Lower Limb and Walking

Functional Electrical Stimulation With Gait Training to Improve Locomotor Function

Author Year; Country
Score
Research Design
Sample Size		 Methods Outcomes

Field-Fote & Roach 2011; USA
PEDro=8
RCT
Level 1
N=64

 Population: Patients with chronic SCI at least 1 year post-injury, mean ages between 38 and 45 of each group; TM group (14 males, 3 females), TS group (14 males, 4 females), OG group (11 males, 4 females), LR group (12 males, 2 females)
Treatment: Training 5 days/week for 12 weeks with: treadmill-based training with manual assistance (TM), treadmill-based training with stimulation (TS), overground training with stimulation (OG), or treadmill-based training with robotic assistance (LR)
Outcome Measures: Walking speed (over 10m), distance walked in 2 minutes, LEMS 
  1. There was a significant time effect of training on walking speed: walking speed significantly increased for the OG group (0.19(0.21) to 0.28(0.28) m/s; Effect Size=0.43), TS group (0.18(0.18) to 0.23(0.18) m/s; ER=0.28).
  2. There was a significant time effect of training on walking distance: walking distance significantly increased for the OG group (24.0(35.3) to 38.3(46.1) m; ES=0.40) and the TS group (20.6(23.1) to 24.4(24.3) m; ES=0.16), but not for the TM (22.1(21.4) to 23.0(21.1) m; ES=0.04) or the LR group (16.8(11.3) to 17.9(11.9); ES = 0.11).
  3. There was a significant time x group interaction, with the increase in the OG group’s walking distance being significantly greater than the TS, TM and LR groups.

Hitzig et al. 2013; Canada
PEDro=7
Parallel-group RCT
Level 1
N=34

 Population: 34 participants with SCI. For the FES group (n=17, 14M 3F); mean (SD) age= 56.6(14); DOI = 8.75 (9.7); 6 AIS C, 11 AIS D. For the control group (n=17, 12M 5F); mean (SD) age=54.1(16.5); DOI= 10.3 (11.1); 7 AIS C, 10 AIS D.
Treatment: Participants were randomized to intervention (FES) or control group. The FES group received FES stimulation while ambulating on a BWS treadmill. Control group exercise program consisted of 20-25 min of resistance and 20-25 min of aerobic training.
Outcome Measures: SCIM; SWLS; IADL; CHART, RNL.
  1. The FES group had a significant increase on SCIM mobility subscores (mean(SD)=17.27(7.2) to 21.33(7.6)) compared to the exercise group (mean(SD)=19.9(17.1) to 17.36(5.5)) from baseline to 1-yr follow-up.
  2. No significant between-group differences were detected for other outcomes.
  3. Both FES and control group reported positive gains in wellbeing from trial participation.
Effect Sizes: Forest plot of standardized mean differences (SMD ± 95%C.I.) as calculated from pre- to post-intervention data and pre-intervention to retention/follow-up data

Kressler et al. 2013; USA
PEDro=7
Single-blind RCT
Level 1
N=62

 Population: 62 participants with SCI; AIS C or D; injury at T10 or higher.
Treatment: Participants trained 5 days/wk for 12 wks. Groups were treadmill-based locomotor training with manual assistance (TM), transcutaneous electrical stimulation (TS), and a driven gait orthosis (DGO) and overground (OG) LT with electrical stimulation.
Outcome Measures: Oxygen uptake, walking velocity and economy, substrate utilization during subject-selected “slow”, “moderate” and “maximal” walking speeds.
  1. All groups increased velocity but to varying degrees: DGO=0.01(0.18) Ln[m/s]; TM=0.07(0.29) Ln[m/s]; TS=0.33(0.45) Ln[m/s]; OG=0.52(0.61) Ln[m/s]. Only the TS and OG groups had significant improvement over DGO (TS: p=.009, OG: p=.001). OG was also significantly higher than TM (p=.015).
  2. Changes in walking economy were only significant for TS (0.26(0.33) Ln[L/m], p=.014) and OG (0.44(0.62)Ln[L/m], p=.025).

Field-Fote et al. 2005; USA
PEDro=5
RCT
Level 2
N = 27

 Population: 27 males and females; age 21-64 yrs; all participants had an incomplete SCI; C3-T10 lesion level; >1 yr post-injury
Treatment: 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).
  1. Significant increases in short-bout walking speed across participants who received BWSTT + FES.
  2. Equivalent effects on long-bout gait speed between the 4 groups.
  3. Tendency for initially slower walkers (<0.1m/s) to show greater improvement (106%) compared to initially faster walkers (17%).

Postans et al. 2004; Scotland
PEDro=3
RCT w/crossover
Level 2
N initial=14
N final=10

 Population: 14 males and females; ages 19-57 yrs; all participants had an incomplete SCI; C4-T9 lesion level; mean 12.2±5.9 weeks post-injury
Treatment:  Crossover design: Intervention – Partial weight-bearing (PWB) supported treadmill gait training augmented by FES for up to 25 minutes a day, 5 days a week for 4 weeks; Control – 4-week period of standard physiotherapy. Patients were randomly assigned to either an AB (4 weeks control then 4 weeks intervention) or BA (4 weeks intervention then 4 weeks control) group.
Outcome Measures: Overground and treadmill walking endurance and speed.
  1. Between the intervention and control periods for the BA group, there was a significant difference in walking endurance (in metres; Mean: 60.10, CL: 9.2 to 110.9, P=.030) as well as for walking speed (in m/s; Mean: 0.22, CL: 0.05 to 0.37, P= .019)
  2. Between the intervention and control periods for the AB group, there was a significant difference in walking endurance (in metres; Mean: 72.20, CL: 39.8 to 104.6, P= .003) as well as for walking speed (in m/s; Mean: 0.23, CL: 0.13 to 0.33, P=.004).
Effect Sizes: Forest plot of standardized mean differences (SMD ± 95%C.I.) as calculated from pre- and post-intervention data

Triolo et al. 2012; USA
Longitudinal
Level 2
N=15

 Population: 15 participants with thoracic or low cervical level SCI (14M 1F); 10 AIS A, 4 AIS B, 1 AIS C; Mean (SD) DOI: 72.6(71.87) months.
Treatment: Participants received the 8-channel neuroprosthesis and completed rehabilitation with the device. This study follows the patients from discharge to follow-up ranging from 6-19 months after discharge (with exception of 1 participant at 56 months).
Outcome Measures: Neuroprosthesis usage, maximum standing time, body weight support, knee strength, knee fatigue index, body weight support, electrode stability, and component survivability.
  1. Levels of maximum standing time, BWS, knee strength, and knee fatigue index were not statistically different from discharge to follow-up.
  2. Neuroprosthesis usage was consistent with participants choosing to use the system on approximately half of the days during each monitoring period. Although the number of hours using the neuroprosthesis remained constant, participants shifted their usage to more functional standing versus more maintenance exercise, suggesting that the participants incorporated the neuroprosthesis into their lives.
  3. Safety and reliability of the system were demonstrated by electrode stability and a higher component stability rate (>90%).

Hesse et al. 2004; Germany
Pre-post
Level 4
N=4

 Population: 3 males; age 45-62 yrs; all participants had a diagnosis of AIS C or AIS D; C5-T8 lesion level; 8-18 months post-injury.
Treatment: Electromechanical gait trainer + FES to quadriceps and hamstrings: 20-25 min, 5x/wk, 5 wks.
Outcome measures: Gait velocity and endurance.
  1. Gait ability improved in all patients; 3 could walk independently over ground with aids. Overall gait speed and endurance more than doubled.
  2. Study made no reports of significance levels or testing of results.

Field-Fote & Tepavac 2002; USA
Pre-post
Level 4
N=14

 Population: 14 males and females; age 18-50 yrs; all participants had a diagnosis of AIS C; C4-T7 lesion level.
Treatment: BWSTT + common peroneal nerve FES: <90 min, 3x/wk, 12 wks.
Outcome measures: Over ground gait speed.
  1. All participants showed an increase in walking speed.
  2. Participants with slower walking speeds showed greater improvement.
  3. Study made no mention of significance levels or testing of results.

Field-Fote 2001; USA
Pre-post
Level 4
N=19

 Population: 19 males and females; mean age 31.7±9.4 yrs; all participants had a diagnosis of AIS C either paraplegia or tetraplegia.
Treatment: BWSTT + common peroneal nerve FES: <90 min, 3x/wk, 12 wks.
Outcome measures: Gait speed.
  1. Significant increase in walking speed (initial 0.12 ± 0.8m/s; final 0.21 ± 0.15m/s, p = .0008, median change of 77%).

Discussion

Findings from five studies, including three high-quality RCTs (Hitzig et al. 2013; Field-Fote & Roach 2011; Field-Fote et al. 2005) and three pretest/posttest (Hesse et al. 2004; Field-Fote & Tepavac 2002; Field-Fote 2001) studies, demonstrated favourable outcomes when BWSTT was combined with FES in people with chronic, incomplete SCI. There was an overall enhancement of short-distance functional ambulation, as measured by overground gait speed over 6 meters, and walking distance when BWSTT was combined with FES of the common peroneal nerve. Hesse et al. (2004) found that BWSTT combined with FES to the quadriceps and hamstrings muscles enhanced functional ambulation. Hitzig et al. (2013) studied the effects of FES stimulation while ambulating on a BWS treadmill, and found a significant increase on SCIM mobility scores from baseline to 1-year follow-up compared to the control group.

The Kressler et al. (2013) study provides evidence for increased benefit of electrical stimulation over manual assistance and braces (driven gait orthosis). In this study, the transcutaneous electrical stimulation group and the overground locomotor training with electrical stimulation group had significantly higher walking speeds while the treadmill-training with manual assistance group and driven gait orthosis group had nonsignificant improvements in walking speed.

Triolo et al. (2012) explored use of an 8-channel neuroprosthesis with rehabilitation training and found that there were no statistically significant differences in walking outcomes. However, the safety and reliability of the neuroprosthesis system were supported.

Conclusion

There is level 1b evidence (Field-Fote & Roach 2011; Field-Fote et al. 2005; Field-Fote & Tepavac 2002; Field-Fote 2001) for an overall enhancement of short-distance functional ambulation, as measured by overground gait speed over 6 meters, and walking distance when BWSTT was combined with FES of the common peroneal nerve.

There is level 1b evidence (Kressler et al. 2013) for increased benefit of electrical stimulation over manual assistance and braces (driven gait orthosis).

There is level 1b evidence (Hitzig et al. 2013) for a significant increase in SCIM mobility scores when participants are stimulated with FES while ambulating on a BWS treadmill.

There is level 4 evidence from one pretest/posttest study (Hesse et al. 2004) suggesting that BWSTT combined with FES to the quadriceps and hamstrings muscles enhances functional ambulation.

There is level 4 evidence from one case series study (Triolo et al. 2012) that an 8-channel neuroprosthesis system is safe and reliable, but its use with rehabilitation training shows no statistically significant difference in walking outcomes.

BWSTT combined with FES of the common peroneal nerve can lead to an overall enhancement of short-distance functional ambulation.

Electrical stimulation is shown to be a more effective form of locomotor training than manual assistance and braces.

Stimulation with FES while ambulating on a BWS treadmill can increase SCIM mobility scores.

BWSTT combined with FES to the quadriceps and hamstrings muscles can enhance functional ambulation.

An 8-channel neuroprosthesis system is safe and reliable, but its use with rehabilitation training has shown no statistically significant difference in walking outcomes.

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