BWSTT in Acute/Sub-Acute SCI
Author Year; Country Score Research Design Sample Size |
Methods | Outcomes |
Alcobendas-Maestro et al. 2012; Spain |
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. |
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Dobkin et al. 2006; USA |
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 |
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Esclarin-Ruz et al. 2014; Spain |
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. |
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Effect Sizes: Forest plot of standardized mean differences (SMD ± 95%C.I.) as calculated from pre- and post-intervention data![]() |
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Dobkin et al. 2007; USA and Canada |
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. |
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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![]() |
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Hornby et al. 2005a; USA |
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 |
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Benito-Penalva et al. 2012; Spain |
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). |
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Wernig et al. 1995; Germany |
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. |
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Harkema et al. 2012; USA |
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 |
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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.
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.