546926 research-article2014

POI0010.1177/0309364614546926Prosthetics and Orthotics InternationalWong et al.

INTERNATIONAL SOCIETY FOR PROSTHETICS AND ORTHOTICS

Systematic Review

Exercise programs to improve gait performance in people with lower limb amputation: A systematic review

Prosthetics and Orthotics International 1­–10 © The International Society for Prosthetics and Orthotics 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav DOI: 10.1177/0309364614546926 poi.sagepub.com

Christopher Kevin Wong, Julie E Ehrlich, Jennifer C Ersing, Nicholas J Maroldi, Catharine E Stevenson and Matthew J Varca

Abstract Background: Few studies have explored the effects of exercise on gait performance in people with lower limb amputations. Objectives: To (1) summarize the effects of exercise programs on gait performance and (2) assess the overall quality of the evidence for adults ambulating with leg prostheses. Study design: Systematic review. Methods: Six databases were searched for one- and two-group studies published through June 2013 reporting effects of exercise on gait speed, a universal measure of performance in lower limb prosthetic users. The search adhered to a predetermined protocol following Cochrane Collaboration guidelines. Results: In all, 623 citations were reviewed and eight studies included. The quality level of the combined evidence was low with few randomized control trials and multiple sources of bias evident within the heterogeneous group of studies. The 11 exercise programs, including three control conditions, demonstrated small to large effect size improvements in self-selected gait speed. Use of exercise to improve gait speed was supported by low-quality level evidence, with low– moderate quality evidence to suggest that specific functional exercise programs were more effective than supervised walking. Conclusion: Using exercise to improve gait speed in people with lower limb amputation received a B grade recommendation. Future high-quality research is required. Clinical relevance Supervised walking, muscle strengthening, balance exercises, gait training, and functional training programs demonstrated small to large effect size gait performance improvements in people with lower limb amputation. Self-selected gait speed was the most consistent outcome measure. Exercise programs emphasizing resisted gait and functional training were more effective than supervised walking. Keywords Amputation, gait, exercise, artificial limb, prosthesis, review Date received: 28 January 2014; accepted: 17 July 2014

Background Rehabilitation after lower limb amputation, once wound healing has been achieved, generally focuses on use of the prosthesis to restore walking ability.1 A team approach after amputation may include initial prosthetic training with a prosthetist at the time of delivery and continued prosthetic training to optimize gait performance with a physiotherapist.2 Physiotherapy includes varying degrees of emphasis, exercise, balance, gait, and functional training within an overall comprehensive plan of care.1 However, no evidence-based best practice guideline for

physiotherapy after lower limb amputation has been established, to the authors’ knowledge.

Neurological Institute, Columbia University, New York, NY, USA Corresponding author: Christopher Kevin Wong, Neurological Institute, Columbia University, 710 West 168th Street, New York, NY 10032, USA. Email: [email protected]

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Physiotherapy in general and the specific exercise programs provided during rehabilitation vary with the rehabilitation settings and individual clinical presentations. For people after lower limb amputation, medical complications can delay readiness for prosthetic fitting3 and prolong the rehabilitation process.4 Delayed rehabilitation and the trend toward shorter hospital stays result in physiotherapy being conducted in a variety of settings including hospitals and rehabilitation centers but increasingly out-patient clinics and individual homes.5,6 In addition to the rehabilitation setting, other variables that influence the rehabilitation process include medical conditions and clinical characteristics such as age, amputation etiology, and amputation level.2 Many of these variables, although beyond the control of the individual and clinician, can affect the rehabilitation process and outcome. Thus, modifiable variables such as the exercise program selected to optimize gait performance could have an important impact on the rehabilitation of the individual after lower limb amputation.7 Clinicians have used a multitude of exercise approaches in amputation rehabilitation8 as well as methods to assess gait performance, including kinetic, kinematic, functional, and self-report measures.9 Perhaps, the simplest and most universal gait measure, gait speed has been suggested as a vital sign for screening physical performance.10 Gait speed has demonstrated responsiveness to change in short bouts of rehabilitation11 and strong correlation to gait indices that incorporate motion analysis measures of prosthetic gait deviations compared to the intact limb to differentiate gait performance abilities.12 Beyond the ability to walk a short distance;13 successful prosthesis use in a community setting requires sufficient ability to walk fast enough to cross a street or engage in other outdoor or functional activities that facilitate a return to vocational and recreational pursuits.14 Few reports of specific exercise programs after lower limb amputation exist and no prior systematic reviews of specific exercise training programs to improve gait performance were identified. The purpose of this systematic review was to (1) summarize and assess the effects of exercise programs on prosthetic gait performance in people with lower limb amputations and (2) assess the overall quality of the combined evidence.

Methods This systematic review adhered to a predetermined study protocol following the Cochrane Collaboration recommendations with the process reported per the PRISMA statement for reviews that evaluate healthcare interventions.15,16

Study inclusion and exclusion criteria Inclusion criteria are as follows: 1. Experimental and quasi-experimental designs including one-group cohort and pre–post studies, and two-group case–control, and control trials. 2. Participants: prosthesis users at least 16 years of age with any unilateral or bilateral lower limb amputation level above the ankle, such as transtibial and transfemoral. 3. Intervention: experimental exposure conditions that emphasized exercise. 4. Outcomes: gait speed was the primary outcome measure. Other temporal, spatial, kinetic, and kinematic gait measures were noted. Exclusion criteria are as follows: 1. Designs including case studies and case series with fewer than three subjects; 2. Participants who did not use prostheses and ablebodied individuals; 3. Interventions based on initiating prostheses or changing prosthetic components; 4. Outcome measures limited to those that could not be converted to gait speed; 5. Reporting not in English.

Search strategy The following databases were searched to identify relevant systematic reviews and studies without language restrictions or time limits through June 2013: Cochrane, DARE, Ovid MEDLINE, PEDro, PubMed, and Web of Knowledge. The search strategy was based on Boolean combinations of the search terms “amputation,” “prostheses,” “muscle strength,” “exercise,” “postural balance,” “training,” “education,” “rehabilitation,” with “gait.” Other potential studies for inclusion were identified by hand searches of the reference lists of all included articles.

Study selection and data extraction After duplicates were removed, two reviewers independently screened all citations and abstracts to identify studies potentially eligible for inclusion. The full texts of all potentially eligible studies were independently reviewed by four reviewers using a study eligibility form. Final study selection was based on consensus discussion. Data extraction for the included studies was facilitated by use of a customized data extraction checklist combined with the standard GATE-lite form for randomized control trials, adapted from the Graphic Appraisal Tool for

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Wong et al. Epidemiological studies, to ensure consistent documentation of relevant study data in PECOT format (Participants, Experimental condition, Comparison condition, Outcome, and Time) and potential bias risks in RAMBO format (Recruitment, Allocation, Maintenance, Blinding, and Objective outcomes).17 Any disagreement regarding potential study eligibility, final inclusion, or the extracted data was resolved through consensus discussions and if necessary adjudication by an additional reviewer, although this was not required.

623 records identified, duplicates removed

623 records screened

589 records excluded

Study data summary and analysis Study data including study design, sample size, experimental and comparison conditions, and gait outcome data were compiled and summarized. The primary outcome measure assessed was gait speed. Reported treatment effects on gait speed including mean differences with standard deviations and p-values were aggregated. Missing data, effect sizes, and percent changes were calculated when possible from data reported in the included studies. Secondary outcome measures were summarized, including kinematic data, multidimensional gait measures, and selfreport outcomes. Study heterogeneity was expected and analyzed qualitatively.

-273 No intervention/training program -188 Specific to prosthetic device -75 Not lower limb amputation -21 Not adults -16 Fewer than 3 participants -8 Not in English language -6 Not a human study -2 Non-analytical study design

34 full-text articles assessed for eligibility

26 articles excluded

-12 No intervention -8 No gait speed measures -4 Full data not available -2 Repeating data

Study quality assessment Each study was assessed using the Cochrane Collaboration Risk of Bias tool for potential study bias in the domains of selection, performance, detection, attrition, reporting, and other bias. While quantitative assessment of study quality is common, the Cochrane Collaboration handbook explicitly discourages numeric rating of study quality due to the arbitrary weighting of scale items, the difficulty of distinguishing between incomplete reporting and study bias, and unreliable assessments of validity for numeric rating scales.16 Risk of bias in each domain was assessed as high, low, or unclear (when reporting left unclear whether specific potential biases had been addressed). Each study was then potentially downgraded or double downgraded based on study biases.16 Rating in this way allowed a level of evidence for each study to be assigned by consensus according to the 2001 Oxford Levels of Evidence chart for comparison to other studies rated.18

Overall evidence quality assessment The overall quality of the evidence was assessed using the Cochrane GRADE system16 as high-, moderate-, low-, or very low-quality evidence based on the level of evidence of the combined studies and consideration of biases in five domains: study design, indirectness of the evidence, unexplained study heterogeneity or inconsistency, imprecise results, and probability of publication bias.16

8 studies included in systematic review

Figure 1.  Systematic review flow chart.

Results The search strategy resulted in 623 article citations for potential inclusion after removing duplicates. As of June 2013, no systematic reviews regarding the effect of exercise on gait performance in people with lower limb amputations were identified. In all, 589 articles were excluded after review of the titles and abstracts and consideration of the inclusion and exclusion criteria. The full texts of the remaining 34 articles were reviewed with 26 additional studies excluded. Overall, 615 articles were excluded for reasons listed in the Systematic review flow chart (Figure 1). The eight included studies, the oldest from 1981, were conducted in North America, Sweden, Republic of Slovenia, Turkey, and Myanmar (Table 1). The studies varied in design, participants, experimental and comparison condition exposures, and outcomes described separately in short summary findings.

Study design Three studies were randomized control trials;20,21,23 five were pretest–posttest designs.19,22,24–26 All three randomized

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Table 1.  Descriptive data for included studies. Author (year) Country Setting

Corio et al. (2010)19

USA

Hyland (2009)21 USA

Rau et al. (2007)20

Myanmar

Slovenia Matjaĉić and Burger (2003)22 Yiğiter et al. Turkey (2002)23

Design

Participant number (female)

Participant Exposure mean age, etiology, level

Outcome measures

Out-patient Pretest–posttest 34 (12)

46.2 years, 8 weeks mixed TTA and TFA

In-patient

RCT

22 (7)

64.4 years, vascular TTA

In-patient

RCT

58 (0)

In-patient

Pretest–posttest 14 (unknown)

36.1 years, 3–7 days mixed TTA and TFA 49 years, non5 days vascular TTA 28.2 years, non- 10 days vascular TFA

Gait speed, cadence, stride length, step length, BOS Gait speed, cadence, step length, % stance time, LCI Gait speed, 2MWT, LCI, PCI, TUG TUG, 10 m walk

Out-patient RCT

50 (0)

10 days

Sjödahl et al. (2001)24

Sweden

Out-patient Pretest–posttest (outside)

9 (4)

33.0 years, mixed TFA

7–14 months

Klingenstierna et al. (1990)25 Kegel et al. (1981)26

Sweden

Out-patient Pretest–posttest

8 (0)

8–12 weeks

USA

Out-patient Pretest–posttest

4 (0)

61.5 years, mixed TTA 60.5 years, mixed TTA

Gait speed, fast gait speed, cadence, stride length, step length, BOS Gait speed, cadence, step length, % stance time Gait speed

8 weeks

Gait speed

TTA: transtibial amputation; TFA: transfemoral amputation; BOS: base of support; RCT: randomized control trial; 2MWT: two-minute walk test; LCI: Locomotor Capabilities Index; PCI: Physiological Cost Index; TUG: timed-up-and-go.

control trials used comparison groups that involved treatments that could potentially benefit gait performance and were not benign no-treatment, placebo, or sham conditions.

Participants The included studies had a range of 4–58 participants, with a combined total of 199 participants. Participants varied with respect to age, amputation etiology and level, and years since amputation. In all, 23 were females and 162 were males (Table 1). Participant age averaged 25–50 years in five studies19,20,22–24 and over 60 years in three studies.21,25,26 Amputation etiology19,25,26 and level19,20 were sometimes mixed within studies. Time since amputation averaged less than 1 year in two studies,21,23 2.5 years in one study,25 and 7–11 years in the others.19,20,22,24,26

Exposure conditions All experimental and comparison condition exposures included exercise programs. In the three randomized control trials, the comparison conditions primarily involved

supervised walking20,21 with specific gait training used in one study.23 The experimental conditions used different types of exercise that can be characterized as specific muscle strengthening exercises, balance training, part-towhole gait training, and functional gait and activity training. Thus, there were five categories of exercise exposure: 1. Supervised walking. The primary treatment provided in two control groups20,21 was supervised walking, consisting of participants walking with and without physical and verbal cues. Nonstandardized and inconsistently described cues were generally directed at correcting gait compensations. 2. Specific muscle strengthening. Three studies used different types of exercise programs aimed at developing specific muscle groups, not performed in standing. Biofeedback training was used during isometric exercises to facilitate strengthening in residual dorsiflexion and plantarflexion muscles.26 Isokinetic training at different speeds was used to strengthen knee flexion and extension muscles.25

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Wong et al. And spinal stabilization exercise with an education program was employed to develop abdominal muscle strength and stability.19 3. Balance training. While dynamic balance exercise is a staple of prosthetic training and was included in several studies in this review, one study used balance training for tasks specifically not involving gait. Computer-based activities involving cursor movement were controlled by weight shifting in the frontal and sagittal planes were performed during standing.22 4. Gait training. Part-to-whole gait training exercise programs emphasized the development of specific parts of the gait cycle and then progression to practice of the whole gait cycle.27 Specific weight shifting and dynamic balance activities required for different phases of gait or locomotor tasks, such as stairs, progressed to practice of the whole activity. This approach28 was used with participants in the experimental group for at least 50% of the treatment time compared to participants in the comparison group who used this approach

Exercise programs to improve gait performance in people with lower limb amputation: A systematic review.

Few studies have explored the effects of exercise on gait performance in people with lower limb amputations...
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