|Author Year; Country|
Alcobendas-Maestro et al. 2012;
Randomized single-blind parallel-group clinical trial
|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|
|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
|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
|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|
|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
Prospective longitudinal study
|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|
|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|
(subacute and chronic)
|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