BWSTT in Chronic SCI
Author Year; Country Score Research Design Sample Size |
Methods | Outcome | |
Labruyere et al. 2014; Switzerland |
Population: 9 individuals- 5 males and 4 females; SCI ranging from C4 to T11; mean age= 59 ± 11y; months post injury= 50 ± 56m. Treatment: Participants with a chronic iSCI were randomized to groups 1 or 2. Group 1 received 16 sessions of RAGT (45 min each) within 4 weeks followed by 16 sessions of strength training (45 min each) within 4 weeks. Group 2 received the same interventions in reversed order. Data were collected at baseline, between interventions after 4 weeks, directly after the interventions, and at follow-up 6 months after the interventions. Pain was assessed repeatedly throughout the study. Outcome Measures: 10 MWT at preferred and maximal speed, walking speed under different conditions, balance, strength, 2 questionnaires that evaluate risk of falling and pain. |
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Nooijen et al. 2009; USA |
Population: All participants had motor-incomplete spinal cord injuries and were at least 1-year post injury; Group 1: mean age = 38.15; T11-C3; Group 2: mean age = 39.47; T9-C4; Group 3: mean age = 41.64; T6-C4; Group 4: mean age = 44.33; L2-C6. Treatment: 12-week training period. All BWSTT: Group 1 = treadmill with manual assistance; Group 2 = treadmill with peroneal nerve stimulation; Group 3 = overground with peroneal nerve simulation; Group 4 = treadmill with assistance from Lokomat. Outcome Measures: Cadence, step length, stride length, symmetry index, intralimb coordination, timing of knee extension onset within the hip cycle; all compared to non-disabled controls. |
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Musselman et al. 2009; Canada |
Population: 2 male and 2 female participants, age 24-61, level of injury C5-L1, all AIS-C. Treatment: All participants received 3 months of BWSTT, then participants underwent 3 months of BWSTT and 3 months of skill training in random order. Outcome Measures: mEFAP; 10MWT; 6MWT; BBS; ABC. |
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Field-Fote et al. 2005; USA |
Population: 27 males and females; age 21-64 yrs; with incomplete SCI; C3-T10 lesion level; >1 yr post-injury. Treatment: Randomized to 4 gait training strategies, 45-50 min, 5X/week, 12 weeks: 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). |
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Lucareli et al. 2011; Brazil
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Population: 14 males and 10 females with incomplete SCI; mean age 31.5; mean YPI 9.8. Treatment: Group A – treadmill gait training with body weight support + conventional physiotherapy; Group B – conventional physiotherapy; both groups underwent 30 semi-weekly sessions lasting 30 min each. Outcome Measures: Spatial temporal gait variables and angular gait variables. |
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Effect Sizes: Forest plot of standardized mean differences (SMD ± 95%C.I.) as calculated from pre- and post-intervention data. | |||
Yang et al. 2014; Canada |
Population: 22 participants; 16 males and 6 females; Level of injury between C2 and T12; mean age= 48 ± 13y; years post injury= 5.7 ± 10.5y. Treatment: Twenty-two participants, ≥7 months post injury, were randomly allocated to start with Precision or Endurance Training. Each phase of training was 5 times per week for 2 months, followed by a 2-month rest. Outcome Measures: Walking speed- 10 MWT, distance- 6 MWT, skill, confidence- Activities specific balance confidence scale, depression- Centre for Epidemiologic Studies- Depression Scale (before training and monthly afterwards), WISCI-II, SCI-FAP. |
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Gorman et al. 2016; USA |
Population: 18 individuals chronic motor incomplete spinal cord injury between C4 and L2; >1 y post-injury. Treatment: Participants were randomized to Robotic-Assisted Body-Weight Supported Treadmill Training (RABWSTT) or a home stretching program (HSP) 3 times per week for 3 months. Those in the home stretching group were crossed over to three months of RABWSTT following completion of the initial three-month phase. Outcome Measures: Peak VO2 was measured during both robotic treadmill walking and arm cycle ergometry: twice at baseline, once at six weeks (mid-training) and twice at three months (post-training). Peak VO2 values were normalized for body mass. |
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Effect Sizes: Forest plot of standardized mean differences (SMD ± 95%C.I.) as calculated from pre- and post-intervention data. | |||
Lam et al. 2014; Canada
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Population: 15 individuals- 9 males and 6 females; chronic motor incomplete SCI; 5 AIS C and 10 AIS D; age range= 26-63y; years post injury> 1y; Treatment: Participants were randomly allocated to BWSTT with Lokomat resistance (Loko-R group) or conventional Lokomat-assisted BWSTT (controls). Training sessions were 45 minutes, 3 times/wk for 3 months. Outcome Measures: Skilled walking capacity (SCI-FAP), 10 MWT, 6 MWT. Timed Up and Go Test (TUG). All outcome measures were measured at baseline, post=training, and 1 and 6 months follow up. |
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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 | |||
Niu et al. 2014; USA |
Population: 40 individuals- 27 males and 13 females; spastic hypertonia in lower extremities Treatment: Each participant was assigned either to the control or intervention (Lokomat training) group according to a permuted block randomization design. All participants were injured within their cervical or upper thoracic (superior to T10) vertebrae. Each participant received a one-hour training session three times per week for four consecutive weeks; as it took 15-20 mins to set up the participant, the gait training lasted up to 45 mins per session. Outcome Measures: 10 MWT, 6MWT, Time up and Go (TUG), isometric torque resulting from MVC, Modified Ashworth Score (MAS), EMG, Walking Index for Spinal Cord Injury (WISCI II) |
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Gorassini et al. 2009; Canada Prospective Controlled Trial Level 2 N=23 |
Population: 17 participants with incomplete SCI, mean (SD) age 43.8(16.5), injury level C3-L1, and 6 AB controls. Participants were divided into 2 groups: those who improved in walking ability (responders, n=9, 4 AIS-C, 5 AIS-D) and those who did not (nonresponders, n=8, 7 AIS-C, 1 AIS-C). Treatment: BWSTT, on average for mean (SD) 3.3(1.3) days/week for 14(6) weeks. Outcome Measures: EMG; WISCI II. |
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Wu et al. 2012; USA |
Population: 10 participants with chronic SCI (8M 2F); mean (SD) age: 47(7); mean (SD) DOI: 5.8(3.8) yrs; level of injury: C2-T10. Treatment: Group 1: BWSTT with 4 wks assistance training, then 4 weeks resistance training. Group 2: BWSTT with 4 wks resistance training, then 4 wks assistance training. Resistance provided by a cable-driven robotic locomotor training system. Sessions were 45 minutes, 3x/wk x 8 weeks. Outcome Measures: Primary: self-selected and fast walking speed, 6MWT, BBS. Secondary: muscle strength tests, WISCI II, Physical SF-36, Activities-specific Balance Confidence Scale. |
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Behrman et al. 2012; USA Prospective Cohort Level 2 N=95 |
Population: 95 participants with SCI (75M, 20F); <1 yr (n=47), 1-3 yrs (n=24), ³3 yrs (n=24) since injury; level of injury: T11 or above; Mean (SD) age: 43(17); median time since injury: 1 year; 31 AIS C, 64 AIS D. Treatment: At least 20 sessions of the NRN Locomotor Training Program consisting of manual-facilitated BWS standing and stepping on a treadmill and overground. Training consisted of 1hr of treadmill training, 30 minutes overground assessment, and 15-30 minutes of community reintegration. Frequency: 5 days/wk for non-ambulators, 4 days/wk for ambulators with pronounced assistance, 3 days/wk for independent walkers. Patients split into phases 1-3 depending on level of ability (higher ability = higher phase). Outcome Measures: ISNSCI AIS, BBS, 6MWT, 10MWT. |
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Buehner et al. 2012; USA |
Population: 225 participants with chronic incomplete SCI (167M, 58F); mean (SD) age=42.5 (15.9); Median DOI=2.45; 57 AIS C, 167 AIS D. Treatment: NRN Locomotor Training Program. Training consisted of 1hr of treadmill training, 30 minutes overground assessment, and 15-30 minutes of community reintegration. Frequency: 5 days/wk for non-ambulators, 4 days/wk for ambulators with pronounced assistance, 3 days/wk for independent walkers. Outcome Measures: LEMS, pinprick, light touch, 10MWT, 6MWT, BBS. |
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Lorenz et al. 2012; USA |
Population: 337 participants with SCI (255M, 82F); mean (SD) age: 40 (17); 99 AIS C, 238 AIS D. Treatment: At least 20 sessions of the NRN Locomotor Training Program. Training consisted of 1hr of treadmill training, 30 minutes overground assessment, and 15-30 minutes of community reintegration. Frequency: 5 days/wk for non-ambulators, 4 days/wk for ambulators with pronounced assistance, 3 days/wk for independent walkers. Outcome Measures: BBS; 6MWT; 10MWT. |
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Wernig et al. 1995; Germany |
Population: Study 1: 44 participants with chronic paraplegia or tetraplegia. Study 2: 53 participants with chronic paraplegia or tetraplegia. Treatment: Study 1: BWSTT: 30-60 min, 5x/wk, 3-20 wks (median 10.5 wks). Study 2: 29 participants underwent BWSTT (as in Study 1) versus 24 historical controls that underwent conventional rehabilitation. Outcome measures: Wernig Walking Capacity Scale. |
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Benito Penalva et al. 2010; Spain |
Population: 29 motor incomplete SCI patients (24 males, 5 females, mean age 47; Group A < 3 months post-injury (n=16), Group B > 3 months post-injury (n = 13) and 13 healthy volunteers (10 males, 3 females, mean age 32) with pre-test only Treatment: Gait training using either the Lokomat or Gait Trainer GT1 (based on availability of the system), 20-45 minutes per sessions (5 days a week for 8 weeks). Outcome Measures: LEMS, WISCI II, 10MWT, H reflex modulation by TMS. |
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Fleerkotte et al. 2014; Netherlands |
Population: 10 individuals- 4 males and 6 females; motor incomplete chronic SCI; 1 AIS B, 5 AIS C, 4 AIS D; mean age= 48.75 ± 11.3y; months post injury= 46.75 ± 41.03 Treatment: Participants participated in an eight-week training program. Participants trained three times per week, for a maximum of 60 minutes per session. The training period was divided in two four-week periods, with one week scheduled for clinical tests in between. During training sessions, rest intervals were introduced if required by the participant or suggested by the therapist. The first training session was used to 1) fit the LOPES to the participant, 2) let participants get used to walking in the device and 3) select their preferred walking speed. Outcome Measures: 10-meter walking test (10MWT), the Walking Index for Spinal Cord Injury (WISCI II), the six-meter walking test (6MWT), the Timed Up and Go test (TUG), Lower Extremity Motor Scores (LEMS), spatiotemporal, kinematics measures. |
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Stevens et al. 2015; USA |
Population: 7 males and 5 females; average age 47.7y; >1y post injury; AIS C and D Treatment: Participants completed 8 weeks (3 × /week) of UTT. Each training session consisted of three walks performed at a personalized speed, with adequate rest between walks. Body weight support remained constant for each participant and ranged from 29 to 47% of land body weight. Increases in walking speed and duration were staggered and imposed in a gradual and systematic fashion. Outcome Measures: Lower-extremity strength (LS), balance (BL), preferred and rapid walking speeds (PWS and RWS), 6-minute walk distance (6MWD), and daily step activity (DSA). |
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Aach et al. 2014; Germany |
Population: 6 males and 2 females; mean age 48 ± 9.43 years; years post injury= 97.2 ± 88.4 months; chronic stage of traumatic SCI; incomplete and complete SCI AIS A-D. Treatment: The participants underwent a BWSTT five times per week using the HAL exoskeleton. Outcome Measures: Walking distance, speed, time, 10m walk test (10MWT), timed-up and go test (TUG test), 6-minute walk test (6MWT), the walking index for SCI II (WISCI II), AIS with the lower extremity motor score (LEMS), spinal spasticity (Ashworth scale), and the lower extremity circumferences. |
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Yen et al. 2013; USA |
Population: 12 participants; traumatic motor incomplete SCI; ASIA D; injuries ranging from C1-T7; mean age= 48 years; years post injury= 5 years. Treatment: Each person participated in one data collection session, about 2.5h long. We recorded each participant’s maximum voluntary isometric contraction (MVC). A robotic system provided resistance during the swing phase of gait. The data collection session consisted of three resistance load conditions: light, medium, and heavy. Outcome Measures: MVC, EMG, stride length, swing time (with and without robotic system) |
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Sczesny-Kaiser et al. 2015; Germany |
Population: 11 individuals- 7 males and 4 females; traumatic SCI with incomplete or complete paraplegia; mean age= 46.9 ± 2.7y; years post injury= 8.8 ± 2.1y. Treatment: Eleven SCI patients took part in HAL® assisted BWSTT for 3 months. Each patient was scheduled for a 30min training session 5 times a week for 12weeks, as previously described by our group. Paired-pulse somatosensory evoked potentials (PpSEP) were conducted before and after this training period, where the amplitude ratios (SEP amplitude following double pulses – SEP amplitude following single pulses) were assessed and compared to eleven healthy control participants. Outcome Measures: 10 MWT, 6 MWT Timed up and Go Test (TUG), Lower Extremity Motor Score (LEMS). |
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Varoqui et al. 2014; USA |
Population: 30 individuals; ambulatory chronic incomplete SCI; mean age= 50.80 ± 2.12y; years post injury= 11.80 ± 2.54y Treatment: 15 iSCI participants performed twelve 1-hour sessions of Lokomat training over the course of a month. The voluntary movement was qualified by measuring active range of motion, maximal velocity peak and trajectory smoothness for the spastic ankle during a movement from full plantar-flexion (PF) to full dorsi-flexion (DF) at the patient’s maximum speed. Dorsi- and plantar-flexor muscle strength was quantified by isometric maximal voluntary contraction (MVC). Clinical assessments were also performed using the Timed Up and Go (TUG), the 10-meter walk (10MWT) and the 6-minute walk (6MWT) tests. All evaluations were performed both before and after the training and were compared to a control group of fifteen iSCI patients. Outcome Measures: Active range of motion, maximal velocity peak and trajectory smoothness from full plantar-flexion to full dorsi-flexion at patient’s maximum speed, maximal voluntary contraction (MVC), Timed up and Go (TUG), 10 MWT, 6 MWT, Modified Ashworth Scale (MAS) |
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Knikou 2013; USA |
Population: 14 participants with chronic SCI (10M 4F); 21-55 yrs old; 0.5-11 yrs post-injury; 1 AIS A, 1 AIS B, 4 AIS C, 8 AIS D. Treatment: All participants received BWS robot-assisted step training with a robotic exoskeleton system (Lokomat). Each participant was trained 1h/day, 5 days/wk. Outcome Measures: WISCI II; 6MWT; number of sit-to-stand repetitions completed within 30s; TUG; EMG measurements. |
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Harkema et al. 2012; USA |
Population: 96 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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Yang et al. 2011; Canada |
Population: 14 males, 5 females; mean age 44±13; >7 months post-injury (mean 5.8±8.9 years); AIS C or D Treatment: 1 hour/day, 5 days/week of BWSTT until parameters did not progress for 2 weeks (minimum 10 weeks total, mean=18 weeks). Outcome Measures: 10MWT, WISCI-II, LEMMT, BBS, EMG measurements (tibialis anterior, soleus, quadriceps, hamstrings), movement at the knee and ankles |
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Stevens, 2010; USA Pre-post (Dissertation) Level 4 N=11 |
Population: 11 participants with incomplete SCI (7M 4F); 23-64 yrs old; 1-28 years post-injury; 9 AIS C, 2 AIS D; all able to walk at least 10 meters with or without an assistive device. Treatment: People participated in an underwater treadmill training exercise program for 8 weeks. Week 1 consisted of 3 5-minute walks, with scheduled increases in walking speed (10% increase biweekly) and duration (up to 8 minute walks) over the following weeks. Each participant completed 24 training sessions in 8 weeks. Outcome Measures: lower limb strength (dynamometry); BBS; WISCI II; 10MWT; 6MWT; daily step activity. |
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Winchester et al. 2009; USA |
Population: Mean (SD) age = 38.3(13.6); 22 male; 23 participants with tetraplegia, 7 with paraplegia; mean (SD) time since injury = 16.3(14.8) months. Treatment: Locomotor training, including: robotic assisted BWSTT, manually assisted BWSTT, and over ground walking. 3 times per week for 3 months. Outcome Measures: WISCI II and 10MWT. |
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Effing et al. 2006; Netherlands |
Population: 3 males; age 45-51 yrs; participant diagnosis were AIS C and D; C5-C7 lesion level; 29-198 months post-injury. Treatment: BWSTT: 30 min, 5x/wk,12 wks. Outcome measures: Wernig Walking Capacity Scale, gait speed over 7m. |
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Hicks et al. 2005; Canada |
Population: 14 males and females; age 20-53 yrs; 2 participants with diagnosis of AIS B and 12 participants with diagnosis of AIS C; C4-L1 lesion level; 1.2-24 yrs post-injury. Treatment: BWSTT: <45 min, 3x/wk, 144 sessions (12 months). Outcome measures: Wernig Walking Capacity Scale. |
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Thomas and Gorassini 2005; Canada |
Population: Age 29-78 yrs; 4 participants with diagnosis of AIS C and 2 participants with diagnosis of AIS D; C5-L1 lesion level; 2-28 yrs post-injury. Treatment: BWSTT: < 60 min, 3-5X/week, 10-23 weeks. Outcome measures: 10MWT, 6MWT, WISCI II. |
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Wirz et al. 2005; Switzerland |
Population: Age range =16-64 yrs; 9 participants with diagnosis of AIS C and 11 participants with diagnosis of AIS D; C3-L1 lesion level; 2-17 yrs post-injury Treatment: BWSTT: <45 min, 3-5x/wk, 8 wks. Outcome measures: WISCI II, 10MWT, 6MWT. |
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Protas et al. 2001; USA |
Population: 3 males; age 34-48 yrs; Participant diagnosis was AIS C and D; T8-T12 lesion level; 2-13 yrs post-injury Treatment: BWSTT: 20 min, 5x/wk, for 12 wks. Outcome measures: Garrett Scale of Walking, Assistive Device Usage Scale, Orthotic Device Usage Scale, gait speed (5m), gait endurance (5 minutes). |
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Wernig et al. 1998; Germany |
Population: 35 males and females; age 19-70 yrs; C4-T12 lesion level; 1-15 yrs post-injury. Treatment: BWSTT: 30-60 minutes, 5x/wk, 8-20 wks. Outcome measures: Wernig Walking Capacity Scale. |
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Discussion
As shown in Table 9, there have been 19 pre-post studies, 9 RCT (Musselman et al. 2009; Nooijen et al. 2009; Field-Fote et al. 2005; Field-Fote & Roach 2011; Lucareli et al. 2011; Gorman et al. 2016; Lam et al. 2014; Labruyere et al. 2014) 5 prospective Controlled Trial (Gorassini et al. 2008) and 2 case-control studies (Wernig et al. 1995; Benito Penalva et al. 2010) that altogether studied 812 persons with complete and incomplete SCI, with chronicity ranging from 1 to 28 years post-injury (although years of chronicity was not specified in Field-Fote et al. 2011 study). Treatment intensity ranged from 45 to 300 minutes per week, and treatment duration lasted between 3 and 48 weeks. Based on the stated primary outcome measure of each study where data was available, about 70% of all participants across these studies showed some improvement following treatment (Musselman et al. 2009; Gorassini et al. 2009; Hicks et al. 2005; Yang et al. 2011; Winchester et al. 2009; Protas et al. 2001; Thomas & Gorassini et al. 2005; Effing et al. 2006; Wernig et al. 1995). In the Harkema et al. 2012 study, 88% of patients had responded to locomotor training treatment, but this study included participants that had been injured less than one year.
All studies generally show improvements in overground walking capacity, whether locomotor training was provided with a treadmill or performed over ground, body-weight support, or involved other variations on walk-based therapies (e.g. over ground training with obstacles, robot-applied resistance. Alternative gait retraining therapies or modified approaches to BWSTT for chronic SCI are being introduced (Musselman et al. 2009; Stevens 2010; Wu et al. 2012; Lam et al. 2014; Yang et al. 2014). Musselman et al. (2009) and Yang et al (2014) compared BWSTT with over ground ‘precision’ skilled walking training. The skilled walking training consisted of task-specific practice (without body weight support) of various gait tasks, such as stair climbing, obstacle crossing, and walking along sloped surfaces. BWSTT was better than precision over ground training in improving walking distance. Surprisingly, both training groups were comparable in improving walking skill. Wu et al. (2012) demonstrated a new cable-driven robotic device to apply resistance against leg movements during BWSTT. Participants were randomized (in a cross-over design) to receive robotic resistance or assistance BWSTT. Although there were no significant differences in outcomes between the two modalities, there was some indication that robotic resistance enabled greater gains in over ground walking speed in people who tended to have better initial ambulatory capacity; conversely, robotic assistance seemed to enable greater gains in walking speed in those who were initially slower walkers. More recently, Lam et al. (2014) showed that training with Lokomat-applied BWSTT with resistance yielded better improvements in skilled walking function that were retained even 6 months post-intervention, vs. Lokomat-assisted BWSTT.
Conclusion
There is level 1b evidence from 1 RCT (Field-Fote & Roach 2011) that different strategies for implementing body weight support gait retraining all yield improved ambulatory outcomes in people with chronic, incomplete SCI, except for robotic-assisted treadmill training which showed little change in walking speed. It is recommended that therapists may choose a bodyweight support gait retraining strategy based on available resources (Field-Fote & Roach 2011).
There is level 4 evidence from pre-test/post-test studies (Behrman et al. 2012; Buehner et al. 2012; Harkema et al. 2012; Lorenz et al. 2012; Winchester et al. 2009; Hicks et al. 2005; Wirz et al. 2005; Thomas and Gorassini 2005; Protas et al. 2001; Wernig et al. 1998) that BWSTT is effective for improving ambulatory function in people with chronic, incomplete SCI.
Body weight-support gait training strategies can improve walking outcomes in chronic, incomplete SCI, but most gait strategies (overground, treadmill, with FES) are equally effective at improving walking speed.
Robotic training was the least effective at improving walking speed, but strategies that provide advanced challenge, such as through the practice of skilled walking tasks over-ground or application of resistance against leg movements during walking show promising results.