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Table 8: Studies Using BWSTT in Acute/Subacute in SCI (<12 Months Post-Injury)

Author Year; Country
Score
Research Design
Sample Size
MethodsOutcomes
 

Alcobendas-Maestro et al. 2012;

Spain

PEDro=8

Randomized single-blind parallel-group clinical trial

Level 1

N=75

 

Population: 75 participants with SCI in total; all <6 months post-injury. For the Lokomat group (N=37), mean (SD) age = 45.2 (15.5); 62%M, 38%F; 68% AIS C, 32% AIS D. For the conventional treatment group (N=38); mean (SD) age= 49.5 (12.8); 63%M, 37%F; 71% AIS C, 29% AIS D.

 

Treatment: Randomized to 2 groups: Lokomat and conventional treatment.

 

Outcome Measures: 10MWT; WISCI II; 6MWT; walking and stairs tasks of the FIM-L section; LEMS subscale; Ashworth Scale and Visual Analogue Scale for pain.

1.     The Lokomat treatment group showed statistically significant differences in favour of Lokomat treatment over conventional treatment in the following outcome measures:
WISCI II: Lokomat [16 (8.5-19)], Conventional [9 (8-16)]
6-minute walk test (m): Lokomat [169.4 (69.8-228.1)], Conventional [91.3 (51.4-178.7)]
LEMS lower limb strength: Lokomat [40 (35-45.5)], Conventional [35 (29.7-40)]
FIM-L: Lokomat [10 (6-12)], Conventional [7 (5-10)]2.     There were no differences between the Lokomat and conventional treatment group in the variables: speed (10MWT), spasticity (Ashworth scale), and pain (Visual Analogue Scale).
Dobkin et al. 2006

USA

PEDro=7

RCT

Level 1

N=292 (enrolled)
N=117 (analyzed)

Population: 117 males and females; age 16-69 yrs; AIS B-D; <8 wks post-injury.

 

Treatment: BWSTT vs. overground mobility training: 5x/wk, 9-12 wks, 30-45 min/session.

 

Outcome measures: FIM-L, walking speed, 6MWT, WISCI at 3 and 6 months

1.      No difference in FIM Locomotor Scale (AIS B & C) or walking speed (AIS C & D) between groups.

2.      AIS C & D participants in both groups improved walking function. No improvement of functional ambulation in the AIS B participants with either intervention.

 

 

 

 

 

Esclarin-Ruz et al. 2014

Spain

RCT

Level 1

PEDro=7

N= 88

Population: 88 individuals; 44 with upper motor neuron SCI and 44 with lower motor neuron SCI; 59 AIS C and 25 AIS D; mean age= 43.6 ± 12; days post injury= 125.6 ± 65.2

 

Treatment: Condition 1: Subgroups A1 and B1 were treated with robotic Locomotor training plus Over ground Therapy (LKOGT) for 60 minutes. Condition 2: Subgroups A2 and B2 received 60 minutes of conventional OGT 5 days per week for 8 weeks. Participants with UMN and LMN were randomized into 2 training groups

 

Outcome Measures: Ten-meter walk test and 6-minute walk test (6MWT). Walking Index for Spinal Cord Injury II, lower extremity motor score (LEMS), and the FIM-Locomotor were secondary outcome measures.

1.     By using the LKOGT program compared with OGT, we found significant differences in the 6MWT for groups A1 and B1.

2.     LKOGT also provided higher scores than did OGT in secondary outcomes such as the LEMS and the FIM-Locomotor.

 

 

 

 

 

 

 

 

 

 

 

 

Effect Sizes: Forest plot of standardized mean differences (SMD ± 95%C.I.) as calculated from pre- and post-intervention data

 

Dobkin et al. 2007

USA and Canada

PEDro=5

RCT

Level 2

N=112

 

Population: 112 males and females; 29 participants with diagnosis of AIS B, 83 participants with diagnosis of AIS C-D; age 16-70 yrs; mean 4.5 wks post-injury

 

Treatment: BWSTT vs. overground mobility training (control): 5x/wk, 9-12 wks, 30-45 min/session.

 

Outcome measures: FIM-L (range from 1 (total physical dependence) to 7 (independence to walk > 150 feet)), walking speed, 6MWT, LEMS.

1.      At 12 weeks, no differences were found between patients who received BWSTT versus control for FIM-L, walking speed, LEMS, or distance walked in 6 minutes.

2.      Combining both interventions, a FIM-L ≥ 4 was achieved in < 10% of AIS B patients, 92% of AIS C patients, and all of AIS D patients; few AIS B and most AIS C and D patients achieved functional walking ability by the end of 12 weeks of BWSTT and control.

3.      Time after injury is an important variable for planning interventions to lessen walking disability.  Patients who started their rehabilitation sooner (<4 weeks after onset) had better outcomes. This does not imply that an earlier start of rehabilitation for walking led to better outcomes. Rather, entry within 4 weeks allowed some patients to start at a lower level of function.

4.      By 6 weeks after entry, most patients who will recover have improved their FIM-L to >3 and are improving in walking speed.

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

Hornby et al. 2005a

USA

PEDro=5

RCT

Level 2

N=30

Population: 30 SCI patients (ASIA classification of B, C, or D)

Inclusion Criteria: traumatic or ischemic SCI above the T10 spinal cord level experienced between 14 and 180 days prior to study enrollment, partial preservation of voluntary motor control in at least one muscle of the lower extremities

 

Treatment: randomly assigned to one of three 8-week training regimens: Robotic-assisted BWSTT, therapist-assisted BWSTT, and overground ambulation with a mobile suspension system

 

Outcome Measures: LEMS, WISCI II, FIM

 

1.     Mean changes in all groups improved significantly during the training regimen, with significant changes in FIM locomotor subscores, WISCI scores, and LEMS.

2.     Significant difference in the total distance ambulated over ground: mean (SD) distance walked 1282 (606) m vs. both robotic-assisted (2859 (111) m) and therapist-assisted (2759 (215) m) BWSTT groups

3.     The number of therapists required to provide gait training on the treadmill or over ground was significantly greater than that required for the robotic-assisted group for the first 5 weeks of training

4.     There were no significant differences noted between therapist- and robotic-assisted BWSTT groups for the final 3 weeks of training

 

 

Benito-Penalva et al. 2012

Spain

Prospective longitudinal study

Level 2

N=105

Population: 105 participants with SCI. 39 randomized to Lokomat treatment and 66 to Gait Trainer GT I treatment. Mean age for both groups = 45 yrs.

For the Lokomat group, 26M 13F and 5 AIS A&B, 18 AIS C, 16 AIS D. For the Gait Trainer GT I group, 45M 21F, and 6 AIS A&B, 26 AIS C, 34 AIS D.

Majority of participants were <1 year post-injury.

 

Treatment: Patients received locomotor training with one of the electromechanical devices [Lokomat or Gait Trainer GT I System], 5 days/wk for 8 wks.

 

Outcome Measures: LEMS, WISCI, 10MWT. Outcomes collected at baseline, midpoint (4wks) and end of program (8 wks).

1.     For the total sample, all 3 clinical outcomes showed statistically significant improvement after the use of electromechanical systems:
LEMS: pre= 22.07(1.08), post=30.56(1.15)
WISCI: pre=3.97(0.49), post=9.16(0.68)
10MWT: pre=0.082(0.01), post=0.26(0.03)2.     Rate of clinical change across the training period was not significantly different between the 2 treatment groups for any of the 3 outcomes.3.     Compared to conventional standard of care from the EM-SCI database, for the LEMS, both ASIA grade C and D patients receiving electromechanical device system gait training had a significantly greater rate of change in motor function when compared to matched patients from EM-SCI group.
Wernig et al. 1995 Germany

Case Control

Level 3
N=97

Population:  Study 1: 12 males and females; 0-4.5 months post injury. Study 2: 85 males and females; 2-30 wks post-injury.

 

Treatment: Study 1) BWSTT: 30-60 min, 5x/wk, 3-20 wks (median 10.5 wks). Study 2) 45 participants underwent 2-22 wks of BWSTT vs. 40 participants (historical controls) underwent conventional rehabilitation.

 

Outcome measures: Wernig Scale of Ambulatory Capacity.

1.     Study 1: 9/12 initially wheelchair-bound could walk without assistance after BWSTT.

2.     Study 2: 33/36 initially non-ambulatory participants could walk after BWSTT.

3.     7/9 initially ambulatory participants improved walking distance after BWSTT.

4.     12/24 initially non-ambulatory participants improved to functional ambulation after conventional rehabilitation.

5.     Results from the remaining 16 participants (who were initially ambulatory) in historical control group not reported.

Harkema et al. 2012

USA

Pre-post

(subacute and chronic)

Level 4

N=196

Population: 196 individuals (148 male, 48 female) with incomplete SCI; mean age 41±15 yrs; YPI- <1 yrs (n=101), 1-3 yrs (n=43), >3 yrs (n=52)

 

Treatment: Locomotor training with three components: (1) 1 hour of step training in the body-weight support on a treadmill environment, followed by 30 minutes of (2) overground assessment and (3) community integration

 

Outcome Measures: BBS, 6MWT, and 10MWT

 

 

 

 

1.       Scores on the Berg Balance Scale significantly improved by an average of 9.6 points

2.       Six-Minute Walk Test distances and 10-Meter Walk Test speeds of all patients significantly improved by an average of 63m and 0.20m/s, respectively

3.       168 (86%) patients (66 of 66 AIS grade C, 102 of 130 AIS grade D) scored lower than 45, the reported threshold for risk for falls for the Berg Balance Scale

-Patients with AIS grade C SCI had significantly lower scores at enrollment than those with AIS grade D classification

– Patients with AIS grade D SCI walked significantly farther than those with AIS grade C SCI

Discussion

Seven studies (summarized in Table 8) have examined the effect of therapist-assisted (Dobkin et al., 2007; Dobkin et al., 2006; Wernig et al., 1995; Hornby et al., 2005a; Harkema et al., 2012; Alcobendas-Maestro et al., 2012; Benito-Penalva et al., 2012) BWSTT in people who had incurred an incomplete SCI <12 months prior (acute/subacute phase) (aggregate N=566). One study also examined overground training and robotic–assisted treadmill training (Hornby et al. 2005a). Treatment time ranged from 90-300 minutes per week and total treatment duration lasted between 3 and 23 weeks.

[su_spoiler title=”Effect Size Forest Plots of RCTs with Available Data” style=”fancy”][su_row]Click on the image to enlarge[/su_row]
[su_lightbox type=”image” src=”/wp-content/uploads/Forest_LLimb_Dobkin_2007.gif”][image_with_animation image_url=”/wp-content/uploads/Forest_LLimb_Dobkin_2007.gif” alt=”Effect size SMD forest plot for Dobkin et al. 2007, body weight supported treadmill training (BWSTT)”][/su_lightbox]
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Although lower levels of study design (non-randomized, non-blinded) suggest that BWSTT in acute/sub-acute SCI yields better outcomes than conventional rehabilitation (Wernig et al., 1995), there exists strong evidence from a single-blind RCT (Dobkin et al., 2006) (n=117) that there are no differences in effects between matched amounts of BWSTT and overground mobility practice in incomplete SCI during inpatient rehabilitation for the locomotor score of the FIM or overground walking speed. These two variables in both groups improved roughly in parallel over the 12 weeks of therapy (Dobkin et al., 2007). In both groups, improvements in walking function were particularly notable in participants with AIS C (92%) or D (100%). Indeed, as reported by Dobkin et al (2006), the initial AIS classification of participants is an important indicator of locomotor recovery. Among the participants who were initially classified as AIS B, those who improved to AIS C within 8 weeks post-injury showed improved walking function while those who remained as AIS B did not (Dobkin et al., 2006). In addition, participants who entered the trial earlier (< 4 weeks post-injury) had faster walking speeds and endurance post-training. This was particularly the case for participants who improved in their AIS classification within 4 to 6 weeks post-injury. Preliminary analysis from a smaller RCT (Hornby et al. 2005) (n = 30) had similar results, showing that there were no differences in motor (lower extremity motor scores) or functional recovery (FIM locomotor subscore or WISCI II score) between those that trained overground, with BWSTT, or with robotic assisted treadmill training. All increases from initial to final evaluations were significant. However, the results from a more recent randomized single-blind parallel-group clinical trial from Alcobendas-Maestro et al. (2012) (N=75) suggested that Lokomat-assisted BWSTT may result in better improvements in the WISCI II, 6MWT, LEMS, and FIM-L scores compared to conventional treatment. However, it is unclear whether the conventional treatment group received an equivalent amount of task-specific locomotor practice, so differences in the intensity and/or specificity of training could account for these contrasting results.

 

Wernig et al. (1995) showed that 86% (49/57) of incomplete SCI participants who underwent BWSTT in the acute phase of injury achieved improvements in functional ambulation. They reported that only 50% of the initially non-ambulatory participants (historical controls) who underwent conventional rehabilitation improved functional ambulation. The results of the remaining 16 historical control participants who were initially ambulatory were not explicitly reported, although it appears from the article’s bar graphs that they also improved in functional class. Thus, it is possible that the proportion of participants who improved functional ambulation after Wernig’s conventional rehabilitation may actually have been closer to 70% ([16+12]/40).

 

A contentious issue in field of gait training has been the appropriateness of the control intervention (Wolpaw, 2006). The ‘conventional’ rehabilitation to which BWSTT was compared was not well defined in Wernig’s studies, although it appeared to focus on wheelchair mobility in addition to gait training in parallel bars and using braces (Wernig, 2006a). The control group in the large RCT (Dobkin et al., 2006) underwent task-oriented overground gait retraining of equivalent intensity to the BWSTT group and therefore may not have offered enough of a contrast in treatment modality to detect significant differences. Moreover, based on retrospective analysis from the participating centres, it appeared that significantly enhanced locomotor outcomes were achieved with both treatment and control conditions as compared to what was achieved with “standard practice” in the centres prior to the study – although it is likely that pre-study practice of gait therapy varied to some degree across the study centres. On the other hand, the more recent RCT Alcobendas-Maestro et al. (2012) did not clearly state whether the conventional training group received an equivalent amount of overground therapy for walking compared to the Lokomat training group. Despite these difficulties, the important message from this work is that intensive task-oriented gait retraining, whether implemented by BWSTT or overground practice, facilitates the recovery of functional ambulation especially <12 months post-injury. However, there is no strong evidence that one rehabilitation approach is superior to another.

Conclusion

There is level 2 (Alcobendas-Maestro et al., 2012) and level 3 evidence (Wernig et al., 1995) using historical controls that BWSTT is effective in improving ambulatory function. However, two level 2 RCTs (Dobkin et al., 2006; Hornby et al. 2005a) demonstrates that BWSTT has equivalent effects to conventional rehabilitation consisting of an equivalent amount of overground mobility practice for gait outcomes in acute/sub-acute SCI.

  • For patients less than 12 months post-SCI, BWSTT may have similar effects on gait outcomes as overground mobility training of similar intensity