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Top Spinal Cord Inj Rehabil. Author manuscript; available in PMC 2012 August 20.
Published in final edited form as:
Top Spinal Cord Inj Rehabil. 2007 ; 13(1): 32–57. doi:10.1310/sci1301-32.

A systematic review of the efficacy of gait rehabilitation
strategies for spinal cord injury
Tania Lam, PhD1,2, Janice J Eng, PhD2,3,5, Dalton L Wolfe, PhD4, Jane T Hsieh, MSc4,
Maura Whittaker, PT2,5, and the SCIRE Research Team
1School of Human Kinetics, University of British Columbia, Vancouver, BC, Canada
2ICORD, University of British Columbia, Vancouver, BC, Canada
3Department of Physical Therapy, University of British Columbia, Vancouver, BC, Canada
4Program of Aging, Rehabilitation and Geriatric Care, Lawson Health Research Institute, London,

ON, Canada

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5GF Strong Rehabilitation Centre, Vancouver, BC, Canada

Abstract
OBJECTIVE—To systematically review the evidence for the efficacy of different rehabilitation
strategies on functional ambulation following spinal cord injury (SCI).
METHODS—A keyword literature search of original articles was used to identify publishedliterature evaluating the effectiveness of any treatment or therapy on functional ambulation inpeople with SCI. The rigor and quality of each study were scored on standardized scales by two
independent reviewers.

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RESULTS—The search yielded 160 articles, of which 119 were excluded for not meeting our
inclusion criteria. The remaining 41 articles covered various strategies for improving gait:
bodyweight supported treadmill training (BWSTT) (n=12), functional electrical stimulation (FES)(n=7), braces/orthoses (n=10), or a combination of these (n=12). There is strong evidence fromrandomized controlled trials that functional ambulation outcomes following body-weightsupported treadmill training (BWSTT) are comparable to an equivalent intensity of overgroundgait training in sub-acute SCI. In chronic SCI, evidence from pre-test/post-test studies shows that
BWSTT may be effective in improving functional ambulation. Pre-test/post-test or post-test only
studies provide evidence that FES may augment functional ambulation in sub-acute/chronic SCI
while braces may afford particular benefits to people with complete SCI to stand up and ambulate
with assistive devices.
CONCLUSIONS—Rehabilitation strategies that facilitate repeated practice of gait offer thegreatest benefits to functional ambulation in sub-acute or chronic SCI. Supportive devices may
augment functional ambulation particularly in people with incomplete SCI.
Keywords
spinal cord injury; ambulation; gait; walking; systematic review; rehabilitation

Corresponding author: Tania Lam, Assistant Professor, School of Human Kinetics, University of British Columbia, 210-6081
University Blvd, Vancouver, BC, V6T 1Z1 Canada, tel: (604) 827-3165, tania.lam@ubc.ca.

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INTRODUCTION
Across the United States and Canada, almost 300,000 individuals live with spinal cord
injury (SCI) and more than 11,000 new cases arise each year.1 Almost half of the injuries
result in incomplete SCI2, 3 meaning that there is some preservation of function below thelevel of the lesion. While the recovery of walking is possible among individuals sustaining
an incomplete SCI,3 the recovery of overground functional ambulation has not been shownin people with clinically complete spinal lesions.4 Rehabilitation strategies to improvefunctional ambulation therefore tend to target individuals who have incomplete SCI withspared motor function (motor-incomplete SCI).5, 6

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Therapeutic strategies for enhancing gait have evolved from those that compensate forweakened or lost function to strategies based on fundamental concepts of the neural controlof walking and motor plasticity. Strategies that employ repetitive and intensive practice ofgait (e.g. treadmill training) are thought to enhance walking through the provision of taskspecific sensory input associated with appropriate stepping movements.7–9 It has been morethan a decade now since it was first demonstrated that body-weight supported treadmill
training (BWSTT) in animals can enhance locomotor activity after a spinal cord injury.10 In
this approach, partial body weight support is provided by an overhead harness while leg
movements are assisted by therapists and a moving treadmill belt. Since then, BWSTT
strategies have been introduced as a promising approach to improve gait in people with
SCI.5, 6, 11–22
There are also other rehabilitation approaches, such as functional electrical stimulation or
bracing, that enable a person to stand up and practice overground walking. The idea ofcompensating for paralyzed function using electrical stimulation was introduced as early as
the 1960s,23 when functional electrical stimulation (FES) of the common peroneal nerve
was found to be effective in assisting foot clearance during the swing phase.23 There are also
more complex systems that involve several channels of stimulation that support proper leg
extension as well as foot clearance during swing.24, 25 These are more suitable for patients
who require assistance in standing as well as gait, such as those with neurologicallycomplete SCI. Mechanical leg braces are also useful for supporting standing and walking,particularly for people with complete SCI. These range from single-joint braces (e.g. anklefoot orthosis, usually for individuals with low, incomplete spinal lesions), to whole-leg/longleg braces that extend from the lower back to the ankle. These devices must be used with awalking aid (e.g. crutches or walker) for functional ambulation.

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Several studies have examined the efficacy of combining these different therapies to further
maximize functional ambulation. Systems that combine FES and bracing have been
available for several years.26–29 One example is the ‘reciprocating gait orthosis (RGO),
which is a long-leg brace with a reciprocal hip joint combined with FES to the thighmuscles. The rationale underlying these ‘hybrid’ systems (FES + bracing) is that while thebrace provides postural stability, FES can be used to assist the leg movements required forfunctional ambulation. More recently, investigators have also explored whether thefacilitatory effects of FES30, 31 or pharmacological agents32, 33 on the expression of
locomotion may be further augmented by task-oriented gait training.
Whatever the strategy chosen, the key outcome from the patient’s perspective is whether thetherapy significantly enhances their functional ambulation. Functional ambulation is definedas “the ability to walk, with or without the aid of appropriate assistive devices (such as
prostheses, orthoses, canes or walkers), safely and sufficiently to carry out mobility-related
activities of daily living.34 Measures of overground gait speed or endurance, degree of
independence, the need for assistive device, or functional classification scales may therefore

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be used as indicators of functional ambulation. These types of measures are essential
outcomes in rehabilitation research studies so that clinicians can readily assess the efficacyof experimental interventions. Note that “functional ambulation” is distinguished here from“ambulatory capacity” which is another term that has been used in the literature to describe
the degree of assistance and independence a person requires to walk in different
environment contexts.35, 36 However, the International Classification of Functioning uses
the qualifier “capacity” in a different context – to describe the ability to execute a task at thehighest probable level of functioning, as opposed to what one actually does in his/her
environment.37 Therefore, to avoid confusion we will use the term “functional ambulation”
to describe walking outcomes.
The objective of this systematic review is to provide rehabilitation and other professionals
an overview of the clinical evidence supporting the efficacy of the various strategies used toenhance functional ambulation in the SCI population. We targeted publications that assessed
the effect of gait rehabilitation strategies using clinically-relevant functional measures ofambulation.

METHODSPMC Canada Author Manuscript

A detailed description of the methods for this systematic review can be found in theaccompanying paper.38 Briefly, a keyword literature search39 of original articles, previous
practice guidelines and review articles was used to identify published literature evaluating
the effectiveness of any treatment or therapy related to SCI ambulation. The rigor andquality of each study was scored by two independent reviewers using either the
Physiotherapy Evidence Database (PEDro) Scale40 or the Downs and Black (D&B) Tool41(see Eng et al38 in this issue for more details). The PEDro Scale40 was used to evaluate themethodological quality of randomized controlled trials (RCTs). It evaluates RCT studies
using an 11-item scale yielding a maximum score of 10. Higher scores indicate bettermethodological quality (9–10: excellent; 6–8: good; 4–5: fair; <4: poor).42
The D&B Tool,41 which is used to assess the methodological quality of non-RCT studies,
uses 27 questions to assess reporting, external validity, and internal validity (bias andconfounding). We used a modified version of the D&B Tool38 to score non-RCT papers outof a maximum of 28, with higher scores indicating better methodological quality.

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After each study was rated with the appropriate tool, conclusions about the level of evidenceof the accumulated studies were drawn using Sackett’s description of levels of evidence.43
We collapsed Sackett’s levels of evidence into 5 categories where Level 1 evidence camefrom “good” to “excellent” RCTs with a PEDro score ≥6 and Level 2 evidence
corresponded to RCTs with PEDro scores ≤5 or non-randomized prospective controlled orcohort studies. Evidence from case control studies were assigned to Level 3. Levels 4 and 5
corresponded to evidence from pre-post/post-test/case-series and observational/case reportstudies, respectively.38
Only articles that described specific gait rehabilitation parameters, including the durationand frequency of specific training tasks, were included. Treatment intensity was defined as
the minutes per week engaged in gait rehabilitation and treatment duration was defined as
the number of consecutive weeks of therapy. An exception was given to studies using FES
or bracing interventions, where specific treatment or usage parameters are typically notprovided. In addition, articles were excluded if they did not measure functional ambulation
outcomes or if they did not analyze pre- vs. post-intervention outcomes. Again, an exception
was given to publications on bracing since pre-test/post-test measurements are not relevant

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PMC Canada Author Manuscriptto this type of intervention. We did not require a minimum sample size due to the relatively
limited number of publications that met these criteria.

RESULTSThe keyword literature search yielded 160 articles related to ambulation following SCI. A
total of 119 articles were removed from the sample because they did not meet the inclusion/
exclusion criteria, leaving 41 articles in the final analysis. The articles were divided
according to specific types of gait training interventions: treadmill training (n=12),functional electrical stimulation (n=7), lower-extremity bracing (n=10), and combination
strategies (n=12) (Note that some publications overlap across different categories). The
results from articles that also compared functional ambulation outcomes between different
interventions are presented separately in the last section.
Treadmill training (Tables 1 and 2)

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Seven articles examined the effect of therapist-assisted12, 14, 19–21 or robot-assisted13, 15
BWSTT in people who had incurred an incomplete SCI < 12 months prior (acute/sub-acutephase) (aggregate N=291). Treatment intensity ranged from 60 to 300 minutes per week andtreatment duration lasted between 3 and 23 weeks. Level 1 evidence from one high quality
RCT12 and two pre-test/post-test studies13, 14 show that therapist-assisted BWSTT enhances
functional ambulation in sub-acute subjects classified as ASIA (American Spinal Injury
Association impairment scale)2 C or D. Data from the RCT12 also showed that functional
ambulation outcomes did not improve in subjects who were classified as ASIA B andremained so following BWSTT.
Table 2 summarizes the results from studies that examined the effect of BWSTT on
functional ambulation in people with chronic SCI (>1 year post-SCI). There were nine pretest/post-test studies6, 11, 13–19 and one case control study21 that altogether studied 129
subjects with incomplete SCI with chronicity ranging from 1 to 28 years post-injury.
Treatment intensity ranged from 21 to 300 minutes per week and treatment duration lasted
between 3 and 48 weeks. Based on the stated primary outcome measure of each study, thereis level 3 evidence that BWSTT may improve functional ambulation in chronic SCI (61% of
all subjects across these studies showed improvement following treatment).
Functional Electrical Stimulation (FES) (Table 3)

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Our search criteria yielded 7 pre-test/post-test studies examining the effect of FES on
functional ambulation in incomplete44–49 or complete50 SCI subjects. Typically, participants
were provided with FES systems to use at home ‘as much as possible’ or ‘as desired’ overthe course of the study.45, 47–49, 51 Only two of the studies reviewed here report specificusage parameters for FES during gait rehabilitation, whereby FES was applied for at least 30
minutes, 3 to 5 times/week for up to 3 months.44, 50 Almost all the participants showed
improvements (e.g. increased walking speed, distance, or step length) when FES was used.
Aggregate data from all subjects across these studies (N=80) provided level 4 evidence thatFES may improve functional ambulation. Several investigators have also reported acarryover effect after FES training such that improvements in functional ambulation (e.g.
overground walking speed and distance, step length) persisted even when the stimulator was
turned off.45, 47, 49
Orthoses/Braces (Table 4)
Our search criteria yielded 2 pre-test/post-test studies52, 53 and 10 post-test only
studies27, 29, 54–61 that reported the effects of training with braces. Subjects in the pre-test/
post-test studies (aggregate N=8) participated in 5 times/week gait training sessions withTop Spinal Cord Inj Rehabil. Author manuscript; available in PMC 2012 August 20.

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long-leg braces for at least 2 weeks. Overall, these 12 studies provided level 4 evidence that
long-leg braces may facilitate the ability of people with sub-acute or chronic complete
paraplegia to stand independently and to achieve some functional ambulation skills, such as
stepping up on curbs or climbing stairs, with assistive devices. The maximum walking
speeds achieved with orthosis-use ranged from 0.13 to 0.63 m/s.29, 52, 53, 55, 57, 59–61
Combination Therapies (Table 5)
Gait Training + FES—(Table 5A) Findings from four studies (1 high quality RCT5 and 3
pre-test/post-test30, 31, 62 studies) demonstrated favourable outcomes in people with chronic,
incomplete SCI. Thus, there was level 1 evidence of an overall enhancement of functional
ambulation, as measured by overground gait speed, when BWSTT was combined with FESof the common peroneal nerve5, 30, 62. There is level 4 evidence from one pre-test/post-test
study suggesting that BWSTT combined with FES to the quadriceps and hamstrings muscles
enhances functional ambulation.31

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Gait Training + Pharmacological Interventions —(Table 5B) We found 2 studies
that used a combination of pharmacological and physical therapy gait training interventions.
One high quality randomized, placebo-controlled, double-blind cross-over study32 (N=9)
provided Level 1 evidence that a combination of physical therapy (including gait training)and GM-1 ganglioside improved motor scores, walking distance and walking speed inchronic SCI subjects compared to physical therapy plus placebo. Other results from a pretest/post-test study33 provide Level 4 evidence that Clonidine and Cyproheptadine inconjunction with BWSTT may be effective in enabling non-ambulatory incomplete SCI
patients achieve overground ambulation with assistive devices.
Bracing + FES—(Table 5C) Our search criteria yielded six post-test only
studies26–29, 60, 63 that examined the combined effect of lower extremity bracing with FES
on functional ambulation in people with complete SCI (aggregate N=110). The data fromthese studies provide level 4 evidence that the combination of long-leg bracing and FES may
enable overground ambulation of between 180 and 1400 m at one time.27–29, 63 Further
details of these studies may be found in the following section.
Comparisons between Interventions

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BWSTT vs. other gait training strategies—One high quality RCT12 and two casecontrol19, 21 studies have examined the issue of whether BWSTT yields better functional
ambulation outcomes than ‘conventional rehabilitation’ approaches. There is Level 1
evidence from a single-blind RCT12 (n=146) that there are no differences between BWSTT
and an equivalent intensity of overground gait training during inpatient SCI rehabilitation
for the primary outcomes of the Locomotor Score of the Functional Independence Measure
or overground walking speed. These two variables in both groups improved roughly inparallel over the 12 weeks of therapy.64 There were also no significant differences between
groups for walking endurance (measured by the 6-minute walk test), Berg Balance Scalescore, Walking Index for Spinal Cord Injury (WISCI), or Lower Extremity Motor Score(secondary outcome measures). In contrast, the non-randomized studies of Wernig19, 21
showed that 87% (87/98) of their incomplete SCI subjects achieved improvements infunctional ambulation with BWSTT in the acute phases of injury while only half (12/24)
improved functional ambulation with conventional rehabilitation. The nature of this‘conventional rehabilitation’ was not specifically defined in these studies, although it
appeared to focus on wheelchair mobility in addition to gait training in parallel bars andusing braces.65

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There is one high quality RCT that compared functional ambulation outcomes between 4
different approaches to gait training: manual- or robot-assisted BWSTT, BWSTT+FES, andoverground gait training.5 Field-Fote et al5 reported that subjects in the BWSTT+FES andthose in the overground gait training group showed significant improvements in walking
speed measured over 6 m following a 12-week training program. Subjects in the manual- or
robot-assisted BWSTT did not show significant improvements in walking speed measured
over 6 m. When walking speed measured over a longer distance (24.4 m) was compared,
however, there were no significant differences between the 4 groups. Thus, there is level 1
evidence that different modes of gait training (e.g. BWSTT vs. overground) result in similareffects.

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Bracing or FES Alone vs. Bracing+FES—Three pre-test/post-test studies26, 27, 29 andone post-test study60 directly compared the effect of bracing+FES with either FES or
bracing alone. When subjects walked with braces or FES alone, maximum walking distance
ranged from 3 to 400 m. When braces were combined with FES, maximum distanceincreased to 200 to 1400 m.27, 29, 60 The combination of bracing+FES was also reported bythree studies to enhance walking speed, although changes were not statistically significant
over bracing alone.26, 27, 29, 60 One study noted that the combination system was helpful topeople who could not use bracing alone.27 Thus there is level 4 evidence that the
combination of bracing+FES may provide additional benefits to functional ambulation overeither intervention alone.

DISCUSSION
An influential concept that has gained popularity over recent years is task-oriented practiceof movements to enhance the recovery of function following SCI. All of the gait
rehabilitation strategies reviewed here either provide direct practice of stepping movements(e.g. treadmill training) or provide secondary assistance to the production of stepping (e.g.
bracing). Of all the studies included in the present review, only 3 were rated as high quality
RCTs.5, 12, 32 Note that since there were no sample size restrictions, some conclusions werebased on small group sizes (N=6 to 9),5, 32 yet these studies were rated highly according to
the standardized PEDro Scale. Other conclusions were drawn from Level 3 evidence or
below.
Intensive gait practice benefits both acute and chronic incomplete SCIPMC Canada Author Manuscript

There is Level 1 evidence from one RCT supported by several non-RCTs that intensive
locomotor training provided over the sub-acute phase in incomplete SCI significantly
enhances functional ambulation.12–15, 19–21 For individuals more than 1 year post-injury(chronic SCI), there is Level 3 evidence that additional improvements in functional
ambulation may be attained with intensive BWSTT.6, 11, 13–19, 21 However, compared toindividuals at the acute/sub-acute phase of injury, outcomes during the chronic stage appear
more variable across the different studies and may be dependent on initial ambulatory status.
Some publications reported little or no change in functional ambulation13, 15, 16 while others
reported dramatic changes (e.g. from non-ambulatory to independent with aids).13, 17, 19, 21
Based on results from a pre-test/post-test study, there is some evidence that the likelihoodfor further functional improvements following BWSTT may be greater for subjects
classified as ASIA C and D rather than ASIA B.16 Further evidence is required before wecan make more specific recommendations about the best candidates for BWSTT during thechronic stage of injury.
The advent of BWSTT represents a shift in rehabilitation practice in recent years from
impairment-driven strategies to task-oriented therapy for the recovery of function following

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SCI. A significant question is whether functional ambulation outcomes following taskoriented BWSTT is better compared with outcomes following ‘conventional rehabilitation’.
The equivalent outcomes observed by Dobkin et al12 have stirred a well-needed debate
among rehabilitation scientists and clinicians about the merits of one approach over another.
One issue is the type of therapy chosen as the control to compare with BWSTT. The control
group in the Dobkin trial12 underwent task-oriented overground gait retraining of equivalentintensity to the BWSTT group. The appropriateness of this ‘control’ has sparked intense
debate as to what should be considered a realistic ‘conventional’ therapy.65–67 Even so,
earlier studies that promoted the superiority of BWSTT unfortunately did not define what
constituted the ‘conventional rehabilitation’ undertaken by the control group.19, 21
Nevertheless, it is apparent that intensive task-oriented gait retraining, whether implemented
by BWSTT or overground practice, facilitates the recovery of functional ambulation
especially <12-months post-injury.

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Much work remains in determining optimum BWSTT parameters and progression for SCI
individuals of varying severity and chronicity. From the studies reviewed here, therelationship between functional ambulation outcomes and treatment intensity, or duration
could not be discerned due to the wide range of treatment parameters, the use of different
outcome measures, varying injury severity and chronicity, and the inability to determine
individual treatment parameters and outcomes. Although data from individual case studies
can be useful for providing the specific training parameters and outcomes for eachindividual,13, 15, 17, 20 there are not enough data to conduct further analysis on appropriate‘prescription’ guidelines for BWSTT.
It is clear that for rehabilitation research to move forward on determining optimum
parameters for gait retraining, the first step is to adopt consistent and standardized outcome
measures across centers. The International Campaign for Cures of Spinal Cord Injury
Paralysis (ICCP) Clinical Guidelines Panel has recently recommended that a combination of
the WISCI and a quantitative timed test (e.g. 10-meter walk test) be used to assess functional
ambulation in SCI subjects.68 Several of the studies reviewed here used other scales offunctional ambulation,11, 12, 16, 18, 19, 21 many of which have not been validated in the SCI
population.
FES can augment existing functional ambulation skills in incomplete SCIPMC Canada Author Manuscript

FES has been used to great benefit to compensate for weak or lost muscle function due toparalysis. We found level 4 evidence from 5 pre-test/post-test studies that suggested
improved functional ambulation (e.g. increased walking speed or distance) with FES-use.
Only 1 pre-post study showed that FES could improve endurance and gait speed in subjects
with complete SCI. Of particular interest, there is level 4 evidence from three pre-poststudies that suggests carryover effects after FES training. These studies reported thatpersistent improvements in functional ambulation were evident even after the stimulator was
turned off45, 47, 49, suggesting the occurrence of neuroplastic changes in response to theregular use of FES during walking. Indeed, it has been shown in non-disabled humansubjects that FES-use can increase corticospinal excitability.69 Improved muscle strengthand conditioning after regular use of FES could also contribute to carryover effects infunctional ambulation.44 Such training effects could also be advantageously combined withintensive task-oriented gait training and may provide additional benefits over BWSTT
alone.5 One caveat about FES systems are that their successful use will depend on factors
such as technical ease of application and patient motivation.49

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Bracing enables ambulation in complete paraplegia
We did not restrict bracing intervention studies to pre-test/post-test measurements since werecognized that such study designs would not be meaningful when braces enable standing
and stepping in individuals with complete SCI who are otherwise not ambulatory. Bracing
devices have typically been prescribed for people with complete paraplegia. These assistive
devices may be used to facilitate sit-to-stand transfers as well as achieve some modest gains
in mobility.29, 53, 55 In some of the studies included in this review, intensive (daily) training
programs were implemented to provide practice of ambulation with the assistance of longleg braces and walking aids.52, 53 These studies provide level 4 evidence, primarily frompost-test studies, that individuals with complete paraplegia may experience gains infunctional ambulation, including the ability to climb up and down stairs, with the practiced
use of braces.53

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As with FES, the successful use of braces is also dependent on other individual andpragmatic factors. It has been recommended that orthoses or braces are best for people who
are well-motivated, with a complete SCI at T9 or below or an incomplete SCI at any level,with good postural control and good level of fitness.29, 54 One recommendation is that thetherapeutic health 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 enhancefunctional ambulation and be a replacement for wheelchair-use.54, 59, 70, 71 The ability for apatient to don/doff the orthosis without difficulty and relatively quickly (e.g. <5 minutes)
also appears to enhance the probability of their acceptance.29, 53–55 Reports of technicalproblems (e.g. mechanical breakdown at the hinges, improper fitting)29, 55 suggest thatclinicians should ensure that there is appropriate technical support of these mechanicaldevices before prescribing them to their patients. These various issues should be consideredwhen prescribing such assistive devices to SCI patients.
Summary

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The studies reviewed here suggest that facilitating the practice of walking during
rehabilitation can enhance the recovery of functional ambulation in incomplete SCI.
Although specific treatment parameters that depend on the injury location, severity, andchronicity remain to be elucidated, there exists some evidence to help guide the clinicaldecision-making process. Task-oriented gait retraining with partial body weight support,
whether provided by a treadmill and partial BWS or overground with assistive devices,
appears to be more beneficial when applied sooner rather than later after the onset of injury
in people with motor-incomplete lesions. Where resources permit, therapists may use abody-weight support system combined with a treadmill and manual assistance fromadditional personnel to implement task-oriented gait training. However, there is increasing
evidence that equivalent outcomes can be obtained independent of the specific gait
retraining strategy.5, 12 For individuals with more chronic spinal lesions and who haverecovered some walking, FES may provide additional gains in functional ambulation. When
resources are available, more complex FES systems, with or without bracing, may be used toprovide support of upright mobility in individuals with complete paraplegia. Further
evidence is required to determine whether combination therapies offer significant
advantages over any given approach alone. Finally, although this review has focused onfunctional ambulation outcomes following various rehabilitation strategies, we must also
keep in mind the additional health benefits (e.g. improved cardiovascular or bone health) ofperforming gait exercises.

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Acknowledgments
We thank the Rick Hansen Man-in-Motion Foundation and Ontario Neurotrauma Fund for their financial support
which made the SCIRE project feasible. JJE is a Michael Smith Foundation for Health Research Scholar andCanadian Institutes of Health Research New Investigator (MSH-63617).

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43. Sackett, DL.; Straus, SE.; Richardson, WS., et al. Evidence-based medicine: how to practice andteach EBM. Toronto, ON: Churchill Livingstone; 2000.
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54. Franceschini M, Baratta S, Zampolini M, et al. Reciprocating gait orthoses: a multicenter study of
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61. Winchester PK, Carollo JJ, Parekh RN, et al. A comparison of paraplegic gait performance using
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62. Field-Fote EC, Tepavac D. Improved intralimb coordination in people with incomplete spinal cord
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63. Solomonow M, Aguilar E, Reisin E, et al. Reciprocating gait orthosis powered with electricalmuscle stimulation (RGO II). Part I: Performance evaluation of 70 paraplegic patients.
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64. Dobkin B, Barbeau H, Deforge D, et al. The evolution of walking-related outcomes over the first
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2 males, age 20–45 yrs, ASIA C and D, C5-C6, 14 wks to 6 months post-injury.
BWSTT (Lokomat): 60 minutes, 3X/wk, 12 wks. Progressed to minimum of 20 min BWSTT(Lokomat) + overground gait training.
Outcome measures: WISCI II, gait speed, combined LEMS
41 males & females, incomplete, 3–16 wks post-injury.
BWSTT: 30–60 min, 5X/wk, 3–22 wks.
Outcome measures: Wernig Scale of Ambulatory Capacity

1 female & 1 male, age 13–40 yrs, ASIA B (reclassified as ASIA D following training), C6-T2,
5–6 wks post-injury.
BWSTT (Lokomat and manual): 3X/wk, 19–20 wks + 3–5 hours/day of PT and OT per day.
Outcome measures: LEMS§§, FIM, WISCI II, 10MWT***, 6MWT, TUG†††, Functional Reach
Test (sit or stand)
2 males, age 71 and 41 yrs, ASIA D & C, T5/9 and C3/5, 0.8 and 0.6 yrs post-injury.
BWSTT: <60 min, 3–5X/wk, 10–23 wks.
Outcome measures: 10MWT, 6MWT, WISCI II.

1 male, age 28 yrs, C5/6, 7 months post-injury.
BWSTT: 20 min, 3X/wk, 6 wks.
Outcome measures: gait speed

Study 1: 12 males & females, 0–4.5 months post injury.
BWSTT: 30–60 min, 5X/wk, 3–20 wks (median 10.5 wks).
Study 2: 85 males & females, 2–30 wks post-injury 45 subjects underwent 2–22 wks of BWSTTvs. 40 subjects (historical controls) underwent conventional rehabilitation.
Outcome measures: Wernig Scale of Ambulatory Capacity

Winchester et al 2005
USA
D&B‡‡=14
N=2
pre-post

Wernig et al. 1998
Germany
D&B=12
N=41
Level 4 pre-post

Hornby et al. 2005
USA
D&B=12N=2pre-post

Thomas & Gorassini 2005
CanadaD&B=12N=2pre-post

Gardner et al 1998
USA
D&B=10N=1case report

Wernig et al. 1995
Germany
D&B=9
N=97
case control

Body-Weight Supported Treadmill Training (therapist-assisted)‡

American Spinal Injury Association (classification scale)†

Physiotherapy Evidence Database (PEDro) Scale (maximum possible score = 10)*

No difference in FIM-L (ASIA B & C) or walking speed (ASIA C &D) between groups. ASIA C & D subjects in both groups improved
functional ambulation. No improvement in functional ambulation in
the ASIA B subjects with either intervention.

146 males and females, age 16–69 yrs, ASIA† B-D; < 8 wks post-injury.
BWSTT‡ vs. overground mobility training: 5X/wk, 9–12 wks, 30–45 min/session.
Outcome measures: FIM-L§, walking speed, 6MWT**, WISCI†† @ 3 & 6 months

Dobkin et al. 2006
USA
PEDro*=7
N=146
RCTStudy 1: All subjects improved (including 7 initially non-ambulatory
Study 2: 33/36 non-ambulatory subjects could walk after BWSTT vs.
12/24 improved to functional ambulation with conventional rehab.

↑ comfortable walking speed (1.22 → 1.37 m/s).
↑ fast walking speed (1.63 → 1.8 m/s).
↑ running speed (2.64 → 3.24 m/s).

Significant improvement in WISCI II score, 6MWT, and 10MWT;
improvements correlated with the increase in corticospinal
connectivity.

improved from non-ambulatory to distances of 144 → 190 m(6MWT) and speeds of 0.55 → 0.58 m/s (10MWT).
Final FIM score = 6.
↑ WISCI II scores: 0 → 13 and 0 → 16.

29/37 initially non-ambulatory subjects improved to walking withaids.
Follow-up (6 months to 6 yrs post-training): 15 subjects showed
continued improvement, 26 had no change.

Both subjects ↑ WISCI-II score (0→ 16 and 6→15), ↑ gait speed(0→80.6 cm/s and 23.8→62 cm/s), ↑ LEMS (23→36 and 32→42).

Results

Methods

ArticlesStudies using BWSTT in acute/sub-acute SCI (<12 months post-injury)

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Table 1Lam et al.
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Lower Extremity Motor Score

Downs and Black Tool (maximum possible score from modified version = 28)§§‡‡

Walking Index for Spinal Cord Injury (I or II)††

6-Minute Walk Test**

Functional Independence Measure - Locomotor

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PMC Canada Author
Methods
27 males & females, age 21–64 yrs, incomplete, C3-T10, >1 year post-injury.
Randomized to 4 gait training strategies, 45–50 min, 5X/wk, 12 wks: 1) manual BWSTT (n=7);2) BWSTT + FES (common peroneal nerve) (n=7); 3) BWS overground+FES (n=7); 4) BWS
Lokomat (robotic gait device) (n=6).
Outcome measures: walking speed over 6 m (short-bout) and 24.4 m (long-bout)
14 males & females, age 20–53 yrs, ASIA B (n=2) & C (n=12), C4-L1, 1.2 to 24 yrs post-injury.
BWSTT: <45 min, 3X/wk, 144 sessions (12 months).
Outcome measures: Walking Capacity Scale (Wernig)

20 males & females, age 16–64 yrs (mean 40, SD 14), ASIA C (n=9) & D (n=11), C3-L1, 2 to
17 yrs post-injury.
BWSTT: <45 min, 3–5X/wk, 8 wks.
Outcome measures: WISCI II, 10MWT, 6MWT
2 males, age 44–49 yrs, ASIA C, C5-C6, 1–4 yrs post- injury.
BWSTT: 60 min, 3X/wk, 12 wks. Progressed to minimum of 20 min BWSTT + overground gait
training.
Outcome measures: WISCI II, gait speed (over 3.66 m walkway), LEMS
3 males, age 34–48 yrs, ASIA C & D, T8-T12, 2–13 yrs post-injury.
BWSTT: 20 min, 5X/wk, 12 wks.
Outcome measures: Garrett Scale of Walking, Assistive Device Usage Scale, Orthotic Device
Usage Scale, gait speed (5 m), gait endurance (5 minutes).
35 males & females, age 19–70, C4-T12, 1 to 15 yrs post- injury.
BWSTT: 30–60 min, 5X/wk, 8–20 wks.
Outcome measures: Walking Capacity Scale (Wernig).

6 males & females, age 29–78 (mean 54.4, SD 14.8) yrs, ASIA C (n=4) & D (n=2), C5-L1, 2 to
28 yrs post-injury.
BWSTT: <60 min, 3–5X/wk, 10–23 wks.
Outcome measures: 10MWT, 6MWT, WISCI II.
1 male, age 43 yrs, ASIA C, C6, 18 months post-injury.
BWSTT: 1–3X/wk, 16 wks + 3 sessions of PT and OT/wk, which included gait and mobility
training.
Outcome measures: LEMS, FIM, WISCI II, 10MWT, 6MWT, TUG, Functional Reach Test
(postural stability in sit or stand)
3 males, age 45–51 yrs, ASIA C & D, C5-C7, 29–198 months post-injury.
BWSTT: 30 minutes, 5X/wk, 12 wks.
Outcome measures: Walking Capability Scale (Wernig), gait speed over 7 m

ArticlesField-Fote et al. 2005‡‡‡
USA
PEDro=6
N= 27
RCTHicks et al. 2005
CanadaD&B=18N=14
pre-post

Wirz et al. 2005
Switzerland
D&B=17
N=20 pre-post

Winchester et al 2005
USA
D&B=14N=2
pre-post

Protas et al 2001
USA
D&B=13N=3pre-post

Wernig et al. 1998
Germany
D&B=12N=35
pre-post

Thomas & Gorassini 2005
CanadaD&B=12
N=6pre-post

Hornby et al. 2005
USA
D&B=12N=1
case report

Effing et al 2006
Netherlands
D&B=11

Studies using BWSTT in chronic SCI (>1 year post-injury)

Top Spinal Cord Inj Rehabil. Author manuscript; available in PMC 2012 August 20.

Gait improvements in all subjects, indicated either by faster gait speed
or higher score in Walking Capability Scale.

No change in LEMS (remained at 31/50).
↑gait speed (0.11 → 0.21 m/s) and endurance (30 → 61 m)
No change in WISCI II (13).

5/6 subjects improved WISCI II score. Overall significant
improvements in 6MWT, and 10MWT and improvements correlatedwith 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 yrs later) all ambulatory patients remained
ambulatory, with changes only in functional class.

All subjects showed ↑ gait speed and endurance.
All subjects showed improvement, indicated by the Garrett Scale ofWalking or the type of assistive or orthotic devices used.

Both subjects initially non-ambulatory. 1 subject improved (WISCI-II=6, gait speed=10.5 cm/s, ↑ LEMS 22→27), other showed no change.

2/20 subjects improved WISCI II scores. Overall ↑ in 10MWT of 0.11+/− 0.10 m/s (56% improvement).
15/16 subjects improved in 6MWT.

6/14 subjects improved, but only 3 maintained improvements at 8
months post- training. 3/10 initially non-ambulatory subjects could
walk (with assistance) post- training.

No significant differences between pre- and post-intervention walking
speed in the manual BWSTT or BWS Lokomat groups. However,there was a tendency for subjects with initially slower walking speeds(< 0.1 m/s) to have a greater percent increase in walking speed (57 to80%) compared to those with initially faster walking speeds (− 19 to5%).

Results

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PMC Canada Author

Only the results from subjects who were in the manual- or Lokomat-assisted BWSTT groups are included in this table.

Timed Up and Go test

‡‡‡

†††

10-Metre Walk Test

Study 1: 44 males & females, chronic para- or tetraplegia.
BWSTT: 30–60 min, 5X/wk, 3–20 wks (median 10.5 wks).
Study 2: 53 males & females, chronic para- or tetraplegia. 29 subjects underwent BWSTT (as inStudy 1) versus 24 historical controls who underwent conventional rehabilitation.
Outcome measures: Wernig Walking Capacity Scale

Wernig et al. 1995
Germany
D&B=9
N=68
case control***

1 male, age 55 yrs, ASIA D, C5/6
BWSTT for 30 min + overground gait training for 20 min, 5X/wk, 9 wks.
Outcome measures: gait speed, WISCI II, # of steps/day

Methods

Behrman et al 2005
USA
D&B=11N=1case report

N=3
pre-post

Study 1: 25/33 initially non-ambulatory could walk after BWSTT. At
6 months post- training, 18/21 ambulatory patients maintained
abilities.
Study 2: 14/18 initially non-ambulatory subjects could walk after
BWSTT, compared with only 1/14 in the conventional rehab group.

↑ self-selected gait speed: 0.19 → 1.01 m/s↑ maximum gait speed: 0.36 → 1.2 m/s↑ WISCI II: 6 → 20
↑ steps/day: 1054 → 3924 steps/day

Results

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PMC Canada Author
Methods
14 males & females, age 25–49 yrs, C3-L1, incomplete, 1.8–19.1 yrs post-injury.
Surface FES: bilateral or unilateral common peroneal nerve, home use as much as possible ~1 yr (26 and56 wks), 2 subjects also had bilateral quadriceps.
Outcome measures: temporal gait measures.
31 males & females, mean age 36 (SD 2) yrs, injury level above lumbar levels, incomplete, mean 6 (SD1) yrs post- injury
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 yrs.
Outcome measures: walking speed, stride length, cycle time.
16 males & females, mean age 28.4 (SD 6.6) yrs, T4-T11, complete, 0.7–9.0 yrs post-injury.
Surface FES: Parastep®: 6 channels (bilateral common peroneal nerve, quadriceps, glutei). 3X/wk, 32
sessions (once subjects had sufficient strength to stand)
Outcome measures: walking distance and speed (with FES)
6 males & females, age 20–40 yrs, C3-L1, Frankel C & D, 2 to 18 yrs post-injury.
Surface FES: quadriceps, hip abductors, hamstrings, erector spinae, common peroneal nerve, home
program >30 min, 5X/wk, 3 months.
Outcome measures: walking speed, stride length, cadence.
2 females, 1 male, age 12–17 yrs, C6-L2, ASIA C, 3 yrs post- injury.
Percutaneous intramuscular FES: pelvis, hip, and knee muscles. Subjects used system at home, as
desired, for 1 yr.
Outcome measures: temporal gait measures.
14 males & females, age 25–49 yrs, C3-L1, incomplete, 1.8–19.1 yrs post-injury.
Surface FES: bilateral or unilateral common peroneal nerve, 2 subjects also had bilateral quadriceps,
home use as much as possible ~1 yr.
Outcome measures: temporal gait measures.
10 males & females, age 20–44 yrs, C2-T10, incomplete, 2.5–10 yrs post-injury.
Surface, percutaneous, or implanted FES of common peroneal nerve, and sometimes quadriceps, glutei,
and psoas.
Outcome measures: speed, gait parameters

ArticlesLadouceur & Barbeau 2000a
CanadaD&B=16N=14
pre-post

Wieler et al. 1999
CanadaD&B= 15
N=31
pre-post

Klose et al. 1997
USA
D&B=15N=16
pre-post

Granat et al. 1993
Scotland
D&B=14N=6
pre-post

Johnston et al. 2003
USA
D&B=14N=3
pre-post

Ladouceur & Barbeau 2000b
CanadaD&B= 13
N=14
pre-post

Stein et al. 1993
CanadaD&B=6
N=10
pre-post

Studies using FES to Improve Locomotor Function

All subjects ↑ gait speed when FES was on (mean change
was 4 m/min), particularly significant for more disabled
subjects.

7/14 subjects showed improvement based on type ofambulatory device. 13/14 subjects ↑ gait speed with FES.
Training/carryover effect after long- term use: ↑ evident
even when FES off in 12/14 subjects↑ voluntary strength.
Significantly ↑ maximum walking distance and speed.
Gains evident even when FES was off.

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

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

Overall ↑ in gait speed which persisted even when FES off.
Greatest % improvements for the initially slower walkers.

Mean ↑ of 0.10 m/s in walking speed and ↑ of 0.12 m in
stride length (both with and without FES) over the first yearof FES-use.

Results

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PMC Canada Author
Methods
26 males & females, age 20–53 yrs, C8-T11, complete, 9–144 months post-injury.
RGO-II§§§ orthosis: long-leg brace with reciprocal hip joint combined with FES to the quadriceps andhamstrings. 4–6 wks 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
5 males and females, age 9–18 yrs, motor-complete, C8-T8, 1–9 yrs post-injury.
Mobility training alternating between FES (<16 channels) and orthosis (long-leg brace or knee-anklefoot): 4 weeks upright mobility training (e.g. stand-and-reach, 6-m walking, stairs).
Outcome measures: Functional Independence Measure
10 males and females, mean age 37 years (SD 8.4), T9-T12, motor complete, 4–19 years post-injury.
Walkabout Orthosis (WO) vs. Isocentric Reciprocal Gait Orthosis (IRGO ): 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
74 males and females, mean age 27 years, T1-T12, complete (Frankel A & B), mean 37 years postinjury.
Orthoses: RGO (n=53), Advanced RGO (RGO with links between mechanical hip joints and hip andknee joints) (n=17), and Hip Guidance Orthosis (HGO) (n=4): practice to don/doff device andfunctional mobility. Follow-up at hospital discharge and 6 months later.
Outcome measures: Garrett Score, ability to climb up and down 12 steps
24 males and females, mean age 33.6 years (SD 3.2), T1-T12, complete (ASIA A), mean 5.3 years (SD2.1) post-injury.
RGO: training, then home-use for 1 year.
Outcome measures: gait speed, going up and down stairs, use of walker or crutches, Garrett Score (outof 6; 6 = community ambulation with no limitations; 1=hospital ambulation).
3 males, age 22–28 yrs, T8–12, ASIA A, 8–12 months post- injury.
Weight Bearing Control Orthosis (WBCO): 1 hour, 5X/wk, 12 wks.
Outcome measures: gait velocity

22 males and females, age 21 to 44 years, T3-T12
Hip Guidance Orthosis (HGO) (aka Parawalker) + crutches vs. Reciprocating Gait Orthosis (RGO) +rollator walker: practice period + 4 months of home use, followed by switch to second orthosis.
Outcome measures: walking speed, cadence, stride length
6 males & females, age 22–50 yrs, C7-T12, severity not reported, 2.5–20.6 yrs post-injury.
Case-Western Reserve University Hybrid Gait Orthosis (modification of IRGO****) combined with
FES to various muscles (combination of 8–16 muscles).
Outcome measures: walking speed and distance

ArticlesThoumie et al. 1995
FranceD&B=19N=26
post-test

Bonaroti et al. 1999
USA
D&B=18N=5post test

Harvey et al. 1997
Australia
D&B=17
N=10
post test

Franceschini et al.
1997
Itlay
D&B=14N=74
post test

Scivoletto et al. 2000
Itlay
D&B=14
N=24
post test

Nakazawa et al 2004
Japan
D&B=14N=3
pre-post

Whittle et al. 1991
UK
D&B=12
N=22
post test

Marsolais et al. 2000
USA
D&B=11
N=6Studies of bracing interventions in SCITop Spinal Cord Inj Rehabil. Author manuscript; available in PMC 2012 August 20.

2 subjects who used the IRGO alone achieved distances of 3 to 90 m
during overground walking with either standard walker or crutches.

No significant differences between orthoses for gait speed, cadence,and stride length. Mean walking speed with either orthosis was 0.24
m/s.
RGO enabled faster sit-to-stand and stepping up on curbs.

All subjects showed ↑ in gait velocity: 7.7→13.2; 11.8→21.2,
22.4→25 m/min.

No difference between RGO-users and RGO- non-users for gait
speed, stair climbing, or ambulatory aid. However, RGO-users
achieved home ambulation with limitations or home ambulation(Level 2–3) while non- users achieved hospital ambulation or homeambulation with limitations (Level 1–2). No one reachedcommunity ambulation levels.

At discharge, 28 patients could climb stairs (13 with crutches, 15
with a walker). The ability to climb stairs or Garrett score atdischarge was associated with continued orthosis-use. 31 patientsachieved functional gait (Garrett = 2–5) and 9 achieved community
ambulation (Garrett=4–5). 19 used orthosis only for exercise(Garrett=1).

Both orthoses resulted in “stand-by” or “minimal” assist for stairs
and curbs and “independent” or “stand-by” for level gait. IRGO
tended to enable faster gait (mean IRGO=0.34 m/s ± 0.18, mean
WO=0.14 m/s ± 0.12; p=.002) and allowed more independent gait
compared to WO.
Neither orthosis enabled subjects to be fully independent in the key
skills necessary for functional ambulation after 8-week training.

Subjects achieved FIM score of at least 4 (“minimal assist”) for 6-m
walking, at least 3 (“moderate assistance”) for stair ascent anddescent.

When subjects with RGO-II alone, they achieved distances of 150 to
400 m. Average walking speed was 0.29 m/s (SD 0.03; range 0.22–
0.41 m/s).

Results

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5 males, age 26–36 yrs, T5-L1, 4 complete (Frankel A) and 1 incomplete (Frankel C), 8.4–70 months
post-injury.
MSH-KAFO††††: long-leg hip-knee-ankle-foot brace with medially-placed single-axis hip joint.
Patients were trained to stand and walk using device daily for 2 wks, followed by an exercise program
1–2X/wk.
Outcome measures: walking speed and distance
5 males and females, age 24–37 years, C2 -T6, 3 ASIA A, 1 ASIA B, 1 ASIA C.
Following conditioning program, RGO+FES bilaterally to quadriceps and hamstrings for home use.
Outcome measures: walking speed over 40 m

Saitoh et al. 1996
Japan
D&B=10N=5pre-post

Sykes et al. 1996aUK
D&B=10N=5
post-test

Isocentric Reciprocating Gait Orthosis****

Reciprocating Gait Orthosis (predecessor to the IRGO)

6 males, age 16–31 yrs, complete (Frankel A), T3-T12, 12–51 months post-injury.
Rehabilitation training with advanced reciprocating gait orthosis for 6–8 weeks (including muscle
strengthening, standing balance, gait training, stair climbing).
Outcome Measures: walking speed over 5 m

Massucci et al. 1998
Italy
D&B=10N=6post test§§§

4 males, age 24–36 yrs, 2 complete and 2 motor-incomplete, T5-T10, 25 to 58 months post-injury.
Gait training with RGO or IRGO: 2 hours, 2–3 times/week (average total time = 35±7.5 hours)
Outcome measures: gait velocity, cadence

Methods

Winchester et al. 1993
USA
D&B=11
N=4
post test

post-test

When subjects walked with RGO alone, they achieved walking
speeds ranging from 0.13 to 0.40 m/s.

4/5 could stand without crutches with MSH- KAFO.
3/5 could climb stairs with crutches and rail. After 3–10 months oftherapy, gait speed ↑ from 0.05–0.2 m/s to 0.17–0.63 m/s) andwalking distance ranged from 300 to 4000 m.

Subjects achieved walking speeds of between 7.8 and 16 m/minwith the orthosis.

Overall, subjects achieved overground velocity of 12.7±1.9 m/minwith RGO and 13.5±2.1 m/min with IRGO; cadence of 30.3±6.2
steps/min with RGO and 31.3±7.9 steps/min with IRGO.

Results

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PMC Canada Author
19 males & females, mean age 31.7 (SD 9.4) yrs, ASIA C, para- and quadriplegia.
BWSTT + common peroneal nerve FES: <90 min, 3X/wk, 12 wks.
Outcome measures: gait speed.

14 males & females, age 18–50 yrs, ASIA C, C4-T7.
BWSTT + common peroneal nerve FES: <90 min, 3X/wk, 12 wks.
Outcome measures: overground gait speed.

3 males, age 45–62 yrs, ASIA C & D, C5-T8, 8–18 months post-injury.
Electromechanical gait trainer + FES to quadriceps and hamstrings: 20–25 min, 5X/wk, 5 wks.
Outcome measures: gait velocity and endurance

Field-Fote 2001
USA
D&B=15N=19
pre-post

Field-Fote & Tepavac 2002
USA
D&B=13N=14
pre-post

Hesse et al 2004
Germany
D&B=11
N=4
pre-post

Only the results from subjects who were in the BWSTT + FES group are included in this table.

‡‡‡‡

Medial-placed, Single-axis Hip joint-Knee-Ankle-Foot Orthosis

27 males & females, age 21–64 yrs, incomplete, C3-T10, >1 year post-injury.
Randomized to 4 gait training strategies, 45–50 min, 5X/wk, 12 wks: 1) manual BWSTT (n=7); 2) BWSTT +FES (common peroneal nerve) (n=7); 3) BWS overground+FES (n=7); 4) BWS Lokomat (robotic gait
device) (n=6).
Outcome measures: walking speed over 6 m (short-bout) and 24.4 m (long-bout)Field-Fote et al. 2005‡‡‡‡USA
PEDro=6
N= 27
RCT

††††

Methods

ArticlesCombination Therapies – Gait Training + FES

Gait ability ↑ in all patients; 3 could walk
independently overground with aids. Overall gait
speed and endurance more than doubled.

All subjects showed ↑ in walking speed. Subjects withslower walking speeds showed greater improvement.

Significant ↑ in walking speed (median: 77%).

Significant ↑ in short-bout walking speed acrosssubjects who received BWSTT + FES. Tendency for
initially slower walkers (<0.1 m/s) to show greater
improvement (106%) compared to initially fasterwalkers (17%).

Results

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PMC Canada Author
9 males & females, age 21–44 yrs, incomplete SCI, C5-L1, 1–13 yrs post-injury.
Treatment: Double-blind, placebo-controlled crossover study design: Intravenous GM-1 ganglioside (Sygen®)or placebo + 2 hours PT (gait training) 6X/wk for 2 months, followed by switch of drug administration (total 4months). All subjects given 6 months of PT before trial.
Outcome measures: motor score, walking distance and velocity.

2 males, age 23–26 yrs, incomplete SCI, C7-T4, 8–11 months post-injury.
combined cyproheptadine and clonidine + BWSTT (manual): 1–2 hours, 3–5 times/wk, 3–8 wks.
Outcome measures: gait speed

Fung et al 1990
CanadaD&B=10pre-post

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

Methods

ArticlesCombination Therapies – Gait Training + Pharmacological Agents

GM-1 + PT resulted in ↑ motor scores, walking distance,
and walking velocity. Effects of GM-1 persisted insubjects who were given GM-1 before placebo.

Both subjects wheelchair-bound pre- treatment. Following
medication and training, both subjects could walkoverground with ambulatory aids (crutches or walker) at
0.1–0.2 m/s.

Results

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5 males and females, age 24–37 years, C2 -T6 (2 tetraplegics ASIA A & C, 3 paraplegics
ASIA A & B), 8–14 years post-injury.
RGO and FES: 20–40 weeks of RGO use at home followed by RGO+FES bilaterally toquadriceps and hamstrings.
Outcome measures: RGO pedometer measured number of steps over 18 months
70 males and females, age 16 to 50, C6-T12, 1–10 years post-injury, severity not reported.
RGO-use and gait training 1–3 hours, 3 times/week, 6 weeks followed by RGO+FES(bilateral quadriceps and hamstrings) for another 6 weeks.
Outcome measures: walking ability, 180 m walk6 males & females, age 22–50 yrs, C7-T12, severity not reported, 2.5–20.6 yrs postinjury.
Case-Western Reserve University Hybrid Gait Orthosis (modification of IRGO*****)
combined with FES to various muscles (combination of 8–16 muscles).
Outcome measures: walking speed and distance3 subjects, age 28–42 yrs, C6 -T8 (tetraplegic incomplete, paraplegics complete), 3–15 yrs
post-injury.
RGO +/− FES: RGO with and without FES to common peroneal nerve stimulation.
Outcome measures: walking speed, stride length
5 males and females, age 24–37 years, C2 -T6, 3 ASIA A, 1 ASIA B, 1 ASIA C.
Following conditioning program, RGO+FES bilaterally to quadriceps and hamstrings forhome use.
Outcome measures: walking speed over 40 m

Sykes et al. 1996b
UK
D&B=13
N=5
post-test

Solomonow et al. 1997
USA
D&B=12
N=70
post-test

Marsolais et al. 2000
USA
D&B=11
N=6
post-test

Yang et al. 1996
UK
D&B=11
N=3
pre-post

Sykes et al. 1996aUK
D&B=10N=5
post-test

Top Spinal Cord Inj Rehabil. Author manuscript; available in PMC 2012 August 20.

Isocentric Reciprocating Gait Orthosis (IRGO)*****

Reciprocating Gait Orthosis (predecessor to the IRGO)

26 males & females, age 20–53 yrs, C8-T11, complete, 9–144 months post-injury.
RGO-II§§§§ orthosis: long-leg brace with reciprocal hip joint combined with FES to thequadriceps and hamstrings. 4–6 wks 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

Thoumie et al. 1995
FranceD&B=19N=26
post-test§§§§

Methods

ArticlesCombination Therapies –FES + bracing

Without FES, subjects’ walking speeds ranged from 0.13 to 0.40 m/s. With
RGO+FES, speeds ranged from 0.14 to 0.45 m/s, corresponding to changes
ranging from −1 to 14%.

RGO+FES: modest (non-significant) ↑ in walking speed and stride lengthcompared with RGO without FES.
When subjects walked with the RGO+FES, average walking speed was 13%
faster and stride length was 5% longer.

Subjects who were unable to use RGO alone could ambulate with hybrid system.
3 subjects 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). 2 subjects could climb stairs with hybrid system.

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).

Number of steps taken per week varied between 306 and 1879 steps (99 to 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 wasvariable, intermittent and generally poor.

21/26 completed the training program, 19 could 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 (mean0.32 m/s; SD 0.02; range 0.21–0.45 m/s) was not significantly different fromthat with orthosis alone (mean 0.29 m/s; SD 0.03; range 0.22–0.41 m/s).

Results

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