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    Consenso Ortesis

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    LEONARDO ALEX CORROTEA

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    International Society for Prosthetics and Orthotics REPORT OF A CONSENSUS CONFERENCE ON THE ORTHOTIC MANAGEMENT OF STROKE PATIENTS Soren Ng POT o em neo array James Campbell STEW Entry Ener Peery eee eT Sea Poeun Pine oe eee International Society for Prosthetics and Orthotics REPORT OF A CONSENSUS CONFERENCE ON THE ORTHOTIC MANAGEMENT OF STROKE PATIENTS Edited by Elizabeth Condie Associate editors James Campbell Juan Martina Held at: Avegoor Conference Centre Ellecom: ‘The Netherlands 21* — 26" September 2003 ORGANISING COMMITTEE Dr James Campbell PhD, CO Mrs Elizabeth Condie FCSP Dr Juan Martina (Chairman) Vice President Reader Physiatrist,Brain Injury Department Becker Orthopedic National Centre for Training Revalidatie Centrum, 635 Executive Drive and Education in Prosthetic Groot Klimmendaal Troy and Orthotics Heijenoordseweg 5 Michigan 48083 Curran Building, 6813 GG USA 131 St James Road Amhem beckerjime@aol.co Glasgow G4 OLS The Netherlands Scotland, UK jmartina@grootklimmendaal.nl mec.condie@strath.ac.uk Stroke Definition - WHO Bulletin, 1976 "A stroke is a clinical syndrome characterised by rapidly developing clinical symptoms and/or signs of focal, and at times global (applied to patients in deep coma and those with subarachnoid haemorrhage), loss of cerebral function, with symptoms lasting more than 24 hours or leading to death, with no apparent cause other than that of vascular origin." — — a CONFERENCE PARTICIPANTS ACKNOWLEDGEMENTS The Organising Committee wishes to express its sincere gratitude to Linda Gilmour for invaluable secretarial support given during the development and report writing phases of the Conference and to ‘Anne Slater for preparing the manuscript for printing. It also wishes to acknowledge the enormous task undertaken by Heather Smart and colleagues at RECAL Information Services, University of Strathclyde in searching for and photocopying some 2,700 Scientific papers which formed the foundations for the Conference. Published 2004 © International Society for Prosthetics and Orthotics Borgervaenget 2100 Copenhagen Denmark ISBN 87-89809-14-9 CONTENTS, Conference Programme 6 State of the Art Presenters 8 Key Reviewers 8 Expert Discussants 10 List of Participants by Profession n Report of a Consensus Conference on the Orthotic Management of Stroke Patients 13 General Recommendations 7 Conclusions and Recommendations Arising from Syndicate and General Discussion Sessions Appendix A: Glossary of Research Terms Appendix B: Guidelines for Stroke Rehabilitation Research Appendix C: Suggested Outcome Measures to Consider for use in Studies of Orthotic Intervention after Stroke 33 RES Compendium - State of the Art and Key Review papers (S = State of the Art, R = Key Review) Sl Stroke ~ Understanding the Problem 37 $2 Clinical and Functional Effects of Stroke 45 $3 Understanding Tone and Spastcity 31 S4 Biomechanics of Lower Limb Function and Gait 55 S6 Applying the Cochrane Methodology, to a Systematic Review of the use of Orthotics in Stroke o S7-A_ Biomechanics of Upper Limb Orthoses n 'S7-B_ Basic Biomechanics of the Upper Limb 7” R1__ Establishing a Scientific Basis for Orthotic Management 8 R2__Non-Articulated Ankle-Foot Orthoses 87 3 Articulated Ankle Foot Orthosis Designs 95 R4 Physiotherapy for the Lower Limb nz 5 Functional Electrical Stimulation of the Lower Limb 130 R6 Pharmacologic Management of Lower Limb Spastic Hypertonia in Stroke: What is the Evidence? 137 R7-A._ Surgery for Stroke in the Lower Eimb 148 R7-B_ Recommended Reading List, Lower Limb Surgery for Stroke Patients 152 R8___Orthotic Management of the Hip and Knee for the Post-Cerebrovascular Population 162 R9-A._ Physiotherapy Management of Upper Extremity Complications after Stroke: Hemiplegic Shoulder Pain, Spasticty and Related Syndromes - A Literature Review m R9-B_ Physiotherapy Management of the Upper Limb after Stroke: Recovery and Training of Motor Function 188 R10 Occupational Therapy Intervention for the Upper Limb following Stroke 204 RII Pharmacology and Upper Limb Post Stroke Spasticity; A Review 217 R12__ACritical Review of Neuromuscular Electrical Stimulation for Treatment of Upper Limb Motor Dysfunction in Hemiplegia 28 R13__ Orthopaedic Management of Upper Extremity Dysfunction following Stroke 238 R14 Orthotic Management of the Upper Limb a7 RIS Service Issues - Who Prescribes and Who Provides? 254 RI7 Outcome Measures for Orthotic Intervention in Stroke Rehabilitation 236 R18 Current Research in Orthotics 269 ] werrsionat sce or Prosthetics and Onhtes PROGRAMME ‘Sunday 20 September 18.00 - 20.00 Welcome cocktails. Introductory remarks 20.00 Dinner ‘Monday 22 September 08.30- 09,00 Introduction and Briefing 09.00-09.50 Stroke- Understanding the problem (Epidemiology, incidence and prevalence) 09.50- 10.40 Clinical and functional effects of stroke. 10.40- 11.10 Coffee 11.10- 11.55 Understanding tone and spasticity. 11.55- 12.40 Biomechanics of lower limb function and gait. 12.40- 13.45 Lunch 13.45 - 14.30 Current situation in lower limb orthotics. 14.30- 15.15 Establishing a scientific basis for orthotic management. 15.15 - 15.25 Questions. 15.25- 15.45 Tea 15.45 - 16.30 AFO and FO - non articulated. 16,30-17.15 AFO - articulated. 17.15- 17.30 Questions ‘Tuesday 23 September 08.30-09.15 Syndicate A (R1,R2, R3) 09.15-09.45 General Discussion 09.45 - 10.15 Coffee 10.15- 11.05 Physiotherapy lower limb 11.05- 11.15 Questions 11.15-11.55 RES. lower limb 11.55 - 12.05 Questions 12.05 - 12.45 Pharmacological management, lower limb 12.45 - 12.55 Questions 12.55- 14.00 Lunch 14.00- 14.45 Syndicate B (R4, R5, R6) 14.45 - 15.20 General Discussion 15.20- 15.40 Tea 15.40 - 16.20 Surgery, lower limb 16.20- 16.30 Questions 16:30 - 17,00 Cochrane systematic reviews: Protocol “Orthotic devices for abnormal posture after stroke or non-progressive cerebral causes of spasticity” Page 6 KEY R- Key Review Paper S- State of the Art Paper J.Martina E.Condie T.Olsen R.Wagenaar J.Becher S. Gard D.Blocka J.Campbell R.Bowers D.Hoy/A.Karas R.Bohannon J.Buurke G-Francisco JPatrick/A Jain RKent SI sz RI a8 R4 R6 R7 86 Report of a Concensus Conference on the Orthotic Management of Stroke Patients ‘Wednesday 24 September 08.30 - 09.10 09.10 - 09.20 09.20 - 09.50 09.50 - 10.15 10.15 - 10.45 10.45 - 11.15 11.15 - 12.05 12.05 - 12.20 12.20 - 13.20 13.20 - 14.00 14.00 - 14.10 14.10 - 14.50 14.50 - 15.00 15.00 - 15.30 15.30 - 16.10 16.10 - 16.20 16.10 - 16.50 16.50 - 17.00 Orthotic management of hip and knee. Questions. Syndicate C (R7, R8) General discussion. Coffee Biomechanics of upper limb. Physiotherapy management of upper limb. Questions. Lunch Occupational Therapy for upper limb. Questions. Pharmacology, upper limb. Questions. Tea FES and upper limb. Questions. Surgery and upper limb. Questions. ‘Thursday 25 September 08.30 - 09.10 09.10 - 09.20 09.20 - 10.05 10.05 - 10.35 10.35 - 11.05 11.05 - 11.45 11.45 - 11.55 11,55 - 12.30 12.30 - 13.30 13.30 - 14.15 14,15 - 14.25 14,25 - 15.10 15.10 - 15.20 15.20 - 15.50 15.50 - 16.35 16.35 - 17.05 17.05 - 18.00 19.00 Orthotic management of upper limb. Questions. Syndicate D (R9,10,11,12,13,14) Coffee General discussion, Service delivery issues. Questions When to prescribe orthoses? Lunch Score scales and outcome measures. Questions. Current research in orthotics. Questions. Tea Syndicate E (R15,16,17,18) General discussion. Review of Conference. Agree consensus and content of report. Reception and Conference Dinner DFish TDibello/D.Plettenburg M. Smith/P.Van Vliet J.Ranka/A.Drummond AYelnik J.Chae M.A.Keenan N, Parent D.Condie M.Hodge V.Pomeroy/S.Lennon C.Morris J.Martina/ E.Condie/J.Campbell s7 Ro R10 RU RI2 R13 RIA RIS RIG RI7 R18 sae Prin Ori STATE OF THE ART PRESENTERS Dr Jules Becher ‘Academisch Ziekenhuis Vrije Universiteit Afdeling Revalidatie Dr Ruth Kent Consultant and Senior Lecturer ‘Academic Unit of Musculoskeletal and Rehabilitation Medicine Motion Analysis Research Laboratory NUPRL & RERP 345. Superior, RIC 1441 De Boelelaan 1117 University of Leeds Postbus 7057, 1007 MB Amsterdam 36 Clarendon Road ‘The Netherlands Leeds Ipbecher@vume.n! West Yorkshire, UK tumkent@leeds ack Mr Dan Blocka Dr Tom Skyhaj Olsen, MD PAD Prosthetic & Orthotic Programs Homemansgade 22 clo SCIL DK-2100 Copenhagen @ Sunnybrook & Women’s College Denmark Health Science Centre ‘Skyhoj.olsen@dadinet. dk 2075 Bayview Avenue Toronto, On. MAN 3M3 Canada hlocka@pbe.gbrowne.on.ca. Mr Thomas DiBello Dr. Dick Pletenburg 7015 Almeda Rd Man Machine Systems and Control Houston, TX 77054-2101 Dept. of Medical Technology & Mechanics USA Delft University of Technology tomd@dynamicoandp.com Mekelweg 2 2628 CD Delft ‘The Netherlands dh plettenbure @whmisudelf. nt Dr Steven Gard PhD ‘Dr Robert Wagenaar Chairman, SAR Rehabilitation Sciences Sargent College of Health & Rehabilitation Sciences Boston University Chicago, IL 60611 635 Commonwealth Avenue ‘sgard@nonhwestem.edu Boston, MA, 02215 USA swagenaar@bu.edu KEY REVIEWERS Dr Richard W Bohannon ‘Mr Amar Jain 130 Middlebrook Road Consultant Orthopaedic Surgeon West Hartford ‘Ninewells Hospital and Medical School CT.06119 Dundee DD1 9SY USA, Scotland, UK Piconsultamt@comcastnet. ‘Katemefee@tubt scotnhs.uk ‘Mr Roy Bowers, Lecturer Dr Mary Ann Keenan, MD NCTEPO Professor of Orthopaedic Surgery University of Strathclyde Director, Neuro-Orthopaedics Program Curran Building ‘The University of Pennsylvania 131 StJames Road Department of Orthopaedic Surgery-Two Silverstein Glasgow G4 OLS. 3400 Spruce Street Scotland, UK Philadelphia, PA 19104, USA j.bowers@strath ac.uk ‘Maryann keenan@uphs.upenn.cdu Poge 8 Mr. Jaap Buurke, PT Roessingh Research and Development ‘Mr Chris Morris, MSc SR Orth ‘National Perinatal Epidemiology Unit Roessinghsbleekweg 336 Institute of Health Sciences 7522 AH Enschede University of Oxford ‘The Netherlands (Oxford OX3 7LF, UK buurke@rrd al shristopher. morris@ perinatal-epidemiology.oxford, ack Dr John Chae, M.D., ME. Nicole Parent Assistant Professor of PM&R 1311 W. Huron St Case Western Reserve University School of Medicine ‘Ann Arbor ‘MetroHealth Medical Center M148103, +2500 MetroHealth Drive USA Cleveland OH 44109, USA parent @umich.edu ichao@metrohealth.org Mr. David Condie Dr John Patrick, Director Consultant Clinical Engineer ORLAU 11 Lansdowne Crescent Robert Jones and Agnes Hunt Hospital Glasgow G206NQ Oswestry Scotland Shropshire ‘sondie @benassynt freeserve.co.uk Dr Avril Drummond Division of Ageing and Rehabilitation Floor B, Medical Schoo! Prof Valerie Pomeroy Centre for Rehabilitation and Ageing ‘St George’s Hospital Medical School Queen's Medical Centre Cranmer Terrace, Tooting ‘Nottingham NG7 2UH London SW17 ORE Avr Daummond@nottingham ack Sepomermy @sghms.ac.uk ‘Deanna Fish, CPO Ms Judy Ranka, BSc (OT), MA, OTR, Ace OT 1508 West EimHlill Circle Program in Occupational Therapy, ‘Taylorsville, UT 84123 USA dlishepo@aol.com ‘School of Occupation and Leisure Sciences The University of Sydney, Cumberland College Campus (C42. “¥” Block), PO Box 170 (East ST), LIDCOMBE, NSW 1825, Australia immka@fhs.usyd.eduau Dr Gerard E Francisco, M.D. Associate Professor TIRR Hospital ‘Mr Mark Smith Clinical Specialist Physiotherapist in Stroke Rehabilitation 1333 Moursund Avenue Royal Victoria Hospital Houston, Texas USA 77030 13 Craigleth Road sfrancisco@houston com Edinburgh EH4 2DN, Scotland ‘mark.smith@lubt scotmhs.uk Ms Margaret Hodge Dr Paulette Van Vliet ‘National Centre for Prosthetics and Orthotics Health Sciences Bldg 2, Room 444 Division of Rehabilitation and Ageing ‘School of Community Health Sciences La Trobe University, Melbourne University of Nottingham ictoria 3086 Australia B Floor, Medical School, Queen's Medical Centre MHodge@latrobe.edu.au Nottingham NG7 2UH Paulette. vanvliet@ntlworld.com Mr David Hoy, CPO Dr Alain Yelnik, MD Mansfield Orthotic and Prosthetic Center Service de Médecine Physique et de RE 240 Marion Ave, GH Lariboisiére-F. Widal, PO Box 3647 200 Rue du Faubourg St Denis ‘Mansfield, OH 44903-2115, USA 75010 Paris analogorth@aol.com Alain,yclnik@Irb ap-hop-paris.fr Dr Sheila Lennon, Physiotherapy University of Ulster at Jordanstown ‘Newtonabbey, County Antrim BT 37 OQB Northern Ireland, UK sdennon@ulster.acuk Report of a Concensus Conference on the Orthotic Management of Stroke Patients Page 9 QD werent sin Prats nd rhs EXPERT DISCUSSANTS Dr Gad Alon, Ph.D. PT Ms Janne Isokangas ‘Ass, Professor, University of Maryland ‘Camp Scandinavia Oy School of Medicine, Dept. of PT. Onmuspellontie 12 100, Penn Street, Baltimore Maryland (00700 Helsinki 21201 USA Finland ‘Analogarth@aol.com Janne isokangas@camp.fi Prof Dr Hans Arendzen Mrs. M. Ann Karas, MA, PT, NCS Wilhelminalaan 7 Assistant Professor 9752 LL Haren (Gr) Department of Health Sciences The Netherlands. Cleveland State University Jharendzen@LUMC nl 1983 E 24” Street, Cleveland, Ohio 44115, USA skaras@csuohio.edu Prof Helena Burger, MD Mr. Liekel Klein Institute for Rehabilitation OIM Amhem Republic of Slovenia Heijenoordseweg 150 Linhartova 51 6813 GC Arnhem 1000 Ljubljana ‘The Netherlands Slovenia Lkicin@oim.nl ‘Helena burger@mail.ir-rs.si Mr Paul Chariton Dr Gert Kwakkel, PT, PaD Onthotst ‘Academisch Ziekenhuis Vrije Universiteit Peacock Medical Group ‘Afdeling Bewegingswetenschappen Benfield Business Park De Boelelaan 1117 Benfield Road Postbus 7057, 1007 MB Amsterdam Newcastle Upon Tyne NE6 4NQ The Netherlands England eKwakkel@yume.n! Rharlton60@aol.com Dr Yoshi (hiro) Ehara Dr Leonard Sheung Wai LI ‘Teikyo University Rehabilitation Unit Morinosato 3-23-3 University Department of Medicine ‘Atsugi-City ‘Tung Wah Hospital Kanagawa 12 Po Yan Street, Sheung Wan 243.0122 Hong Kong, SAR, China Japan Iswli@hkeucs bu NAHOS120@nifiynejp Lic. Elena Georgi Dr Thomas Meiners, Clinica Encauce Director Marco Bruto 1345 ‘Wemer Wicker Klinik Montevideo 11300 34530 Bad Wildungen-Reinhardshausen ‘Uruguay Im Kreuzfeld 4 Germany imeiners@ wemer-wicker-klinikde DrHermie Hermens Dr Sumiko Yamamoto Roessingh Research and Development International University of Health and Welfare P.O. Box 310 2600-1, Kitakanemaru, Ohtawara 7500AH Tochigi, 324-8501 Enschede Japan ‘The Netherlands sumiko-y@iuhw.ac.jp hemmens@rd.nl Page 10 Report of a Concensus Conference on the Orthotic Management of Stroke Parents LIST OF PARTICIPANTS BY PROFESSION ‘THERAPISTS ‘ORTHOTISTS PHYSICIANS AND BIOENGINEERS/SCIENTISTS ‘State of The Art Presenters and | State of The Art Presenters and | SURGEONS. State of The Art Presenters and Key Reviewers Key Reviewers State of The Art Presenters and | Key Reviewers 1. R. Bohannon (USA) 1. D. Blocka (Canada) Key Reviewers 1. S. Gard (USA) 2. M, Smith (Seotiand) 2. J. Campbell (USA) 1. T.Olsen (Denmark) 2. D. Plettenburg (Netherlands) 3. P.van Vliet England) 3. R Bowers (UK) 2. J. Becher (Netherlands) 3. D. Condie (Scotland) ‘4 J:Ranka (Australia) 4, D. Hoy (USA) 3. G. Francisco (USA) 4, R. Wagenaar (USA) A: Drummond (not in 5. D. Fish (USA) 4. J. Patrick (UK) attendance) (England) 6. N. Parent (USA) 5. A. Jain (Scotland) Expert Discussants 5. ¥; Pomeroy (England) 7. M, Hodge (Australis) 6. R.Kent (England) . ¥.Ehara Gapan) 6 S.Lennon Greland) 8. C. Morris (England) 7. A. Yelnik France) 6... Yamamoto (Japen) 7. 4. Buurke (Netherlands) 9. T. Dibello (USA) 8. J.Chae (USA) 17. Hermens (Netherlands) 9. M.A. Keenan (USA) Expert Discussants Expert Diseussants 8. E-Condie (Scotland) 10.L. Klein (Neth) Expert Discussants 9. E, Georgi (Uruguay) 11, P. Charlton (England) 10, J. Martina (Netherlands) 10.G. Alon (USA) 12,3. Tsokangas (Finland) 11. Burger (Slovenia) 11, G, Kwakkel (Netherlands) 12. H. Arendzea (Netherlands) 12. A. Karas (USA) 13,L-Li (Hong Kong) 14.7. Meiners (Germany) Page I Report of a Concensus Conference on the Orthotic Management of Stroke Patients REPORT OF A CONSENSUS CONFERENCE ON THE ORTHOTIC MANAGEMENT OF STROKE PATIENTS BACKGROUND The use of orthoses in the management of patients with stroke has been recognised as a treatment option for many years. There is, however, widespread variation in the nature of orthotic intervention, not just between countries but also between centres at a local level. In particular, there is no agreed ‘best practice’ in terms of selection of patients for orthotic fitting, design of the orthosis, and timing of orthotic intervention. Further, evidence of the effectiveness of orthoses, both for the upper and lower limb is scanty and the decision as to whether or not to use an orthosis, when, and of which design is normally based on clinical experience and practitioner preference rather than scientific evidence. There is no complete understanding of how orthotic management relates to other treatment modalities such as physio and occupational therapy, FES, pharmacology and surgery. I became particularly aware of these issues when, as co-ordinator of the short, post graduate course programme for health care professionals at the National Centre for Training and Education in Prosthetics and Orthotics, my colleagues and I were regularily challenged by course participants to defend our teaching that the use of orthoses for selected stroke patients was a “good thing”. I therefore approached the Executive Board of ISPO in 2001 with the proposal that a “Consensus Conference” on the subject of the ‘Orthotic Management of Stroke Patients’ be convened. A justification for this type of conference is to be found in several international publications, and a key document published by the NHS Health Technology Assessment Programme (1) states that “Consensus methods are used to develop clinical guidelines (good practice) which define key aspects of quality health care, particularly appropriate indications for interventions”. ISPO has organised five such conferences over the past 14 years and as a multidisciplinary, international society is a very appropriate organisation to undertake such a project. PREVIOUS CONSENSUS CONFERENCES DATE (YEAR) + 1990 - Report of a Consensus Conference on Amputation Surgery * 1994 - — Lower Limb Orthotic Management of Cerbral Palsy * 1995 - Appropriate Prosthetic Technology for Developing Countries * 1997 - — Consensus Conference on Poliomyelitis : Consensus Statements and Syndicate Reports * 2000 - — Appropriate Prosthetic and Orthotic Technology for Low Income Countries. Page 13 Qwest nt Ort The Board agreed to this proposal and a small organising committee was established comprising Jim Campbell, a prosthetist/orthotist from Scotland currently working in North America, Juan Martina, a doctor in rehabilitation medicine from Holland who as a member of the ISPO Executive Board would act as Chairman, and myself. SCOPE ‘At our first planning meeting in April 2002, the Scope of the conference was decided. It would include the biomechanical design of, assessment for and prescription of orthoses for both the upper and lower limb. It would exclude the immediate medical management of stroke patients and would deal, primarily, with the rehabilitation phase, which was defined as beginning as soon as the patient is medically stable. The rehabilitation of stroke patients requires an integrated system of care from many specialities, and it was therefore felt important to include consideration of the following treatment options as they relate to orthotic management; - medical and pharmacological management ~ surgery - therapy (PT. and O.T.) - functional electrical stimulation OBJECTIVES These were to Trace, review and rank all the international literature relevant to the scope of the conference. Identify gaps in the literature where scientific evidence was weak or absent Discuss key questions arising from this review By means of expert group discussions, achieve consensus on ‘best practice’ in the absence of any scientific evidence * Document and report the recommendations of conference ‘* Encourage the dissemination and implementation of the recommendations internationally METHOD A. IN ADVANCE A budget was agreed with the ISPO Executive Board, which would allow 45 experts in the field (not necessarily ISPO members) to attend with their travel and hotel costs being paid in full. Participants were selected in almost equal numbers from the following professions : orthotics, physio/occupational therapy, medicine and surgery, ‘A total of 14 countries were represented. Each participant was allocated the task of ‘key reviewer’, ‘state of the art presenter’ or ‘expert discussant’, Alll would be expected to actively participate in the group discussions throughout the week.There would be no observers. Page 14 Report of a Concensus Conference on the Orthotic Management of Stroke Patients Acomprehensive literature search starting from the year 1990 was conducted by Heather Smart (Infor- ‘mation Officer at the NCTEPO) and colleagues using the RECAL database, with a supplementary search of Medline, Embase, CDSR, CCTR, ACP Journal Club, Dare and Premedline conducted by Glasgow Royal Infirmary Information Service. A total of approximately 2700 articles were identified. A preliminary scan was conducted by the organising committee to remove any wholly inappropriate paper after which photocopied sets of papers were allocated and sent to each “key reviewer”. They were asked to rank the evidence contained in each paper according to a recognised system of criti- cal appraisal described by Greenhaugh in 1997(2) (Tablel). The appraised papers were then to be graded and grouped as falling into categories A, B, C or * as defined by Shekelle et al (3) (Table 2). Key reviewers were invited to include any appropriate article known to them, but not provided by the committee, in order to achieve as comprehensive a review as possible. ‘The meeting was held at the Avegoor Conference Centre on the outskirts of Arihem, Holland. This venue, a very pleasant and comfortable hotel, was in keeping with the HTA guidelines for consensus conferences, which state that “a comfortable environment for meetings is likely to be preferred by participants and to be conducive to discussion”. LEVEL OF EVIDENCE Rating of Study Design Type of Study I ‘Systematic Review and or meta analysis (where statistical techniques are used to pool the results of included studies) a Randomized Controlled Trial (with definitive results that do not overlap the threshold clinically significant effect) Ub Randomized Controlled Trial (with non definitive results i.e. a point estimated that suggests a clinically effective effect with confidence intervals that overlap the threshold clinically significant effect) 1 Cohort Studies (Two or more groups are selected on the basis of differences in their exposure to a particular agent and followed up to see how many in each group developed a particular disease or other outcome) Vv Case Control Studies (Patients with a particular disease or condition are identified and matched with controls, like cohort studies case control studies are generally concerned with the etiology of a disease) v Cross Sectional Survey (Data are collected at a single time point but may refer retrospectively to health experiences in the past) VI Case Reports val Expert Opinion ‘Table 1 Page 15 @] eis fr Prt ont Oot GRADE OF RECOMMENDATION A Directly based on Category I or Ila evidence, at least one meta analysis. B Directly based on Category Ib, III or IV evidence or extrapolated from Category I, I, II or 1, c Directly based on Category V or VI evidence or extrapolated from Category, I, Il, IT or IV. Good practice point, recommended best practice based upon clinical experience of the guideline development group. ‘Table? B. AT CONFERENCE Seven ‘state of the art’ presenters provided an overview of current practices in specified topic areas. These were followed by eighteen ‘key review papers’, which were based on a structured review and appraisal of the available literature as previously described. Each reviewer, along with the session chairman and scribe, then met with members of the organising group to agree upon areas where there was no evidence or agreement in the literature, or where the evidence fell below Grade B as defined by Shekelle et al (3). These formed the basis for subsequent ‘syndicate sessions’ where all participants worked in pre-organised small groups, each with a chairman and scribe, to formulate recommendations based on the expert opinion of the syndicate. These recommendations were then brought back to the entire group for general discussion and ‘conclusions and recommendations of conference’ were agreed and are reported in this document. C, AFTER CONFERENCE Page 16 All presenters were given the opportunity to revise or amend their paper prior to publication and were asked to submit the final version for preparation for publication within 3 months. The conclusions and recommendations were drafted by myself and distributed to all participants for comment and approval before publication. The report can therefore be said to represent the agreed views of an international group, expert in the field of stroke management, and in the true spirit of consensus. The Conference, and its preparation, demanded a very significant amount of work on the part of all participants, including my colleagues on the Organising Committee. That the conference achieved five out of six of its original objectives was entirely due to the commitment and hard work of each and every one of those involved. The sixth objective, to disseminate and implement the recommendations, will require further efforts on the part not only of the conference attendees, but members of ISPO worldwide. Itis my fervent hope that these recommendations will result in improvements to the care of stroke patients, and it is only then that we can claim to have fully accomplished our aim. Elizabeth Condie January 2004 Report of a Concensus Conference on the Orthotic Management of Stroke Patients GENERAL RECOMMENDATIONS, The use of orthoses, both for the lower and upper limb, should be considered in the management of patients.with stroke. The indications for the use of appropriate orthoses should be included in the education and train- ing of all professional staff involved in the rehabilitation of stroke patients. This may take place at thder-or-post-graduate level. if should be included as part of a stroke rehabilitation team and should contribute to assessment for and prescription of orthoses. They should be specifically responsible for manufacture and delivery of orthotic devices with the exception of circumstances detailed at point 4 below. Conference agreed with the statement made in an earlier ISPO consensus conference report on the Lower Limb Orthotic Management of Cerebral Palsy (4) that “Orthotic Care cannot effectively be provided in isolation”. Conference recognised, however, that a qualified orthotist may not be available at all times; reasons include: ‘remote geographic regional clinic without full clinic team + inadequately resourced service + “visiting” orthotists attending intermittent clinics In these circumstances, it was agreed that other professional staff with specific post-registration training may provide temporary orthoses including low temperature, thermoplastic, upper limb and hand orthoses used in combination with occupational and/or physiotherapy. The scientific literature on the orthotic management of stroke is generally poor both in terms of quality and quantity with very few papers reviewed reaching Grades A or B as described by le etal (3). Conference therefore recommended that academic institutions, researchers and clinicians make strenuous efforts to increase the body of evidence by means of good quality, scientific research in this area, Well-controlled, multi-centre trials involving large numbers of patients are urgently needed. NB Conference recognised that many health care professionals are not skilled in experimental design and may lack research experience. Papers by Chris Morris and Robert Wagenaar, both conference participants, were therefore commissioned by conference entitled, respectively, “Glossary of Research Terms” and “Guidelines for Stroke Rehabilitation Research”. These re included at Appendix A and Appendix B. ‘Many of the recommendations and conclusions in this report are graded as *- ‘good practice. points’. This means that there is a lack of scientific evidence in support of these statements. Conference therefore recommends that these ‘good practice points’ are used as a basis fr priority research in this field. It was apparent from the literature reviews and from discussions at conference that terminology used both within and between professional groups is inconsistent. This can relate to both orthotic components (¢.g. “non-articulated” or “solid ankle” AFO) and to patient description (e.g. “varus”, “supinated” or “inverted” foot position). Ambiguous terms such as “dynamic” are commonly used. The correct classification of spasticity is not well known nor totally accepted. ‘Where International, standard terminology exists as, for example, contained in ISO documents (4.5.6.7), this should be adopted and implemented with immediate effect. This may not, however adequately describe all contemporary orthoses and conference therefore recommends that an Intemational Working Group is established as soon as possible to investigate the issue of orthotic terminology and agree standard definitions. Conference suggested that ISPO is an ideal organisa- tion to implement this recommendation. Page 17 ] rein se or rsh nd es 10. 12, 13, 14, 15, Grade of Recommendation In many of the reviewed papers, the research methodology is sound however the description of the orthotic device is incomplete and, at times, absent. This greatly reduces the validity of the research project as it is impossible to judge whether or not the biomechanical design of the orthosis is appropriate. Further, rates of, and reasons for, rejection of the orthosis by the experimental group are frequently missing. Conference therefore recommends that the biomechanical design, materials and components of orthoses which are the subject of research should be clearly stated. Rejection rates, and reasons for rejection, should also be listed. ‘The question of who should be responsible for the written prescription for an orthosis was posed. ‘Traditionally, a doctor has fulfilled this role, however it was recognised that not all doctors have the appropriate knowledge or experience. Further, the writing of a prescription for an orthosis, Pambination of these, 01 orthotic referral should include (not in any particular order) * Diagnosis and relevant history, including adjunct treatment + Precautions (e.g. diabetic neuropathy, decreased sensation) + Musculoskeletal impairments, including a statement as to whether a joint deformity/contracture is fixed or not. * Gait analysis details (instrumented if available and/or visual) if the patient is mobile + Functional limitations + Result of a validated scale of status, impairment or measure of severity * Clinical objectives and functional requirements + Broad category of orthosis (AFO/KAFO) ‘The orthotic specification or description should be written by an orthotist and include: + Description of the mechanical force system required, including a detailed description of any joint or articulation + The alignment of the orthosis, e.g. the ankle angle of a non-articulating AFO or range of ‘motion at the orthotic ankle joint. + Components and materials, including types of closure e.g. straps, buckles or Velcro. The design of all orthotic devices should be based upon sound biomechanical principles. Conference recommended that during the period of recovery, regular monitoring of gait and upper extremity function is essential to inform the adjustment of the design of the orthosis as necessary. Conference agreed that the maintenance of complete records of any treatment provided is an integral part of the clinical duties of the orthotist like any other health care professional. ‘The dissemination and implementation of this report and the recommendations contained within it are crucial if the quality of orthotic care for stroke patients is to be influenced. Conference therefore recommends that a ‘task officer’ be appointed to take responsibility for these matters and for the organisation of interdisciplinary courses based on the content of this report and using recognised experts from each discipline. Page 18 should not be necessary given the professional training of orthotists and it was agreed that referral isamore accurate term. The conclusion was therefore that the crt lb en ‘am pppoe or heres. or en Sinn of ese, depending ee — o Report of a Concensus Conference on the Orthotic Management of Stroke Patients CONCLUSIONS AND RECOMMENDATIONS ARISING FROM SYNDICATE AND GENERAL DISCUSSION SESSIONS, In view of the volume of the material covered by the reviewers, this section primarily lists the conclusions and rec- ‘ommendations agreed by conference during the syndicate and discussions sessions. A comprehensive list of detailed recommendations, duly graded, may be found in the key review papers themselves. 16. Indications for a non-articulated AFO were agreed as follows: * Poor balance, instability in stance * * Inability to transfer weight onto affected leg in stance ic} * Moderate to severe foot abnormality; equinus, valgus or varus, or a combination c * Moderate to severe hypertonicity . ‘+ As above, but with mild recurvatum or instability of the knee c + To improve walking speed and cadence c 17. Indications for an articulated AFO were agreed as follows: + Dorsiflexor weakness only * ‘+ Where passive or active range of dorsiflexion is present . ‘+ Where dorsiflexion is needed for sit-o-stand or stair climbing . * To control knee flexion instability only, articulated AFO with dorsiflexion stop . * To control recurvatum only, articulated AFO with plantar flexion stop * * To improve walking speed and cadence B 18. Conference agreed that a custom-made Posterior Leaf Spring (PLS) ankle foot orthosis falls neither into the “articulated” nor “non-articulated” AFO category, and for the purposes of this report is therefore referred to as a flexible AFO. Indications for its use were agreed as follows: + Tsolated dorsiflexor weakness * ‘+ No significant problem with tone * + No significant medio-lateral instability . + No need for orthotic influence on the knee or hip. . 19 Conference considered the use of prefabricated, “off-the-shelf” AFO’s and recommended that their use should be limited to the following situations only: * As a temporary, evaluation orthosis. . * where there is a need for early mobilisation before a custom orthosis can be provided * N.B. Conference does not recommend an offthe-shelforthosis in the presence of problematic increased * tone in plantar or dorsiflexor muscles, or in the presence of significant medio-lateral instability. 20. Conference considered the question of providing an AFO for use in weight bearing as soon as the patient is medically stable. There is no evidence in the literature in support of this practice however conference that the following benefits can be extrapolated from the literature on the orthotic Saar e ‘of cerebral palsy: ~ Encourages balanced standing ~ Provides ankle stability ~ Promotes postural alignment ~ Maintains range of motion at the ankle - Supports early mobilisation Page 19 @] rion sie Proshes a bas 21. 22. 23. 25. In See presence of “dropped foot”, FES of the dorsiflexor muscles has a Positive effect on walking 21. 28. 29. 31. ‘Conference recommended that orthoses can be used in combination with physiotherapy for minimis- ing the development ofcontractures/Seformites in the cary acute phase N.B.Conference noted the differences in the interpretation of “early ‘chronic”, and “late” * phases with regard to rehabilitation. It therefore recommends that there should.be.an.agreement of. this terminology by all professional groups involved in this field. Suengih wining vous of aden. xoluns ad desaionseia enon tancesaeee soci (A) and A,B can Tesulf if incféase in function (B), beyond those realised in the absence of such training. Adequate volumes of aerobic exercise (cycle or treadmill) alone.or in combination with other exercise, will result in increased ae iy, SOC a ~~ Non ambulatin anc poorly ambulating pasiensparisipatng in adequate volumes of treadmill training improve more in gait tha Similar patients not so treated. and the Physi t Index (PCD) During the period of recovery, regular monitoring of gait is needed to modify the biomechanical design of the orthosis as necessary. ‘Where both FES and orthotic management are available and appropriate, conference concluded that the final choice between the treatment modalities should be made by the patient based on the appear- ance and ease of use of the SES a ‘treatments. NB. When considering FES, Conference Was Advised that FES referred to functional electrical stimulation and NMES to neuro muscular electrical stimulation and both terms have been used in the literature on stroke rehabilitation. ‘The long-term, or “carry over” effects of both FES and lower limb orthotics use havc . Prove ‘There is good evidence that BTX-A.is effective in reducing lower limb spasticity. A ‘The evidence of the efficacy of drugs administered orally is stronger.(B) than for drugs-administered _ by other means suchas inathecally or chemical neurolysis with pheno or alcohol). ‘Where increased muscle tone interferes with orthotic treatment with regard to fit or function, phar- m one inte Stor hoon Pe Conference agreed that an improvement awareness of this treatment option is recommended. oo 32. 33. 34. 35. 36. As with AFOs, where standit instabilit it may be * appropriate to consi Inthe presence of moderate to severe genu recurvatum or when an AFO is unsuccessful in controlling = g these conditions, then a KAFO should be considered. Conference agreed strongly that genu recurvatum should not be ignored. It stressed the importance of identifying the.cause, and that prevention, wherever possible, is important. Where there is an underlying problem of increased tone in ae eee ‘extensor muscles, this should be addressed by other N.B. Conference was made aware of the development of “new” designs of orthotic knee joints which ‘may offer improved function to patients requiring a KAFO. ‘The following two recommendations apply to all lower limb orthoses (AFO and KAFO). Aimmaas ofthe orthosis at ternal sancefpreswing is eritical and will influence step length, gait symetry, speed and < A contracture at any joint of the lower limb may limit the effectiveness of an orthosis. Page 20 Report of a Concensus Conference on the Orthotic Management of Stroke Patients Grade of Recommendation 37. There is extrapolated evidence from the literature on the orthotic management of cerebral palsy that | ower linn orthosis can have a positive effect on the range of motion of the hip joint. This is * supported by the clinical experience of conference. 38. There is a place for orthopaedic surgery in the management of stroke patients, however this should . not: normally be considered in the early phase of recovery. 39. The age of the patient is not.a contraindication for surgery, * 40. Orthopaedic can be considered for fixed deformities, comectable deformities (sometimes . re as “dynamic) or contractures and acombination of both _ however 41. Surgery should only be a consideration for non-fixed or correctable deformities which are not pee ct ecient . 1-The term “dynamic” can be interpreted in different ways. “Volitional” may be a more appropriate faccurate adjective. 42. Conference recommends that the type of surgery and its functional effects should be informed by clinical gaitanalysis, both observational and isiamental, when available. Dynamic poly-electromy- ography is strongly recommended prior to surgery when the goal isto improve active function ofthe * limb. Dynamic EMG is not required when the goal is to improve passive range of motion. N.B. Itwas acknowledged that both physio and, more often, occupational therapists have traditionally been responsible ‘for the supply of upper limb and hand orthoses in many clinical settings. This responsibility is shared with orthotists ‘experienced in upper limb management, however appropriately skilled orthotists are often in short supply. This, coupled with the overlap in professional roles which is frequently encouraged in effective stroke rehabilitation teams, has led to some confusion and, at times, heated debate, as to which profession should provide an upper limb orthotic service. As a consequence of this multi-professional management of U.L. problems, there is more literature on the subject of ‘orthoses and the U.L.' published by physio and occupational therapy practitioners. Conference agreed, however, that the research findings remain, in general, inconclusive and PT. and 0.T. orthotic interventions for the arm and hand remain controversial. Conference made the following recommendations: 43, The General Recommendations (points 1-15), conclusions and recommendations) apply equally to upper limb and lower limb orthotic management. 44. Conference recommended that in an ideal situation, where both trained orthotic and therapy staff are included in the stroke team, the complexity of the device will determine who should provide the orthosis i.e. more complex orthoses should be provided by orthotists. ‘Temporary upper limb orthoses and off-the-shelf devices with relatively simple “fitting” requirements may be provided by appropriately trained professional staff other than orthotists e.g. occupational therapists, physiotherapists and nurses with specific skills in this area. 45 Team training in the design, use and fitting of upper limb and hand orthoses is strongly recommended. * 46. Well identified, measurable goals should be agreed by the clinic team in conjunction with the patient. . 47, Although the relationship between shoulder pain and subluxation is not absolute, there is weak evidence and a clinical rational behind the institution of shoulder supports as an adjunct to physiotherapy. a 48. The design of any shoulder orthosis, in common with all orthotic devices, should be: based on sound biomechanical principles. easy to don/doff * cleanable of a design which allows the patient to be cleaned Page 21 @ +r seer renters on Oro Grade of Recommendation 49. Orthotic treatment of the upper limb and hand should be considered during the early rehabilitation phase, with the emphasis on prevention of contracture and deformity and on enabling function 50. The evidence in support of the use of lycra cuffs, reinforced elastic bandages, airsplints and resting splints is weak. 51. There is good evidence of the positive effect of repetitive function and strength training for the hand and upper limb. 52. There is conflicting evidence about the efficacy of constraint induced therapy and robot-aided training =, for dexterity of the upper paretic limb. 53. There is no compelling evidence that an upper limb neuroprosthesis based upon present technology is effective in improving hand function of stroke patients. C 54, There is good evidence that pharmacological treatment can reduce muscle tone. Treatment is ikely tobe most effective when itis combined with other therapies including orthotics and surgery. 55. There is strong evidence thatthe use of botulinum toxin reduces spasticity inthe upper limb andy hand. ‘56. Studies of surgery for the upper limb and shoulder have been conducted for many years with some positive results. Numbers of patients tend to be small, however, and the research methodology weak. Conference recommends that more evidence is needed to scientifically establish the effectiveness of * using orthopaedic surgery to treat upper extremity dysfunction or deformity following stroke. 57. Conference agreed that a range of measures will be needed from which researchers and clinicians can select the most appropriate measure(s). list of validated measures of impairment, activity and. icipation or function which may be of use in studies of orthotic intervention after stroke is included nihsrepon Appendin 3). enenonatier sake iene Te] 58. The majority of studies included in the review of outcome measures have chosen measures of impair- ‘ment matched to the aims of the orthotic intervention tested, however many studies have not moni- tored these effects at the level of walking function. Conference recommends that studies of orthotic intervention should include, wherever feasible, measures of function which are of relevance to the patient, and that issues broadly defined as “quality of life” and which may be influenced by orthotic intervention should also be measured. 59. Any chosen outcome tool should match the aim of i tion and demonstrate the key measurement tbs of valli eliabisy and seni. For evalua validity, reliability and sensitivity. For evaluative instruments, sensitivity * to clinically important change is an additional requirement for validity. 60. There was agreement that the great majority of published studies on the subject are low in the hier- archy of levels of evidence. Conference has made recommendations earlier in this report which may * ‘go some way to improve the quality of research evidence. 61. Conference further recommends the initiation of multi-centre, even multi-national trials where large ‘groups of patients are entered into rigorously conducted, methodologically sound research projects which are sufficiently large to answer the research questions with the least chance of statistical error. * To be fully effective, this can only take place after the recommendations on standardising terminology and definitions have been implemented. 62. Conference strongly supports the concept of multi-professional research into the orthotic management lor stoke patients Page 22 Report of a Concensus Conference on the Orthotic Management of Stroke Patients REFERENCES 1, Health Technology Assessment 1998; Consensus development methods, and their use in clinical guideline development vol, 2: no. 3 2. Greenhaulgh T. (1997) ‘How to read a paper. The basis of evidence based medicine’. BMJ Publishing Group, England. 3. Shekelle PG, Woolf SH, Eccles M and Grimshaw J (1999). ‘Clinical Guidelines ~ Developing Clinical Guidelines’. BMJ, 318, 593-596, 4. 180 8549-1:1989-Prosthetics and orthotics-Vocabulary-Part1.: General terms for external limb prostheses and external orthoses. International Standards Organisation ,1989 5. 180 8549-3:1989.Prosthetics and orthotics- ocabulary-Part 3: Terms relating to external orthoses International Standards Organisation, 1989 6. 180 8551:2003. Prosthetics and orthotics-Functional deficiences -Descripton of the person to be treated with an orthosi of treatment and functional requirements ofthe orthosis. International Standards Organisation, 2003, clinical objectives 7. 18013404 Prosthetics and orthotics-Classiication and description of external orthoses and orthotic components, International Standards ‘Organisation (in preparation) Page 23 Weer socie fr Presa and Orthos APPENDIX A GLOSSARY OF RESEARCH TERMS Christopher Morris MSC, SR Orth [RESEARCH ‘Some systematic and unbiased method of answering questions. EFFICACY ‘Whether an intervention demonstrates a treatment effect in controlled experimental conditions EFFECTIVENESS “Whether an intervention demonstrates a treatment effect in routine clinical practice. EFFICIENCY “Economic and expedient delivery of heal services. RESEARCH METHODOLOGY ‘Selecting an appropriate research design wo answer the specified question ‘OBSERVATIONAL RESEARCH ‘Descriptive information is collected but events are not infiuenced by the researchers, EXPERIMENTAL RESEARCH "The researchers deliberately influence events and monitor what happens as a result, CONTROL, Th order to test fa new intervention has a treatment effect we need ‘comparison patient or parallel group that is weated in some other way, standard treatment or placebo. ‘BLINDING “The extent wo which clinicians, patients and those evaluating ‘outcomes can be prevented from know which treatment has been allocated in a clinical trial, this i difficult in orthotics. BIASES Fair tests of treatments require the avoidance of bia a all tages in the research proces, including: how patents are selected, that ‘comparison treatments are appropriate, allocation of treatment is concealed from clinicians, observer or measurement ero is ‘minimised, that all results are reported. (www jameslindlibrary org) RANDOMISED CONTROLLED TRIAL ‘Subjects are randomly assigned to groups that vary only by their ‘exposure to the intervention, Statistical analysis is between groups META-ANALYSIS. ‘Statistical aggregation of the results of several separate but similar studies ‘CONTROLLED CLINICAL TRIAL "An experiment where an intervention is compared with another or ‘no weatment but there is no attempt to randomly allocate subjects to different groups. ‘COHORT STUDY ‘A group is opportnistically identified by their exposure 10 a ‘medical intervention or noxious agent, followed and their outcome ‘compared with another group not exposed tothe agent or treatment; ‘for example identifying subjects ‘using’ and ‘not using’ an AF. and following them up to see whether there isa difference in the ‘proportion in each group that develops ankle equinus. Cohort studies are therefore prospective. ‘CASE-CONTROL STUDY 'A group is identified because they have an outcome (the cases) ‘and their exposure to a medical intervention or suspected agent is ‘compared with a group that donot have the outcome (the controls) For example, identifying subjects who have a fixed equinus deformity and those who do not, and investigating whether there isa difference in the proportion in each group that used an AFO. Case-contol studies are retrospective. ‘The difference between cohort and case-control studies may be ‘confusing, the issue depends upon whether subjects ae identified by their exposure toa causal agent (cohort of whether they are ‘denied by having sustained some outcome (case-control). Tis affects the procedures for statistical analysis Page 24 Report of a Concensus Conference on the Orthotic Management of Stroke Patients ‘WITHIN SUBIECT COMPARISON STUDY ‘Also called a ‘before and after” design, the subject acs as their own contro, for instance walking with and without an orthosis at one point in time, A more rigorous approach follows the subject for longer making several assessments; this sa time-series study ‘CROSSOVER STUDY “A vatation of the within-subject comparison design, subjects receiv all the treatments being compared, usually in @ random onder. A period of n0 weatment usually occurs between comparison interventions o alow the effets ofthe rst weatment to washout. Forexample providing subjects wi either arg o hinged AFO for a month and then after two weeks of no treatment providing the other typeof AFO, and comparing subjects functional ability ‘between the two types of AFO. Statistical analysis is within groups. ‘CROSS-SECTIONAL STUDY ‘in across sectional stady all the information is collected about subjects atone point in time. These are usually descriptive studies, called surveys, but can also be used to explore astocations, ‘SAMPLE SIZE “The numberof subjects required in an experiment testing a ‘hypothesis that is likely to detect a worthwhile and statistically significant effect when i exists, and conversely, not find an effect ‘when it does not. Without calculating a sample size two types of ‘error are risked: ‘Type I or a error - Believing there are benefits from orthoses when it fact there are not. ‘Type I or 8 error - Rejecting using orthoses which may actually confer benefit ‘CONFIDENCE INTERVAL ‘When i has not been possible to calculate a sample size results can ‘be presented together with a range of values within which the tue ‘value is expected to be, this isthe confidence interval (CD and is usually set at 95%. This means the tre value can be expected to ‘be within the specified range 95% of the time, however iis also possible to calculate a 99% CI. The wider the range represented by the confidence interval the less precise the result, and conversely the narrower the range the more precise the result HEALTH STATUS MEASUREMENT Patient and family self reports of ther abilities or quality of Life are now commonly used along side more conventional indicators cof heath in clinical trials and routine practice. Discriminative ‘measures are used to tell people apart, for example by he severity of their movement ability, by contrast evaluative measures are ‘responsive to change in individua’ abilities RELIABILITY “The reliability of an assessment or outcome measure, for example clinical test or quality of life questionnaire, reflects the amount (of systematic or random error inherent in the measure. Forms of reliability include the reproducibility of observations made by

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