Lower Limb Table 1: Systematic Reviews Lower Limb

Authors; Country

Date included in the review

Number of articles

Level of Evidence

Type of Study

Score

Method:

Databases:

Conclusions

Louie et al. 2015

Canada

Systematic Review

AMSTAR= 8/11

N= 15

Methods: A systematic search in computerized databases was conducted to identify articles that reported on walking outcomes when using a powered exoskeleton. Individual gait speed data from each study was extracted. Pearson correlations were performed between gait speed and 1) age, 2) years post-injury, 3) injury level, and 4) number of training sessions.

Databases: MEDLINE (1946 to

May 6, 2015), EMBASE (1980 to May 6, 2015), Cochrane Central Register of Controlled Trials (1991 to May 6,

2015), and CINAHL (1982 to May 6, 2015)

  1. Gait speed, ranged from 0.031m/s to 0.71m/s. The mean gait speed attained by the 84 participants in these 12 studies was 0.26m/s (SD: 0.15m/s)
  2. An aggregate mean of 19.8 (SD= 18.6, n= 79) training sessions was calculated across all studies; training sessions were 60 to 120min in duration.
  3. Participants ambulated on a body weight-supported treadmill while wearing the Hybrid Assistive Limb (HAL). At the end of the intervention period, the participants improved their mean gait speed without the exoskeleton from 0.28m/s to 0.50m/s (p< 0.05, n= 8, effect size= 0.71). They also demonstrated an improvement in mean 6MWT distance from 70.1 m to 163.3 m (p< 0.05, n= 8, effect size= 0.64).
  4. A significant correlation was found between increasing age and faster gait speed (r= 0.27, 95% CI 0.02–0.48, p= 0.03, n= 63). However, no relationship was found between injury duration and gait speed (r= 0.19, 95% CI−0.09–0.44, p= 0.18, n= 53) from 10 studies. From the 12 studies, we found a significant correlation between injury level and gait speed (r= 0.27, 95% CI 0.02–0.48, p = 0.03, n = 63).

Bochkezanian et al. 2015

Australia

Systematic Review

AMSTAR= 9/11

N= 9

Methods: A search was conducted for randomized controlled trials (RCTs), controlled trials, uncontrolled clinical trials, case series and cross-over studies involving exercise interventions that included a combination of aerobic and strength components, either in circuit-mode or in sequence for people with SCI. Methodological quality was independently rated using the PEDro scale and key findings were extracted from trials by two reviewers.

Databases: PEDro, Web of Science, MEDLINE via OvidSP, AMED—Allied and Complementary Medicine via OvidSP, Cinahl via Ebsco and Scopus from earliest record till February, 2013.

  1. One of the RCT studies of ‘fair’ quality that used a twice weekly circuit resistance in combination with arm ergometry intervention, showed a significant within-training group effect on aerobic fitness with MD (95% CI) of 13.8bpm W−1(0.63–26.9) and between-group effect on aerobic fitness with MD (95% CI) value of 13.1bpm. W−1 (0.2–25.98) but only for participants with tetraplegia.
  2. Four studies of poor quality and with no control groups found no statistically significant within-group improvements in aerobic measures.
  3. Most of these studies showed statistically significant within-group differences in muscle strength on some of the muscle groups assessed.
  4. The only ‘fair’ quality study that used a control group reported statistically significant improvements in muscle strength only on one of the muscle groups assessed. In this case, the within-group MD (95% CI) was 4.5 kg (0.93–8.06) and 4.3 kg (0.10–8.49), for right and left biceps, respectively. A significant between-group effect was found for right biceps only with a MD (95% CI) of 4.6 kg (0.38–8.8)

Federici et al. 2015

Italy

Systematic Review

AMSTAR= 7/11

N= 27

Methods: The PRISMA guidelines were used to review literature on the use of powered and active lower limb exoskeletons for neurorehabilitative training in paraplegic participants. We reviewed 27 studies published between 2001 and 2014, involving a total of 144 participants from the USA, Japan, Germany, Sweden, Israel, Italy, and Spain. Seventy percent of the studies were experimental tests of safety or efficacy and 29% evaluated rehabilitative effectiveness through uncontrolled (22%) or controlled (7%) clinical trials.

Databases: Articles were retrieved in a search of the electronic databases PubMed, EBSCO, Web of Science, Scopus, ProQuest, and Google Scholar.

  1. The studies confirmed that the HAL, Tibion Bionic Technologies, and Ekso devices were safe to use in controlled environments, and with the assistance of expert professionals.
  2. Exoskeletons provide a safe and practical method of neurorehabilitation which is not physically exhausting and makes minimal demands on working memory.
  3. It is easy to learn to use an exoskeleton and they increase mobility, improve functioning and reduce the risk of secondary injury by reinstating a more normal gait pattern.

Lajeunesse et al. 2015

Canada

Systematic Review

AMSTAR= 5/11

N= 7

Methods: Systematically review the usefulness of lower limb exoskeletons used for functional mobility of people with spinal cord injury. Seven articles were selected.

 Databases: A systematic review of the literature (January 2004 to April 2014) was done using the databases PubMed, CINAHL and EMBASE and groups of keywords associated with “exoskeleton”, “lower limb” and “paraplegia”.

  1. The applicability and effectiveness of lower limb exoskeletons as assistive devices have only been demonstrated in the lab, but not yet in the community.
  2. More research is needed on walking performance with these exoskeletons compared to other mobility devices and other training contexts in the community.

Wall et al. 2015

Sweden

Systematic Review

AMSTAR= 8/11

N= 7

Methods:  Systematically review the literature on clinical applications of the Hybrid Assistive Limb system for gait training. Out of 37 studies, 7 studies fulfilled inclusion criteria. Six studies were single group studies and 1 was an explorative randomized controlled trial. In total, these studies involved 140 participants of whom 118 completed the interventions and 107 used HAL for gait training.

Databases: A systematic literature search was conducted using Web of Science, PubMed, CINAHL and clinicaltrials.gov and additional search was made using reference lists in identified reports. Abstracts were screened, relevant articles were reviewed and subject to quality assessment.

  1. Most studies applied HAL training ≥2 times per week during ≥4 weeks with durations of ≥20 min per session. In studies involving persons with SCI, Aach et al. (2014) used a mean of 51.75 sessions while the number of sessions for persons with SCI in the study by Kubota et al. (2013) was 16.
  2. The explorative RCT (Watanabe et al., 2014) compared the effect of HAL-training to the effect of conventional training in the subacute phase after stroke and included 11 participants in each group. The study shows a significant difference (p = 0.04) according to the Functional Ambulation Categories (FAC) between groups, in favor for the HAL training group.

do Espirito Santo et al. 2014

Brazil

Systematic Review

AMSTAR= 8/11

N= 5

Methods: The systematic review explored the effectiveness of body weight-support treadmill training (BWSTT) for muscle atrophy management in people with spinal cord injury (SCI). A total of 5 studies were included. The methodological quality of the articles included was classified according to Jovell and Navarro-Rubio.

Databases: The following databases were consulted from January to October 2013: PubMed, Institute for Scientific Information (ISI), Science Direct and Lilacs.

  1. The period of intervention with BWSTT therapy ranged from 9 to 48 weeks, with a minimum and maximum session number of 45 and 144 respectively, and a mode of 48 sessions was the predominant quantity number. The frequency of therapeutic approach ranged from two to five times a week, and there was a predominance of two sessions per week, lasting a minimum of 5 min (initial sessions) and a maximum of 30 min.
  2. The treadmill speed, another parameter of training intensity, was initially established at an average of 0.3m/s. For two studies, the reduction of the BWS resulted in increased speed; however, in one article, the final speed was omitted. The average of the final evaluated speed was 0.6 m/s.
  3. In acute incomplete SCI, the CSA of the thigh muscles and calf increased in 12 and 14% of the participants, respectively, compared with baseline. In chronic incomplete SCI, BWSTT was also effective for increasing the muscle trophism of the lower limbs (thigh and calf), and the values increased from 2.3 to 16.8%, compared with the reference group that did not receive locomotor training muscle trophism was only observed when BWSTT was combined with NMES, where the quadriceps CSA increased from 49.81 ± 9.36 to 57.33 ±10.32 cm.

Arazpour et al. 2015

UK

Systematic Review

AMSTAR= 6

N= 16

Methods: Papers were selected from peer-reviewed journals, which demonstrated or reported temporal–spatial, kinematics, and kinetic effects or clinical efficacy by the use of relevant tests, such as the 6-min walk test, 10-m walk test, and self-efficacy measures, or by assessing physiological cost index (PCI) when SCI participants used powered orthoses after being screened for relevance. To be included, the intervention involved a powered reciprocating gait orthosis (RGO), but without the use of partial bodyweight relief; the participants were all diagnosed with SCI; the assessment of gait was undertaken using recognized tests.

Databases: ISI Web of Knowledge, PubMed, Google Scholar, Science Direct, Scopus

  1. Efficacy was demonstrated in producing activated motion of lower limb joints.
  2. Powered gait orthoses have a beneficial effect on the kinetics, kinematics, and temporal–spatial parameters of gait, but their effect on muscle activity in individuals with spinal cord injury is still unclear.
  3. Magnitudes of the muscle activity of tibialis anterior, quadriceps, and hamstrings were higher with the new RGO with a variable constraint hip mechanism, orthosis as compared to a mechanical IRGO and normal walking

Bani et al. 2014

UK

Systematic Review

AMSTAR= 7/11

N= 20

Methods: This review examined papers which assessed purely mechanical orthosis (consisting of RGO, medial single joint orthoses and hip guidance orthoses, and also included KAFOs) on independence, energy expenditure, gait parameters, stability, system reliability, comfort and cosmesis in people with SCI. Any papers evaluating orthoses utilizing FES or actuators on other patient groups or healthy participants were excluded. Only papers written in English from 1960 to 2012 with full text available were studied.

Databases: PubMed, ISI web of knowledge and Science Direct

  1. Independence and cosmesis are improved when using MLOs
  2. Gait parameters, energy expenditure and stability are all improved when using RGOs

Ibitoye et al. 2014

Malaysia

Systematic Review

AMSTAR= 7/11

N= 59

Methods: We conducted a systematic review to examine the effectiveness of eEMG potentials to assess muscle force and fatigue, particularly as a biofeedback descriptor of FES-evoked contractions in individuals with spinal cord injury. At the outset, 2867 citations were identified, and 59 trials met the inclusion criteria.

Databases: IEEE Xplore, IOP Science, MEDLINE, Science Direct, Scopus, SpringerLink, PubMed, Nature, Google Scholar

  1. eEMG is effective at quantifying muscle force and fatigue during isometric contraction, but may not be effective during dynamic contractions including cycling and stepping.
  2. Positive correlation of up to r = 0.90 (p < 0.05) between the decline in the peak-to-peak amplitude of the eEMG and the decline in the force output during fatiguing isometric contractions has been reported.
  3. In the available prediction models, the performance index of the eEMG signal to estimate the generated muscle force ranged from 3.8% to 34% for 18 s to 70 s ahead of the actual muscle force generation.

Panisset et al. 2015

Australia

Systematic Review

AMSTAR= 10/11

N= 11

Methods: A comprehensive search (Any-2014) of eleven databases identified studies evaluating exercise interventions initiated within 12 weeks after SCI on muscle and bone loss in paralyzed limbs and comparing with standard care or immobilization. Two reviewers assessed methodological quality. One reviewer extracted data and critiqued results according to the Spinal Cord Injury Rehabilitation Evidence body of evidence framework.

Databases: Academic Search Complete, CINHAL, Cochrane, DOAJ, MEDLINE (OVID interface), Pedro, PhysEdIndex, PubMED, SCOPUS, Sports & Rehab and SPORTSDiscus, Google Scholar

  1. Two studies found significant positive effects of high-load FES-resisted stance on physiological measures of muscle.
  2. Three reported positive effects of 3 months of Functional Electrical Stimulation (FES) on muscle size.
  3. Two studies found positive effects of 6-month body-weight supported treadmill training or FES on trabecular bone using pQCT.

Ellaway et al. 2014

UK

Systematic Review

AMSTAR= 3/11
N= 5

Methods: This article reviews the attempts that have been made to restore sensorimotor function and to obtain functional benefits from the application of repetitive transcranial magnetic stimulation (rTMS) of the cortex following incomplete spinal cord injury.

Databases: Not specified

  1. High-frequency (20 Hz) rTMS lead to a significant improvement in clinical lower extremity motor scores.
  2. A 5 Hz rTMS protocol decreased the H-reflex to M-wave ratio for the soleus muscle and, when repeated during a 2-week period, rTMS produced long-lasting (at least 1 week) clinical improvement in spasticity of lower limbs.

Mehrholz et al. 2012;

Germany

 

Reviewed published and unpublished articles from many databases (listed to the right)

N=5

Level of evidence:

Assessed using PEDro scale

Type of study:

5 RCTs

AMSTAR: 9

Method: Review randomized controlled trials involving people with SCI that compared locomotor training to a control of any other exercise or no treatment to assess the effects of locomotor training on the improvement in walking speed and walking capacity for people with traumatic SCI.

Database: Cochrane Injuries Group’s Specialised Register (searched Nov 2011); Cochrane Central Register of Controlled Trials; MEDLINE (1966 to Nov 2011); EMBASE (1980 to Nov 2011); CINAHL (1982 to Nov 2011); Allied and Complementary Medicine Database (1985 to Nov 2011); SPORTDiscus (1949 to Nov 2011); PEDro (searched Nov 2011); COMPENDEX (1972 to Nov 2011); INSPEC (1969 to Nov 2011). Online trials databases Current Controlled Trials (www.controlled-trials.com/isrctn) and Clinical Trials (www.clinicaltrials.gov) was searched.

  1. 4 trials involving a total of 274 participants measured walking speed and found that the use of bodyweight supported treadmill training (BWSTT) as locomotor training for people after SCI did not increase walking velocity. The pooled mean difference (fixed-effect model) was 0.03m/s (95%CI: -0.05-0.11).
  2. 3 trials involving a total of 234 participants measured walking distance (6MWT) and found that the use of BWSTT as locomotor training for people after SCI did not significantly increase walking distance (pooled mean difference (random-effects model) = -1.25 m (95%CI: -41.26=3.77).
  3. 1 trial involving 146 participants measured recovery of independent walking and found that use of BWSTT as locomotor training for people after SCI did not increase the chances of walking independently.
  4. 1 trial involving 74 participants found that the use of robotic-assisted locomotor training as locomotor training for people after SCI did not significantly increase the walking velocity (mean difference = 0.06 m/s (95%CI: 0.01-0.13)) and actually decreased walking distance at final follow-up (mean difference = 10.29 m (95%CI: 0.15-20.43).
  5. 1 trial involving 88 participants found that people with SCI who used functional electrical stimulation combined with BWSTT did not significantly increase walking speed (mean difference = -0.03 m/s (95%CI: -0.11-0.06)).
  6. 1 trial involving 74 participants found that people with SCI who used functional electrical stimulation combined with BWSTT did not significantly increase walking distance (mean difference = 2.43 m (95%CI: -10.82-15.67))).

Mehrholz et al. 2008;

Germany

Review published articles from 1949 to June 2007

N=4 (n=222)

Level of Evidence:

PEDro scale

Type of study:

4 RCTs

AMSTAR=8

Methods: Literature search for articles with randomized controlled trials (RCT) that compared locomotor training to any other exercise provided with the goal of improving walking function after SCI or to a no-treatment control group.

 

Interventions include:

Lokomat, BWSTT and BWSTT+FES.

Outcome measures include speed of walking, 6MWT and FIM.

 

Databases:

Cochrane Injuries Group Specialized Register (last searched June 2007); Cochrane Central Register of Controlled Trails (CENTRAL) (The Cochrane Library 2007, Issue 2); MEDLINE (1966-June 2007); EMBASE (1980- June 2007); National Research Register (2007, Issue 2); CINAHL (1982-June 2007); Allied and Complementary Medicine Database (1985- June 2007); SPORTDiscus; PEDro (the Physiotherapy Evidence Database) (searched June 2007); COMPENDEX (engineering databases) (1972-June 2007); INSPEC (1969 –June 2007); National Research Register

(2007, Issue 2); Zetoc; Current Controlled Trials

  1. No statistically significantdifference in theeffect of various locomotor training on walking function after SCI comparing bodyweight supported treadmill training with or without functional electrical stimulation or robotic-assisted locomotor training.
  2. Adverse events and drop- outs were not more frequent for participants who received BWSTT with or without FES or robotic-assisted locomotor training

Domingo et al. 2012;

Canada

Reviewed published articles from 1980 to 2009

N=11 (2 SCI)

Level of evidence:

PEDro scale and modified Downs & Black was used to evaluate studies

Type of study:

5 RCT

2 prospective controlled trial

3 Pre-post

1 Post-test

AMSTAR: 7

Method: Systematically review the effects of pharmacological agents on gait in people with SCI. Studies were included if they specifically reported outcome measures associated with gait. Exclusion criteria include animal studies, non-English, less than half the reported population had a SCI, or there were no measurable outcomes associated with the intervention.

Database: MEDLINE/PubMed, CINAHL, EMBASE, PsycINFO and hand-searching.

  1. One RCT provided Level 1 evidence that GM-1 ganglioside in combination with physical therapy improved motor scores, walking velocity and distance better than placebo and physical therapy in persons with incomplete SCI.
  2. Multiple studies (levels 1-5 evidence) showed that clonidine and cyproheptadine may improve locomotor function and walking speed in severely impaired individuals with incomplete SCI.
  3. Gains in walking speed associated with GM-1, cyproheptadine and clonidine are low compared to those seen with locomotor training.
  4. There is Level 1 evidence that 4-aminopyridine and L-dopa were no better than placebo in helping to improve gait.
  5. 2 Level 5 studies showed that baclofen had little to no effect on improving walking in persons with incomplete SCI.

Wittwer et al. 2013;

Australia

Reviewed published articles up to June 2011

N=14 (2 SCI)

Level of evidence:

Study quality was assessed with the method used by Lim et al. “Effects of external rhythmical cueing on gait in patients with Parkinson’s disease: a systematic review

Type of study:

Both studies with SCI participants were non-RCTs

AMSTAR: 6

Method: Reviewed published English articles that explored effect of intentional synchronization of overground walking to externally generated rhythmic auditory cues on temporal and/or spatial gait measures. Only studies with adult participants (>16 yrs) and gait disorders of neurological origin (excluding Parkinson’s) were included.

Database: AGELINE, AMED, AMI, CINAHL, Current Contents, EMBASE, MEDLINE, PsycINFO, PubMed.

  1. 2 non-controlled studies with a total of 46 participants found no significant changes in measures of velocity, cadence, stride length or symmetry. Therefore, the best evidence synthesis indicates there is insufficient evidence of the effect of rhythmic auditory cueing on measures of gait in people with SCI.

Morawietz & Moffat 2013;

UK

Reviewed published articles from first date of publication until May 2013 for the databases listed to the right

N=8

Level of evidence:

Assessed using PEDro scale

Type of study:

8 RCTs

AMSTAR: 4

Method: Reviewed randomized controlled trials evaluating locomotor therapies after incomplete SCI in an adult population. Restricted to English, German and Dutch publications only.

 

Database: Allied and Complementary Medicine Database, CINAHL, Cochrane Database of Systematic Reviews, MEDLINE, Physiotherapy Evidence Database, PubMed.

  1. For acute participants, gait parameters improved slightly more after BWSTT and robotic gait training.
  2. For chronic participants, improvements were greater after BWSTT with functional electrical stimulation and overground training with functional electrical stimulation/body-weight support compared with BWSTT with manual assistance, robotic gait training, or conventional physiotherapy.

Hamzaid & Davis 2009;

Australia

Reviewed published articles from 1830 to 2008

N= 33

 

Level of Evidence:

No formal validity assessment was described

Type of study:

1 RCT, 32 quasi-experimental

AMSTAR=4

Methods: Literature search for published articles written in any language and related to functional electrical and neuromuscular stimulation, exercise, health and fitness, and lower limbs of neuromuscular stimulation

 

Interventions include:

FES training (cycling, ergometry, rowing, leg muscle contraction, knee extension and treadmill).

Outcome measures include: cardiovascular and peripheral blood flow, aerobic fitness, functional exercise capacity, bone mineral density and psychosocial outlook.

 

Databases: Ovid MEDLINE (1966- July 31 2008), Ovid MEDLINE Daily Update, PREMEDLINE, Ovide OLDMEDLINE (1950-1965), SPORTDiscus (1830-July 31, 2008), Web of Science (1900- July 31, 2008), Cochrane Library and Database

 

 

  1. FES-evoked exercise studies demonstrated positive changes within skeletal muscle, enhanced cardiovascular and peripheral blood flow, altered metabolic responses and increased aerobic fitness, and improved functional exercise capacity- strength and endurance
  2. Positive bone health improvements with FES-evoked leg training only on some localized areas of bones, particularly in the hips, knee area and shank – FES-induced treadmill walking delivered more positive outcomes than other modalities
  3. Bone mineral density changes and alterations of psychosocial outlook were less consistently reported or outcomes were deemed equivocal.
  4. FES-evoked leg exercise promotes certain health and fitness benefits for people with SCI

Lam et al. 2008;

Canada

Reviewed published articles from 1980 to 2007

N= 41

Level of Evidence:

SCIRE Procedures– PEDro

(9–10: excellent; 6–8: good; 4–5: fair; <4: poor)

Modified Downs &Black scale (0-28)

Type of study:

Not clearly described

AMSTAR=4

Methods:  Literature search for published literature evaluating the effectiveness of any treatment or therapy on functional ambulation in people with SCI

 

Interventions include:

BWSTT, FES, braces/orthoses and hybrid therapies.

Outcome measures include FIM, WISCI-II, walking distance, and walking speed.

 

Databases:  PubMed/MEDLINE, CINAHL, EMBASE, PsycINFO

 

 

  1. There is level 1 evidence of an overall enhancement of functional ambulation, as measured by overground gait speed, when BWSTT was combined with FES of the common peroneal nerve.
  2. There is level 1 evidence that a combination of physical therapy and GM-1 ganglioside improved motor scores, walking distance, and walking speed in chronic SCI participants.
  3. There is level 1 evidence that different modes of gait training (BWSTT vs. overground) result in similar effects.

 

Swinnen et al. 2010;

Belgium

Review published articles from 1990 to January 2009

N= 6

 

Level of Evidence:

Van Tulder criteria list– RCTs, maximum score of 19

The evaluation of quality of an intervention study”- non RCTs, maximum of 48 points

– quasi experimental trials: clinical trials without random assignment

– pre-experimental: case reports, uncontrolled clinical trials

Type of study:

2 RCTs

4 pre-experimental trials

AMSTAR=4

Methods: Literature search for articles written in English, French, German or Dutch, that included incomplete and complete adult SCI patients, over 18 years of age, participating in robot-assisted gait training intervention

 

Outcome measures include trials without random assignment – pre-experimental; case reports, uncontrolled clinical trials

 

Databases:  MEDLINE, Web of Knowledge, Cochrane Library, Physiotherapy Evidence Database (PEDro) and Digital Academic Repositories (DAREnet) (1990–2009)

 

 

  1. There is currently noevidence that robot-assisted gait training improves walking function more than other locomotor training strategies
  2. Some improvements were reported related to body function (i.e. motor function) and limitations in activities (i.e. walking speed)

 

 

Karimi 2013;

Iran

Reviewed published articles from 1960 to 2010

 

N=17

Level of evidence:

Original studies assessed using Downs & Black tool

Type of study:

5 review articles

12 case studies

2 clinical trials

AMSTAR: 3

Method: Review the differences in performance of SCI subjects standing and walking with functional electrical stimulation (FES) systems and hybrid orthoses (combine FES with structural support of an orthosis) based on results in published literature. Inclusion criteria: study focused on SCI with specification of level of injury, type of injury, and device used. English-only articles. Mechanical orthoses were not included in the study.

Database: PubMed, EMBASE, ISI Web of Knowledge

  1. Using FES does not influence the performance of subjects with SCI. The magnitude of energy consumption based on the Physiological Cost Index (PCI) increased while walking with hybrid orthosis based on reciprocal gait orthosis (RGO) compared to the mechanical orthosis.
  2. There is no evidence to support the positive effect of FES on cardiovascular fitness.
  3. User performance with the mechanical orthoses was generally better than that of the hybrid and FES systems based on subject stability and energy consumption while walking. Subjects also reportedly experienced a higher incidence of problems with the use of hybrid orthoses and FES systems compared with mechanical orthoses.
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