 8.6 Obstructive Sleep Apnea in SCI ...................................................................................8-21 8.6.1 Prevalence and Risk Factors ........................................................................................8-22 8.7 Secretion Removal.........................................................................................................8-23 8.8 Summary.........................................................................................................................8-25 Reference................................................................................................................................8-27

This review has been prepared based on the scientific and professional information available in 2005. The SCIRE information (print, CD or web site www.icord.org/scire) is provided for informational and educational purposes only. If you have or suspect you have a health problem, you should consult your health care provider. The SCIRE editors, contributors and supporting partners shall not be liable for any damages, claims, liabilities, costs or obligations arising from the use or misuse of this material. Sheel AW, Reid WD, Townson AF, Ayas N (2006). Respiratory Management Following Spinal Cord Injury. In: Eng JJ, Teasell RW, Miller WC, Wolfe DL, Townson AF, Aubut J, Abramson C, Hsieh JTC, Connolly S, editors. Spinal Cord Injury Rehabilitation Evidence. Vancouver, p 8.1-8.30. www.icord.org/scire

Respiratory Management Following Spinal Cord Injury
8.1 Introduction The respiratory system, including the lung, respiratory muscles, and neural control system, is a complex integrated physiological system that is not yet fully understood. The respiratory system is unique in that it must operate in a cyclical and highly coordinated fashion for 24 hours per day in order to sustain life. Respiratory complications continue to be one of the leading causes of morbidity and mortality in people with spinal cord injury (SCI), especially among cervical and higher thoracic injuries. This continues to be the case despite recent advances in SCI patient care where acute and long-term mortality rates have been significantly reduced (DeVivo et al. 1993; 1999). Respiratory system complications can be exacerbated by pre-existing medical conditions, history of smoking, advanced age and by therapeutic measures to manage the resuscitation phase of the injured patient. Respiratory dysfunction resulting from cervical SCI depends on the level of injury and the extent of innervation. The higher level lesions result in denervation of progressively more of the expiratory and inspiratory muscles as illustrated in Figure.8.1. Although the primary consequence of SCI is dennervation of the respiratory pump, secondary consequences occur within the lungs because of the inability to effectively distend and inflate the lung to its full capacity. As a consequence, the compliance of the lungs diminishes with increasing time after SCI. Figure 8.1 Innervation of the respiratory muscles

Primary Muscles of Inspiration Diaphragm C3-C5 Scalenes C2-C7

Accessory Muscles of Inspiration & Muscles of Expiration Sternomastoid Accessory Nerve & C2-C3

Intercostals T1-T11

Abdominal Muscles especially Transversus Abdominus T7-L1

Complete paralysis of all muscles involved with respiration occurs when the lesion is above C3; this type of injury requires immediate and permanent ventilatory support in order to sustain life. The primary goal of ventilatory support is to ensure arterial blood gas homeostasis. When the

8-1

injury is between C3 to C5 (innervation of the diaphragm), respiratory insufficiency occurs via respiratory muscle dysfunction. Although primary and some accessory muscles of inspiration are fully innervated with injuries below cervical lesions, the ability to ventilate at higher levels is still compromised because the intercostals and other chest wall muscles do not provide the integrated expansion of the upper chest wall as the diaphragm descends during inspiration. Furthermore, ventilation during exercise can be greatly compromised. The expiratory muscles actively contract in healthy people whereas partial or fully denervated expiratory muscles in those with SCI will diminish exercise ventilation and ventilatory reserve. Lung volumes reflect these diminished capacities for full inspiration and forced expiration in people with SCI. These pulmonary function measures are derived by having the person breathe normally followed by full inspiration and full expiration in and out of an apparatus that measures lung volumes (Figure 8.2). As expected lung volumes like the inspiratory capacity (IC) and expiratory reserve volume (ERV), are progressively smaller in higher cervical lesions versus lower thoracic and lumbar lesions (Baydur et al. 2001). Figure 8.2 Measurement of lung volume

Lung Capacities
Inspiratory capacity (IC): maximal volume of air that can be inhaled (sum of VT and IRV). Functional residual capacity (FRC): volume of air remaining in the lungs at the end of an ordinary expiration, i.e. at the resting level or end-expiratory level. Vital Capacity (VC): maximum volume of air that can be expelled after a maximum inspiration, i.e. from total lung capacity (TLC) to residual volume. Total Lung Capacity (TLC): total amount of air in the lungs after a maximal inspiration. TLC= RV + ERV + VT (TV) + IRV.

Lung Volumes
Tidal volume (VT but also known as TV): volume of air inhaled or exhaled during breathing (at rest or during exercise). Inspiratory reserve volume (IRV): maximum volume of air that can be inhaled to total lung capacity over and above the tidal volume. Expiratory reserve volume (ERV): maximum volume of air that can be exhaled from the endexpiratory level or from functional residual capacity (FRC) to residual volume. Residual volume (RV): volume of air remaining in the lungs after a maximal expiration.

The forced expiratory volume in one second (volume of air that can be exhaled in the first second = FEV1) and forced vital capacity (maximum volume of air that can be exhaled = FVC) are usually measured in apparently healthy people to detect airways obstruction. Due to reduced inspiratory muscle force, these measures are diminished in people after SCI with higher lesions and especially in people with tetraplegia (Linn et al. 2000; Baydur et al. 2001) and demonstrate moderate correlation with injury level (Baydur et al. 2001). Longer duration of injury and smoking are two factors associated with greater loss while incomplete lesions

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(compared to complete lesions) have less loss of forced expiratory measures of FEV1 and FVC (Linn et al. 2000). People with SCI at most levels affect innervation of the abdominal muscles (Figure 8.1), which severely compromises the ability to generate cough and clear respiratory secretions. Cough generation is accomplished primarily by the expiratory intercostals muscles (thoracic roots) and the abdominal muscles (T4-L1). Cough is important as a defense mechanism to prevent respiratory tract infections and atelectasis. The respiratory system has other important roles such as speaking and posture-related activities which can also be negatively impacted by the SCI, especially with higher lesions. In summary, the respiratory consequences of SCI are readily apparent and are largely dependent on the level of injury. Additional large-scale cross sectional and longitudinal studies are required to fully characterize pulmonary function in SCI. Secondary respiratory complications related to other respiratory pathologies (i.e., chronic obstructive pulmonary disease, asthma) are not well described. In particular, the consequences of aging on pulmonary function are not well defined in SCI. With healthy aging there is a decline in lung function, primarily because of a loss of elastic recoil. Moreover, additional age-related changes that are known to negatively affect gas exchange are decreased surface area of the lung, decreased pulmonary capillary blood volume, increased dead space ventilation and decreased distensibility of the pulmonary arterial vasculature. A greater understanding of the interactions between SCI, aging and the respiratory system are necessary for comprehensive patient management. While it is clear that the respiratory system can be compromised with SCI, the salient question is: what intervention strategies are known to be effective in patient management? The subsequent sections are divided into commonly used respiratory-related interventions used for the respiratory management of the patient with SCI. The following commonly used respiratory abbreviations are used:
IMT MVV SIP FEV1 FVC TLC IC ERV PEFR inspiratory muscle training maximal voluntary ventilation sustained inspiratory pressure forced expiratory volume in the first second forced vital capacity total lung capacity inspiratory capacity expiratory reserve volume peak expiratory flow rate PaCO2 PaO2 RV MIP MEP VE VT (TV) fb Ti/Ttot partial pressure of arterial carbon dioxide partial pressure of arterial oxygen residual volume maximal inspiratory pressure maximal expiratory pressure minute ventilation tidal volume frequency of breathing inspiratory duty cycle; inspiratory time/total time for one breath

8.2 Exercise Training As with able-bodied individuals, there is strong evidence in support for the use of exercise training for improving cardiovascular health among people this SCI (see Chapter 7). This is important because there is a high incidence of physical inactivity in individuals with SCI and as such they are at increased risk of secondary conditions such as cardiovascular disease, diabetes, osteoporosis and obesity. There is clear evidence that the cardiovascular and skeletal muscle systems adapt positively to exercise training in both able-bodied and SCI people. However, the lungs and airways do not change appreciably in response to exercise training. It is likely that exercise is not sufficiently stressful to warrant an adaptive response. This may be even more so when considering the small muscle mass used in wheelchair propulsion or arm 8-3

cranking exercise. On the other hand, respiratory muscles are both metabolically and structurally plastic and they respond to exercise training. This statement is based largely on direct evidence from animal models and indirect evidence from able bodied humans. Exercise training may influence the control of breathing and respiratory sensations (i.e., dyspnea). It is generally accepted that exercise training results in a lower minute ventilation at any given absolute oxygen consumption or power output. This is likely due to a reduction in one or more of the mechanisms (neural and/or humoral) purported to cause the hyperpnea (increased respiratory rate) associated with exercise. As such, the positive effects of exercise training in SCI may reside in an increase in respiratory muscle strength and endurance as well as a reduced ventilatory demand during exercise. A lower ventilation and/or sensation of dyspnea during exercise would lower the work of breathing and prevent early termination of exercise respectively. Table 8.1 Exercise training
Author Year; Country Score Research Design Total Sample Size Methods Population: 24 subjects (12 paraplegics, 12 able-bodied individuals), median age SCI: 31 yrs (range 22-54), control: 30 (range 22-52), T1-T12, all ASIA A, >3 yrs after injury. Treatment: Arm cranking aerobic training: 30 mins, 3x/wk x 6 wks. Outcome measures: Spirometry. 1. Outcome

After aerobic training, SCI subjects showed significant ↑ in FVC (P<0.05) and the ventilatory muscle endurance (P<0.001), so that max Silva et al. 1998; Brazil voluntary venilitation at 70% time Downs & Black score=16 values post-training were not Pre-post different from the initial values of N=24 able bodied individuals. 2. Severely limited ventilatory muscle endurance in people with paraplegia can be improved by arm cranking. Population: 20 people with SCI (12 men, 8 1. After training, FVC, FEV1, and VC, were significantly higher than the women), 14 complete, 6 incomplete (T6baseline values T12), 3.8±5.8 yrs, Mean age 31.31±8.17 2. Exercise testing showed increased Sutbeyaz et al. 2005; years. Treatment: Ventilatory and upper extremity peak VE and peak workload and a Turkey reduction in the ratio of physiological Downs & Black score=15 muscle exercise: 1h, 3x/wk x 6 wks; dead space to tidal volume Diaphragmatic, pursed lip breathing for Pre-post compared to baseline values. N=20 15min; Air shifting for 5min; voluntary isocapneic hypernea 10min; arm-crank exercise. Outcome measures: Spirometry. Population: 6 subjects (5 male, 1 female), 1. At maximal exercise, peak VE (75%), peak fb (-13.4%), peak VT T6- & T11/12, age 29±14 years (range:18(+28.9%), and the ventilatory 54), Mean time since injury: 94 days reserve (12.9%) improved after (range:73-137 days). 1training. The oxygen cost of VE ↓ Treatment: Wheelchair Interval-training significantly decreased (-20%) after Program – 30 min (6 x 5 min bouts: 4 min Le Foll-de-Moro et al. training. moderate intensity and 1 min of high 2005; France 2. For the wheelchair test, at the same intensity) 3x/wk for 6 wks; Progressed Downs & Black score=14 workload after training, VE and fb ↓ throughout training program to achieve 50% Pre-post and VT ↑ consistent with improved and 80% of heart rate. N=6 ventilatory efficiency and greater Outcome measures: Spirometry. reliance on aerobic capacity after training. 3. Spirometric values and lung volumes showed small trend towards improvement after training.

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Author Year; Country Score Research Design Total Sample Size

Methods Population: 8 SCI (4 males, 4 females), 1. Low intensity group: C5-T7 (age range 2636yrs), Moderate Intensity group: C5-T9 (age range 2. 23-36yrs) Treatment: Aerobic training: WC ergometry 20 min 3 x/wk for 8 wk 3. Low Intensity exercised at a power output = 50-60% of maximal heart rate. Moderate Intensity exercised at a power output = 7080% maximal heart rate. Outcome measures: maximal oxygen uptake, peak power.

Outcome After training, no changes to maximal oxygen uptake or peak power. No detectable changes during submaximal or maximal exercise were detected. Training intensity was insufficient, subjects did not comply with the program, or study was underpowered due to small sample size and heterogeneity of subject responses.

Hooker & Wells 1989; USA Downs & Black score=12 Pre-post N=8

Discussion Evidence for exercise training for the respiratory management of the SCI person includes four experimental, non-randomized control trials. Studies describing the acute responses to exercise in people with SCI were not included nor were those studies concerned with competitive athletes with SCI. Of the studies included, they were difficult to interpret because of woefully small sample sizes, differences in exercise modality (wheelchair vs. arm crank exercise) as well as inconsistency in the frequency, intensity and duration of exercise training. Although one study included a control group (Silva et al. 1998), the control group consisted of able-bodied subjects which was used for the normative values, but cannot be considered a true control group for SCI subjects. There is insufficient evidence to strongly support exercise training as a means to improve pulmonary function or ventilatory responses to exercise in SCI people. There is some evidence (Le Foll-de-Moro et al. 2005) to demonstrate that following exercise training that peak VE, VT and ventilatory reserve improve. However, the training intensity needs to be relatively high (7080% of maximum heart rate at a minimum of 3X/week for 6 weeks) as lower intensities have not been shown to be effective (Hooker & Wells 1989). Additional well-designed randomized controlled trials are necessary to elucidate if exercise training is an effective means by which to improve pulmonary function at rest and during exercise. Nonetheless, from the limited SCI data and the well-known able bodied response to upper limb training it appears that changes to exercise ventilation and ventilatory efficiency can be positively changed. Conclusion There is Level 4 evidence to support exercise training as an intervention that might improve resting and exercising respiratory function in people with SCI. For exercise training to improve respiratory function the training intensity must be relatively high (70-80% of maximum heart rate) performed three times per week for six weeks. Ideal training regimes have not been identified.

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8.3 Inspiratory Muscle Training As expected, the loss of inspiratory muscle function is related to the level of injury as illustrated in Figure 8.1. Dyspnea, defined as a subjective report of breathlessness or shortness of breath, is common in people with SCI and is greatest in people with tetraplegia (Ayas et al. 1999). Approximately two-thirds of the prevalence of dyspnea in this group is attributed to the inspiratory muscle loss (Spungen et al. 1997). Improved inspiratory muscle strength and endurance could potentially improve cough and maximal exercise ventilation in addition to decreasing dyspnea. The inspiratory muscles can be trained similar to the limb muscles with inexpensive devices that increase the resistive or threshold inspiratory load on the inspiratory muscles (Reid et al. 2004). Table 8.2 outlines common measures that are indicative of respiratory muscle strength and endurance. In neuromuscular disorders like SCI, maximal lung volumes that measure inspiratory capacity also can reflect increased inspiratory muscle strength. Table 8.2 Measures of respiratory muscle strength and endurance
Term Maximal Inspiratory Pressure Maximal Expiratory Pressure Abbreviation MIP or PImax MEP or PEmax Definition Estimate of inspiratory muscle force as reflected by the maximal pressure exerted by the inspiratory muscles measured at the mouth. Estimate of expiratory muscle force as reflected by the maximal pressure exerted by the expiratory muscles measured at the mouth. Maximum ventilation in 15 seconds, which reflects the “sprint” capacity of the respiratory muscles. The maximum ventilation can be measured over several minutes - between 4 and 15 minutes – which is more reflective of the endurance of the respiratory muscles. Maximum mouth pressure sustained during a 10 minute period of threshold loading which is usually lower than the MIP. This is an estimate of the endurance of the inspiratory muscles. The endurance time while breathing on a resistive or threshold trainer at a defined level of the MIP The maximal load (usually defined as an inspiratory mouth pressure) attained on an incremental threshold loading test whereby the load is progressively increased every 2-3 minutes.

Maximum voluntary ventilation

MVV

Maximal sustainable mouth pressure Endurance time sustained on training load Maximal incremental threshold load

SIP Tlim TLmax

Commercially available hand-held devices can be used for inspiratory muscle training. The two main types of devices are the resistive and threshold trainers (Figure8.3). Both of these devices have a one-way valve that closes during inspiration so that the subject must breathe through a small diameter hole for the resistive trainer or against a spring loaded valve for the threshold trainer. The one-way valve opens during expiration such that no load is imposed during the expiratory phase of respiration. Evidence showing decreased dyspnea and improved strength and endurance after IMT is well documented in people with other health conditions like chronic obstructive pulmonary disease (COPD) (Reid et al. 2004; Geddes et al. 2005). Two main types of commercially available trainers are used to improve the strength and endurance of the inspiratory muscles. Both trainers have a one way valve that opens during expiration such that no load is imposed during the expiratory phase of respiration.

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Figure 8.3 Inspiratory muscle trainers
Threshold trainer (top) has an adjustable spring-loaded valve that imposes the inspiratory load. The inspiratory load can be increased by winding the spring more tightly. Advantage of this trainer is that the same load is imposed on the inspiratory muscles regardless of breathing pattern. Resistive trainer (bottom) has holes of different diameters. The inspiratory load can be increased by setting the dial to holes of lesser diameter. Disadvantage of this trainer is that the subject can reduce the inspiratory load by breathing more slowly. If this device is used for training, a target must be used. Various targets have been designed that set a breathing rate (flow and/or inspiratory pressure) for the subject. Threshold® and P-Flex ® trainers available from Respironics HealthScan Inc., 41 Canfield Rd., Cedar Grove, NJ7, 0009-1201. 1-800-962-1266.

Table 8.3 Inspiratory Muscle Training
Author Year; Country Score Research Design Total Sample Size Methods Population: 12 subjects with complete motor loss below C6-C7 (n=6 control, n=6 training) >1yr post injury, Age IMT:31±4.1 yrs, Controls: 35±12 yrs. Treatment: Resistive IMT without target at 85% SIP for 15 minutes twice daily, 5 days per wk × 8 wks. Outcome measures: Spiropmetry. Outcome 1. ↑ MIP and Maximal sustainable mouth pressure (SIP) in both the control group (30%±19% and 31%±18% respectively), and IMT group (42% + 24% and 78%±49% respectively) but no difference in post-training improvements between groups. 2. The increased MIP and SIP resulted in a slower and deeper breathing pattern and a significantly shorter inspiratory time:total time of respiratory cycle in both trainers and control subjects. 1. Pre-post % change of vital capacity (VC) and total lung capacity (TLC) in IMT group was greater compared to change in control values. 2. MIP improved in both groups which might be due to natural progression of improvement from SCI, learning to do the maneuver, and/or insufficient length of training. 1. Significant improvements within both groups in forced vital capacity (FVC), maximal voluntary ventilation (MVV), peak expiratory flow rate (PEFR) and Maximal Inspiratory Pressure (MIP) (p<0.001 to 0.05) between week 1 and week 7. 2. No significant differences between treatment groups for any of the

Loveridge et al. 1989; Canada PEDro=5 RCT N=12

Liaw et al. 2000; Taiwan Pedro=4 RCT N=30

Derrickson et al. 1992; USA PEDro=3 RCT N=40

Population: 30 men & women with SCI (C4-C7, 30-134 post-injury); 20 subjects completed (13 control,17 IMT group), 8M:2F in each group, age RIMT:30.9+11.6yrs; control:36.5+11.5yrs Treatment: Target resistive IMT or control; 15-20min 2x/day × 6wks; other rehab activities continued. Outcome measures: Spiropmetry, MIP.. Population: 40 subjects met admission criteria; 11 subjects completed (9 males, 2 females), neurologically complete, C4-C7; 2-74 days post-injury, studied at >24hrs after spontaneous breathing, Age:28.5±5.6 yrs. Treatment: Resistive IMT without target (n=6) and (n=5) breathing with abdominal weights, 5 days per wk × 7 wks.

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Author Year; Country Score Research Design Total Sample Size

Methods Outcome Measures: Spiropmetry.

Outcome improvements in pulmonary variables; however, mean changes between week 1 and 7 tended to be larger for the IMT group. TLmax, a measure of inspiratory muscle endurance increased after both sham training and IMT (p<0.05 and p=0.01, respectively). No significant improvement in MIP for either group or differences in post-training change between groups. Significant ↑ in peak power, VT and oxygen consumption during maximal exercise test at 6-12wks of IMT (p<0.05). During training, progressive and significant increases in MIP and the critical mouth pressure that resulted in EMG signs of diaphragm fatigue.

Uijl et al. 1999; Netherlands Downs & Black score=14 Prospective Controlled Trial N=10

Gross et al. 1980; Canada Downs & Black score=12 Pre-post N=6

Population: 10 men and women began, M:F= 8:2; 9 subjects completed (8 males, 1 female), all tetraplegic C3-C7, 2-27yrs post-injury; ASIA A (n=3), B (n=3), C and D (n=3); Age: mean 34.4 yrs (range 20-49 yrs) Treatment: No resistance sham training (6 weeks) then Target flow IMT (6 weeks). 15 min twice daily for each phase of 6 wks. Outcome measures:.Spirometry, MIP, Maximal incremental threshold load (TLmax). Population: 4 males:2 females; age range:18-41 yrs; >1 yr post injury Treatment: Resistive IMT without target 30 min per day, 6 days per wk × 16 wks. Outcome measures: MIP Population: 20 (2F:18M) in acute posttraumatic phase; 10 tested at 4 months, 10 others were discharged, non-compliant or had medical complications. Treatment: Resistive IMT without target 15min 2x/day ×6wks. Outcome measures: MIP. Population: 9 people after SCI C4-C7, > 1 yr since injury; Age: 24-65 yrs with mean 36 yrs Treatment: Resistive IMT without target 15 min twice daily × 8 wks. Outcome measures: MIP, spirometry.

1.

2.

3.

1.

Hornstein & Ledsome 1986; Canada Downs & Black score=11 Case Series N=20

1. Four months after IMT began, 10 subjects showed improvement in MIP from 45+4.1 mmHg to 59+6.8 mm Hg but no statistics were performed on data. 2. Two case reports showed improvement in MIP and decreased dyspnea. 1. Significant ↑ in MIP and lung volumes after IMT 2. At 6 months, 4 months after training stopped, trends towards baseline and repeat measures in 7 of 8 subjects showed no difference between baseline and 6 months outcomes. 3. Compliance ranged between 48 and 100% of IMT sessions. 1. Number of respiratory infections decreased from 3 to 2 2. Number of respiratory infections requiring acute care hospitalization decreased from 2 to 0. 3. MIP ↑ from 10 to 42 cm H2O. 4. Daily suctioning 10x daily ↓ to intermittent suctioning not required daily.

Rutchik et al. 1998; USA Downs &Black score=10 Pre-post N=9

Ehrlich et al. 1999; Canada Downs & Black score=7 Case Series N=1

Population: 26 yr old male,C3-C4 Treatment: Threshold IMT and Positive expiratory pressure value (Peripep) for one year. Outcome measures: MIP, infection number.

Discussion There is insufficient evidence to strongly support IMT for people with SCI. Most studies are not comparable and could not be combined in a meta-analysis (Brooks et al. 2005) because of research design, heterogeneity of subject characteristics or differences in training techniques. None of the studies that used an RCT design incorporated an optimal IMT protocol. In 8-8

particular, several used an inspiratory resistive device with no target to control for decreasing resistance with slower flows so the training methods may have induced an alteration in breathing pattern towards slower inspiratory flows rather than a training response against higher inspiratory pressures. The few studies that utilized a RCT design also showed improvement in both control (or sham) and training groups. Comparable improvement in measures of inspiratory muscle and lung function in the control and IMT groups may reflect learning of testing maneuvers, benefit from other rehabilitation or lifestyle activities, and/or natural progression of improvement after SCI. Some of the pre-post design studies showed improvement in inspiratory strength and endurance measures, however, this type of design can show an exaggerated treatment effect. The single subject report by Ehrlich et al. (1999), utilized the threshold trainer, which imposes a constant inspiratory load regardless of breathing pattern. Given that threshold IMT has consistently shown improvements in inspiratory muscle strength and endurance in people with chronic obstructive pulmonary disease, this technique warrants a larger RCT to determine its benefit for people after SCI. Future research to determine a potential treatment effect of IMT after SCI, should utilize: 1) larger samples; 2) a research design that controls for the influence of learning or recovery from SCI on IMT outcome measures of inspiratory muscle strength and endurance, and dyspnea; 3) optimal training techniques of threshold loading, targeted resistive devices, or isocapnic hyperpnea, (see Reid et al. 2004 for details of these training techniques); 4) outcomes of inspiratory muscle strength and endurance; dyspnea; quality of life; daily function; 5) a comparison of the effectiveness of IMT relative to or as an adjunct to other rehabilitation interventions. Until more solid research is performed to further delineate the most effective IMT protocols and criteria for responders and non-responders, prescription of IMT should be approached cautiously. Other types of exercise training and rehabilitation interventions may provide more benefit. Of equal importance, overly aggressive prescription of IMT has the potential to fatigue and injure the inspiratory muscles, which can increase the person’s predisposition to respiratory compromise. The article by Reid et al. (2004) provides a table that outlines parameters to monitor during IMT in order to avoid untoward responses such as muscle fatigue and hypercapnia. For inspiratory muscle training to improve ventilation, decrease dyspnea, and to improve daily function after SCI, parameters to optimize IMT are only available for people with other respiratory conditions. For people with chronic obstructive pulmonary disease, the optimal IMT protocol should utilize threshold or targeted resistive trainers, at an intensity of 30-70% of MIP, for a duration up to 30 minutes per session, performed continuously or in intervals, 4-6 days/week and be continued indefinitely (Geddes et al. 2006). Progression of intensity (MIP) should not exceed 5% per week. Conclusion There is Level 4 evidence to support IMT as an intervention that might decrease dyspnea and improve inspiratory muscle function in some people with SCI

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T There is limited evidence that inspiratory muscle training improves respiratory muscle strength or endurance in people with SCI.

8.4 Pharmaceutical Interventions 8.4.1 Airway Hyperresponsiveness and Bronchodilators Subjects with spinal cord injuries have a restrictive ventilatory impairment that is dependent upon the level and completeness of injury. However, there is also a body of evidence that patients with cervical spinal cord injuries have a component of obstructive ventilatory impairment. Subjects with tetraplegia demonstrate bronchial hyperresponsiveness to multiple agents including methacholine, histamine and distilled water (Dicpinigaitis 1994a; Singas 1996; Fein 1998; Grimm 1999; Singas 1999). There are several potential mechanisms for hyperresponsiveness in tetraplegia including loss of sympathetic autonomic input with relatively unopposed parasympathetic input, (Dicpinigaitis 1994a; Grimm 1997; Singas 1999), altered mechanical lung properties with decreased deep breathing and “stretching” of airways (Singas 1999) and nonspecific airway hyperresponsiveness similar to subjects with asthma (Grimm 1997). Despite evidence regarding the presence of airway hyperresponsiveness in tetraplegia, the use of anticholinergic bronchodilators such as ipratropium and beta 2 selective agonists such as metaproterenol in SCI has not been well studied. The use of bronchodilators is routinely recommended as add-on therapy in other conditions with airway hyperreactivity such as chronic obstructive pulmonary disease (COPD) and asthma, but it is not clear if these recommendations can be generalized to the SCI population. For mechanically ventilated subjects, bronchodilators are routinely administered to relieve dyspnea and reverse bronchoconstriction. They can be administered by metered-dose inhaler (MDI) or by nebulizer. Again, the long-term use of bronchodilators and the best route of administration in mechanically ventilated subjects with SCI have not been studied. The measurement of airway responsiveness with inhaled bronchoconstrictor stimuli such as methacholine or histamine involves the patient inhaling increasing doses or concentrations of a stimulus until a given level of bronchoconstriction is achieved, typically a 20% fall in forced expired volume in one second (FEV1). Airway responsiveness is then expressed as the dose or concentration of the stimulus required to achieve this degree of bronchoconstriction (PD20 and PC20, respectively). Table 8.4 Bronchodilators
Author Year; Country Score Research Design Total Sample Size Schilero et al. 2004; USA Downs & Black score=13 Pre-post N=10 Methods Population: 5 tetraplegia (C4-C7), 2 complete, 3 incomplete, age:45±16 yrs, 17±8 yrs post-injury; 5 paraplegia (below T5), 2 complete, 3 incomplete, age:40±9 yrs, 19±10 yrs post-injury. Outcome 1. In subjects with tetraplegia, inhaled metaproterenol resulted in significant increase in specific airway conductance and significant increases in FEV1 and forced

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Author Year; Country Score Research Design Total Sample Size

Methods Treatment: Inhalation of 0.3 mL of 5% solution of metaproterenol sulfate via nebulizer Outcome Measures: Spirometry and specific airway conductance as measured by body plethysmography pre- and postbronchodilator. Population: tetraplegia (C4-C7); all male, age range 23-57 years, 6 on chronic oral baclofen and 8 controls Treatment: Administration of increasing concentrations of nebulized methacholine. Outcome Measures: Spirometry, PC20.

Outcome expiratory flow 25-75%. 2. In subjects with paraplegia, inhaled metaproterenol resulted in significant increase in specifc airway conductance although the increase was considerably less than that seen in tetraplegia. There was no significant change in FVC, FEV1 and forced expiratory flow 25-75%. 1. 8 out of 8 control subjects showed significant bronchoconstrictor response to methacholine (mean PC20= 1.42±1.6) 2. 2 out of 6 baclofen subjects had borderline to mild bronchoconstrictor response to methacholine. 4/6 baclofen subjects did not respond to methacholine (mean PC20= 15.0±9.1 for baclofen group). There was no correlation between PC20 and dosage or duration of baclofen. 1. 48% of subjects had a positive bronchodilator response (6/10 smokers and 6/15 non-smokers). 2. There were no significant correlation between the response to ipratropium and dyspnea at rest, smoking history, or sensory completeness of cord lesion. 1. 12/15 subjects had a significant bronchoconstrictor response to aerosolized histamine (geometric mean PC20 1.27 mg/mL). 2. There were no significant differences in FVC and FEV1 values between responders and nonresponders. 3. All 12 subjects initially responsive to histamine were again hyperresponsive at the time of rechallenge following ipratropium (geometric mean PC20 1.50 mg/mL). 1. All 13 control subjects (methacholine and histamine) and all 6 oxybutyninhistamine subjects had a significant bronchoconstrictor response (PC20<8 mg/mL). 2. The oxybutynin-methacholine subjects had a normal response to methacholine. (PC20>=25 mg/mL).

Dicpinigaitis et al. 1994b; USA Downs & Black score=12 Prospective Controlled Trial N=14

Almenoff et al. 1995; USA Downs & Black score=11 Pre-post N=25

Population: 25 tetraplegia: 6 complete,19 incomplete, all male, age: 43±3yrs, 11±2 yrs post-injury. Treatment: Administration of 72 mcg ipratropium bromide by inhaler with spacer Outcome Measures: Spirometry pre- and post-bronchodilator (improvement in FVC or FEV1>=12%) Population: 15 tetraplegia (C4-C7): 5 complete and 10 incomplete, all male, age range:24-64yrs, time since injury range:331 yrs Treatment: Increasing inhaled concentrations of aerosolized histamine diphosphate. Responders to histamine were retested on a separate day after pretreatment with ipratropium bromide 72 mcg. Outcome Measures: Spirometry, PC20. Population: 25 tetraplegia (C4-C7): 10 complete & 15 incomplete, all males, age range:23-63yrs, 1-40yrs post-injury, 12 maintained on oral oxybutynin & 13 agematched controls. Treatment: 6/12 oxybutynin subjects were challenged with methacholine, & 6/12 with histamine; 7/13 control subjects were challenged with methacholine & 6/13 with histamine. Increasing concentrations of aerosolized histamine or methacholine were administered. Outcome Measures: Spirometry, PC20.

Fein et al. 1998; USA Downs & Black score=10 Pre-post N=15

Singas et al. 1999; USA Downs & Black score=9 Prospective Controlled Trial N=25

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Author Year; Country Score Research Design Total Sample Size

Methods Population: 9 tetraplegia (C4-C7) and 6 paraplegia (T9-L1), 4 complete & 11 incomplete, all male, age:25-61yrs, 4-32yrs post-injury Treatment: Increasing duration of exposure time to ultrasonically nebulized distilled water (UNDW). 5 subjects responding to UNDW returned on a separate day for UNDW challenge following the inhalation of aerosolized ipratropium bromide. Outcome Measures: Spirometry, PD20 Population: tetraplegia: 34 males, all motor complete, non-smokers’ mean age:40±5 yrs, smokers’ mean age:48±3 yrs, 11.8±1.6 yrs since injury Treatment: Inhalation of 2.5 ml metaproterenol sulfate inhalation solution. Outcome Measures: Spirometry pre- and post-bronchodilator (improvement in FEV1>=12%

Outcome 1. 8/9 tetraplegic subjects (known histamine response positive) had a significant bronchoconstrictor response to UNDW (PD20 7.76 +/7.67 mL). 2. 0/6 paraplegic subjects (known histamine response negative) demonstrated a response to UNDW (PD20 24 mL). 3. 5/5 tetraplegic responders to UNDW no longer responded after pretreatment with ipratropium bromide. 1. 41% of subjects demonstrated a significant response in FEV1 to inhaled metaproterenol (5/12 non-smokers and 9/22 smokers). 2. In the non-smokers, the correlation of FVC and FEV1 with level of lesion was positive and significant prior to administration of bronchodilator and became more significant postbronchodilator. 3. In the smokers, FVC and FEV1 failed to significantly correlate with level of lesion. 1. 11/14 subjects on baclofen and 8/10 control subjects had significant bronchoconstrictor response to histamine. 2. There was no significant difference in mean PC20 between the baclofen and control groups (mean PC20= 2.91±2.3 and PC20 =2.18±1.9, respectively). 3. The methacholine and histamine PC20 were almost identical in controls. ¾ balcofen subjects had significantly different responses to methacholine and histamine.

Grimm et al. 1999; USA Downs & Black score=9 Pre-post N=15

Spungen et al. 1993; USA Downs & Black score=9 Pre-post N=34

Grimm et al. 1997; USA Downs & Black score=9 Prospective Controlled Trial N=24

Population: tetraplegia (C4-C7), all male, age range:23-65, time since injury range:229 yrs, 14 on chronic oral baclofen and 10 age-matched controls Treatment: Administration of histamine by inhaler in 14 baclofen subjects and 10 controls. Administration of methacholine in 4 baclofen subjects and 5 controls. Outcome Measures: Spirometry, PC20

Discussion Both ipratropium and metaproterenol have been studied in SCI. Both drugs have shown a positive effect with improvements in FEV1 in subjects with tetraplegia. Almenoff et al. (1995) showed that 48% of tetraplegic subjects given inhaled ipratropium bromide responded with greater or equal to 12% improvement in FEV1 and/or FVC. In a study looking at the effects of metaproterenol in tetraplegia, 41% of tetraplegic subjects responded to metaproterenol with a greater or equal to 12% improvement in FEV1 (Spungen et al. 1993). Schilero et al. (2004) also found a significant improvement in FEV1 in tetraplegic subjects treated with metaproterenol. In the short-term, both ipratropium and metaproterenol appeared to be effective in improving pulmonary function. There are concerns that ipratropium’s anticholinergic effects could cause thickening of secretions and block release of surfactant 8-12

which could compromise its ultimate effects on respiratory function (Consortium for Spinal Cord Medicine 2005). Although these studies only provide level 4 evidence for the use of bronchodilators in SCI, they cannot be considered in isolation of the large body of literature regarding bronchodilators in other conditions. The recommendations for the use of bronchodilators in asthma and chronic obstructive pulmonary disease are well supported by the literature and there is a strong likelihood that SCI shares some clinical and pathophysiologic similarities to those conditions. Nevertheless, it is important to recognize that literature in SCI remains lacking. In addition to traditional bronchodilators, there is evidence that airway hyperresponsiveness in tetraplegia can be modulated by medications used for other conditions in SCI, such as baclofen and oxybutynin. Baclofen, a GABA agonist, is commonly used to treat spasticity. GABA receptors have been found in peripheral tissue, including lung, raising the possibility that baclofen may have the potential to affect airway hyperreactivity. Oxybutynin, a medication used to treat bladder spasms, has the potential to affect airway hyperreactivity through its anticholinergic properties. The effects of both baclofen and oxybutynin have been studied in small controlled trials in tetraplegia. In each study, the study group was a group of subjects who were already maintained on the medications for the usual indications. The studies did not look at the bronchodilator effects of the medications, but focused on their ability to block bronchoconstrictor challenges to methacholine and histamine. Pre-treating tetraplegic subjects with inhaled ipratropium bromide blocked hyperresponsiveness to methacholine (Dicpinigaitis 1994a). Baclofen and oxybutynin also decreased hyperresponsiveness to methacholine (Dicpinigaitis 1994b; Grimm 1997; Singas 1999). In contrast to the findings with methacholine, pre-treating tetraplegic subjects with inhaled ipratropium bromide did not block hyperresponsiveness to histamine (Fein 1998). Similarly, oxybutynin and chronic oral baclofen did not block hyperresponsiveness to histamine in tetraplegia (Grimm 1997; Singas 1999). Although these results are intriguing, the results of these small studies cannot necessarily be extrapolated to the clinical situation where a bronchodilator effect is required. There are no long-term studies on the use of bronchodilators in SCI. Further studies on the selection of bronchodilators, route of administration and role in long-term mechanical ventilation in SCI should be undertaken. Studies looking at the clinical effects of other commonly used SCI medications with potential bronchodilator effects such as baclofen and oxybutynin are warranted. Conclusion There is level 4 evidence that ipratropium and metaproterenol have a positive effect on pulmonary function in subjects with tetraplegia. There is level 2 evidence that chronic oral baclofen and chronic oxybutynin and level 4 evidence that ipratropium bromide decrease or block hyperresponsiveness to methacholine, but not histamine in tetraplegia.

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The use of bronchodilators should be considered in subjects with tetraplegia who demonstrate an element of obstructive airway impairment. The effects of other medications commonly used in the management of SCI such as baclofen and oxybutynin should be considered when reviewing airway hyperreactivity in subjects with tetraplegia. 8.4.2 Anabolic Agents Anabolic steroids are derivatives of testosterone. Their exact physiologic effects on the respiratory system are unclear, but they have been studied as a possible treatment in chronic obstructive pulmonary disease, especially for their role in potentially increasing muscle mass. Anabolic steroids have potentially serious side effects, including effects on liver function, lipid profile and the reproductive system. The long-term safety of anabolic steroids such as oxandrolone in SCI has not been established. Table 8.5 Anabolic steroids
Author Year; Country Score Research Design Total Sample Size Methods Population: 10 tetraplegia (C4-5), motor complete, all male, mean age: 41±9 yrs, 16±8 yrs post-injury Treatment: Administration of oxandrolone 20 mg/day for 1 month. Outcome Measures: Weight gain, spirometry, MIP, MEP, resting self-rate of dyspnea (Borg scale), serum lipid profiles and liver function tests. 1. 2. 3. Outcome On average, subjects gained 1.4±1.5 kg (2±2% ↑ p=0.01). A significant improvement was seen in combined measures of spirometry (9±2% p<0.005). A significant improvement was seen in MIP (10±7% p<0.001. The improvement in MEP was not significant (9±13%). Borg scale ↓ an average of 37±28% p<0.01.

Spungen et al. 1999; USA Downs & Black score=16 Pre-post N=10

4.

Discussion There is one study in the literature on the effects of anabolic steroids on pulmonary function in SCI. Spungen et al. (1999) treated 10 male subjects with motor complete C4-C5 tetraplegia with a one month course of oxandrolone, an oral anabolic steroid. Following oxandrolone, significant improvements were seen in weight gain, forced vital capacity, FEV1 and forced inspiratory vital capacity. There was a significant increase in maximal inspiratory pressure (PI max) from baseline and a non-significant increase in maximal expiratory pressure (PE max). Subjects experienced a significant decrease in subjective dyspnea. There was no long-term follow-up of subjects to see if any of the improvements were permanent. Conclusion There is level 4 evidence that the short-term use of oxandrolone improves pulmonary function in subjects with tetraplegia.

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The short-term use of oxandrolone should be considered to improve pulmonary function in subjects with tetraplegia.

8.4.3 Other pharmaceuticals There are many other medications with potential benefit for the treatment of pulmonary function in SCI. The use of anticoagulants for the prevention of deep vein thrombosis and pulmonary emboli is covered in Chapter 15. Other medications used in the treatment of asthma and/or chronic obstructive pulmonary disease such as cromolyn sodium, methylxanthines and inhaled corticosteroids have not been studied in SCI. 8.5 Assistive Devices 8.5.1 Mechanical Ventilation and Weaning Protocols The indications for mechanical ventilation and the acute management of respiratory issues in SCI are outside the scope of this review which focuses on rehabilitation. However, the longterm complications associated with chronic ventilator dependency need to be mentioned in order to highlight their importance. The overall life expectancy for individuals with SCI who are ventilator dependent has been increasing, especially for those individuals who survive the first year following injury. (DeVivo 1995) Despite advances, mortality for individuals with ventilator dependency remains high. (DeVivo 1995). In general, subjects with complete neurologic injuries at C2 and above have no diaphragmatic function and are ventilator dependent. Subjects with complete neurologic injuries at C3 or C4 have variable diaphragmatic function. Although they may have the potential for ventilator weaning, it is difficult to predict whether they will ultimately be successfully weaned. Subjects with complete injuries at C5 and below have intact diaphragmatic function. They may require ventilatory support initially post-injury, but are usually able to wean from the ventilator. The approach to ventilator weaning in SCI remains an important and somewhat neglected issue. The PVA Consortium for Spinal Cord Medicine—Respiratory management following spinal cord injury: a clinical practice guideline for health-care professionals (2005) suggest the consideration of “ …progressive ventilator free breathing over synchronized intermittent mandatory ventilation”. Table 8.6 Weaning protocols
Author Year; Country Score Research Design Total Sample Size Peterson et al. 1994; USA Downs & Black score=16 Case Series N=52 Methods Population: tetraplegia (C3-C4), ventilator dependent Treatment: Retrospective review of 82 ventilator weaning attempts in 52 subjects using intermittent mandatory ventilation(IMV), progressive ventilator free breathing (PVFB) or a combination of other ventilator weaning techniques Outcome Measures: Successful ventilator Outcome 1. 26/82 weaning attempts used IMV, 34/82 used PVFB and 22/82 used a combination of various techniques. 2. PVFB weaning success rate was 67.6 % (23/34) and IMV was 34.6% (9/26) (p=0.02) and other techniques was 11/22. 3. Overall 43/52 (83%) of subjects were successfully weaned. 6/52

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Author Year; Country Score Research Design Total Sample Size weaning.

Methods

Outcome were partially weaned. 2/52 subjects died. 1. Subjects with low tetraplegia achieved significant gains in inspiratory & and expiratory muscle strength, VC, mean on-ventilator endurance & off-ventilator endurance. 2. Subjects with high tetraplegia had non-significant improvements in inspiratory & expiratory muscle strength and VC and were able to discontinue mechanical ventilation. 3. 4/5 low tetraplegic subjects with low tetraplegia were weaned from the ventilator. 1/5 low tetraplegic subjects died.

Gutierrez et al. 2003; USA Downs & Black score=14 Pre-post N=7

Population: 7 tetraplegia: C2(n=2), C4C7(n=5), incomplete, all male, age range: 45-68 years, time on ventilator: 4-36 months Treatment: Implementation of an evidence-based resistance endurance protocol (REP) designed to help discontinue mechanical ventilation by improving ventilatory muscle strength and endurance Outcome Measures: Pulmonary function tests; on-ventilator endurance and offventilator endurance.

Discussion Peterson et al. (1994) retrospectively compared weaning methods in 52 subjects with C3 and C4 SCI. Overall 83% of subjects were successfully weaned with progressive ventilator free breathing (PVFB, also known as T-piece weaning) being the most successful technique. However, most of the PVFB trials occurred at a single institution and in subjects who were longer post-injury whereas most of the intermittent mandatory ventilation trials (IMV) occurred in a variety of institutions in subjects who were earlier post-injury. Gutierrez et al. (2003) developed an evidence based resistance and endurance protocol to improve ventilatory muscle strength and endurance in subjects with ventilator-dependent cervical SCI. The evidence was based on SCI literature where possible, but was also derived from the general respiratory literature where required. The protocol included 4 daily phases with rests in between each phase: pre-training optimization (Trendelenberg positioning, trachea suctioning, bronchodilator use, and lung hyperinflation); inspiratory/expiratory resistance training; on-ventilator endurance training; and off-ventilator endurance training. Although the pilot study only included 7 subjects, it did show promising results with respect to increasing inspiratory pressure, expiratory pressure and vital capacity and ultimately ventilator weaning, especially in subjects with low tetraplegia (C4-C7) (Gutierrez et al. 2003). Prospective studies on weaning protocols are required to determine the best way to assess, treat and wean subjects requiring mechanical ventilation following SCI. Conclusion There is level 4 evidence that progressive ventilator free breathing (PFVB) protocol is more successful for weaning subjects with C3 and C4 spinal cord injuries than intermittent mandatory ventilation (IMV). There is level 4 evidence that a resistance and endurance protocol increases inspiratory pressure, expiratory pressure and vital capacity especially in low tetraplegia (C4-C7).

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Progressive ventilator free breathing protocol should be considered for ventilator dependent subjects with tetraplegia who are appropriate for ventilator weaning. Resistance and endurance training should be considered in subjects who are candidates for ventilator weaning. 8.5.2 Other methods of ventilation Non-invasive ventilation (Bach 1990), phrenic nerve stimulation (Glenn et al. 1972) and diaphragmatic stimulation (Onders 2004, Di Marco 2006) are all potential alternatives to traditional mechanical ventilation following SCI. Complication rates, cost and quality of life are among the many important factors to consider in all forms of assisted ventilation. The evidence for various methods of assisted ventilation will be addressed in a future edition. The evidence for traditional mechanical ventilation, non-invasive ventilation, phrenic nerve stimulation and diaphragmatic stimulation will be addressed in a future edition. 8.5.3 Tracheostomy Decannulation Subjects with SCI often undergo tracheostomy if it is anticipated that they are going to require ventilatory support for longer than 3 weeks. Evidence for the decannulation of subjects with SCI is lacking. Subjects may not meet the traditional criteria for decannulation and should be assessed on an individualized basis (Bach 1990; Ross & White 2003). Table 8.7 Tracheostomy decannulation
Author Year; Country Score Research Design Total Sample Size Ross & White 2003; Australia Downs & Black score=15 Case Series N=4 Methods Population: tetraplegia (n=3) and paraplegia (n=1), level:C5-T9, ASIA A (n=3) & B(n=1), age: 20-71 yrs Treatment: Interdisciplinary evaluation and assessment Outcome Measures: Successful decannulation. Outcome 1. 4 subjects who had evidence of aspiration were successfully decannulated after assessment by a multidisciplinary team. 2. None experienced respiratory deterioration.

Discussion Ross and White (2003) describe a case series of 4 subjects with SCI who were successfully decannulated despite the presence of traditional contraindications for decannulation such as evidence of aspiration. These 4 subjects were carefully selected by a multidisciplinary team who opted for decannulation after assessing the overall risks of decannulation versus the risks of prolonged tracheostomy. Further studies examining the criteria for decannulation of subjects with SCI are required. Conclusions There is level 4 evidence that decannulation can be successful in subjects with evidence of aspiration.

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Case by case consideration should be given to tracheostomy decannulation in subjects with SCI. The indications and criteria for tracheostomy decannulation have not been established in SCI. 8.5.4 Girdle/abdominal Binder Abdominal binders are used to prevent the abdominal contents from falling forward in upright subjects with SCI. Abdominal binders are most commonly used in subjects with loss of abdominal wall strength (generally lesions above T6). Some early work (primarily level 4 studies) looking at the effects of abdominal binders on respiratory function in SCI was done prior to 1980 but was not included in this review. Studies on the effects of abdominal binders need to include positioning information as position greatly influences lung volumes in tetraplegia. In addition to being used as a respiratory intervention, abdominal binders are used as an intervention in subjects with postural hypotension (see chapter 16). Table 8.8 Abdominal binding
Author Year; Country Score Research Design Total Sample Size Methods Population: 7 tetraplegia, 3 paraplegia, mean age: 35.8 yrs, age range:18-56 yrs, 3-27 months post-injury, post-traumatic SCI levels: C5-T6, ASIA A, Treatment: Custom girdle, designed to provide truncal stability and abdominal support Outcome measures: Spirometry Outcome Abdominal binding resulted in: 1. decrease in respiratory effort measured by Borg scale (4.3±1.8 to 2.3±1.8; p=0.02). 2. increase in inspiratory capacity and forced vital capacity, 3. decrease in functional residual capacity ; 4. increase in diaphragm pressuretime product - a measure of diaphragm work; 5. increases in twitch and maximal transdiaphragmatic pressure – measures of diaphragm force. Abdominal binding in SCI resulted in: 1. increase inspiratory capacity in all positions, and total lung capacity in the tilted and sitting positions 2. decrease in functional residual capacity in all positions 3. an increase in rib cage dimensions at TLC. Strapping the abdomen in SCI resulted in: 1. Increase in vital capacity; 2. Decrease in FRC and residual volume. 3. Small but inconsistent increases in maximal esophageal pressure and expiratory flow rate that might not improve cough.

Hart et al. 2005; France Downs & Black score=16 Pre-post N=10

McCool et al. 1986; USA Downs & Black score=10 Prospective Controlled Trial N=13

Population: 13 tetraplegia (C4-C7), 9 able-bodied controls, all male, age:29.9±11.4 yrs Treatment: 3 Body Positions: supine, head-up tilted (37o) and seated – w/ & w/o abdominal binders Outcome measures: Spirometry Population: 8 subjects with SCI; Age range: 21-41 years; level of injury C5-C8; length of injury: 6-200 months Treatment: Abdominal strapping Outcome measures: Spirometry

Estenne et al. 1998; USA Downs & Black Score=10 Pre-post N=8

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Discussion Well-designed studies demonstrate that abdominal binders in tetraplegia significantly increase inspiratory capacity or vital capacity, and decrease FRC in all positions (McCool et al. 1986; Estenne et al. 1998; Hart et al. 2005). One study examining a small sample (n=10) showed that a custom girdle reduces the sensation of respiratory effort as measured by the Borg Rating of Perceived Exertion (Hart et al. 2005). Abdominal binding does not appear to consistently improve expiratory flow rates to enhance cough (Estenne et al. 1998). Worthy of further study, the diaphragmatic pressure-time product increases after abdominal binding which may represent enhanced diaphragmatic force production but does not provide information about enhanced efficiency of breathing. All studies on abdominal binding examined short-term response of measures that relate to lung volumes, expiratory flow rates, and/or inspiratory muscle force. No studies have examined the long-term effects of abdominal binding over several hours or intermittent use over several days. Appreciation of the long-term effects of abdominal binding is essential in order to provide evidence-based clinical guidelines. Important outcomes to evaluate are comfort of intervention, sensation of breathlessness, inspiratory muscle efficiency, inspiratory muscle fatigue, and overall fatigue after several hours of abdominal binding. Some of these outcomes may adapt or show deleterious effects over several days or weeks of daily sessions of abdominal binding; such knowledge about repetitive use of the binder will also guide clinical practice. Interventions to increase abdominal pressure and decrease the laxity of abdominal chest wall, which in turn affects diaphragm length and position, have been used in other patient groups. The acute impact on lung volumes and inspiratory muscle force has been documented in small samples of people with SCI. Abdominal binding for people with SCI should be introduced cautiously and be rigorously assessed because of the potential for alteration of diaphragm length to result in mechanical inefficiency, increased dyspnea, and inspiratory muscle fatigue. There is a lack of literature and only anecodotal evidence on the intermediate or long-term effects of abdominal binding on people with SCI above T6. Positioning and using other interventions that increase abdominal pressure in other chronic respiratory conditions improve diaphragm force production but also can induce diaphragm fatigue and have variable influence on dyspnea reduction. The clinical outcomes of abdominal binding should be carefully evaluated for each individual. Abdominal binding could potentially have positive or deleterious effects on inspiratory muscle efficiency and dyspnea in different people after SCI. Conclusions: There is level 2 evidence that abdominal binding in tetraplegic individuals has immediate improvement in respiratory function, but longer term effects have not been studied. Abdominal binding can be used to achieve immediate improvements in respiratory function, but long term effects have not been established.

8.5.5 Vibration Vibration of the muscle tendon to enhance muscle contractile force has been studied in healthy people and in people after SCI. This modality may have the potential to decrease disuse 8-19

atrophy in some people after SCI who have partial voluntary control of muscle and is described as being more comfortable than electrical stimulation (Ribot-Ciscar et al. 2003). Alternatively, vibration also has been considered as an intervention to diminish involuntary muscle contraction after SCI (Butler et al. 2006). The literature on the use of vibration to improve inspiratory and expiratory muscle contraction or to control unwanted spasm of these muscles after spinal cord injury is almost non-existent. One early report examining the physiologic response to this modality in people with spinal cord injury is outlined in the following table. Table 8.9 Vibration
Author Year; Country Score Research Design Total Sample Size Methods Population: 13 people after SCI (11 males, 2 females), ages:17-49 yrs, C4-T1 lesions, 1 incomplete, 12 complete); 19-49 months post-injury Treatment: Application of vibratory stimulus to the 1) parasternal intercostal spaces; 2) 7th -10th intercostal spaces anterior to midaxillary lines; 3) Inspiratory and expiratory vibrations were combined to produce alternating in phase vibration. Outcome measures: Spirometry. 1. Outcome Inspiratory, expiratory and combined in-phase vibrations increased VT and VE while decreasing fb. The combined-alternating in-phase vibration increased VT more than inspiratory or expiratory in-phase vibration alone.

Homma et al. 1981; USA Downs & Black score=9 Pre-post N=13

2.

Discussion One report has shown that alternating in-phase vibration applied during inspiration (over the parasternal intercostals) or during expiration (applied over the 7th-10th intercostal spaces) significantly increased tidal volume (VT) and minute ventilation (VE) with an even greater effect on these two variables when in-phase vibration was applied during inspiration and expiration. Further study is required to examine the long-term utility and compliance of this modality to enhance ventilation in people with SCI. Further, the specific parameters of vibration that enhance versus diminish muscle excitation and contraction needs to be explored in people with different levels and types of SCI. Conclusion There is level 4 evidence that the use of chest wall vibration increases tidal volume and minute ventilation in subjects with tetraplegia. Chest wall vibration may improve pulmonary function while the vibration is applied, but carryover effects when the vibration is not in use has not been evaluated. 8.5.6 Immersion The effects of immersion in shoulder-deep water on spirometry in SCI have been studied. While immersion in water does not represent a treatment modality for pulmonary function, the effects of immersion are important to note from a clinical perspective because many subjects with SCI undergo pool-based therapy that exposes them to shoulder-deep immersion in water.

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Table 8.10 Immersion
Author Year; Country Score Research Design Total Sample Size Methods Population: 34 men: 23 complete (C4-C8) tetraplegia & 11 healthy controls. median age:25yrs (treatment) & 27yrs (control), 289 months post-injury, ASIA A-B Treatment: Spirometry immediately before and 5-15min following immersion to shoulder level in water (33.5ºC-34.5ºC) and 5-10min after withdrawal from the water. All subjects were studied in upright, seated posture, in & out of the water. Outcome Measures: Spirometric measurements. 1. Outcome Immersion increased the FVC and FEV1 of tetraplegic subjects. FVC and FEV1 decreased in control subjects. Among the subjects with tetraplegia, the lower the preimmersion vital capacity (VC), the greater the percentage of improvement following immersion. No relationship was found between the time elapsed since cervical cord injury or its level and the degree of improvement.

Thomaz et al. 2005; Brazil Downs & Black socre=10 Pre-post N=34

2.

3.

Immersion in shoulder-deep water results in changes in lung function tests in tetraplegic subjects. Bosch and Wells (1991) showed that in comparison to able-bodied and paraplegic subjects, tetraplegic subjects have a significant decrease in residual volume with immersion. In a pre-post trial involving 23 motor complete tetraplegic subjects and 11 healthy controls, Thomaz et al. (2005) concluded that overall, immersion in water appeared to improve breathing mechanics in subjects with tetraplegia. Conclusion: There is level 4 evidence that the use of immersion to shoulder-deep 33-34° Celsius water improves pulmonary function in tetraplegia.

There is limited evidence that immersion to shoulder-deep 33-34° Celsius water may improve pulmonary function, but carry-over effects following immersion has not been evaluated.

8.6 Obstructive Sleep Apnea in SCI Obstructive sleep apnea is a disease characterized by recurrent collapse of the upper airway during sleep leading to nocturnal hypoxemia and sleep fragmentation. Characteristic symptoms include loud snoring, excessive daytime sleepiness, and nocturnal choking. Risk factors for disease include alcohol use, sedatives, obesity, increased age, and male gender. Because of activation of systemic inflammation and the sympathetic nervous system, sleep apnea may be an independent risk factor for the development of cardiovascular disease. In the able-bodied, sleep apnea is relatively common and under-diagnosed. Treatment of obstructive sleep apnea includes lifestyle counseling (i.e., weight loss, avoidance of alcohol). For patients with substantial disease, continuous positive airway pressure (CPAP) therapy is considered to be first-line therapy. This consists of a mask placed on the face attached to an air compressor via plastic tubing. CPAP devices establish a positive pressure in the upper airway preventing its collapse during sleep. Studies of CPAP in people without SCI demonstrate significant benefits in terms of reducing sleepiness and preventing motor vehicle crashes. Other therapies that have been used to treat obstructive sleep apnea include mandibular advancement devices (dental splints) and upper airway surgery.

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8.6.1 Prevalence and Risk Factors Breathing disorders including sleep apnea appear to have a higher prevalence in people after SCI than those without. In general, the studies that examined the prevalence of obstructive sleep apnea were limited by small sample sizes and by an experimental design that lacked an able-bodied control group that could be directly compared to the SCI patients. Both overnight oximetry and full polysomnography were used to diagnose disease. The prevalence rate ranged from 9.1-83% (Short et al. 1992; Burns et al. 2000; Burns et al. 2001; Stockhammer et al. 2002; Berlowitz et al. 2005). Obesity was identified as a risk factor for sleep apnea in most studies. The use of muscle relaxants was identified as a potential risk factor for sleep disordered breathing in some but not all studies (Short et al. 1992; Ayas et al. 2001; Burns et al. 2001 Berlowitz et al. 2005). Table 8.11 Treatment of obstructive sleep apnea
Author Year; Country Score Research Design Total Sample Size Methods Population: 50 people with SCI lesion levels between C3 and C8; M:F – 40:10; Age: 48.6±14.0, range from 20-81 years; Mean 11.4 years post injury (range from 0.5 to 37 years) Treatment: CPAP 1. Outcome 31 out of the 50 tetraplegic patients had a respiratory disturbance index (RDI) of 15 or more (mean 30.5) defined as sleep disordered breathing (SDB). 16 patients accepted a trial of CPAP; of these, 11 continued to use CPAP after a few weeks. Of these 11 patients, 10 patients reported an improvement of symptoms after using long term CPAP therapy. CPAP continually used by 63% of the participants out of 32 (80%) of participants who tried it. Main reasons for not using CPAP were inability to fall sleep, mask discomfort & claustrophobia. Most common side effects were nasal congestion in 12 and mask discomfort in 8. In two patients, CPAP treatment decreased daytime sleepiness, improved sleep and oxygen saturation. One patient improved after losing 33 kg, and reducing alcohol intake and smoking

Stockhammer et al. 2002; Switzerland Downs & Black score=15 Pre-post N=50

2.

Burns et al. 2005; USA Downs & Black score=14 Case Series N=40

Population: 40 men after SCI (37 tetraplegics) 2 BMI: 29.2±6.6 kg/m ; most of whom were diagnosed with sleep apnea . Treatment: Survey requesting information about long-term treatment outcomes and side effects of sleep apnea treatment in persons with SCI. Population: 3 people after SCI, ages: 47, 54, 56 yrs, C6 incomplete, T2 complete/; Duration of injury: 19, 6, 37 years. All 3 patients reported severe daytime sleepiness and sleep complaints Treatment: Continuous positive airway pressure (CPAP) via a nasal mask

1. 2. 3. 1.

Biering-Sørensen et al. 1995; England Downs & Black score=8 Case Series N=3

2.

Discussion Obstructive sleep apnea is very common in patients with SCI; obesity appears to be a consistent risk factor. There are few studies that have assessed the impact of sleep apnea therapy in patients with SCI. In a three person case series, Biering-Sorensen demonstrated successful therapy with CPAP in two patients, and with weight loss in the third. No randomized controlled trials of CPAP have been reported. One study (Burns et al. 2000) demonstrated a low acceptance rate of CPAP (2 of 8 patients) given a trial of therapy. However, two larger studies demonstrated greater rates; Burns et al. (2005) demonstrated a long-term acceptance rate of CPAP of 63% (20/32) in patients offered CPAP therapy, and another (Stockhammer et al. 2002) 8-22

a long-term rate of 69% (11/16 who accepted a trial). Patients who continued to use CPAP in general reported beneficial effects. No reports concerning the treatment of SCI patients with sleep apnea with a dental appliance or upper airway surgery were identified. There is a paucity of studies that have examined the impact of therapy on health and quality of life outcomes; this should be a focus of future investigations. Conclusion There is level 4 evidence to support therapies to treat obstructive sleep apnea in people with SCI. Patients with SCI have a high prevalence of obstructive sleep apnea, and therapy may improve quality of life and other outcomes. Therefore, we recommend vigilance for suggestive signs and symptoms (e.g., snoring, obesity, witnessed apneas, daytime sleepiness) and further testing in patients with suggestive symptoms/signs (with overnight oximetry or polysomnography).

8.7 Secretion Removal People with spinal cord injury are at risk for retention of secretions because of an increased prevalence of pneumonia compounded by lower expiratory flows during cough. Increased prevalence of respiratory infections, although decreased during the rehabilitation phase of recovery, is still higher in people with SCI compared to age-matched healthy people. Reduction in expiratory flows during cough is related to the higher levels of SCI. Of considerable surprise, several devices that have been shown to be effective in people with other chronic respiratory conditions have not been evaluated in people with spinal cord injury. Table 8.12 Secretion Removal
Author Year; Country Score Research Design Total Sample Size Kang et al. 2006; Korea Downs & Black score=17 Prospective Controlled Trial N=40 Methods Population: 40 traumatic CSCI Treatment: Compared four types of cough 1. unassisted peak cough flow 2. inspiratory assist cough flow 3. abdominal thrust cough flow 4. inspiratory assist & abdominal thrust cough flow. Outcome Measures: Spirometry, Maximum Inspiratory Pressure (MIP), Maximum Expiratory Pressure (MEP). Population: 11 people with complete SCI (C4 & below), Age group 1: 38±11.4 yrs, group 2: 36.7±7.2 yrs, average time since injury: 12.3 (grp.1), 18yrs (grp.2) Treatment: Assisted coughing by: 1. manual assist or 2. functional electrical stimulation (FES) Outcome Measures: Maximum Expiratory Pressure (MEP). 1. 2. Outcome MIP more so than MEP showed stronger relationships with peak exp flow during cough maneuvers. All three assisted techniques (2,3, & 4) showed higher peak expiratory flows. The combined assist (4) showed significantly higher values than the inspiratory or abdominal thrust assist. (Group 1) MEP generated from spontaneous coughing, manual assist and FES was 27.3±6.4, 83±18.7 and 60±22.8 cm H2O, respectively. (Group 1) In all patients in the study, the MEP ↑ w/ abdominal muscle FES as well as w/ manually assisted cough. (Group 2) Portable FES compared to spontaneous cough ↑ the mean MEP from 32.3 to 58 cm H2O.

1.

Linder 1993; USA Downs & Black score=15 Prospective Controlled Trial N=11

2.

3.

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Author Year; Country Score Research Design Total Sample Size

Methods Population: 18 SCI patients (C1-T3), 88% were C5 or higher Methods: Surveyed preference for: suctioning or maximal inexsufflation (MI-E). Outcome measure: Not Specified. 1.

Outcome MI-E was less irritating, less painful, less tiring, less uncomfortable (p<0.01 or p<0.001). All were clinically significant changes (except less tiring). 16 of 18 patients preferred MI-E and one preferred suctioning; 1 patient had no preference. When surveyed, average time from MI-E was 146 days and from suctioning was 253 days (p<0.001) Number of respiratory infections decreased from 3 to 2. Number of respiratory infections requiring acute care hospitalization decreased from 2 to 0. MIP increased from -10 to -42 cm H2O. Daily suctioning 10x daily decreased to intermittent suctioning not required daily Airway pressure was 90, 82, and 132 cm H2O during stimulation of electrodes stimulated at T9, L1, or combined, respectively. Stimulation causes trunk motion but this was tolerated without pain or discomfort. Maximal stimulation ↑ gastric pressure to 76.0±11.7 in controls and 29.9±3.7 cmH2O in SCI subjects (p=0.002). The cumulative thickness of the four abdominal muscles was 34% smaller in the people with SCI than in control subjects and correlated positively with changes in gastric pressure induced by stimulation.

Garstang et al. 2000; USA Downs & Black score=11 Pre-post N=18

2. 3. Population: 26 yr old M C3-C4 Treatment: Threshold IMT and Positive expiratory pressure value (Peripep®) for one year Outcome Measures: Frequency of suction, Maximum Inspiratory Pressure (MIP), number of respiratory infection. 1. 2. 3. 4. 1.

Ehrlich et al. 1999; Canada Downs & Black score=7 Case Series N=1

DiMarco et al. 2006; USA Downs & Black score=7 Pre-post N=1

Population: 52 y/o male, incomplete C5C6, 7 yrs ago; ASIA C Treatment: Electrical stimulation via epidural electrodes in T9, T11 and L1 spinal cord regions Outcome Measures: Airway pressure Population: 16 subjects: (8 SCI, 8 matched controls), complete tetraplegia, C4-C7, mean age SCI: 39±3.1yrs; controls: 38±1.8yrs Treatment: Magnetic stimulation of abdominal muscles. Outcome Measures: Gastric pressure.

2. 1.

Estenne et al. 2000; Belgium Downs & Black score=5 Pre-post N=16

2.

Discussion Very few studies have examined the effectiveness of secretion removal techniques in people with SCI even though respiratory complications are a primary cause of morbidity and mortality in this population. Studies performed to date are limited by a survey (Garstang et al. 2000) or case study design (Ehrlich et al. 1999) or lack of documentation of valid measurement technique of standard pulmonary function (Kang et al. 2006). Limited evidence supports the postulate that improving inspiratory muscle strength (Ehrlich et al. 1999; Kang et al. 2006) in addition to expiratory muscle force (Estenne et al. 2000) are important to maximize expiratory flows during cough. Inspiratory muscle training (Ehrlich et al. 1999) and electrical stimulation of the expiratory muscles (Linder 1993; Estenne et al. 2000; DiMarco et al. 2006) are two potential therapies that can maximize the force produced by the inspiratory and expiratory muscles, respectively, in order to increase expiratory flows during cough. RCTs examining the effectiveness of these techniques in people after SCI have not yet been performed. Other issues that require further study in SCI is to examine the effectiveness of hand-held

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devices that facilitate airway clearance, such as those that apply continuous (Peripep®) or oscillating positive expiratory pressure (Flutter®). Of equal concern is to evaluate the comfort and preference of airway clearance techniques that are readily adhered to and performed by people with SCI. Some evidence supports the effectiveness of these positive expiratory pressure devices and other secretion removal techniques such as autogenic drainage in people with cystic fibrosis and other chronic respiratory diseases; however, the evidence to date is somewhat equivocal (Hess 2001; Reid & Chung 2004). Conclusion Secretion removal techniques are common practice in people with spinal cord injury and yet only level 4 evidence supports the use of some airway clearance techniques to facilitate secretion removal in this population. No evidence supports the selective use of the best airway clearance technique nor are criteria available to indicate when to implement the various airway clearance techniques. Urgent evaluation is required to determine the most efficient and effective techniques that are comfortable and readily adhered to for people with SCI in order facilitate airway clearance, to improve their quality of life, and decrease health care costs. There is limited evidence that suggests that improving inspiratory and expiratory muscle force is important to maximize expiratory flow during cough. Cough effectiveness can be enhanced by a variety of methods including manual assistance by a caregiver and/or electrical stimulation triggered by the person with SCI. Hand-held expiratory pressure devices may enhance secretion removal in people with SCI.

8.8 Summary Pulmonary function alteration and respiratory complications continue to be a major cause of morbidity and mortality in patients with SCI. There are currently no widely accepted clinical practice guidelines for the long term respiratory management of the SCI patient. Much of the SCI-respiratory literature focuses on the acute care of the SCI patient. However, given that long-term survival rates following SCI injury have increased in recent years a greater understanding of the effects of chronic SCI on the respiratory system is necessary. Moreover, identifying interventions that can improve (or minimize the decline in) pulmonary function and reduce respiratory complications are of great importance. Despite this need there are also no widely accepted clinical practice guidelines available for the respiratory management of the SCI patient following hospital discharge. This is largely due to the fact that there have been relatively few well designed studies that point to effective management strategies. Interpretation of the available literature is difficult because many studies have a least one, and more often multiple methodological or research design concerns. Specific major concerns include an overall lack of RCTs; patient sample sizes are often small with little or no consideration for statistical power; lack of appropriate control or placebo groups; and inadequate characterization of the SCI. In addition, most studies do not take into account gender, time since injury, smoking history and other respiratory complications. As such, the amount and quality of the literature can be considered modest at best and the ability to generalize is limited. 8-25

Despite the above caveats and research design shortcomings, some conclusions can be cautiously drawn regarding commonly used respiratory intervention strategies. (i) Exercise Training. The evidence that the respiratory system is positively influenced by exercise training is not strong. There is some evidence that rigorous training can improve respiratory muscle strength, endurance and efficiency in SCI. There have been no reports of negative consequences of exercise training. Exercise training should be encouraged for maintenance of general cardio-respiratory health in people with SCI. (ii) Respiratory Muscle Training. Specific training of the respiratory muscles in SCI is not well supported by the available research. Well designed studies are lacking but there is some evidence to show that respiratory muscle training can improve respiratory muscle strength and endurance. From the available literature on other subject groups (healthy, lung disease) it appears that training of the respiratory muscle may improve ventilation, decrease dyspnea and improve daily respiratory function. Consistent improvement in respiratory function following respiratory muscle training has not been demonstrated in people with SCI. (iii) Pharmaceutical Interventions. Restrictive ventilatory impairment is common in SCI and is dependent on lesion level and degree of completeness. Obstructive ventilatory impairment is present with cervical injury. There is some evidence to show that use of bronchodilators can elicit a positive response in pulmonary function. Bronchodilators can be recommended for shortterm use in patients with obstructive impairment. The long-term effects are unknown. There is limited evidence to support the use of anabolic steroids for improvement in pulmonary function. (iv) Assistive Devices. Ventilatory weaning in SCI is important but there is no consensus on the ideal weaning protocol. There is some evidence that progressive ventilator free breathing is more effective than intermittent mandatory ventilation in cervical SCI. There is insufficient research to advocate the long-term use of abdominal binding or vibration to improve indices of pulmonary function. (v) Obstructive Sleep Apnea. There is a higher prevalence of sleep apnea in SCI relative to able-bodied individuals. Treatment options include CPAP and weight loss but there is limited research evidence to suggest positive long-term benefits. Anecdotal and patient reports suggest that therapy for sleep apnea is beneficial. (vi) Secretion Removal. Retention of secretions is common in SCI because of a diminished capacity for cough generation. Elimination of secretions is commonplace in clinical practice and is generally considered an integral part of maintaining respiratory health in SCI. There are several commonly used secretion removal techniques but there is no consensus on their effectiveness.

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Estenne M, Pinet C, De Troyer A. Abdominal muscle strength in patients with tetraplegia. Am J Respir Crit Care Med. 2000;161(3 Pt 1):707-12. Estenne M, Van Muylem A, Gorini M, Kinnear W, Heilporn A, De Troyer A. Effects of abdominal strapping on forced expiration in tetraplegic patients. Am J Respir Crit Care Med 1998;157:95-8. Fein ED, Grimm DR, Lesser M, Bauman WA, Almenoff PL. The effects of ipratropium bromide on histamine-induced bronchoconstriction in subjects with cervical spinal cord injury. J Asthma. 1998;35:49-55. Garstang SV, Kirschblum SC, Wood KE. Patient preference for in-exsufflation for secretion management with spinal cord injury. J. Spinal Cord Med. 2000;23:80-85. Geddes EL, Reid WD, Brooks D, Crowe J, O’Brien K. A Primer on Inspiratory Muscle Trainers. Buyers Guide for the European Respiratory Society. 2006 Geddes EL, Reid WD, Crowe J., O’Brien K, Brooks D. Inspiratory muscle training in adults with chronic obstructive pulmonary disease: A systematic review. Respir Med. 2005;99:14401458. Glenn WW, Holcomb WG, McLaughlin AJ, O'Hare JM, Hogan JF, Yasuda R. Total ventilatory support in a quadriplegic patient with radiofrequency electrophrenic respiration. N Engl J Med 1972;286:513-6. Grimm DR, Arias E, Lesser M, Bauman WA, Almenoff PL. Airway hyperresponsiveness to ultrasonically nebulized distilled water in subjects with tetraplegia. J Appl Physiol. 1999;86:1165-9. Grimm DR, DeLuca RV, Lesser M, Bauman WA, Almenoff PL. Effects of GABA-B agonist baclofen on bronchial hyperreactivity to inhaled histamine in subjects with cervical spinal cord injury. Lung. 1997;175:333-41. Gross D, Ladd HW, Riley EJ, Macklem PT, Grassino A. The effect of training on strength and endurance of the diaphragm in quadriplegia. Am. J. Med. 68:27-35, 1980. Gutierrez, CJ, Harrow, J, Haines, F. Using an evidence-based protocol to guide rehabilitation and weaning of ventilator-dependent cervical spinal cord injury patients. J Rehabil Res Dev. 2003 ;40(5 Suppl 2):99-110. Hart N, Laffont I, de la Sota AP, Lejaille M, Macadou G, Polkey MI, et al. Respiratory effects of combined truncal and abdominal support in patients with spinal cord injury. Arch Phys Med Rehabil 2005 Jul;86(7):1447-1451. Hess DR. The evidence for secretion clearance techniques Respir Care. 2001 Nov;46(11):1276-93. Homma I, Nagai T, Sakai T, Ohashi M, Beppu M, Yonemoto K. Effect of chest wall vibration on ventilation in patients with spinal cord lesion. J Appl Physiol 1981;50(1):107-111. Hooker SP, Wells CL. Effects of low- and moderate-intensity training in spinal cord-injured persons. Med. Sci. Sports Exerc. 1989;21(1):18-22. Hornstein S, Ledsome JR. Ventilatory muscle training in acute quadriplegia. Physiotherapy Canada. 1986;38(3):145-149. Kang SW, Shin JC, Park CI, Moon JH, Rha DW, Cho D-h. Relationship between inspiratory muscle strength and cough capacity in cervical spinal cord injured patients. Spinal Cord. 2006;44:242-248. Le Foll-de-Moro D, Tordi N, Lonsdorfer E, Lonsdorfer J. Ventilation efficiency and pulmonary function after wheelchair interval-training program in subjects with recent spinal cord injury. Arch. Phys. Med. Rehabil. 2005;86:1582-1586. Liaw M-Y, Lin M-C, Cheng P-T, Wong M-K A, Tang F-T. Resistive inspiratory muscle training: its effectiveness in patients with acute complete cervical injury. Arch Phys Med Rehabil. 2000;81:752-756. Linder SH. Functional electrical stimulation to enhance cough in quadriplegia. Chest. 1993;103:166-9. 8-28

Linn WS, Adkins RH, Gong H. Jr., Waters RL. Pulmonary function in chronic spinal cord injury: A cross-sectional survey of 222 southern California adult outpatients. Arch. Phys. Med. Rehabil. 2000;81:757-763. Loveridge B, Badour M, Dubo H. Ventilatory muscle endurance training in quadriplegia: effects on breathing pattern. Paraplegia. 1989;27:329-339. McCool FD, Pichurko BM, Slutsky AS, Sarkarati M, Rossier A, Brown R. Changes in lung volume and rib cage configuration with abdominal binding in quadriplegia. J Appl Physiol 1986;60:1198-202. Onders RP, Dimarco AF, Ignagni AR, Aiyar H, Mortimer JT. Mapping the phrenic nerve motor point: the key to a successful laparoscopic diaphragm pacing system in the first human series. Surgery 2004;136:819-26. Peterson W, Charlifue W, Gerhart A, Whiteneck G. Two methods of weaning persons with quadriplegia from mechanical ventilators. Paraplegia 1994;32:98-103. Reid WD, Geddes EL, Brooks D, O’Brien K, Crowe J. Inspiratory muscle training in chronic obstructive pulmonary disease. Special Series on Skeletal Muscle Training. Physiotherapy Canada 56(3):128-142, 2004 Reid, W.D., Chung, F. Clinical Management Notes and Case Histories in Cardiopulmonary Physical Therapy. Thorofare, NJ: SLACK Publishers; 2004. Ribot-Ciscar E, Butler JE, Thomas CK. Facilitation of triceps brachii muscle contraction by tendon vibration after chronic cervical spinal cord injury. J Appl Physiol 94:2358-2367, 2003 Ross J, White M. Removal of the tracheostomy tube in the aspirating spinal cord-injured patient. Spinal Cord. 2003;41:636-42. Rutchik A, Weissman AR, Almenoff PL, Spungen AM, Bauman WA, Grimm DR. Resistive IMT in subjects with chronic spinal cord injury. Arch. Phys. Med. Rehabil. 1998;79:293-297. Schilero GJ, Grimm D, Spungen AM, Lenner R, Lesser M. Bronchodilator responses to metaproterenol sulfate among subjects with spinal cord injury. J Rehabil Res Dev. 2004; 41:59-64. Short DJ, Stradling JR, Williams SJ. Prevalence of sleep apnoea in patients over 40 years of age with spinal cord lesions. J Neurol Neurosurg Psychiatry. 1992 Nov;55(11):1032-6. Silva AC, Neder JA, Chiurciu MV, da Cunha Pasqualin D, da Silva RCQ, Fernandez AC, Lauro FAA, de Mello MT, Tufik S. Effect of aerobic training on ventilatory muscle endurance of spinal cord injured men. Spinal Cord. 1998;86:240-245,. Singas E, Grimm DR, Almenoff PL, Lesser M. Inhibition of airway hyperreactivity by oxybutynin chloride in subjects with cervical spinal cord injury. Spinal Cord. 1999;37:279-83. Singas E, Lesser M, Spungen AM, Bauman WA, Almenoff PL. Airway hyperresponsiveness to methacholine in subjects with spinal cord injury. Chest. 1996;110:911-5. Spungen AM, Dicpinigaitis PV, Almenoff PL, Bauman WA. Pulmonary obstruction in individuals with cervical spinal cord lesions unmasked by bronchodilator administration. Paraplegia. 1993;31:404-7. Spungen AM, Grimm DR, Lesser M, Bauman WA, Almenoff PL. Self-reported prevalence of pulmonary symptoms in subjects with spinal cord injury. Spinal Cord. 1997;35:652-657, Spungen AM, Grimm DR, Strakhan M, Pizzolato PM, Bauman WA. Treatment with an anabolic agent is associated with improvement in respiratory function in persons with tetraplegia: a pilot study. Mt Sinai J Med. 1999;66:201-5. Stockhammer E, Tobon A, Michel F, Eser P, Scheuler W, Bauer W, Baumberger M, Muller W, Kakebeeke TH, Knecht H, Zach GA. Characteristics of sleep apnea syndrome in tetraplegic patients. Spinal Cord. 2002 Jun;40(6):286-94. Sutbeyaz ST, Koseoglu BF, Gokkay NKO. The combined effects of controlled breathing techniques and ventilatory and upper extremity muscle exercise on cardiopulmonary responses in patients with spinal cord injury. Int. J. Rehabil. Res. 2005;28:273-276.

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Thomaz S, Beraldo P, Mateus S, Horan T, Leal JC. Effects of partial isothermic immersion on the spirometry parameters of tetraplegic patients. Chest. 2005;128:184-9. Uijl SG, Houtman S, Folgering HT, Hopman MT. Training of the respiratory muscles in individuals with tetraplegia. Spinal Cord. 1999;37:575-9.

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CHAPTER NINE
Bone Health Following Spinal Cord Injury
Maureen C Ashe, PhD, PT B Cathy Craven, MD FRCPC Andrei Krassioukov, MD, PhD Janice J Eng, BSc (PT/OT), PhD

Key Points Fragility fractures, especially around the knee, are very common in people with SCI. Ideally, bone loss intervention should be introduced early following SCI as a large portion of bone is loss during the first year. Oral Tiludronate and Clodronate prevent a decrease in BMD of the hip and knee region with no adverse effects on bone mineralization in men with paraplegia. Oral Etidronate prevents a decrease in BMD of the hip and knee region in people with incomplete paraplegia or tetraplegia. Pamidronate 30 mg IV or 60 mg IV 4x/year is not effective for the prevention of BMD loss at the hip and knee region early after SCI people with motor complete paraplegia or tetraplegia. Alendronate 10 mg daily and Calcium 500 mg orally 3x/day is effective for the maintenance of BMD of the wrist, hip and knee region for men with paraplegia. Short term (6 weeks) therapeutic ultrasound is not effective for preventing bone loss after a SCI. FES-cycling does not improve or maintain bone at the tibial midshaft in the acute phase. Electrical stimulation can maintain or increase BMD over the stimulated areas. Six months of FES cycle ergometry may increase lower extremity BMD over areas stimulated. There is inconclusive evidence for Reciprocating Gait Orthosis (RGO), long leg braces, passive standing or self-reported physical activity as a treatment for low bone mass. Early assessment and monitoring of bone mass after SCI are essential to identify low bone mass and risk for fragility fractures. Prevention with oral bisphosphonates (Tiludronate, Clodronate and Etidronate) may slow the loss of BMD early after SCI, but there is limited evidence that treatment with oral bisphosphonates maintains bone mass late after SCI. There is a lack of definitive evidence supporting nonpharmacological interventions for either prevention or treatment of bone loss after a SCI.

Table of Contents
9.1 Introduction ........................................................................................................................9-1 9.2 Fracture risk following a SCI ............................................................................................9-1 9.3 Bone Outcome Measures..................................................................................................9-2 9.4 Pharmacologic Therapy: Bisphosphonates....................................................................9-3 9.4.1 Pharmacologic Therapy: Prevention (within 12 months of injury).......................................9-3 9.4.2 Pharmacologic Therapy: Treatment..................................................................................9-5 9.5 Non-Pharmacologic Therapy: Rehabilitation Modalities ...............................................9-6 9.5.1 Non-Pharmacologic Therapy: Prevention (within 12 months of injury) .............................9-7 9.5.2 Non-Pharmacologic Therapy: Treatment..........................................................................9-8 9.5.2.1 Electrical stimulation ......................................................................................................9-9 9.5.2.2 FES Cycle Ergometry ..................................................................................................9-10 9.5.2.3 Standing.........................................................................................................................9-11 9.6 General Discussion ...........................................................................................................9-12 References................................................................................................................................9-16

This review has been prepared based on the scientific and professional information available in 2005. The SCIRE information (print, CD or web site www.icord.org/scire) is provided for informational and educational purposes only. If you have or suspect you have a health problem, you should consult your health care provider. The SCIRE editors, contributors and supporting partners shall not be liable for any damages, claims, liabilities, costs or obligations arising from the use or misuse of this material. Ashe MC, Craven C, Krassioukov A, Eng JJ (2006). Bone Health Following Spinal Cord Injury. In: Eng JJ, Teasell RW, Miller WC, Wolfe DL, Townson AF, Aubut J, Abramson C, Hsieh JTC, Connolly S, editors. Spinal Cord Injury Rehabilitation Evidence. Vancouver, p 9.1-9.18. www.icord.org/scire

Bone Health Following Spinal Cord Injury
9.1 Introduction Preserving and maintaining bone mass after a spinal cord injury (SCI) is crucial to decrease the risk of fragility fractures that results from bone loss. The pathophysiology of this loss is such that within the first few days following a spinal cord injury there is an increase in excreted calcium (known as hypercalciuria) that is 2-4 times that of individuals who are confined to prolonged bedrest but without a SCI (Bauman & Spungen 2001) and reflects excessive bone resorption. Longitudinal studies also highlight a higher rate of hypercalcemia (excessive calcium in the blood) for people after a SCI that leads to rapid bone mineral loss in the first 4-6 months that slows for the remaining first year post injury (Hancock et al. 1980; Frey-Rindova et al. 2000). Early studies also suggest that bone mineral density (BMD) stabilizes by 1-2 years after SCI (Griffiths et al. 1976; Hancock et al. 1980; Garland et al.1992) at 25-50% below that of ablebodied peers in the hip and knee region. More recent investigations support a continual loss of bone mass with time since injury (Demirel et al. 1998; Bauman et al. 1999) and suggest that a steady-state of lower extremity bone mineral homeostasis is not reached. The immediate and excessive loss of bone mass post SCI is believed to result mostly from a decrease in mechanical loading as a result of reduced or complete loss of muscle function and/or weight-bearing activities. Neural, vascular, hormonal and nutritional changes may also negatively impact bone but the relative contributions of these factors is not known. Aging and inactivity accentuate bone loss resulting in site-specific decrease in bone mineral content (trabecular>cortical bone). Specifically, the decreased systemic calcium and vitamin D (with subsequent increase in parathyroid hormone) that results from SCI can be accentuated by inadequate dietary calcium intake, decreased sunlight exposure and the potential for hyperparathyroidism (Bauman et al. 1995). Further evidence suggests that women with a complete SCI experience bone loss around the hip and knee during menopause that is greater than age-matched able-bodied women (Garland et al. 2001). These factors all contribute to the increased risk for low-trauma or fragility fractures in people who sustain a SCI. 9.2 Fracture Risk following a SCI There is overwhelming evidence that supports the importance of addressing bone health issues early after a SCI. A high incidence of lower extremity fragility fractures (1-46%) exist in people who sustain a SCI (Table 9.1); the majority of fragility fractures occur following transfers or activities that involve minimal or no trauma (Ragnarsson & Sell, 1981). The distal femur and proximal tibia are most at risk, consistent with site-specific decreases in bone mineral density around the knee such that fractures of the distal femur are referred to as ‘the paraplegic fracture’ (Comarr et al. 1962). There are many notable risk factors for fragility fracture after SCI. There is a greater risk for women compared with men (Vestergaard et al. 1998; Garland et al. 2004), also with increasing age and longer time since injury. Further, paraplegics have more fractures compared with tetraplegics and those with complete injuries have greater bone loss compared with incomplete injuries (Garland et al. 2004). In the general population, individuals with a prior history of fragility fracture or a maternal history of fracture have a greater risk for future fracture, and these risk factors should also be considered in people with SCI.

9-1

Table 9.1 Fracture Incidence and risk factors for Fragility fractures after SCI
First Author /Year Comarr et al. 1962 Ragnarsson & Sell 1981 Freehafer 1995 Frisbie 1997 Vestergaard et al. 1998 McKinley et al. 1999 Lazo et al. 2001 Nelson et al. 2003 Zehnder et al. 2004 41 45 100 0.4-30 yrs <1 yr 1-9 yrs 10-19 yrs 20-29 yrs 26-52 2-43 yrs 2%/yr 1%/yr 1%/yr 3%/yr 5%/yr N 1,363 578 133 120 438 17-77 12-62 20-79 20-39 40-59 60-79 10-80 1-39 40-59 >60 27-83 >10 months 21±12 yrs > 1 yr <1.1% 1-54 yrs 33% 15% 31% 46% 21% 2% 9% 34% Women >Men; Family history of fractures Women >Men; Time since injury Time since injury; ↓ tibia BMD ↑ Age Age Time to 1st Fracture Fracture incidence 6% 4% Risk Factors A complete injury > risk than incomplete injury.

Women >Men; Family history of fractures; Time since SCI > 3 years

Garland et al. 2004

28

Fracture BMD threshold < 0.86 gm/cm2; breakpoint BMD at 0.49 gm/cm2; Women >Men ↑ Age; low BMI; Completeness of injury post SCI

Fragility fractures, especially around the knee, are very common in people with SCI. 9.3 Bone Outcome Measures Evaluation of bone occurs in many ways depending on the tools used for investigation. Common methods of bone evaluation include urine and blood (serum) analyses yielding biochemical markers to quantify rates of bone turnover. The most commonly used biochemical markers of bone turnover include osteocalcin, n-telopeptide and hydroxyproline. Areal bone mineral density is quantified non-invasively with imaging technologies such as dual energy X-ray absorptiometry (DXA) and previously with dual energy photon absorptiometry (DPA). Dual energy X-ray absorptiometry is considered by the World Health Organisation as the “gold or criterion standard” to diagnose osteoporosis and is the most widely used assessment technique for osteoporosis. DXA can measure BMD for the spine, hip or the limbs at relatively low cost and minimal risks to the patient. Volumetric bone mineral density is assessed using peripheral quantitative computed tomography (pQCT). Peripheral quantitative computed tomography (pQCT) is a safe and precise technique to differentiate cortical from trabecular bone and assess both bone geometry and volumetric density. Histomorphometry are measurements from bone biopsies and analyzed at the tissue and cellular level to provide an in-depth understanding of bone. There are two types of bone histomorphometry, dynamic and static. Dynamic histomorphometry involves using substances

9-2

such as tetracycline to measure tissue growth. Static histomorphometry involves determining the size and types of cells; measurements include length, area or cell counts. Static histomorphometry involves embedding bone in a resin then sanding the specimen down until it is very thin (<150 microns) and the images are viewed under microscope at various magnifications. Although bone histomorphometry is considered an important tool, it is not always feasible because it requires taking surgically removed bone specimens from willing participants. In this section, prevention and treatment interventions for bone health after a SCI are discussed. As bone loss is greatest immediately following a SCI, pharmacological and non-pharmacological interventions are classified as either prevention (the participants are less than 1 year post SCI) or treatment (study involved participants who are > 1 year after the injury). The intent is to address two distinct clinical questions: 1.What is the best way to prevent acute regional declines in bone mineral density?; and 2. What are the best treatments for low bone mass of the hip and knee region for people with longstanding SCI? 9.4 Pharmacologic Therapy: Bisphosphonates Within weeks after SCI, there is a marked increase in bone resorption (taking bone away) with a decrease in bone formation (adding new bone) and this is responsible for the significant loss in BMD. Bisphosphonates are a group of medications that are used to prevent declines in bone mass or treat low BMD; they act to slow down excessive bone resorption. Etidronate (Didrocal), Alendronate (Fosamax) and Risedronate (Actonel) are oral bisphosphonates, which are currently approved for the treatment of postmenopausal osteoporosis in Canada (Brown et al. 2002). Clodronate (Benefos or Ostac) is available intravenously (IV) and orally for the treatment of osteoporosis. Tiludronate (Skelid) is available in oral form in the United States. Giving calcium and vitamin D at the same time as bisphosphonate therapy has the potential for greater efficacy for bisphosphonates. Concurrent supplementation with calcium and vitamin D have been important additions to bisphosphonate therapy for other medical conditions (such as postmenopausal osteoporosis) (Brown et al. 2002). 9.4.1 Pharmacologic Therapy: Prevention (within 12 months of injury) Table 9.2 Prevention Studies using Pharmacology for Bone Health after a Spinal Cord Injury.
Author Year; Country Score Research Design Total Sample Size Methods Population: 14 men and women, ages 2161, motor complete para/ tetraplegia. Treatment: Pamidronate for 12 months. Participants randomized to 1. 60mg IV or placebo(saline) at 1, 2, 3, 6, 9, 12-mos. post SCI (N=6). 2. Placebo (N=5). Outcome measures: BMD by DXA, bone turnover markers. Population: 21 men and women, ages 1554 years, complete paraplegia. Treatment: Clodronate for 3.5 months. Participants randomized to 1. 400mg per day (N=7); 2.1,600 per day (N=7); or 3. Placebo (N=7). Outcome measures: BMD dual photon absorptiometry (DPA), histomorphometry 1. 2. Outcome There was no significant between group differences in BMD decline at 1 year. The treatment group had significantly lower 24-hr urinary calcium at 1month vs. placebo group (P<0.05) and there were no significant changes in markers of bone formation over the 12 month study. No reported adverse effects on bone mineralization with intervention. ↑ in serum and urine markers in the Placebo group (↑ bone turnover). Effective for acute prevention of declining bone mass and a maintenance of BMC of the femur and tibia in the treatment groups.

Bauman et al. 2005; USA PEDro=10 RCT N=14

1. 2. 3.

Minaire et al. 1981; France PEDro=10 RCT N=21

9-3

Author Year; Country Score Research Design Total Sample Size Chappard et al. 1995; France PEDro=9 RCT N=20

Methods Population: 20 men and women, ages 1650, injuries between C5-T12. Treatment: Tiludronate for 3 months. Participants randomized to 1. 400 mg/day (N=7); 2. 200 mg/day (N=7); or 3. Placebo (N=6). Outcome measures: histomorphometry. Population: 13 men and women, ages 2257, injuries between C5-T12, ASIA: A or D. Treatment: Etidronate for 30 weeks. Participants randomized to 1.800mg daily (N=6) or 2. Conventional rehab and calcium 1000mg/day (N=7). Outcome measures: DXA and adverse event rate. Population: 21 men and women, ages 1554, complete paraplegia. Treatment: Clodronate for 100 days. . Participants randomized to 1.400mg per day (N=7); 2. 1,600 per day (N=7); or 3. Placebo (N=7). Outcome measures: DXA, histomorphometry, biochemical bone turnover markers. Population: 24 men and women, ages 2557, injuries between C5-T12, ASIA: A-D. Treatment: Pamidronate for 6 months. Participants randomized to 1. 30mg IV every 4wks x 6doses (total 180mg/participant) (N=14) or 2. conventional rehab (N=10). Outcome measures: BMD by DXA, urine biochemical bone markers. 1.

Outcome There was an ↑ in total bone volume in the treatment group 1(400mg/day) vs. treatment group 2 (200mg/day) and placebo groups. ↑ bone resorption indicators in the placebo group vs. the treatment groups. BMD loss at the distal femur was 26% and 22% at the proximal tibia. The rate of decline in BMD was greatest amongst the ASIA A patients. BMD of lower extremity for the Etidronate treated ASIA D patients were preserved. Oral Etidronate was safe and well tolerated by participants. There was a greater ↑ in bone removal markers in Placebo group (48%), compared with treatment groups (1727%). BMD was maintained in treatment groups with a ↓ in placebo group. Lower bone turnover markers in treatment groups. There was a lower % decline in BMD in treatment vs. control group. The mean overall bone loss was 8.7% in the placebo group but only 2.7% in the treatment group (p=0.02). The average loss of BMD was 3.1% in the ASIA D group and 7.7% in the ASIA A group.

2. 1.

Pearson et al. 1997; Canada PEDro=8 RCT N=13

2. 1.

Minaire et al. 1987; France PEDro=7 RCT N=21

2. 3. 1.

Nance et al. 1999; Canada PEDro=4 RCT N=24

Discussion Evidence for pharmacological prevention of SCI bone loss includes 6 randomized controlled trials (RCT) (n=113 participants) (Table 2). These studies were difficult to interpret as a group due to the variability in selection of the primary outcome measure, relatively short durations of follow-up, small sample sizes, and the lack of stratification based on impairment level. Preventing bone loss immediately following SCI is challenging given the rapid bone resorption especially in ASIA A patients. The majority of studies found bisphosphonates resulted in a reduction of bone loss compared to a control group. The two studies which report that first generation bisphosphonates (Clodronate) can maintain bone were short in duration (3 month intervention) and participants had less severe injury (paraplegia, incomplete SCI) (Minaire et al. 1981, 1987). In two studies (Pearson 1997; Nance 1999), both groups continued to lose bone, except ASIA D participants who had bone density preservation in the lower extremity with bisphosphonates while participants with ASIA A had the greatest decline in both studies. A recent study which used a secondgeneration version of the bisphosphonate, Pamidronate and a longer intervention period found no significant differences between groups for bone loss after 1 year (Baumann 2005).

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Conclusion There is Level 1 evidence that oral Tiludronate and Clodronate prevent a decrease in BMD of the hip and knee region with no adverse effects on bone mineralization in men with paraplegia. There is Level 1 evidence that oral Etidronate prevents a decrease in BMD of the hip and knee region in people with incomplete paraplegia or tetraplegia (ASIA D impairment) who return to walking within 3 months of the SCI. There is Level 1 evidence that Pamidronate 30 mg IV or 60mg IV four times per year is not effective for the prevention of BMD loss at the hip and knee region early after SCI in men and women who have motor complete paraplegia or tetraplegia.

Ideally, bone loss intervention should be introduced early following SCI as a large portion of bone is loss during the first year. Oral Tiludronate and Clodronate prevent a decrease in BMD of the hip and knee region with no adverse effects on bone mineralization in men with paraplegia. Oral Etidronate prevents a decrease in BMD of the hip and knee region in people with incomplete paraplegia or tetraplegia. Pamidronate 30 mg IV or 60 mg IV 4x/year is not effective for the prevention of BMD loss at the hip and knee region early after SCI people with motor complete paraplegia or tetraplegia.

9.4.2 Pharmacologic Therapy: Treatment Table 9.3 Treatment Studies Using Pharmacology for Bone Health after a Spinal Cord Injury
Author Year; Country Score Research Design Total Sample Size Methods Population: 65 men, ages 18-60, complete injuries between T1-L3, ASIA: A, B. Treatment: Alendronate for 6 months. 1.10mg per day plus 500mg calcium per day (N=33) or 2. calcium alone (500mg per day) (N=32). Outcome measures: BMD by DXA and bone turnover markers. 1. Outcome ↓ BMD of the tibia in calcium group but remained stable in the Treatment group (group difference, p = 0.017). There was no change in wrist BMD and a significant ↑ in lumbar spine BMD in both groups. BMD of the mid-shaft tibia and hip were maintained in the Treatment group and ↓ in the calcium group. Biochemical markers of bone absorption were significantly ↓ from baseline in the Treatment group. There was a mean ↑ in upper extremity BMD that was greater in Treatment vs. calcium group. There were no group differences for BMD of the lumbar spine, lower extremity or whole body BMD and lower extremity T-score.

Zehnder et al. 2004; Switzerland PEDro=7 RCT N=65

2. Population: 19 men (< 50 yrs) and women (< 35 yrs), para/tetraplegia, ASIA: A, B, or C Treatment: Alendronate for 6 months. 1. 10mg and calcium 500mg bid (N=10) and 2. calcium (500mg bid) (N=9). Outcome measures: BMD by DXA 1.

Moran de Brioto et al. 2005; Brazil PEDro=6 RCT N=19

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Discussion Evidence for pharmacological treatment of SCI bone loss includes 2 RCTs (n=84 participants). In both studies, the treatment group experienced improvement in bone health at various sites. However, the extent of improvement was greater in the study by Zehnder et al. (2004) who found an increase in BMD at the spine with maintenance of BMD at the tibia and hip. In contrast, Moran de Brioto et al. (2005) only found an increase in BMD at the wrist. The difference in outcomes could be a result of the younger participants with less severe injuries in the work by Zehnder and coworkers. This review has provided strong support for second generation bisphosphonates for treatment for low bone mass. This review has provided strong support for using first and second generation oral bisphosphonates for prevention and treatment for low bone mass. Despite the benefits of these medications, they are not without their complications. Oral bisphosphonates must be ingested on an empty stomach, with 4-8oz of water, followed by sitting up for one-hour post ingestion prior to taking any other food or medication. Only 1% of the ingested oral bisphosphonate is absorbed in the upper intestine, yet it remains in the body in an inactive form for several months or years thereafter. Oral bisphosphonate therapy can cause side effects; joint pain and stomach upset being the most frequently reported adverse effects. Intravenous formulations of bisphosphonates are available in daily, monthly and quarterly preparations, and have a greater relative potency. Although their common short-term side effects include fever, low serum calcium and transient decrease in white blood cells, IV preparations are attractive due to the flexibility in dosing regimens, assured compliance and the reduced relative risk of an adverse upper gastrointestinal event. Bisphosphonates should be used with caution in pre-menopausal women due to the unknown effects of these medications on the fetus during pregnancy. Patients taking acetylsalicylic acid (ASA), corticosteroids or NSAIDS may require preventative measures because using these medications with bisphosphonates increases the relative risk of upper gastrointestinal side effects. Conclusion There is Level 1 evidence that Alendronate 10 mg daily and Calcium 500mg orally 3x/day is effective for the maintenance of BMD of the wrist, hip and knee region for men with paraplegia.

Alendronate 10 mg daily and Calcium 500 mg orally 3x/day is effective for the maintenance of BMD of the wrist, hip and knee region for men with paraplegia. 9.5 Non-Pharmacologic Therapy: Rehabilitation Modalities Rehabilitation options after a SCI for bone health focus on stimulating muscles and encouraging weight-bearing. Functional electrical stimulation (FES) is an important option to stimulate muscle with the goal of increasing regional BMD and involves the use of surface or implanted electrodes to stimulate standing, ambulation or bicycling (cycle ergometry). The FES-cycle ergometer uses a series of electrodes placed over the hamstrings, quadriceps and gluteal muscles of the legs to simulate a cycling pattern. Weight-bearing activities are also used for bone health after a SCI; these modalities include either passive (tilt-table or standing frame) or active weight-bearing activities with or without assistance from FES. Many FES studies have enrolled participants with both acute and chronic injuries and are therefore difficult to classify as pure prevention or 9-6

treatment interventions. For the purpose of this review, studies that enrolled participants that ranged from the acute phase to > 1 year were included with the treatment literature as the majority of their participants were in the chronic phase. 9.5.1 Non-Pharmacologic Therapy: Prevention (within 12 months of injury) Table 9.4 Prevention Studies Using Rehabilitation Modalities for Bone Health after SCI
Author Year; Country Score Research Design Total Sample Size Methods FES-cycle ergometer Population: 38 men and women, mean 1. age = 33, complete injuries between C5T12, (19 participants, 19 controls). Treatment: FES-cycle ergometer. Progressive training sessions until able to cycle for 30 mins. Then 3x/wk for 6 mos. from this baseline. On the remaining 2days of the week there was passive standing. Control group performed 30 mins. of passive standing 5 days/week. Outcome measures: CT Standing/Walking Population: 19 men, ages 19-59, injuries 1. between C4-T12, ASIA: A-D Treatment: Standing/Walking. Group 1 had 0-5 hrs per week loading exercises with standing frame. Group 2 had 5+hrs of standing exercises per week (standing). Group 3 had 5+hrs of standing and treadmill (walking). Interventions lasted 25 wks. Outcome Measures: vBMD by pQCT Treadmill training Population: 2 men and 3 women, ages 19-40, injuries between C3-C8, ASIA: B and C. no controls. Treatment: Body-weight supported treadmill training. Initial session started at 5mins and was ↑ gradually to 10-15mins in all but 1 participant during 48 sessions of 2x/wk-training over a period of 6-8 months. Outcome measures: BMD by DXA and CT. Ultrasound Population: 15 men, ages 17-40, injuries between C5-T10, ASIA: A-B, (within group design) Treatment: Pulsed therapeutic ultrasound. Applied to both calcanei for each participant for 20 min/day, 5x/wk over a consecutive 6-wk period. Right and left calcaneus within each participant was randomized. Outcome measures: BMD by DXA and quantitative ultrasound (QUS). 1. 2. 3. Outcome

Eser et al. 2003; Switzerland Downs & Black score=14 Prospective Controlled Trial N=38

Both groups had a 0-10% ↓ in tibial cortical BMD. There was no difference between groups for BMD after the intervention.

de Bruin et al. 1999; Switzerland PEDro=6 RCT N=19

Marked ↓ in trabecular BMD at the left tibia for the immobilized group but minimal ↓ in trabecular BMD in Group 2 and 3.

Giangregorio et al. 2005; Canada Downs & Black score=13 Pre-post N=5

↓ in BMD for all participants at almost all lower limb sites after training, ranging from -1.2 to -26.7%. Lumbar spine BMD changes ranged from 0.2 to -7.4%. No consistent changes in bone geometry at distal femur and proximal tibia. Did not alter the expected pattern of change in bone biochemical markers over time.

1.

For specified dose, no significant effect of QUS for any skeletal measurement parameter (p>0.05).

Warden et al. 2001; Australia PEDro=11 RCT N=15

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Discussion Evidence for non-pharmacological prevention of SCI bone loss includes 4 investigations (n=77 participants). This includes 2 RCTs (34 participants), 1 non-randomized controlled trial (38 participants) and 1 pre-post studies (5 participants) (Table 4). As with pharmacology prevention studies, there were difficulties with interpretation because of low numbers of participants and variability with the primary outcome measures. For each of the four different modalities there is only one study available and there was variability for the primary outcome of interest. Only the therapeutic ultrasound study by Warden and coworkers found no significant improvement in bone health after a 6 week intervention. Although prospective observational data (Frey-Rindova et al. 2000) highlight the loss of bone in the early phase (first 6-months post SCI), there was no significant influence of self-reported physical activity level. Overall, the evidence suggests that rehab modalities were not successful in reducing bone loss in the acute phase after SCI. Conclusion For NON-PHARMACOLOGICAL PREVENTION of bone loss after a SCI: There is Level 1 evidence from one RCT that short-term (6 weeks) ultrasound is not effective for treating bone loss after a SCI. There is Level 2 evidence that FES-cycling did not improve or maintain bone at the tibial midshaft in the acute phase. There is Level 4 evidence that walking and standing in the acute phase did not differ from immobilization for bone loss at the tibia.

Short term (6 weeks) therapeutic ultrasound is not effective for preventing bone loss after a SCI. FES-cycling does not improve or maintain bone at the tibial midshaft in the acute phase.

9.5.2 Non-Pharmacologic Therapy: Treatment In this section, non-pharmacological rehabilitation treatment modalities are divided into 4 subsections: Patterned electrical stimulation (PES), functional electrical stimulation (FES) cycle ergometry, standing and walking (Tables 5-7). Both PES and FES use cyclical patterns of electrical stimulation that simulate muscular activity. However, FES is directed towards the attainment of purposeful tasks such as cycling or walking. PES, on the other hand, is focused on producing muscle contractions (isometric, isotonic). In some applications, PES techniques are used as a training stimulus to prepare muscles for a subsequent FES training condition.

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9.5.2.1 Electrical Stimulation Table 9.5 Treatment Studies Using Electrical Stimulation for Bone Health after SCI
Author Year; Country Score Research Design Total Sample Size Methods Population: 14 men and women, ages 2342, complete and incomplete injuries between C5-T6, 14 able-bodied controls. Treatment: PES. Quadriceps training was conducted 5 days/wk for 24 wks. Participants trained for 1hr/day or until fatigue. Right quadriceps were stimulated with no resistance (but against gravity) while the left quadriceps were stimulated against a resistance. Outcome measures: BMD by DXA Population: 12 men and women, ages 1963, para/tetraplegia, complete/incomplete, no controls (only 9 participants had BMD) Treatment: PES. Each participant trained for a total of 36 sessions (3x/wk for 12wks) using a progressive intensity protocol for PES stimulated knee extension. This progression was continued to a maximum 15 kg load. Outcome measures: BMD by DXA Population: 10 men and women, ages 2745, injuries either C6 or T2, no controls Treatment: PES. Stimulated the legs for 30 min, 3x/wk for 12 mos. followed by 1x/wk for 6 mos. Outcome measures: BMD by DXA, biochemical markers. 1. Outcome At baseline BMD from the experimental group was lower at the distal femur, proximal tibia and midtibia (↓ range: 25.8% to 44.4%) than able-bodied controls. ↑ BMD with training (p<0.05) for both sides of SCI participants, but the type of training had no effect (resistance vs. no resistance). There was a significant ↑ in the BMD of the distal femur and proximal tibia, but not in the mid-tibia. Tibial BMD was not significantly changed after PES protocol (p>0.05), but BMD was better than predicted values.

Bélanger et al. 2000; Canada PEDro=11 Prospective Controlled Trial N=28

2.

1.

Rodgers et al. 1991; USA Downs & Black score=10 Pre-post N=12

1.

Mohr et al. 1997; Denmark Downs & Black score= 9 Pre-post N=10

2. 3.

After 12 mos. of training, there was a significant 10%↑ in proximal tibia BMD (p< 0.05) but no change at the lumbar spine or femoral neck. After 6 mos. of reduced training, BMD for the proximal tibia returned to baseline. Blood and urine markers were within normal limits at baseline and there was no significant change with PES.

Discussion Although there were no randomized controlled trials that assessed the effect of patterned electrical stimulation, Bélanger et al. (2000) produced impressive results with a level 2, nonrandomized trial which used 1 limb as the treatment and the other as the control limb. Following training, the BMD recovered 30% of bone loss compared with able-bodied values. Stimulation effects only occur over the areas of stimulation and return to baseline within months once stimulation is stopped (Mohr et al. 1997). Conclusion There is Level 2 evidence that electrical stimulation either increased or maintained BMD over the stimulated areas.

Electrical stimulation can maintain or increase BMD over the stimulated areas.

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9.5.2.2 FES Cycle Ergometry Table 9.6 Treatment Studies Using FES Cycle Ergometry for Bone Health after SCI
Author Year; Country Score Research Design Total Sample Size

Methods
Population: 15 men, ages 23-37, complete, C6-T8. 15 able-bodied controls Treatment: FES-cycle ergometer. Participants performed FES-cycling exercises with minimal resistance for 30 minutes/day, 5 days/week for 6 months. Follow-up 6 months after intervention. Outcome measures: BMD by DXA 1. 2.

Outcome At baseline, participants’ BMD at the femoral neck, distal femur and proximal tibia was lower than controls. After 6 months, BMD of the distal femur and proximal tibia ↑ significantly (p<0.05) and BMD of the calcaneus (p>0.05) showed a trend toward increasing. BMD in the distal femur, proximal tibia, and heel ↓ significantly after 6 mos. without intervention (p<0.05). The BMD of the femoral neck ↓ progressively throughout the treatment (p>0.05). The BMD of the proximal femurs were below normal before commencing exercise intervention (compared with matched able-bodied individuals). After 7 months of exercise training there was no significant difference in BMD for any of the sites of the proximal femurs compared to normal values. At baseline, SCI participants were not significantly different from agedmatched able-bodied ambulatory men for lumbar-spine BMD. However, BMD was significantly lower for participants at the hip (p<0.025) for bilat trochanters, Wards triangles, and femoral necks. Only the L2-L4 values demonstrated any positive training effects (p=0.056). Further training (Phase 3b) did not demonstrate further increase in BMD at any site. No significant change in lumbar spine and femoral shaft and/or distal tibia trabecular BMD after the intervention.

Chen et al. 2005; Taiwan Downs & Black score= 9 Pre-post N=30

Leeds et al. 1989; USA Downs & Black score=12 Pre-post N=6

BeDell et al. 1996; USA Downs & Black score=10 Pre-post N=12

Pacy et al. 1988; UK Downs & Black score=10 Pre-post N=4

Hangartner et al. 1994; USA Downs & Black score= 9 Pre-post N=15

Population: 6 men, ages 18-27, tetraplegia, no controls. Treatment: FES+ FES-cycle ergometer. 1month quads strengthening exercise, followed by 6-mos cycle ergometry (CE). Knee extension sessions were 45 lifts/leg 3x/week for 1month. CE sessions were 3X/wk up to 30 mins for 6 mos. Outcome measures: BMD by DXA Population: 12 men, ages 23-46, complete injuries between C5-T12, no controls. Treatment: FES+ FES-cycle ergometer. Participants participated in a 3-phase training program of FES-CE. Phase 1: quads strengthening. Phase 2: FES-CE progression until 30 min continuously. Phase 3a: 24x 30-mins continuous exercise sessions performed 3x/wk. Phase 3b: An extra 24x 30-min sessions adding simultaneous arm ergometry (8 participants only). Outcome measure: BMD by DXA Population: 4 men, ages 20-35, paraplegia, no controls Treatment: FES+ FES-cycle ergometer. Part 1 was quads strengthening with ↑ load ranging from 1.4-11.4 kg bilateral for 15 mins for 5x/wk (10 wks). Part 2 was CE at 50 rpm with resistance (0-18.75 W). Performed for 15 mins, 5x/wk (32 wks). Outcome measures: BMD by DXA Population: 15 men and women, ages 1746, complete and incomplete injury between C5-T10, no controls. Treatment: FES+ FES-cycle ergometer. Either 1. FES knee extension exercises (n=3) or 2. FES cycling (n=9) or 3. both (n=3). Sessions were 3x/week for 12 wks except Group 3 had 24 weeks. Outcome measures: CT

1.

2.

1.

2.

1.

1.

Participants in the exercise groups continued to lose bone at the distal and proximal end of the tibia, but it was less than expected from the regression lines.

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Discussion For FES-Cycling there are mixed results for bone parameters. One study found an 11-13% increase in BMD at the proximal tibia or distal femur while there was no significant withinparticipant BMD change in 3 pre-post studies. The FES-cycling study which reported a positive effect on bone parameters used a protocol that was 3 sessions/week for at least 6 months in duration, increased bone parameters were over areas directly affected by stimulated muscles (e.g. quads, distal femur and proximal tibia), and FES-cycling intervention needed to be maintained or bone gains were lost. FES shows promise as an effective treatment; however the limited availability of cycle ergometry for home or longitudinal use may limit its generalizibility if the therapy cannot be sustained outside a clinical trial scenario. Conclusion There is Level 4 evidence that 6 months of FES cycle ergometry increased regional lower extremity BMD over areas stimulated amongst paraplegics.

Six months of FES cycle ergometry may increase lower extremity BMD over areas stimulated.

9.5.2.3 Standing Table 9.7 Treatment Studies Using Standing or Walking for Bone Health after SCI
Author Year; Country Score Research Design Total Sample Size Methods Standing (n=4 studies) Population: 6 men, ages 36-65, complete and incomplete, C5-T12, no controls. Treatment: Passive standing frame. Increased gradually until able to "stand" 30 mins 3x/day. Progressed to 45 mins 2x/day then participants completed 45 mins of standing 2x/day for 5 mos. Outcome measures: BMD and fracture risk by DPA Population: 16 men and women, mean age=29, complete injuries, T4-T11, no controls. Treatment: Standing and ambulation. 32 sessions then participants continued ambulation for 8 more weeks. Outcome measures: BMD by DPA Population: 8 men and women, ages 1956, incomplete tetraplegia, no controls. Treatment: Tilt-table weight-bearing and strengthening exercises. Each tilt table session lasted at least 20mins 1x/day, and 0 the tilt table angle attained was ≥45 . Two groups: 1) early (within 6 mos of SCI) and 2) late group (12-18 mos post SCI). Outcome Measures: urinary calcium excretion Outcome

1.

Kunkel et al. 1993; USA Downs & Black score=12 Pre-post N=6

There was no significant change in fracture risk as measured with BMD for femoral neck or lumbar spine with "standing".

1.

Needham-Shropshire et al. 1997; USA Downs & Black score=10 Pre-post N=16

There were no significant changes in BMD in the femoral neck, Ward's triangle, or the trochanter.

1.

Kaplan et al. 1981; USA Downs & Black score= 8 Pre-post N=8

2.

Significant improvement (p<0.01) in calcium excretion, urinary calcium, and calcium balance for the early group. The late group had a significant improvement for urinary calcium, and calcium balance.

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Author Year; Country Score Research Design Total Sample Size

Methods Walking (n=2 studies) Population: Bone assessment with 2 men and 2 women, ages 16-42, paraplegia. no controls. Treatment: Reciprocal gait orthosis. No protocol provided. Quantitative computed tomography repeated every 6 mos from the 1st referral, orthotic fitting and training, to independent and regulator ambulation (mean=5 mo). The RGO was used daily on average for 3 hrs. Outcome measures: BMD by QCT Population: For bone assessment there were 6 men and 1 woman, ages 26-33, injuries between T2-T10. no controls. Treatment: RGO-II hybrid orthosis. Completed the protocol within 3-14 mos (2hr sessions 2x/wk). Outcome measures: BMD by DPA

Outcome

1.

Three of 4 participants increased or maintained femoral neck BMD but no change in lumbar spine.

Ogilvie et al. 1993; England Downs & Black score= 8 Pre-post N=4

1.

Thoumie et al. 1995; France Downs & Black score= 8 Pre-post N=7

2.

At baseline, participants (compared with age-matched Z-score) had no significant change in L-spine BMD but a ↓ in femoral neck BMD. After the training program (16 mos), no consistent changes at the femoral neck BMD among participants (4 participants ↓ BMD, 1 participant ↑ BMD and no change in 2 participants).

Discussion There is inconclusive evidence for Reciprocating Gait Orthosis (RGO), long leg braces or passive standing as a treatment for bone loss. One cross-sectional study (Goemaere et al. 1994) used a self-report physical activity measure to highlight the potential for standing to reduce bone loss at the femoral shaft; patients with long leg braces had a significantly higher trochanter and total BMD compared with standing frame or standing wheelchair. In contrast, another cross-sectional investigation of bone outcomes and self-report physical activity measures found no effect of activity on lower extremity bone parameters (Jones et al. 2002). Conclusion There is inconclusive evidence for Reciprocating Gait Orthosis (RGO), long leg braces, passive standing or self-reported physical activity as a treatment for low bone mass. There is inconclusive evidence for Reciprocating Gait Orthosis (RGO), long leg braces, passive standing or self-reported physical activity as a treatment for low bone mass.

9.6 General Discussion The risk for fragility fractures after a SCI has been established and low bone mass is an important factor to be considered. In 2002, the Canadian Medical Association published clinical practice guidelines for prevention and treatment of bone health (Brown et al. 2002). Currently, these guidelines do not specifically address persons with spinal cord injury, but they do provide a resource for osteoporosis diagnosis, prevention and treatment. Hopefully future guidelines will provide recommendations for people who have paralysis such as after a stroke, SCI, multiple

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sclerosis or other neurological impairments that lead to reduced weight-bearing, muscle activity and physical activity levels. In the past 40 years there have been a number of interventions (both medications and rehabilitation modalities) aimed to maintain or retard bone loss after SCI yet, consistent methodological oversights have emerged including: small sample sizes and broad inclusion criteria that do not always account for gender, time since injury or impairment differences between participants. The pharmacological interventions (either prevention or treatment interventions) discussed here report stronger methodologies— all were RCTs with PEDro scores ranging from 6-10 indicating moderate to high quality. In contrast, the studies employing rehab modalities had low numbers of participants and only 2 of the 17 studies were RCTs. These factors contribute to difficulties drawing generalisible conclusions regarding the impact of rehab interventions on bone parameters. Nonetheless, despite the lack of evidence to establish the effectiveness of these rehab modalities on bone parameters, it does not negate these treatments as beneficial to other body systems. For example, FES-cycling may have small effects on bone, but this modality has been shown to have large effects on cardiovascular health (Jacobs & Nash 2004). There are a few key points to consider when interpreting the results from interventions designed to maintain and/or improve bone parameters after a SCI. These include biological differences in bone development and maintenance between men and women, the natural loss of bone with aging and the type of primary outcome measure used. Age-related changes affect both women and men but the pattern of change is different because estrogen plays such a dominant role in bone remodeling. Consequently in women, the loss of estrogen at the menopause initiates a rapid loss of bone that eventually slows but continues throughout life. Men do not experience the rapid phase of bone loss with aging rather, only the slower phase of bone loss is observed. Therefore, keeping in mind that bone is lost over time, a study that reports no significant difference in BMD between two time periods 6 months apart may be interpreted as positive because of the expected loss. Due to the nature of different primary outcomes (BMD by DPA, DXA or pQCT, urine or blood markers) it can be difficult to determine the level of evidence. When measuring parameters such as urine or blood biomarkers, studies of short duration may yield significant results. However, using imaging, cortical bone remodeling can take at least 6 months in order to observe changes within participants over time. Consequently, investigations that did not maintain an intervention for at least 6-months may not show changes, but, the results cannot be interpreted as negative. Importantly all primary outcomes for bone health after a SCI are surrogate measures, that is, there has yet to be a study published in this area that investigates the effect of an intervention (either pharmacological or non-pharmacological) on reducing fractures. Generally, these types of studies are too costly due to the large number of participants that would need to be enrolled and followed for a long time period. Consequently, the clinical significance of the interventions based on fractures for this population remains to be determined. Conclusion There is a significant risk for lower extremity fragility fractures after a SCI; the risk increases with gender, type and time since injury. Early assessment and ongoing monitoring of bone health is an essential element of SCI care. There is Level 1 evidence for the prevention and treatment of bone loss using medications, however, nonpharmacological evidence for preventing bone loss and treating bone health is limited by small studies, different treatment protocols, participant groups that are too heterogeneous, relatively short treatment sessions given the time required to detect

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improvements in bone parameters and variability with imaging technologies and measured regions of interest.

Early assessment and monitoring of bone mass after SCI are essential to identify low bone mass and risk for fragility fractures. Prevention with oral bisphosphonates (Tiludronate, Clodronate and Etidronate) may slow the loss of BMD early after SCI, but there is limited evidence that treatment with oral bisphosphonates maintains bone mass late after SCI. There is a lack of definitive evidence supporting non-pharmacological interventions for either prevention or treatment of bone loss after a SCI. 9.7 Summary There is Level 1 evidence that oral Tiludronate and Clodronate prevent a decrease in BMD of the hip and knee region with no adverse effects on bone mineralization in men with paraplegia. There is Level 1 evidence that oral Etidronate prevents a decrease in BMD of the hip and knee region in people with incomplete paraplegia or tetraplegia (ASIA D impairment) who return to walking within 3 months of the SCI. There is Level 1 evidence that Pamidronate 30 mg IV or 60mg IV four times per year is not effective for the prevention of BMD loss at the hip and knee region early after SCI in men and women who have motor complete paraplegia or tetraplegia. There is Level 1 evidence that Alendronate 10 mg daily and Calcium 500mg orally 3x/day is effective for the maintenance of BMD of the wrist, hip and knee region for men with paraplegia. For NON-PHARMACOLOGICAL PREVENTION of bone loss after a SCI: There is Level 1 evidence from one RCT that short-term (6 weeks) ultrasound is not effective for treating bone loss after a SCI. There is Level 2 evidence that FES-cycling did not improve or maintain bone at the tibial midshaft in the acute phase. There is Level 4 evidence that walking and standing in the acute phase did not differ from immobilization for bone loss at the tibia. There is Level 2 evidence that electrical stimulation either increased or maintained BMD over the stimulated areas. There is Level 4 evidence that 6 months of FES cycle ergometry increased regional lower extremity BMD over areas stimulated amongst paraplegics. There is inconclusive evidence for Reciprocating Gait Orthosis (RGO), long leg braces, passive standing or self-reported physical activity as a treatment for low bone mass.

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There is a significant risk for lower extremity fragility fractures after a SCI; the risk increases with gender, type and time since injury. Early assessment and ongoing monitoring of bone health is an essential element of SCI care. There is Level 1 evidence for the prevention and treatment of bone loss using medications, however, nonpharmacological evidence for preventing bone loss and treating bone health is limited by small studies, different treatment protocols, participant groups that are too heterogeneous, relatively short treatment sessions given the time required to detect improvements in bone parameters and variability with imaging technologies and measured regions of interest.

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References Bauman WA, Spungen AM, Wang J, Pierson RN Jr, Schwartz E. Continuous loss of bone during chronic immobilization: a monozygotic twin study. Osteoporos Int 1999;10:123-7. Bauman WA, Spungen AM. Body Composition in Aging: Adverse Changes in Able-Bodied Persons and in Those with Spinal Cord Injury. Top Spinal Cord Inj Rehabil 2001;6:22-36. Bauman WA, Wecht JM, Kirshblum S, Spungen AM, Morrison N, Cirnigliaro C, et al. Effect of pamidronate administration on bone in patients with acute spinal cord injury. J Rehabil Res Dev 2005;42:305-313. Bauman WA, Zhong YG, Schwartz E. Vitamin D deficiency in veterans with chronic spinal cord injury. Metabolism 1995;44:1612-6. BeDell KK, Scremin AM, Perell KL, Kunkel CF. Effects of functional electrical stimulation-induced lower extremity cycling on bone density of spinal cord-injured patients. Am J Phys Med Rehabil 1996;75:29-34. Belanger M, Stein RB, Wheeler GD, Gordon T, Leduc B. Electrical stimulation: can it increase muscle strength and reverse osteopenia in spinal cord injured individuals? Arch Phys Med Rehabil 2000;8:1090-1098. Bloomfield SA, Mysiw WJ, Jackson RD. Bone mass and endocrine adaptations to training in spinal cord injured individuals. Bone 1996;19:61-68. Brown JP, Josse RG; Scientific Advisory Council of the Osteoporosis Society of Canada. 2002 clinical practice guidelines for the diagnosis and management of osteoporosis in Canada. CMAJ 2002;12;167(10 Suppl):S1-34. Chappard D, Minaire P, Privat C, Berard E, Mendoza-Sarmiento J, Tournebise H, et al. Effects of tiludronate on bone loss in paraplegic patients. J Bone Miner Res 1995;10:112-118. Chen B, Mechanick JI, Nierman DM, Stein A. Combined calcitriol-pamidronate therapy for bone hyperresorption in spinal cord injury. J Spinal Cord Med 2001;24:235-240. Chen SC, Lai CH, Chan WP, Huang MH, Tsai HW, Chen JJ. Increases in bone mineral density after functional electrical stimulation cycling exercises in spinal cord injured patients. Disabil Rehabil 2005;27:1337-1341. Comarr AE, Hutchinson RH, Bors E. Extremity fractures of patients with spinal cord injuries. Am J Surg 1962;103:732-739. de Bruin ED, Frey-Rindova P, Herzog RE, Dietz V, Dambacher MA, Stussi E. Changes of tibia bone properties after spinal cord injury: effects of early intervention. Arch Phys Med Rehabil 1999;80:214-220. Demirel G, Yilmaz H, Paker N, Onel S. Osteoporosis after spinal cord injury. Spinal Cord 1998;36:822-5. Eser P, de Bruin ED, Telley I, Lechner HE, Knecht H, Stussi E. Effect of electrical stimulationinduced cycling on bone mineral density in spinal cord-injured patients. Eur J Clin Invest 2003;33:412-419. Freehafer AA. Limb fractures in patients with spinal cord injury. Arch Phys Med Rehabil 1995;76:823-827. Frey-Rindova P, de Bruin ED, Stussi E, Dambacher MA, Dietz V. Bone mineral density in upper and lower extremities during 12 months after spinal cord injury measured by peripheral quantitative computed tomography. Spinal Cord 2000;38:26-32. Frisbie JH. Fractures after myelopathy: the risk quantified. J Spinal Cord Med 1997;20:66-69. Garland DE, Adkins RH, Kushwaha V, Stewart C. Risk factors for osteoporosis at the knee in the spinal cord injury population. J Spinal Cord Med 2004;27:202-206. Garland DE, Adkins RH, Stewart CA, Ashford R, Vigil D. Regional Osteoporosis in Women Who Have a Complete Spinal Cord Injury. J Bone Joint Surg Am 2001; 83:1195-1200. Garland DE, Stewart CA, Adkins RH, Hu SS, Rosen C, Liotta FJ, Weinstein DA. Osteoporosis after spinal cord injury. J Orthop Res 1992;10:371-8. 9-16

Giangregorio LM, Hicks AL, Webber CE, Phillips SM, Craven BC, Bugaresti JM, et al. Body weight supported treadmill training in acute spinal cord injury: impact on muscle and bone. Spinal Cord 2005;43:649-657. Goemaere S, Van Laere M, De Neve P, Kaufman JM. Bone mineral status in paraplegic patients who do or do not perform standing. Osteoporos Int 1994;4:138-143. Griffiths HJ, Bushueff B, Zimmerman RE. Investigation of the loss of bone mineral in patients with spinal cord injury. Paraplegia 1976;14:207-12. Hancock DA, Reed GW, Atkinson PJ. Bone and soft tissue changes in paraplegic patients. Paraplegia 1979;17:267-71. Hangartner TN, Rodgers MM, Glaser RM, Barre PS. Tibial bone density loss in spinal cord injured patients: effects of FES exercise. J Rehabil Res Dev 1994;31:50-61. Jacobs PL, Nash MS. Exercise recommendations for individuals with spinal cord injury. Sports Med 2004;34:727-51. Jones LM, Legge M, Goulding A. Intensive exercise may preserve bone mass of the upper limbs in spinal cord injured males but does not retard demineralization of the lower body. Spinal Cord 2002;40:230-235. Kaplan PE, Roden W, Gilbert E, Richards L, Goldschmidt JW. Reduction of hypercalciuria in tetraplegia after weight-bearing and strengthening exercises. Paraplegia 1981;19:289-293. Kunkel CF, Scremin AM, Eisenberg B, Garcia JF, Roberts S, Martinez S. Effect of "standing" on spasticity, contracture, and osteoporosis in paralyzed males. Arch Phys Med Rehabil 1993;74:73-78. Lazo MG, Shirazi P, Sam M, Giobbie-Hurder A, Blacconiere MJ, Muppidi M. Osteoporosis and risk of fracture in men with spinal cord injury. Spinal Cord 2001;39:208-214. Leeds EM, Klose J, Ganz W, Serafini A, Green BA. Bone mineral density after bicycle ergometry training. Archives of Physical Medicine and Rehabilitation 1990;71:207-9. McKinley WO, Jackson AB, Cardenas DD, DeVivo MJ. Long-term medical complications after traumatic spinal cord injury: a regional model systems analysis. Arch Phys Med Rehabil 1999;80:1402-1410. Minaire P, Berard E, Meunier PJ, Edouard C, Goedert G, Pilonchery G. Effects of disodium dichloromethylene diphosphonate on bone loss in paraplegic patients. J Clin Invest 1981;68:1086-1092. Minaire P, Depassio J, Berard E, Meunier PJ, Edouard C, Pilonchery G, et al. Effects of clodronate on immobilization bone loss. Bone 1987;8 Suppl 1:S63-8. Mohr T, Podenphant J, Biering-Sorensen F, Galbo H, Thamsborg G, Kjaer M. Increased bone mineral density after prolonged electrically induced cycle training of paralyzed limbs in spinal cord injured man. Calcif Tissue Int 1997;61:22-25. Moran de Brito CM, Battistella LR, Saito ET, Sakamoto H. Effect of alendronate on bone mineral density in spinal cord injury patients: a pilot study. Spinal Cord 2005;43:341-348. Nance PW, Schryvers O, Leslie W, Ludwig S, Krahn J, Uebelhart D. Intravenous pamidronate attenuates bone density loss after acute spinal cord injury. Arch Phys Med Rehabil 1999;80:243-251. Needham-Shropshire BM, Broton JG, Klose KJ, Lebwohl N, Guest RS, Jacobs PL. Evaluation of a training program for persons with SCI paraplegia using the Parastep 1 ambulation system: part 3. Lack of effect on bone mineral density. Arch Phys Med Rehabil 1997;78:799-803. Nelson A, Ahmed S, Harrow J, Fitzgerald S, Sanchez-Anguiano A, Gavin-Dreschnack D. Fallrelated fractures in persons with spinal cord impairment: a descriptive analysis. SCI Nurs 2003;20:30-37. Ogilvie C, Bowker P, Rowley DI. The physiological benefits of paraplegic orthotically aided walking. Paraplegia 1993;31:111-115. Pacy PJ, Hesp R, Halliday DA, Katz D, Cameron G, Reeve J. Muscle and bone in paraplegic patients, and the effect of functional electrical stimulation. Clin Sci (Lond) 1988;75:481-487. 9-17

Pearson EG, Nance PW, Leslie WD, Ludwig S. Cyclical etidronate: its effect on bone density in patients with acute spinal cord injury. Arch Phys Med Rehabil 1997;78:269-272. Ragnarsson KT, Sell GH. Lower extremity fractures after spinal cord injury: a retrospective study. Arch Phys Med Rehabil 1981;62:418-423. Rodgers MM, Glaser RM, Figoni SF, Hooker SP, Ezenwa BN, Collins SR, et al. Musculoskeletal responses of spinal cord injured individuals to functional stimulation-induced knee extension exercise training. J Rehabil Res Dev 1991;28:19-26. Thoumie P, Le Claire G, Beillot J, Dassonville J, Chevalier T, Perrouin-Verbe B, et al. Restoration of functional gait in paraplegic patients with the RGO-II hybrid orthosis. A multicenter controlled study. II: Physiological evaluation. Paraplegia 1995;33:654-659. Vestergaard P, Krogh K, Rejnmark L, Mosekilde L. Fracture rates and risk factors for fractures in patients with spinal cord injury. Spinal Cord 1998;36:790-796. Warden SJ, Bennell KL, Matthews B, Brown DJ, McMeeken JM, Wark JD. Efficacy of lowintensity pulsed ultrasound in the prevention of osteoporosis following spinal cord injury. Bone 2001;29:431-436. Zehnder Y, Luthi M, Michel D, Knecht H, Perrelet R, Neto I, et al. Long-term changes in bone metabolism, bone mineral density, quantitative ultrasound parameters, and fracture incidence after spinal cord injury: a cross-sectional observational study in 100 paraplegic men. Osteoporos Int 2004;15:180-189. Zehnder Y, Risi S, Michel D, Knecht H, Perrelet R, Kraenzlin M, et al. Prevention of bone loss in paraplegics over 2 years with alendronate. J Bone Miner Res 2004;19:1067-1074.

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CHAPTER TEN
Depression Following Spinal Cord Injury
Steven Orenczuk, PsyD Jim Slivinski, MA Robert W Teasell, MD FRCPC

Key Points Depression is a common consequence of SCI. Despite methodological challenges, our understanding of post-SCI depression, treatment, and associated psychological conditions is growing. Cognitive behavioural interventions provided in a group setting appear helpful in reducing post-SCI depression and related difficulties. The benefits of drug treatment for post-SCI depression are largely extrapolated from studies in non-SCI populations. Programs to encourage regular exercise, reduce stress, and improve or maintain health appear to have benefits in reducing reports of depressive symptoms in persons with SCI.

Table of Contents
10.1 Introduction ..................................................................................................................10-1 10.2 Prevalence of Depression Post-SCI ...........................................................................10-2 10.3 Interventions for Treatment of Depression following SCI........................................10-4 10.3.1 Cognitive Behavioural Therapy...................................................................................10-4 10.4 Pharmacotherapy for Treatment of Depression in SCI ..........................................10-10 10.5 Other Treatments for Depression following SCI .....................................................10-11 10.6 Summary.....................................................................................................................10-16 References............................................................................................................................10-17

This review has been prepared based on the scientific and professional information available in 2005. The SCIRE information (print, CD or web site www.icord.org/scire) is provided for informational and educational purposes only. If you have or suspect you have a health problem, you should consult your health care provider. The SCIRE editors, contributors and supporting partners shall not be liable for any damages, claims, liabilities, costs or obligations arising from the use or misuse of this material. Orenczuk S, Slivinski J, Teasell RW (2006). Depression Following Spinal Cord Injury. In: Eng JJ, Teasell RW, Miller WC, Wolfe DL, Townson AF, Aubut J, Abramson C, Hsieh JTC, Connolly S, editors. Spinal Cord Injury Rehabilitation Evidence. Vancouver, p 10.1-10.19. www.icord.org/scire

Depression Following Spinal Cord Injury
10.1 Introduction Practitioners providing clinical rehabilitation services to individuals who have suffered catastrophic injuries and illnesses focus much interest on the issue of psychological adjustment. This chapter summarizes evidence garnered from SCI research that investigates the treatment of post-SCI depression and other psychosocial factors potentially affecting successful recovery. Though as yet quite limited, these findings can assist in developing a foundation for evidencebased practice, and hopefully lead to improved and more consistent care. It should be emphasized however that evidence-based practice constitutes more than the routine use of treatments supported by the best research evidence available. Such practice also necessitates that the practitioner employ his or her clinical judgment in determining the applicability of such research conclusions to the treatment provided each patient (APA 2005). Concerns regarding “depression” are commonly reported by SCI survivors, staff, or their families. Indeed, Elliott and Umlauf (1995) report that depression is the most frequently researched psychological issue in individuals who have sustained a SCI. Given the innumerable modifications necessitated following a SCI, an individual will likely encounter repeated strains upon their available coping resources. The occurrence of depression is not a surprising outcome of such challenges (Kemp et al. 2004) and some early investigators have described it as an “inevitable” outcome (e.g. Hohmann 1975). Of added concern, rates of suicide average approximately 3 to 5 times that reported in the general population (e.g. DeVivo et al. 1989; Charlifue & Gerhart 1991; Hartkopp et al. 1998) and stand in contrast to the reductions achieved in other preventable causes of death following SCI (e.g. septicemia, respiratory illness, diseases of the urinary system) (Soden et al. 2000). The term “depressed mood” refers to a state of dysphoria that occurs routinely and is a normal process (Elliott & Frank 1996). In contrast, a diagnosable “depressive syndrome” refers to a constellation of observable affective, cognitive and neurovegetative symptoms of sufficient frequency and severity to negatively impact upon an individual’s functioning. The Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR 2000) is a frequently cited classification system for establishing diagnoses of various depressive and other mental disorders. For example, a diagnosis of Major Depressive Disorder in an adult requires at least a two-week period of five or more symptoms, with at least one either depressed mood or a loss of interest or pleasure in almost all activities. Further, symptoms may include weight changes, changes in sleep, psychomotor agitation or retardation, fatigue, feelings of worthlessness or guilt, indecisiveness or decreased concentration, and/or thoughts of death or suicide. Symptoms together must result in an impairment in functioning (social, occupational or other) and are not due to the direct physiological effects of a substance or medical condition. Identifying depression is often more difficult than might be anticipated. Even rehabilitation staff have been shown to overestimate it in inpatient populations (Cushman & Dijkers 1990) while underestimating patients’ reported coping ability and mental health (Siosteen et al. 2005). Similarly, the life satisfaction and well-being of persons in the community with complete tetraplegic injuries (including those who required ventilator support) was also shown to be underestimated by health care professionals (Bach & Tilton 1994).

10-1

Various methodological issues have “served to constrain” the study of depression in the SCI population (Elliott & Frank 1996). The use of ambiguous definitions and the unclear or inconsistent use of diagnostic criteria are two of many such challenges. Others issues include a lack of theoretical models, selection biases, and limited longitudinal studies. How best should the occurrence of depression be viewed in the process of adjustment to SCI? Anecdotal models of adjustment have incorporated the “clinical lore” that depression was to be universally anticipated soon after injury (Elliott & Kennedy 2004), and demonstrating the individual’s rational acceptance of the permanence of the injury and associated losses (Frank et al. 1985). Taken further, those individuals who do not evidence depression were often considered to be in “denial” and potentially vulnerable to a more precarious adjustment (e.g. Siller 1969). Accordingly, it had been also proposed that depression be induced to encourage appropriate grieving (Nemiah 1957). Indeed both the universality and the benefits of depression in the adjustment process have since come into question by investigative findings (e.g. Howell et al. 1981; Judd et al. 1986). Given the many negative outcomes associated with depression post injury (e.g. longer hospitalization, decreased longevity, increased rates of suicide, reduced health, daily functioning, limited community participation) it is likely best viewed as a secondary complication or sequelae rather than an adaptive process facilitating overall emotional adjustment (Consortium for Spinal Cord Medicine 1998). Contrary to expectations, Kemp et al. (2004) note that depression is not simply a necessary consequence of sustaining a spinal cord injury – not all who sustain a spinal cord injury become depressed. Tirch et al. (1999) used several self-report depression scales in a study of 11 pairs of monozygotic twins where one of the pair had sustained a SCI. The SCI and non-SCI cotwins did not differ significantly in their self-reports, lending additional support to the view that SCI does not inevitably lead to increased depression. Further, there is little relationship between depression and the level of SCI or the completeness of the lesion (Kemp et al. 2004). As an example, Hall et al. (1999) sampled 82 individuals with C1-4 quadriplegia between 14 and 24 years post injury, and these individuals reported their self-esteem and quality of life to be high – with 95% feeling they were “glad to be alive”. In reality, it appears more likely that depression post-SCI is a function of difficulties coping with the multiple environmental, social and health related problems that follow. If depression is not inevitable following SCI, then it is noteworthy that depression is related to modifiable factors that play a role in its development and maintenance (Kemp et al. 2004). Elliott and Shewchuk (2000) note that an individual’s primary concerns soon after injury (i.e. restorative and curative therapies) tend to change over time, with those with SCI becoming increasingly interested in addressing social and interpersonal barriers as well as age-related health issues. In a summary of the extant adjustment literature, Elliott and Rivera (2002) review a model determining psychological well being and physical health post-SCI. The components include demographics, injury characteristics, preinjury behaviours and psychopathology, personality factors, social/environmental factors and styles of appraisals. The authors highlight how the consequences of physical disability exist within a larger context and that changes in public and health policies can dramatically impact post-injury quality of life. 10.2 Prevalence of Depression Post-SCI Estimates of the prevalence of depression are affected by the nature of the measures used, how depression is defined, and when symptoms are assessed post injury. The common research practice of employing self-report measures is both convenient and cost-effective.

10-2

However, the resulting prevalence rates may reflect subjective anxiety and overall distress rather than symptoms specific to depression, per se. In clinical practice, self-report measures may serve to alert the clinician to the need for additional evaluation. Depression rates post-SCI range from 16-30%, with up to 25% of men and 47% of women (Consortium for SCI Practice Guideline 1998). Krause et al. (2000) suggest a rate of depression of 42% overall with a 21% probable rate of major depression – indicative of a 4-fold increase of depressive disorders among individuals with SCI compared with samples of nondisabled individuals. In an Italian sample averaging 6 years post-SCI, Scivoletto et al. (1997) found 16% reported significant symptoms of depression and 13% of anxiety. In a 6-year follow-up study of 233 Albertans with SCI, 28.9% were treated for depression following their traumatic spinal cord injuries, with approximately 59% of these individuals beginning treatment during their initial hospitalization (both acute and rehabilitation admissions). An additional 10% of people were treated during the remainder of the first year. This exceeded depression treatment rates reported in able-bodied controls (approximately 11%) (Dryden et al. 2004), with those at highest risk reporting permanent neurological deficit, a preinjury history of depression, or substance abuse (Dryden et al. 2005). Kennedy and Rogers (2000) reported that anxiety, depression and hopelessness gradually increased beginning at week 30 post injury and continued until discharge from rehabilitation (week 48). At that point 60% of SCI clients scored above a clinical cut-off for depression (i.e. Beck Depression Inventory). It has been questioned whether, despite its reported prevalence, efforts to improve the detection and treatment of depression in individuals with SCI have improved (Bombardier et al. 2004). In an editorial comment, Faber (2005) expressed concern that given possible underestimates, about half of all persons hospitalized for traumatic SCI may benefit from treatment for depression. Similarly, while a substantial percentage of their SCI clinic sample reported symptoms suggestive of major depression, Kemp and Krause (1999) found that none were receiving treatment (psychotherapy or medications). Bombardier et al. (2004) surveyed over 800 SCI survivors at one-year post injury. Using the Patient Health Questionnaire – 9, a self-report screening measure, 11.4% met criteria for DSMIV major depressive disorder. Interestingly, the results supported an “inclusive” approach to diagnose MDD, one that suggests somatic symptoms such as appetite changes, sleep disturbance, and poor energy should be included in identifying MDD in those with SCI. As noted, concerns regarding depression post-SCI are frequently cited in the literature. Data obtained in earlier studies has also suggested that in newly injured persons who met a criteria for major and minor depression, many may remit within 3 months of onset (Kishi et al. 1994) and that the frequency of reported problems decreases over the first year (Richards 1986). Conclusion While not universal, for many persons with spinal cord injury, depression can be a complication that poses a significant impediment to their functioning and adaptation. Identifying depression can be difficult, but is most likely to develop during the initial year post injury. Self-report measures should be viewed as screening tools to alert the clinician to arrange a more thorough evaluation. Depression is a common consequence of SCI.

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10.3 Interventions for Treatment of Depression following SCI The American Psychological Association (APA 2005) states that evidence-based practice involves the integration of the best of existing research with clinical expertise and the reality of the patient’s needs and wishes. However both the exigencies of the SCI population and practical concerns limit the nature of SCI research topics and designs. Specific to the issue of depression, Elliott and Kennedy (2004) have questioned whether the current “glaring lack of intervention data” reflects a lack of interest by consumers, researchers and funding agencies to examine the effects of various interventions for depression in those with SCI. Difficulties inherent in conducting intervention studies are numerous (King & Kennedy, 1999). The SCI population can be varied. Most sites do not have access to a large number of patients, thus obtaining treatment and appropriate control groups becomes difficult and would likely require the participation of multiple sites. Also, ethical concerns over providing the best possible care to all SCI patients are obvious, so that withholding aspects of treatment in order to establish control conditions is not acceptable. Current research strategies frequently use selfreport screening measures (e.g. Beck Depression Inventory, Zung Depression Inventory, Patient Health Questionnaire-9, Center for Epidemiological Studies – Depression Scale), and while they offer many benefits (e.g. low cost, quick, easy to complete), they require further evaluation to support a diagnosis of depression. Typical SCI interventions to encourage adjustment are often multi-faceted, thereby posing difficulties in identifying which combination of components can offer optimal care for any particular patient. Further, psychosocial interventions cannot be independent of other aspects of care (e.g. medical, rehabilitation). In addition, many pre-morbid psychological and historical influences are very difficult to determine. As many SCI studies lack one or several aspects of “gold standard” research, the generalizability of the findings may be limited. Despite these challenges, researchers have made invaluable clinical contributions using smaller groups, non-randomized control groups, or controls chosen from historical data. In summarizing the limited research currently available however, Elliott and Kennedy (2004) suggest “we have many untested assumptions regarding the available treatments for depression among persons with SCI”. Conclusion Despite methodological challenges, our understanding of post-SCI depression, treatment, and associated psychological conditions is growing.

10.3.1 Cognitive Behavioural Therapy In the SCI population, the application of cognitive behavioural therapy (CBT) approaches to aid in the management of anxiety and depression is described as a prudent choice given its demonstrated effectiveness in a wide range of disorders (Craig et al. 1997). CBT strategies can include addressing “irrational” or negative thoughts, increasing opportunities for participating in rewarding activities, and instruction in relaxation, among others. Within this context, issues of assertiveness, social skills and discussions of sexuality have also at times been included to address the unique concerns of SCI individuals. Employing a group setting to provide CBT can also be a cost effective opportunity for peer support, practice of social skills and the opportunity for gaining additional viewpoints. Several authors have described the effects of group CBT

10-4

interventions for individuals following SCI to reduce psychological distress and/or provide “immunization” against future difficulties. Table 10.1 CBT Group Interventions
Author Year; Country Score Research Design Total Sample Size Methods Population: 27 treatment gr, 31 controls. Intervention: 10 week program. Small groups (4-5 per group), for 1.5 hours per week. Major aim was to provide cognitive and behavioural skills to cope with the psychological and social difficulties encountered upon entering the community. Cognitive behavioural therapy included muscle relaxation, visualization techniques, self-hypnosis and cognitive restructuring, social skills and assertiveness training, and sexuality sessions. Outcome Measures: State-Trait Anxiety Scale (STAIC); Beck Depression Inventory (BDI) scale. 1. Outcome No significant differences were noted across time for anxiety but there were significant differences noted for depression overall, (p<0.05). Both the treatment and the control groups appeared to be less depressed 1 and 2 yrs after injury. For individuals who scored high on the depression scale before therapy, (9 from each group) there were significant differences after treatment. (p<.01) with the control group reporting higher levels of depressive mood. Depressive mood scores showed significant differences across time (p<0.01) with scores 1 and 2 years post injury were significantly lower than pretreatment scores (p<0.01). Those that scored high on the anxiety scale (n=19 in total), there were significant differences in scores overall across time (p<0.1) with anxiety scores decreasing over time.

2. 3.

Craig et al. 1998a; Australia Downs & Black score=21 Prospective Controlled Trial (Continuation of Craig et al. 1997) Initial N=69; Final N=58

4.

5.

King & Kennedy 1999; UK Downs & Black score=20 Pre-post Initial N=38; Final N=38

Population: Ages:16 –65; new injured Intervention: Consisted of 60-75 minute session run twice a week in small groups of 6 to 9 people. Sessions included a mixture of didactic presentations, practical exercises and time allocated for open group discussions. Following components made up the program: appraisal training, cognitive behavioural coping skills training, and strategies for choosing an adaptive match between appraisal and coping skills, and obtaining and maintaining social support. Outcome Measures: Functional Independence Measure, Social Support Questionnaire, Beck Depression Inventory, State Anxiety Inventory, COPE (for coping).

Kennedy et al. 2003; UK Downs & Black score=19 Pre-post Initial N=85; Final N=85

Population: Ages 16-65 years, newly injured traumatic SCI. Intervention: consisted of 7, 60-75 minutes sessions that ran twice a week in small groups of 6-9 participants. Session topics were: normalizing stress, appraisal

Pre-intervention comparisons of groups: 1. On the coping scale two items (religion and humor) showed significant differences, Religion (intervention group mean score was higher, p<0.05). 2. Humor (control group mean higher, p<0.05). There were no preintervention differences between the groups on range of injury, social support, FIM scores, coping, depression or anxiety. Post-intervention comparison of groups: 1. Depression and Anxiety: Across time there were significant decrease in the depression scores (p<0.05) but not for anxiety (p=ns). 2. Coping: No significant differences between the groups or across time. Pre-intervention comparisons of groups: 1. Intervention group was older more likely to have a complete injury and to have been injured longer than the control group (p<0.01).

10-5

Author Year; Country Score Research Design Total Sample Size

Methods skills, problem solving, examination of thoughts feeling and behavior, awareness of negative assumptions, and choosing appropriate ways both to cope and to increase social supports. Outcome Measures: State Anxiety Inventory, Beck Depression Inventory, Coping Strategies Scale, Self Perception Scale, and Functional Independence Measure. Measures were taken before and immediately after the intervention, and at a 6wk follow-up with the intervention group, and every 6 weeks with the historic control group. 2.

Outcome Intervention group tended to use active and religious coping strategies (p<0.05). 3. Intervention group tended to use drugs/alcohol less frequently (adjusted for unequal variance p<0.05). Post-intervention comparison of groups: 1. Overall the intervention was successful in decreasing both depression and anxiety. 2. Mood: depression scores decreased for the intervention group following the intervention (p=0.001). 3. Anxiety: decreased for the intervention group following the intervention (p=0.001). 4. Coping: alcohol use was significantly lower for the intervention group, (p=0.003). 5. Self perception scale: intervention group only-ideal self scores had significantly greater scores than either how they would see themselves without injury (p<0.05) or “as I am” on all items (p<0.001). Percentages are reported for each area measured. 1. Re-admission: More control were readmitted following discharge (X²=3.93, P<0.05). 2. Drug usage: Controls were found to have higher self-reported drug usage than the treatment group (cases) (X²=4.12, P<0.05). 3. Relationships and Social discrimination: No significant differences were noted between the two groups in relation to the types of relationship each person developed. 4. Self-reports of adjustment: Treatment groups said they had a higher number of persons who felt they had adjusted well compared to the controls. (X²=12.0, P<0.01). 1. No pre-treatment differences between the treatment and the control groups on LCB (t=0.686). 2. No significant differences were found between groups overall for locus of control as a result of treatment (F1.67 = 0.928). 3. No significant differences occurred across time for LCB (F3.201 = 2.07). 4. No significant interactions present between group and time (F3.201 = 0.199). 5. A repeated measure MANOVA was

Craig et al. 1999; Australia Downs & Black score=18 Case Control (Continuation of Craig et al. 1997) Initial N=58; Final N=58

Population: Gender: m=57, f=12, age: 1673yrs, SCI (new injured), 68%-71% complete injury. Intervention: 10 weeks in small groups. Each session lasted from 1.5 to 2 hours replacing normal rehab therapy. Patients underwent cognitive behaviour therapy (CBT) attempts to change behaviour and feeling associated with the problem and considered maladaptive. Main aim of the program was to provide cognitive and behavioural skills to cope with the psychological and social difficulties encountered upon entering the community (as described above). Outcome measures: Re-admissions, drug usage, relationships, social discrimination, self-reports of adjustment Population: Gender: m=57, f=12, age: 1673yrs, SCI (new injured), 68%-71% complete injury. Intervention: 10 week program. Small groups (4-5 per group), for 1.5 hours per week. Major aim was to provide cognitive and behavioural skills to cope with the psychological and social difficulties encountered upon entering the community. Cognitive behavioural therapy included muscle relaxation, visualization techniques, self-hypnosis and cognitive restructuring,

Craig et al. 1998b; Australia Downs & Black score=17 Prospective Controlled Trial (longitudinal) (Continuation of Craig et al. 1997) Initial N=69; Final N=58

10-6

Author Year; Country Score Research Design Total Sample Size

Methods social skills and assertiveness training, and sexuality sessions. Outcome Measures: Locus of Control of Behaviour Scale (LCB), and the Beck Depression Inventory (BDI) scale.

Outcome completed on participants (n=26) who scored higher than 33 on the LCB. 6. Significant differences were noted between the two groups (F1.23 = 4.94, p<0.05). 7. Across time there was a significant reduction in LCB scores across time. (F1.69 = 7.33, p<0.05). 8. Post hoc Scheffe tests indicated posttreatment scores to be lower than pretreatment scores (p<0.01). 9. A significant association was found between depressive mood and locus of control post-therapy, 1 year later and 2 years later. 10. For the control group locus of control was mildly associated with depressive mood and for the treatment groups locus of control was not significantly associated with depressive mood at anytime. 1. Significantly greater self-esteem for treatment group (t=3.18, df=67, p<0.01). Taking this into account, no significant differences between the groups were found immediately after injury or 1 year later. 2. No significant initial differences were found between the groups on anxiety F(1,67) =.47) and depression F(1,67)=.24 when comparing pre, post and 1-year scores. 3. BDI scores were significantly lower for both conditions one year after injury F (2,124) = 4.34, p=0.014. 4. Neither anxiety nor self-esteem scores improved significantly over the year. 5. Those who scored higher than 14 on the depressive mood scale were analyzed using repeated measures ANOVA. 22 persons (from both groups) were looked at. Significant differences were noted between the groups (F1, 20) =7.41, p<0.01). 6. Significant differences were also noted across time for the BDI scores. F (2, 40) =7.1, p<.01. Post hoc tests showed that the treatment group had significantly greater levels of improvement across time (p<0.05).

Craig et al. 1997; Australia Downs & Black score=15 Prospective Controlled Trial N=69

Population: Gender: m=57, f=12; age: 1673yrs; SCI (new injured); 68%-71% complete injury. Intervention: 10 week program. Small groups (4-5 per group), for 1.5 hours per week Provided cognitive and behavioural skills to cope with the psychological and social difficulties encountered upon entering the community. Cognitive behavioural therapy included muscle relaxation, visualization techniques, selfhypnosis and cognitive restructuring, social skills and assertiveness training, and sexuality sessions. Outcome Measures: State-Trait anxiety Inventory (STAIC); Beck Depression Inventory (BDI) scale, Rosenberg SelfEsteem scale.

Discussion In Australia, Craig et al. reported several investigations (1997, 1998a, 1998b, 1999) employing a 10 week CBT based group treatment format involving newly injured SCI rehabilitation inpatients with permanent injuries. They developed a CBT based treatment protocol implemented by a

10-7

psychologist and an occupational therapist. Treatment groups consisted of 4-5 individuals and sessions approximated 1.5 to 2 hours weekly. A matched control group of SCI patients received traditional rehabilitation services. Measures of depression, anxiety and self-esteem were completed when individuals were no longer immobilized in bed, after conclusion of therapy (3 months post-injury) and at one year post injury. Prior to treatment, the treatment group reported greater self-esteem than did controls, but did not differ on other outcome measures. Anxiety did not change over time. Both treatment and control groups reported fewer symptoms of depression at 12 months post injury. Taking into account pretreatment group differences in selfesteem, there was no significant improvement over time for either group. Given that neither group had high levels of depressive mood before treatment, a further analysis of those with elevated scores on depression revealed that the mean score for the treatment group (n= 10) showed improvement after treatment and further gains one year later. Controls (n = 12) who were moderately to severely depressed initially remained at these levels over the year. Patients with initially high levels of anxiety (in either condition) showed symptom decreases over the year, with a trend for those in the treatment group to improve more so than did those in the control group. CBT did not significantly impact upon self-esteem in individuals with recent onset SCI. The authors conclude that clinicians servicing SCI rehabilitation wards should evaluate individuals soon after admission to identify those with high levels of depression and/or anxiety and then recommend CBT. Further, not all persons with SCI are depressed, anxious or low in self-esteem, and may not require intervention. In a follow-up report, Craig et al. (1998a) surveyed a subset of the SCI CBT treatment group participants and SCI controls (noted above) at 24 months post injury. Group differences were not significant for measures of depression and anxiety. At 1 and 2 years post injury, subjects were less depressed but levels of anxiety were essentially unchanged. For those subjects with elevated depressive symptoms prior to treatment, levels of depression over the long term were lower for the treatment than the control group. Differences over time were also noted, with the short-term improvements in the depressive symptoms of the treatment group maintained over the two-year period. In contrast, controls did not show improvement in the short term and were only slightly improved after 1 to 2 years. Interestingly, the authors report that none of the treatment group had sought further treatment for depression between the 12 and 24-month period. Both groups became less anxious over time. The small number of subjects precluded identification of significance, but an inspection of the data revealed that the treatment group lowered their elevated anxiety scores to within the normal range at two years, while the control subjects’ scores averaged approximately one standard deviation above general population norms. The authors conclude that not all individuals with recent onset SCI require specialized psychological intervention. For those with elevated levels of reported depression and anxiety, these symptoms hypothetically could return to normal levels in the absence of intervention. However, such improvements could require a protracted period and result in both increased health costs and a diminished quality of life. This study further suggests the merits of screening and ongoing benefits of an intervention program. In a related study, Craig et al. (1998b) used the Locus of Control Behaviour Scale (LCB) to assess subjects’ perceptions that circumstances were within or beyond their control. No treatment differences were found when comparing SCI CBT group participants and controls over a two-year post injury period. Both groups averaged scores in the range suggestive of a more internal rather than external orientation. When subjects with scores suggestive of an external locus of control scores were identified (9 treatment subjects and 16 controls), the treatment group showed a significant reduction in externality over time while controls did not. The finding supports the conclusion that CBT was effective for those in the treatment group who perceived living with a SCI (and related concerns) to be out of their control. Associations of 10-8

locus of control scores and depressive mood (Beck Depression Inventory) almost all reached significance for the control group when assessed pre treatment, post treatment, and at one and two year intervals. In contrast, no associations were evident between LCB scores and reports of depressive symptoms in SCI treatment subjects, even for those who were external in their perceptions prior to participation in the CBT group. The authors speculated that CBT “positively interfered in the determination of depressive mood”. While there may be a substantial group at risk for developing psychological difficulties following spinal cord injury, the majority did not show problematic levels of externality and helplessness. As such, the authors concluded that CBT for all SCI survivors is costly and unnecessary. Craig et al. (1999) continued a long term (2 years post injury) assessment of persons with SCI who previously participated in a non-randomized longitudinal controlled trial of CBT during their inpatient admission to a rehabilitation ward (1991-1992). These responses were compared with those of control subjects who received only traditional rehabilitation services during their hospital stay. Treatment subjects indicated 15% fewer hospital readmissions, 25% less drug use and much more often reported a positive adjustment than did controls. Of concern, approximately 40% of controls frequently used drugs. Forty three percent of controls reported that they had not adjusted well, while only one treatment subject held a similar view. Neither group reported the occurrence of suicide over the two years. Self-reports of adjustment were negatively correlated with Beck Depression Scale scores. The groups did not differ in the frequency of relationship breakups, with the majority of those married at the time of injury remaining so at two years. Further, about half who were unmarried had formed new relationships. The findings again are seen as suggesting benefits of CBT group treatment in encouraging positive adjustment following SCI. Two studies conducted at the National Spinal Cord Injuries Centre (NSCIC) in the UK investigated group Coping Effectiveness Training (CET). CET includes CBT, didactic, and practical elements. The first (King & Kennedy 1999) was a pilot study of CET, and the second (Kennedy et al. 2003) continued the work with additional subjects and measures. Both studies used matched historic controls from the NSCIC database, although there did remain some significant pre-intervention differences between groups. Results suggest that their intervention package produced a number of positive changes, including less depression and anxiety, less use of alcohol, and more positive self-perception. Participants said that they found the sharing of views and experiences and reviews of “real life” scenarios to be most valuable aspects of the group. In summary, this series of studies has demonstrated the long term benefits of CBT group programming on various aspects of adjustment. Receiving CBT during the initial rehabilitation phase has been reported to reduce depressive mood, helplessness, anxiety, and is associated with fewer hospital readmissions, less drug use and greater self-reported adjustment. Conclusion A variety of logistical and ethical factors limit the study of depression in SCI samples. Attempts to treat depressive symptoms using multifaceted packages that incorporate cognitive behavioural skills appear encouraging in reducing the incidence of depression, anxiety and encourage positive adjustment post-SCI, particularly for individuals who exhibit substantial emotional distress in the acute phase of rehabilitation. The use of a group format appears to offer a cost-effective method of intervention.

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There is level 2 evidence from 6 non-RCT studies to support the use of small group CBT based treatment packages to decrease depression symptoms following SCI. (Note that 4 of these studies were based on the same groups and intervention.) Cognitive behavioural interventions provided in a group setting appear helpful in reducing post-SCI depression and related difficulties.

10.4 Pharmacotherapy for Treatment of Depression in SCI Several case series studies have reported positive results using pharmacotherapy for depression in SCI individuals (e.g. Kim et al. 1977 (amitriptyline); Fullerton et al. 1981; Judd et al. 1986 (mianserin and nomifensine); Judd et al. 1989 (tetracyclic and tricyclic)). Overall, support for pharmacological treatment of depression in individuals with SCI is largely an extrapolation from the extant literature concerning use in the general population and comparative trials of medications and cognitive behavioural interventions are “sorely needed” (Elliott & Kennedy 2004). Table 10.2 Combined Individual Psychotherapy and Pharmacotherapy for Treatment of Depression in SCI
Author Year; Country Score Research Design Total Sample Size Methods Population: Gender: m = 32; f = 11, Age: 20-74 yrs, time since injury: 5-37 years, 28 treated for depression, 15 acted as quasicontrols. Intervention: 6 months of individual treatment. 2 components-psychotherapy and medication were offered to all. Therapy began once a week for the first 2 months then was reduced to twice a month. All were prescribed an antidepressant based upon their needs and physician’s decision. Treatment fidelity: average number of therapy session completed was 14 out of 17 (range from 6 to 17). Outcome Measures: Health and mood questionnaire (OAHMQ) Hamilton Depression rating scale Community activities checklist Life satisfaction scale (11 item Likert scale looking at satisfaction with family life, health, economics, and community safety). 1. Outcome Depression Outcomes: A decrease was observed in depression scores from 0-24wks in the treatment group (F (2,26)=51.2, p<0.001). Paired t-tests indicated a 24% decline in depression scores from 0-8wks (time 1=15.7, time 2=11.9, t(27)=6.77, p<0.001) and from 8-24wks (6.7) (t(27)=5.26, p<0.001). 8 subjects continued to score in the range for major depression. If cases with variable treatment adherence were eliminated 100% of participants treated no longer had scores in the range of major depression. Community activities: There was a significant increase in community activities from 0-24wks of treatment (F (2, 26) = 15.7, p<0.001). T-tests showed a 40% increase in activities from 0-8wks (time 1=11.1, time 2=15.5, t (27) =3.73, p<0.001). A further increase was noted between 8 and 24 weeks (time 2=15.5, time 3=22.3, t (27)=4.55, p<0.001). The correlation between the change in # of depressive symptoms and the change in the # of community activities was high (-0.81, p<0.001). Life satisfaction: While a significant overall effect was observed for life satisfaction scores (F(2,26)=14.0,

2.

3.

Kemp et al. 2004; USA Downs & Black score=20 Pre-post Initial N=43; Final N=28

4.

5. 6.

7.

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Author Year; Country Score Research Design Total Sample Size

Methods

Outcome p<0.001), significant differences in life satisfaction were noted only between 8 and 24 weeks (time 2=23.5, time 3=28.4, t(27)=5.20, p<0.001). Non-treatment group: Scores on the depression measure did not change significantly over time.

8.

Discussion Kemp et al. (2004) used a pre-post treatment design to assure access to services and avoid ethical concerns that might arise in a randomized trial. A total of 43 community living adult SCI survivors were identified as depressed using the Older Adult Health and Mood Questionnaire and confirmed by clinical interview. Citing distance problems, 15 subjects subsequently declined participation but served as a “quasi-control” group. The 28 remaining subjects began a combined 6-month trial of antidepressant medications and individual cognitive behavioural psychotherapy. The participants were somewhat older but did not differ from non-participants in terms of level of injury, gender, or race/ethnicity. Medications employed included SSRI and tricyclic antidepressants. Psychotherapy included education regarding the signs, symptoms and consequences of depression, cognitive restructuring and encouraging greater community involvement (average of 14 sessions). During the treatment trial, four subjects discontinued their medications, one discontinued psychotherapy and three developed medical complications. After eliminating these eight results, all of the remaining 20 subjects improved, no longer meeting criteria scores for major depression (12 appeared mildly depressed and eight appeared non-depressed). Their participation in community activities doubled over the 24 weeks, while life satisfaction showed improvement, primarily during the final 16 weeks of the program. The average depression score for non-treated subjects did not change significantly over a 24-month follow-up period and suggests that untreated depression can become a chronic disorder. Conclusion Evidence of the benefits of pharmacotherapy alone and in combination with individual psychotherapy in the treatment of depression in individuals with SCI is encouraging, although support is largely from investigations in other populations. There is level 4 evidence from a single non-RCT study indicating the effectiveness of psychotherapy combined with pharmacotherapy for treatment of depression in SCI. The benefits of drug treatment for post-SCI depression are largely extrapolated from studies in non-SCI populations.

10.5 Other Treatments for Depression following SCI Strategies to encourage health, reduce secondary complications and consequently support positive emotional adjustment following SCI have emerged as a source of increasing research interest. As examples, the following studies review the impact of access to medical care,

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wellness education, regular exercise and massage upon various measures of physical health and emotional well-being. Table 10.3 Other Treatments for Depression following SCI
Author Year; Country Score Research Design Total Sample Size Methods Population: Gender: both, Age: 19-65yrs, Time since injury: 1-24yrs. Treatment: Experimental group participated in a progressive exercise training program twice weekly for 9 mths on alternative days 90-120 mins starting with warm up, upper extremity stretching, and 15 to 30 min of aerobic training. As the rate of perceived exertion decreased, workload was increased. Some resistance training took place. Outcome Measures: Changes in cardiovascular function, muscle strength & quality of life. 1. Outcome Quality of life components: Exercisers reported less stress, fewer depressive symptoms, and greater satisfaction with their physical functioning than the controls. (p=0.06). Exercisers reported less pain (p<0.01) and a better Q of L (p<0.05). Performance on the 3-stage arm crank protocol was different paraplegics and tetraplegics. (p<0.05). No changes in HR and BP between groups or after 9 months of training. Arm crank protocol was different between tetraplegia and paraplegia. Training induced increases occurred in all subjects in the experimental group. No significant differences in heart rate response over the 9 mths. Significant group x lesion x time interactions were found in stages 2 (F(3.48)=4.64), p=0.006 and stage 3 (F(3.48)=3.55, p=0.02), indicating the tetraplegics had the greatest decrease in heart rate. Changes in muscle strength: Experimental group showed changes in muscle strength over the 9 mth period. The control group did not show any significant changes. Interaction effect on STAI scores F(1, 18) = 14.51, p<.01. Massage group had significantly lower anxiety scores immediately after treatment on the first (t[9] = 5.05, p<.01) and the last (t[9] = 4.93, p<.01) sessions. CES-D scores obtained on first day vs. last day assessment by group. Repeated measures ANOVA showed a group by day interaction effect F(1, 18) = 5.05, p<.05). t-tests revealed greater decrease in CES-D depression scores for the massage therapy group (t[9] = 2.30, p<.05). Path A (treatment-exercise to outcome) (ΔR2=0.19, p<0.05), and path B (exercise and perceived pain) (ΔR2=0.28, p<0.01) and stress (ΔR2=0.23, p<0.01) were significant. Path C (mediator-outcome) revealed that depression was predicted by stress (β=0.49, p=0.02) but not by

2. 3. 4.

Hicks et al. 2003; Canada PEDro=8 RCT Initial N=43; Final N=32

5. 6.

7.

Diego et al. 2002; USA PEDro=8 RCT N=20

Population: Gender: m = 15, F= 5, Age: average 39 years, Tetraplegia, Time since injury: minimum 1 year. Treatment/Controls: One group received a 40 min massage 2 x per week for 5 weeks by a massage therapist while the other was taught an exercise routine that they performed 2 x per week for 5 wks on their own. Outcome Measures: State Anxiety Inventory (STAI), Center for Epidemiological Studies – Depression Scale (CES-D), Manual muscle test, Modified Barthel Index, range of motion. Population: Gender m = 5, f = 16; Age: 19-65 years, Years post injury 1-24yrs. Treatment/Controls: A nine-month program of twice-weekly small group exercise sessions of 60-90 minutes duration incorporating stretching, arm ergometry, and resistance exercise under the supervision of volunteers at a university

1. 2.

3.

4.

1.

Latimer et al. 2004; Canada PEDro=6 RCT Initial N=34; Final N=21

2.

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Author Year; Country Score Research Design Total Sample Size

Methods health promotion centre. Control subjects were instructed to continue with their normal activities and were requested to refrain from starting a regular exercise routine during the length of the study. Monthly health information sessions were discontinued due to poor attendance. Outcome Measures: Pain perception (two items from the Short Form 36-Item Health Survey - SF-36 scale); Perceived stress scale (14 items-Likert scale), CES-D scale (score out of 60). Population: Gender: m = 23; f = 11; complete/incomplete; Age: average 38.6 yrs; tiem since injury: average 10.4 yrs Intervention: Those in the exercise group participated in 5 min of stretching, 15 to 30 min of aerobic arm ergometry exercise and 45 to 60 min of resistance exercise. These subjects trained twice weekly in small groups. Participants in the nonexercise group were asked to continue their usual activities but they were asked not to exercise regularly. Outcome Measures: Pain perception (two items from the Short Form 36-Item Health Survey - SF-36 scale); Symptom self efficacy and perceived control (2 core items from the Beliefs Scale a modified version of the Arthritis Beliefs Scale); Perceived Stress Scale (14 items-Likert scale).

Outcome perceived pain (β=0.29, p=2.25).

1.

2.

Ginis et al. 2003; Canada PEDro=6 RCT Initial N=34; Final N=34

3.

4.

Zemper et al. 2003; USA PEDro=4 RCT Initial N=67; Final N=43

Population: 43 SCI, M=30 F = 13, mean age 47 range 22-80, 28% single, 23% married, 8% divorced, average 14 years post injury, range 1-49 years, 42% paraplegia, 39% tetraplegia, 3% ambulatory. Participants recruited from an outpatient clinic or Center for Independent living. Intervention group was more educated and had fewer retirees despite random assignment. Intervention: A series of six 4 hr workshop sessions held over a 3 month period, promoting health and wellness. Sessions included lifestyle management, physical activity, nutrition, preventing secondary conditions, individual coaching

1.

2.

Changes in potential mediators: Stress and Pain--ANCOVA showed that after 3 mths of training the exp group showed less stress than controls (F(1,27)=6.98,p=0.01) and less pain (F(1,27)=4.99, p=0.03). Changes in QofL, Physical self concept and depression: After 3 months differences appeared between the 2 groups for QofL (F(1,27)=8.47, p=0.007); satisfaction with physical function (F(1,27)=20.17, p<0.01); satisfaction with physical appearance (F(1,27)=8.47, p=0.007); depression (F(1,27)=6.16, p=0.02). Stress and pain (mediators of QofL): Once baseline pain and stress values were controlled for, the 3 month scores for pain was (R2=.15, p<0.01) and for stress was (R2=0.12,p<0.01). These were significant predictors of baseline adjusted 3 month QofL. Stress and pain as mediators of depression: Changes in pain but not stress explained significant variance in baseline adjusted depression scores (R2=0.19 & 0.04). Adjusted pain scores showed variance in the adjusted 3 month depression scores (R2=0.19, <0.01). The intervention group showed statistically significant improvement after intervention in several areas as compared to the control group: Abilities for Health Practices (SAHP): (p<0.05). Health Promoting Lifestyle (HPLP-II): (p<0.001). Nutrition (HPLPII subscale): improvement in nutritional awareness and behaviour (p <0.05) Stress (HPLP-II subscale): Increased use of stress management techniques and decreases in perceived stress (p =.001). Secondary Conditions (SCS): fewer and less serious secondary conditions (p<0.001) Depression was less though

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Author Year; Country Score Research Design Total Sample Size

Methods sessions, follow-up phone calls during the 4 months following the workshops. Controls participated in pre/post assessment but received no intervention Outcome Measures: Health Promoting Lifestyle Profile II, Secondary Conditions Scale, Self-rated Abilities for Health Practices scale (SAHP), Perceived Stress Scale, Physical activities with disabilities (PADS), Arm crank ergometer testing, neurologic exam, Body Mass Index (BMI). Population: Gender: mixed group-with more males, time since injury: mean 18.44yrs. Intervention: Follow-up after initial rehabilitation was completed addressing the secondary conditions post-SCI as well as the primary effects of their spinal cord injury. The focus is wellness, health promotion, and illness prevention through a continuum of coordinated care. Outcome Measures: The Secondary Surveillance Instrument (SCSI) and the Check Your Health Questionnaire (CHY) (rating the “absence” of depression.

Outcome did not reach significance. Physical Activity – (self-reported on various scales of the HPLP-II): Increased reported physical activity and improved physical fitness (p = 0.001). However there was no improvement in either measured Physical Activity (PADS) or physical fitness measures. An overall difference between the two groups was found (F3,343 = 6.211; p=0.0004). Medical Follow-up group reported a significantly higher subjective rating than did the No-F/U group on 3 variables: Health (p=0.0068), Independence (p=0.005), Absence of depression (p<0.0001). (Fisher’s protected least significant diff. test). A MANOVA showed a main effect on education on health, independence and absence of depression (F15,900 =2.063, p=0.0098). Further analysis showed that as education increased subjects reported greater health, and independence and lower depression.

3.

4.

1. 2.

Dunn et al. 2000; USA Downs & Black score=17 Non-RCT Initial N=371; Final N=371

3.

Discussion Dunn et al. (2000) reported that veterans approaching 20 years post-SCI with access to medical follow-up through a specialty comprehensive outpatient program reported better health, independence, and less depression than a demographically similar (civilian) group without access to follow-up care. Neither group reported “depression” with sufficient frequency to earn it a top ten ranking from a list of 40 possible complications. However, those without access to medical follow-up who did endorse depression considered it of sufficient intensity to rank it among the ten most severe problems. While the types of secondary complications were similar, these were less frequent and less severe in those receiving health care. Noting a variety of methodological concerns that limit conclusions and generalizability, the authors reported that their findings were consistent with those in other studies (involving SCI and other patient groups). Zemper et al. (2003) examined a holistic wellness program for SCI patients. The intervention in this RCT study involved six group workshop sessions focused upon lifestyle management (including sexual health and stress management), physical activity, nutrition, and preventing secondary complications. It also included individual coaching sessions and follow-up phone calls. Assessments were completed at three times: prior to the series, two weeks following completion and four months later. Results of this study pointed to improvements in awareness and behavior in areas of health practices, nutrition, and stress. Also secondary conditions were fewer and less serious. Reports of depression intensity decreased but did not reach

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significance. Self-reports indicated improvements in physical activity, while more objective tests showed no improvement in physical fitness. In a series of Canadian studies, Ginis et al. (2003), Hicks et al. (2003) and Latimer et al. (2004) reported RCT investigations of sedentary community dwelling SCI adult volunteers who participated in 3, and later 9 month trials of twice weekly, 60-90 minute sessions of stretching, aerobic arm ergometry and resistance exercises or a “wait” control condition who were asked to continue usual activities and refrain from beginning an exercise program. Among other findings, Exercisers reported less stress, fewer depressive symptoms and greater satisfaction with physical functioning than did controls. While the average frequency of depressive symptoms in the intervention group did not vary substantively over the 9 months (and remained below clinically significant levels), depressive symptoms in the control group increased and the average exceeded levels considered “at risk” for clinical depression. The authors suggested the benefits of exercise as offering a prophylactic or stabilizing effect on pain – perhaps reducing the propensity for flare-ups, and the potential benefits of targeting sources of recurrent pain (i.e. shoulder pain). Consistent with the Chronic Pain Process Model, a series of regression analyses the nine-month data revealed that changes in perceived pain mediated changes in stress, and the change in stress mediated a change in reported depression. It was recommended that clinicians prescribe exercise as a therapeutic modality for improving and maintaining well-being among people with SCI. With a university clinic group of 20 outpatients with quadriplegic injuries, Diego et al. (2002) compared the effects of a 5-week massage therapy program to those of an independently performed exercise routine conducted over a similar period. Subjects were stratified according to range of motion and then assigned to either of the two treatment groups. While both groups averaged pretreatment depression scores approaching the clinically depressed range, only the massage therapy group showed a decrease in reported post treatment depression symptoms. The massage therapy group also reported lower anxiety immediately after treatment on the first and last days of the protocol. The authors suggested that the significant gains in upper limb muscle strength and wrist range of motion demonstrated by the massage therapy group may have contributed to their reported reduction in subjective distress. Conclusion Access to medical follow-up for individuals with SCI can lead to reports of better health, independence, less depression and fewer secondary complications. Wellness education can assist in encouraging improved health practices and reducing the frequency and seriousness of secondary conditions, including reported depression. Regular physical exercise may contribute to a reduction of pain, stress, and depression as well as potentially offering a prophylactic effect on sources of recurrent pain and in preventing a decline in quality of life following SCI. Massage may aid in decreasing depression and anxiety in SCI individuals, with gains in physical strength potentially contributing to a reported decrease in distress. There is level 2 evidence from 1 RCT and 1 non-RCT that a wellness and health promotion program can decrease depression symptoms. There is level 1 evidence from 3 RCTs that exercise based programs can contribute to reduced depression symptoms. There is level 1 evidence that massage therapy can reduce depression symptoms. 10-15

Programs to encourage regular exercise, reduce stress, and improve or maintain health appear to have benefits in reducing reports of depressive symptoms in persons with SCI.

10.6 Summary This chapter has summarized research highlighting several promising approaches to the management of post-SCI depression. The research has also provided some evidence for these approaches being effective for related therapeutic targets such as anxiety and self-esteem. When leavened with clinical judgment, this research offers preliminary empirical support to guide the practitioner in employing evidenced-based therapeutic strategies. Future investigations, particularly those employing more stringent research designs, will continue to expand the options and confidence of clinical efforts to assist those individuals who have sustained spinal cord injuries. The reader is encouraged to also consider the following topic reviews of depression and SCI (Consortium for Spinal Cord Medicine 1998; Elliott & Frank 1996; Elliott & Kennedy 2004) and also, more generally, a recent state of the science review of SCI rehabilitation (Sipski & Richards 2006). There is level 2 evidence from 6 non-RCT studies to support the use of small group CBT based treatment packages to decrease depression symptoms following SCI. There is level 4 evidence from a single non-RCT study indicating the effectiveness of psychotherapy combined with pharmacotherapy for treatment of depression in SCI. There is level 2 evidence from 1 RCT and 1 non-RCT that a wellness and health promotion program can decrease depression symptoms. There is level 1 evidence from 3 RCTs that exercise based programs can contribute to reduced depression symptoms. There is level 1 evidence that massage therapy can reduce depression symptoms.

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