JPT200106_JGPT 8/18/11 11:18 PM Page 109
Systematic Review
Balance Interventions for Diabetic Peripheral
Neuropathy: A Systematic Review
Katherine I. Ites, PT, DPT1; Elizabeth J. Anderson, PT, DPT2;
Megan L. Cahill, PT, DPT3; Jenny A. Kearney, PT, DPT4;
Emily C. Post, PT, DPT4; Laura S. Gilchrist, PT, PhD4
ABSTRACT
Diabetic Peripheral Neuropathy (DPN) is a complication of dia-
betes experienced by more than 30% of all diabetic patients. It
causes decreased sensation, proprioception, reflexes, and
strength in the lower extremities, leading to balance dysfunc-
tion. The purpose of this study was to assess the effectiveness
D iabetic peripheral neuropathy (DPN) is a serious
of interventions used by physical therapists to minimize bal-
ance dysfunction in people with DPN. Currently, no systemat-
ic review exists that explores the effectiveness of these
interventions. When conducting this systematic review, we
searched the electronic databases CINAHL, EMBASE,
Cochrane Review, and Medline using specific search terms for
the period from inception of each database to June 2009. Two
independent reviewers analyzed the abstracts obtained to
determine whether the article focused on balance interventions
that are within the scope of physical therapy practice. All study
designs were eligible for review with the exception of case
reports and systematic reviews. The Delphi criteria was used to
assess methodological quality. This literature search and meth-
ods assessment resulted in 2213 titles, 82 abstracts, and 6
articles, including 1 randomized controlled trial eligible for
inclusion. The 6 articles contained 4 physical therapy inter-
ventions including monochromatic infrared energy therapy,
vibrating insoles, lower extremity strengthening exercises, and
use of a cane. Upon thorough analysis of outcome measures,
statistical significance, and clinical relevance, the intervention
of lower extremity strengthening exercises was given a fair rec-
ommendation for clinical use in treating balance dysfunction in
patients with DPN. All others had insufficient evidence to either
support or refute their effect on balance in this population.
Key Words: balance, diabetes, peripheral neuropathy, systematic
review
(J Geriatr Phys Ther 2011;34:109-116.)
1Children’sHospitals and Clinics of Minnesota,
Developmental and Rehabilitation Services, Minneapolis,
Minnesota.
2Aegis Therapies, Martin Luther Care Center, Bloomington,
Minnesota.
3Regions Hospital, St Paul, Minnesota.
4Department of Physical Therapy, St Catherine University,
Minneapolis, Minnesota.
Address correspondence to: Katherine Ites, PT, DPT,
Children’s Hospitals and Clinics of Minnesota,
Developmental and Rehabilitation Services, 2530 Chicago
Ave South, Minneapolis, MN 55404 (katherine.ites@
childrensmn.org).
DOI: 10.1519/JPT.0b013e318212659a
Journal of GERIATRIC Physical Therapy
Copyright © 2011 The Section on Geriatrics of the American Physical Therapy Association. Unauthorized reproduction of this article is prohibited.
complication of both type 1 and type 2 diabetes.1 In
2008, it was estimated that 18.82 million Americans,
or 6.29% of the population, had diagnosed diabetes.2 A total
of 1.6 million new cases of diabetes are diagnosed each year
in the United States, a number that is on the rise as the inci-
dence of obesity continues to increase. Although diabetes can
affect people at any stage of development, its prevalence
increases with age and it is estimated that 23.8% of individu-
als 60 years of age and older have diabetes.3
One of the many side effects of diabetes mellitus is dia-
betic peripheral neuropathy. It is estimated that 60% to
70% of individuals with diabetes have mild to severe forms
of nervous system damage.2 A simple definition of DPN is
“the presence of symptoms and/or signs of peripheral nerve
dysfunction in people with diabetes after exclusion of other
causes.”4 Although there are several types of DPN associat-
ed with diabetes, this article will focus on chronic sensori-
motor DPN, the most common type of neuropathy in dia-
betes mellitus.4 Symptoms of peripheral neuropathy include
numbness or insensitivity to pain or temperature, paresthe-
sias, sharp pains or cramps, and extreme sensitivity to touch.
In addition, as many as 30% of people with DPN experience
muscle weakness, loss of ankle reflexes, and decreased bal-
ance and coordination.2 This can significantly impair physi-
cal function by limiting walking and standing activities and
may also increase the risk for falls in people with DPN.
Peripheral neuropathy is caused by microvascular abnor-
malities resulting in nerve damage.5 Chronic hyperglycemia
impairs microvascular circulation by disrupting normal cellu-
lar communication and initiating signaling cascades. Through
the production of advanced glycation end products and protein
kinase C signaling cascade, chronic hyperglycemia causes dam-
age to nerves.5 Specifically, it results in axonal thickening and
decreased capillary blood flow resulting in poor nerve perfu-
sion and endonural hypoxia.5 These cellular-level impairments
are manifested as loss of ankle reflexes, decreased position and
vibratory sense, and sensory ataxia.6 In addition, patients with
DPN often demonstrate delayed reflex responses to postural
perturbations as a result of decreased nerve conduction veloci-
ty and are subsequently more likely to demonstrate balance
impairments and an increased risk for falls.6
Management of DPN is generally multifaceted. Avoidance
of complications through excellent blood glucose control
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Systematic Review
appears to be the most effective strategy for prevention.4
Pharmacological interventions for symptom management are
available. Some medications have been found effective but side
effects often limit their use.4 Physical therapy interventions uti-
lized to reduce the balance dysfunction can range from restora-
tion of the health of the neurons to sensory integration to com-
pensatory strategies.7 Examples of such interventions include
improving circulation, guided practice of integrating internal
and external sensory input, education on sensation loss and
fall risk, instruction on home modifications, and introduction
of assistive devices to minimize balance dysfunction.7,8
Although physical therapists can play an important role
in the management of balance dysfunction as a result of
DPN, there has been no comprehensive review published
on this topic. Therefore, we performed a systematic review
of the literature to determine the effectiveness of physical
therapy interventions on balance dysfunction in adults with
DPN. This study was conducted in line with the PRISMA
Statement for systematic reviews.9
METHOD
Literature Search
A comprehensive computerized database search of 4 elec-
tronic databases was conducted from inception to June 2009:
CINAHL, starting at 1981, EMBASE starting at 1972,
Medline starting at 1966, and Cochrane Review starting at
1988. Search terms included a combination of the terms
“peripheral neuropathy,” “balance,” and “diabetes melli-
tus.” Bibliographies of retrieved articles were also searched
for additional studies.
The article titles from the search were each reviewed inde-
pendently by 2 authors. Titles were accepted if they contained
the topics of diabetes and neuromuscular balance, and/or falls
risk. In this review, balance was defined as the ability to main-
tain a steady position in a weight-bearing standing posture.7
When the 2 individual reviewers did not agree, a decision for
inclusion or exclusion was made by a third independent review-
er. Abstracts of the included titles were obtained and analyzed
by using the same method. Abstracts often contained words
such as “falls risk” and “fear of falling” in addition to balance.
Study Selection
Once an article was included on the basis of abstract con-
tent, it was considered appropriate for this systematic
review if the following criteria were met.
Design
All study designs were eligible for review, with the excep-
tion of case reports. Lack of available research on this sub-
ject prevented us from limiting articles to randomized con-
trolled trials alone. Only full reports were included;
abstracts, unpublished articles, and studies in a language
other than English were excluded.
Study population
A study was included if the study population consisted
predominantly of adults with DPN. Studies that included
110
Copyright © 2011 The Section on Geriatrics of the American Physical Therapy Association. Unauthorized reproduction of this article is prohibited.
subgroups of patients with other types of neuropathy were
excluded if the data for patients with DPN could not be
analyzed independently of the other groups.
Intervention
All studies were required to include interventions that are
within the physical therapy scope of practice. Excluded inter-
ventions included pharmacological treatment, surgical inter-
ventions, and acupuncture.
Outcome measures
The studies were required to report a primary outcome
measure of balance.
Each of the characteristics mentioned earlier was extracted
from the articles for analysis.
Data Analysis
A statistical analysis was conducted to determine the magni-
tude of the treatment effect. Effect size (ES) and number need-
ed to treat (NNT) statistics were used to determine the mag-
nitude of the treatment effect for each intervention. Effect size
is reported with 95% confidence intervals. Insufficient evi-
dence for each intervention prevented pooling of data for
meta-analysis.
Assessment of Individual Study Quality
Once the articles were selected for complete review, 5
authors independently read each article and analyzed the
study methods using the Delphi criteria (Table 1). The
Delphi criteria has been shown to be a valid and reliable
tool for the assessment of clinical trials and has also been
used in systematic reviews.10 A recent systematic review
by Olivo et al,11 which assessed the scales used to evalu-
ate the methodological quality of randomized controlled
trials in health care research, concluded that the Delphi
List had good validity and was relevant for use in the field
of physical therapy.
The Delphi criteria is composed of 9 questions to assess
treatment allocation, patient population, eligibility criteria,
subject and assessor blinding, outcome measures, and
Table 1. Delphi Criteria Used to Assess Individual Study Qualitya
Treatment Allocation
Was a method of randomization performed?
Was the treatment allocation concealed?
Were the groups similar at baseline regarding the most important
prognostic indicators?
Were the eligibility criteria specified?
Was the outcome assessor blinded?
Was the care provided blinded?
Was the patient blinded?
Were point estimates and measures of variability presented for the
primary outcome measures?
Did the analysis include an intention-to-treat analysis?
aAdapted from Verhagen et al.10
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Systematic Review

patient dropouts. For an answer of “yes,” the question was Table 3. Determining Factors of Grading for Clinical
given a score of 1. For an answer of “no” or “don’t know,” Recommendationsa
the question received a score of zero. Using this scale, an Grade Clinical Recommendations
overall score out of 9 was given to each article, with a score A Good evidence to recommend a beneficial treatment
of 6 of 9 considered to be high quality evidence.10
B Fair evidence or mixed results to recommend a beneficial
Group consensus was reached between all 5 reviewers to
treatment
determine the Delphi score for each article. The independ-
ent reviewers were not blinded in regard to article title, C Poor evidence to recommend a beneficial treatment;
statistical significance unimportant
author, journal, or funding source. None of the authors
have a conflict of interest or previous publications in this aData from Philadelphia Panel Evidence-Based Clinical Practice Guidelines.12

subject manner that would bias the results of this study.

Assessment of Intervention Categories
Intervention grading
First a numeric grade was given to each intervention type
on the basis of the quality of available research, according
the guidelines seen in Table 2.12 The numeric level, using a
5-point scale, was based on the design of the studies for the
intervention category only.
Second, a letter grade (Table 3) was assigned to the inter-
vention category that evaluated each intervention on the basis
of magnitude of treatment effect on the intended outcome of
functional balance. An intervention received a higher grade if
the outcome measure was based on balance or function/quality
of life. In addition, outcome measures were required to have
demonstrated validity and reliability to obtain a higher grade.
Each intervention was given both a numeric level of evi-
dence, based on the design of the available studies, and a
letter grade reflective of the magnitude of intervention effect
on the intended outcome of functional balance. Therefore,
it is possible to have a well-designed trial that indicated no
effect of interventions.
Individual reviewers determined both the numeric level
of evidence and the letter grade appropriate for each inter-
vention. Both were discussed, and group consensus was
used to finalize the level of evidence and the clinical recom-
mendations grade for each intervention.
alone because they did not include neuromuscular balance.
Of the 82 abstracts, 69 articles were excluded because they
focused solely on improvements in sensation without direct
measurement of balance, or they did not discuss interven-
tions that are within the physical therapy scope of practice,
such as medication management. Articles that focused on
ionic balance were also excluded. Thirteen potential arti-
cles8,13-24 were assessed for inclusion in our review, with 7
articles being excluded on the basis of our study’s inclusion
criteria. None of these articles met our search criteria; all
lacked specific interventions and results for subjects with
diabetic peripheral neuropathy.
A total of 6 articles were reviewed for their method-
ological quality using the Delphi criteria (Table 4). Of the 6
articles, only 1 article received a Delphi score of 7/9
(Leonard et al13) indicating high methodological quality;
this was the only randomized controlled trial found. The
remaining 5 articles scored between a 1/9 to 5/9 on the
Delphi criteria, indicating poor methodological quality.
Intervention Characteristics
This systematic review includes studies that assess 4 differ-
ent physical therapy interventions with potential to

RESULTS
Selection of Studies
Figure 1 provides an overview of the literature search and
study selection. From the total of 2213 article titles consid-
ered for review, 2131 were excluded on the basis of the title
Table 2. Level of Evidence Used for Each Interventiona
Level of Evidence Study Design
Level I At least 1 randomized controlled trial
Level II-1 Controlled trial without randomization
Level II-2 Cohort or case-control analytic studies
Level II-3 Comparisons between times of places with/without
interventions
Level III Collected from respected authorities on the basis
of clinical experience
aData
Figure 1. Graphic illustration of selection process and
from Philadelphia Panel Evidence-Based Clinical Practice Guidelines.12
results of titles, abstracts, and articles reviewed.

Journal of GERIATRIC Physical Therapy 111

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JPT200106_JGPT 8/18/11 11:18 PM Page 112

Systematic Review

improve balance in patients with DPN. These interventions
include monochromatic infrared energy (MIRE) therapy,
vibrating insoles, lower extremity strengthening exercises,
and the use of a cane as a compensatory strategy. There
was a wide variation in the type and quality of the outcome
measures used to measure balance dysfunction across
studies (Table 4).
Description of the Individual Trials Categorized
by Intervention
Monochromatic Infrared Energy Therapy
The search of the literature resulted in 3 articles that inves-
tigated the effects of MIRE on balance and falls risk in
patients with DPN. The methodological quality of the
studies varied greatly, with scores on the Delphi criteria
ranging from 1/9 to 7/9. Although all 3 studies utilized an
Anodyne Therapy System, we were unable to compare
dosages and parameters across studies, as this information
was not consistently provided by the authors. Each study
found similar results regarding the use of MIRE to improve
balance deficits in patients with DPN, yet all had major
methodological limitations, limiting generalization of the
results.
The study by Leonard et al13 scored a 7/9 on the Delphi
criteria. In this double-blinded, randomized, placebo-
controlled study, the intervention group received 4 weeks of
MIRE treatment, while the control group received 2 weeks
of sham treatment followed by 2 weeks of active treatment.
Strengths of this study included high methodological -
quality, clearly defined inclusion and exclusion criteria, and
clearly explained treatment parameters. The primary

Table 4. Studies Included in Systematic Review

Delphi
Study Score Study Design Population Intervention Control Group Outcome Measure Reported Findings
Leonard 7/9 Double-blind, DPN only, divided MIRE Sham treatment Question about Decreased
et al13 randomized, into 2 groups to 1 leg balance and perception of
placebo- on the basis perception of falls risk in
controlled of degree of falls risk both group
sensory loss
(N ⫽ 27)
Kochman8 1/9 Nonrandomized, Peripheral MIRE plus No control Tinetti Balance Tinetti mean
noncontrolled, neuropathy. stretching, Assessment, improvement
retrospective N ⫽ 38, strengthening, Number of falls 10.4 ⫾ 3.9,
chart review included and balance 93% reduction
27 patients training in falls
with DPN
Powell et al14 1/9 Retrospective Adults with DPN, MIRE unit provided No control Questions about 55% reduction in
cohort study loss of protective for home use number of falls number of
sensation and and fear of reported falls
history of falling 79% improve-
improved ment in fear of
sensation with falling
MIRE (N ⫽ 252)
Priplata 5/9 Repeated Adults with DPN Vibrating Insoles: No vibration Sway parameters Reduction in all
et al15 measures (N ⫽ 15) Standing on sway parameters
design custom insoles from 2.9% to
that delivered 53.8%
subsensory
vibration
Richardson 4/9 Prospective, Adults with DPN Lower extremity Neck flexion and Tandem stance, Significant
et al16 controlled, (N ⫽ 20) strengthening: scapular single-leg improvement in
single blind Open and closed stabilization stance, all 3 functional
study chain ankle exercises functional measures,
strengthening, reach, ABC improved ABCs
wall slides, and scale score but not
single-leg stance significant
Ashton-Miller 2/9 Nonrandomized, Adults with DPN Use of single-end No cane Failure rate during Four-fold reduction
et al17 case-control (N ⫽ 8) and cane weight transfer in failure rate,
study age and gender task to unipedal to a level better
matched stance with a than controls
controls tilting support
(N ⫽ 8) surface
Abbreviations: ABC, Activities-specific Balance Confidence; DPN, Diabetic Peripheral Neuropathy; MIRE, monochromatic infrared energy.

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JPT200106_JGPT 8/18/11 11:18 PM Page 113
balance measure was the question “Do you ever feel off bal-
ance or like you are going to fall?” Limitations of this study
included a small sample size, the use of subjects as their own
control, the control intervention being administered to only
one leg with active treatment to the other leg at the same
time, and the lack of a reliable and valid balance outcome
measure. Although there were positive results with this
study, the absence of a true control for balance dysfunction
prevented computation of ES or NNT. It must be noted that
the primary aim of this article was to measure improve-
ments in sensation, and that balance dysfunction was a sec-
ondary outcome.
Kochman8 examined the effects of combining MIRE
therapy with more traditional physical therapy interven-
tions with proven effectiveness, such as neuromuscular
reeducation and therapeutic exercise. This study was a non-
randomized, noncontrolled, and retrospective chart review
of 38 patients and received a score of 1/9 on the Delphi cri-
teria. Patients participated in an average of 12 physical ther-
apy sessions consisting of MIRE treatment along with bal-
ance, strengthening, and stretching exercises. At the conclu-
sion of the study, subjects demonstrated a significant
decrease in risk for falls, as demonstrated by improvements
on the Tinetti balance assessment scores (ES ⫽ 2.3 ⫾
0.459). A 93% decrease in the number of falls was report-
ed at a 3-month follow-up interview (ES ⫽ 1.7 ⫾ 0.459).
Strengths of this study included the use of a valid and clin-
ically relevant outcome measure and a 3-month follow-up
period for fall occurrence. Limitations of this study includ-
ed a small sample size, lack of randomization and control
groups, absence of inclusion and exclusion criteria, and lack
of specified treatment parameters. Because of the mixed
intervention and lack of a control group, improvements
seen in this study cannot be exclusively attributed to MIRE.
Powell et al14 reported a retrospective cohort study,
which received a score of 1/9 on the Delphi criteria. Subjects
consisted of 252 community-dwelling individuals with doc-
umented DPN, loss of protective sensation, and a history of
improved sensation following MIRE therapy. Using tele-
phone interviews, subjects were asked 5 questions regarding
number of falls, balance, and fear of falling recalling back
to the period prior to treatment and comparing it to the
period following treatment for DPN. In the period follow-
ing MIRE therapy, subjects reported a 55% reduction in
number of falls and 79% improvement in fear of falling,
both of which were statistically significant differences
(NNT ⫽ 6.29). Strengths of this study include a large sam-
ple size, clear methodological outline, and clinically relevant
outcomes. This study is limited by outcomes based solely on
subject recollection to a time period prior to and after treat-
ment for DPN, using perceived improvement as a measure,
and poor study design. Also, this study lacked a control
group to minimize the effect of confounding variables, such
as exercise and diet recommendations.
Vibrating Insoles
Our search of the literature produced an article by Priplata
et al15 that examined the effects of subsensory mechanical
Journal of GERIATRIC Physical Therapy
Copyright © 2011 The Section on Geriatrics of the American Physical Therapy Association. Unauthorized reproduction of this article is prohibited.
Systematic Review
noise on balance in individuals with DPN (Table 4). This
single-blinded prospective study with 15 subjects scored 5/9
on the Delphi criteria. Individuals with DPN participated in
trials of quiet, undisturbed standing with eyes closed, both
with and without vibrating insoles. Eight sway parameters
were measured, all of which decreased in the vibrating
insoles trials (ES ⫽ 0.513 ⫾ 0.385 for AP sway and
0.256 ⫾ 0.321 for ML sway). Strengths of this study includ-
ed clearly defined inclusion and exclusion criteria, random-
ization of intervention presentation, and a low dropout
rate. Limitations of this study included a small sample size
and limited applicability of the outcome measure to func-
tional balance. In addition, raw data was not available to
calculate ES or NNT; calculations were estimated from
graphs. Although this article provided evidence to support
the use of mechanical noise to reduce sway in static stand-
ing in patients with DPN, the transferability of these results
to balance activities such as walking and climbing stairs is
limited because the study was conducted in a laboratory
setting with patients in quiet-standing with eyes closed.
Lower Extremity Strengthening Exercises
The search of the literature produced 1 article by
Richardson et al16 that examined the effects of a focused
exercise regimen on balance in 20 subjects with peripheral
neuropathy. This prospective, single blind cohort study
received a score of 4/9 on the Delphi criteria. Participants in
the intervention group participated in lower extremity exer-
cises consisting of open and closed chain ankle exercises,
wall slides, and single-leg stance for 3 weeks. Participants in
the control group performed neck flexion and scapular
stabilization exercises. Subjects in both groups performed
3 trials of each outcome measure (tandem stance, single-leg
stance, and functional reach) and completed the Activities-
specific Balance Confidence (ABC) scale before and after
the intervention. At the end of the study, the intervention
group showed significant improvements in all 3 functional
outcome measures when compared with the control group,
which showed no significant improvements (ES ⫽ 1.32 ⫾
0.63 for single-leg stance, 0.476 ⫾ 0.553 for functional
reach, and 0.448 ⫾ 0.539 for tandem stance). In contrast,
there were no significant differences noted in ABC scores
for either group. These results showed that a brief, intense
lower extremity exercise regimen could lead to improve-
ments in 3 clinical parameters of balance in a group of older
persons with peripheral neuropathy. Strengths of this study
included the use of 3 clinical measures of balance and clear-
ly defined exercise regimens for both groups. Weaknesses of
this study included a small sample size and lack of ran-
domization and matched-control subjects. Although the
article scored poorly on the Delphi criteria indicating low
methodological quality, the outcome measures were of
clinical relevance.
Single-End Cane
A search of the literature resulted in 1 article that examined
the effects of a cane on balance in individuals with DPN.17
This nonrandomized controlled trial by Ashton-Miller et al17
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Systematic Review
scored 2/9 on the Delphi Criteria. Subjects consisted of
8 patients with DPN and 8 age- and gender-matched con-
trols. All subjects stood in a frame with a computerized base
and hand railings. Subjects were cued to shift weight to
1 leg and balance for a minimum of 3 seconds, while expe-
riencing a perturbation. Participants completed 28 trials in
each of 4 conditions: eyes open, eyes closed, eyes open with
cane, and eyes closed with cane. Failure rate, defined as the
inability to maintain single-leg stance for 3 seconds without
touching the handrails or placing the other foot on the
ground, was measured during each of the conditions.
Results of the study showed that patients with DPN had a
significantly higher failure rate in all 4 conditions. In the
DPN population, the use of a cane significantly reduced the
failure rate in both the eyes open and eyes closed conditions
(ES ⫽ 3.56 ⫾ 0.707; NNT ⫽ 1.78). Strengths of this study
included use of an appropriate control group and selection
of a challenging balance situation. Limitations were a small
sample size and lack of randomization or blinding. Although
the article revealed good statistical evidence supporting the
use of a single-end cane (SEC) for patients with balance dys-
function secondary to DPN, it lacked a clinically applicable
outcome measure and high methodological quality.
DISCUSSION
Considering articles that met the criteria for this systematic
review, the intervention of lower extremity strengthening
exercise presents the best clinical evidence for treating bal-
ance dysfunction in patients with DPN (Table 5).
Monochromatic infrared energy, vibrating insoles, and use
of a cane do not have research-based outcomes to support
their use at this time because they lack quality studies with
strong methods and clinically important outcomes.
Although the lower extremity strengthening exercise
demonstrated the best clinical evidence when addressing
balance impairments for patients with DPN, the study had
methodological flaws and small sample sizes resulting in
low scores on the Delphi criteria.
According to several studies,25-30 decreased lower extrem-
ity strength is a significant risk factor for falls in the geriatric
population. Diminished ankle strength and rate of force pro-
duction may lead to balance impairments, as normal recov-
ery from perturbation involves rapid production of adequate
muscle force to maintain the body’s center of mass over its
base of support. The article supporting lower extremity
strengthening exercise scored 4/9 on the Delphi criteria sug-
gesting low to moderate methodological quality.16 However,
it used a clinically important outcome measure and showed
statistically and clinically significant results and was thus
given a grade of B for clinical recommendation. Despite the
low to moderate level of evidence, the article demonstrated
good clinical relevance and utilized clinically valid outcome
measures. Lower extremity strengthening exercise was the
only intervention found that can be supported with research
evidence to treat balance dysfunction in patients with DPN.
The use of a single-end cane in patients with DPN and
balance dysfunction does not address the sensation loss
114
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Table 5: Level of Evidence and Clinical Recommendation Grade
Clinical
Intervention Level of Evidence Recommendation
MIRE I C
Exercise II-I B
Cane II-2 C
Vibrating Insoles II-2 C
itself, but teaches compensation in hopes of minimizing fall
risk. Previous research has shown that biomechanically, a
cane functions to increase a person’s base of support, allow-
ing a greater range of center of mass motion without com-
promising stability.31 In addition, a cane allows the hand to
be an additional point of somatosensory feedback.31
Utilizing 2 separate scales for grading methodology and
clinical importance, the use of a single-ended cane received
a grade of level II-2 evidence for methodological quality and
a grade C for clinically relevant findings as seen in Table 5.
Although the study on cane use reported both statistically
significant and clinically relevant results, suggesting a bene-
ficial effect, it scored a 2/9 on the Delphi criteria and does
not have research evidence to support its clinical use in the
treatment of balance dysfunction in patients with diabetic
peripheral neuropathy. One considerable limitation is that
this study was conducted in an artificial laboratory setting,
leading us to question the generalizability of the findings to
a patient’s daily environment. The intervention of cane use
received a grade C, a poor recommendation for clinical use,
based on the quality of evidence, methodology, and strong
effect size and NNT.
Vibrating insoles demonstrate the potential for improv-
ing balance dysfunction in patients with DPN. Previous
research has shown that the presence of subsensory noise
can enhance sensory and motor function and improve bal-
ance in patients with somatosensory deficits.32 Patients with
DPN display significantly elevated thresholds for detecting
sensory information such as tactile, vibratory, and joint
angle and muscle force (proprioceptive) input, leading to an
increased risk for falls.33 Thus, it is thought that low-level
noise applied directly to sensory neurons enhances their
ability to detect weak stimuli.
Although the Priplata et al15 study demonstrated an
improvement in sway parameters with the use of subsenso-
ry vibrating insoles, this intervention received a grade of
level II-2 evidence and grade C. Despite receiving a 5/9 on
the Delphi criteria, the study lacked a functional outcome
measure applicable in clinical situations. In addition, the
effect size calculations for this study were small to moder-
ate. The use of vibrating insoles is not likely a feasible inter-
vention for physical therapists at this time as such insoles
are not commercially available. Thus, vibrating insoles to
treat balance dysfunction in patients with DPN cannot be
recommended for clinical use at this time.
Monochromatic infrared energy therapy is a type of
phototherapy that transmits heat to exposed surfaces via a
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low-level laser through pads placed on the skin.34 The exact
mechanism of action remains unclear, but it has been pro-
posed that MIRE triggers a release of nitric oxide from
hemoglobin in exposed tissues. Nitric oxide leads to vasodi-
lation, increased circulation, and decreased swelling. It may
also stimulate angiogenesis, leading to accelerated tissue
healing and ultimately decreasing sensory impairments and
improving balance.34 Monochromatic infrared energy
therapy is thus enticing, as the proposed mechanism of
action purports to improve the nerve dysfunction itself.
Monochromatic infrared energy received the highest level
of evidence grade, level I, due to the inclusion of 1 ran-
domized controlled trial. However, the methodological
flaws in the balance dysfunction portion of the Leonard
et al13 trial decreases the weight of the clinical evidence pro-
vided by this trial specifically for balance dysfunction.
Although the Kochman8 study does not yield evidence on
MIRE alone, it appears to have a meaningful clinical effect,
because the MIRE therapy was paired with unspecified
stretching, strengthening, and balance training. In fact, the
ES of MIRE plus the exercise program appears to be close
to that of the ES of the exercise alone trial in the single-leg
stance outcome. The combination of the 3 studies, there-
fore, does not provide sufficient evidence to recommend
MIRE intervention for balance dysfunction at this time and
was given a grade C clinical recommendation. Of note, the
Anodyne Therapy System (Anodyne Therapy, LLC, Tampa,
FL), used to deliver MIRE, has not been approved by the
FDA to be marketed for the treatment of DPN.35
Limitations
Limitations of this systematic review include a change in
databases while this study was being conducted. Following
the first literature search, the databases EMBASE and
CINAHL were combined into 1 database at our facility.
Although this makes it difficult to replicate this study, it is
believed that all articles from the original EMBASE and
CINAHL searches can be found in the merged database
Weaknesses of this systematic review include a lack of
available published research on this subject, which prevented
us from conducting a meta-analysis. Also, initial search terms
may not have found all potentially relevant articles. We
attempted to address this limitation by also searching the bib-
liographies of retrieved articles. In addition, numbers for some
of the NNT and/or ES calculations were estimated from pub-
lished graphs secondary to the lack of data reported in some
of the articles. A further limitation in this study is publication
bias; only previously published research was included.
CONCLUSION
Lack of high-quality studies in this area of research is evi-
denced by only 1 randomized controlled study. Without ran-
domization, studies are biased toward positive results. This
systematic review revealed that there is a significant need for
further research to investigate the effectiveness of physical
therapy interventions to improve balance in patients with
DPN. Currently, there is very little evidence to support such
Journal of GERIATRIC Physical Therapy
Copyright © 2011 The Section on Geriatrics of the American Physical Therapy Association. Unauthorized reproduction of this article is prohibited.
Systematic Review
interventions. Of the evidence that is available, many studies
are poorly designed and do not utilize reliable and valid out-
come measures. Future research should investigate the
effects of these physical therapy interventions on balance
impairments in patients with DPN but should be designed
and completed in a fashion that provides higher-level evi-
dence. Research including randomized controlled trials with
a greater number of subjects and meaningful outcome meas-
ures will enhance the quality of evidence to support inter-
ventions for improvement in balance. On the basis of the
available research and this review, the intervention of lower
extremity strengthening exercise can be given a fair recom-
mendation for clinical use in addressing balance dysfunction
in patients with DPN.
ACKNOWLEDGMENTS
We would like to acknowledge John Schmitt, PT, PhD, for
his assistance with reviewing this manuscript and providing
statistical suggestions.
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