For people with SCI, walking with braces can be tiring, and thus few people use them. Hybrid systems combine conventional bracing with FES to activate large lower extremity muscles in the hopes of improving the gait pattern and reduce upper extremity exertion. The FES is used to improve trunk and hip stability and to facilitate forward progression.
| Author Year; Country Score Research Design Sample Size | Methods | Outcomes |
| Marsolais et al. 2000 USA Post-test Level 4 | Population: 6 participants; age 22-50 yrs; all participants had a SCI; C7-T12 lesion level; 2.5-20.6 yrs post-injury.
Treatment: Case-Western Reserve University Hybrid Gait Orthosis (modification of IRGO) combined with FES to various muscles (combination of 8-16 muscles).
Outcome measures: walking speed and distance. | 1. Participants who were unable to use RGO alone could ambulate with hybrid system. 3 participants who were previously ambulatory with either RGO or FES alone showed improvement in walking distance with the hybrid system (from 3-90 m to 200-350 m). 2. Two of the participants were capable of stair-climbing with the hybrid system. |
| Solomonow et al. 1997 USA Post-test Level 4 N=70 | Population: 70 participants; age 16-50 yrs; all participants had a SCI; C6-T12 lesion level; 1-10 yrs post-injury
Treatment: RGO use and gait training 1-3 hr, 3x/wk, 6 wks followed by RGO+FES (bilateral quadriceps and hamstrings) for another 6 wks.
Outcome measures: Walking ability, 180 m walk. | 1. After training, 57 patients could walk at least 180 m (19 could walk > 450 m). 77% of patients could walk independently on different surfaces (grass, ramps, curbs). |
| Sykes et al. 1996a UK Post-test Level 4 | Population: 5 participants; age 24-37 yrs; all participants had a diagnosis of AIS A-C; C2 -T6 lesion level; 8-14 yrs post-injury.
Treatment: RGO and FES: 20-40 weeks of RGO use at home followed by RGO+FES bilaterally to quadriceps and hamstrings.
Outcome measures: RGO pedometer measured number of steps over 18 months. | 1. Number of steps taken per week varied between 306 and 1879 steps (99-845 m/week). 2. Use of the RGO was low and no increase in use or function after hybrid system supplied. 3. One participant (AIS C) was already a community ambulator and showed most frequent use of RGO but across all participants, RGO-use was variable, intermittent and generally poor. |
| Sykes et al. 1996b UK Post-test Level 4 N=5
| Population: 5 participants; age 24-37 yrs; all participants had a diagnosis of AIS A-C; C2-T6 lesion level.
Treatment: Following conditioning program, RGO+FES bilaterally to quadriceps and hamstrings for home use.
Outcome measures: Walking speed over 40 m. | 1. Without FES, participants’ walking speeds ranged from 0.13 to 0.40 m/s. With RGO+FES, speeds ranged from 0.14 to 0.45 m/s, corresponding to changes ranging from -1% to 14%. |
| Yang et al. 1996 UK Post-test Level 4 | Population: 3 participants; age 28-42 yrs; participants had a complete or incomplete SCI; C6 -T8 lesion level; 3-15 yrs post-injury.
Treatment: RGO ± FES. RGO with and without FES to common peroneal nerve stimulation.
Outcome measures: walking speed, stride length. | 1. RGO + FES: Modest (non-significant) increase in walking speed and stride length compared with RGO without FES. 2. When participants walked with the RGO+FES, average walking speed was 13% faster and stride length was 5% longer. |
| Thoumie et al. 1995 France Post-test Level 4 | Population: 26 participants; age 20-53 yrs; all participants had a complete SCI; C8-T11 lesion level; 9-144 months post-injury
Treatment: RGO-II orthosis: long-leg brace with reciprocal hip joint combined with FES to the quadriceps and hamstrings. 4-6 weeks of gait training with orthosis alone followed by RGO-II+FES (hybrid) program (total program time: 2-5 months inpatients, 3-14 months outpatients).
Outcome measures: walking distance and speed with RGO and with RGO+FES. | 1. 21/26 completed the training program, 19 were able to stand up alone. Following program, walking distance ranged from 200-1400 m with hybrid orthosis, 150-400 m with RGO II. 2. Maximal walking speed with the hybrid orthosis (mean (SD) 0.32 (0.02) m/s; range 0.21-0.45 m/s) was not significantly different from that with orthosis alone (mean (SD) 0.29 (0.03) m/s; range 0.22-0.41 m/s) |
We found 6 post-test studies (Marsolais et al. 2000; Solomonow et al. 1997; Sykes et al. 1996a; Sykes et al. 1996b; Yang et al. 1996; Thoumie et al. 1995) that examined the combined effect of lower extremity bracing with FES on functional ambulation in people with complete SCI (aggregate N=115). Most studies found that the combination of long-leg bracing and FES may enable overground ambulation of between 180 and 1400 m at one time (Marsolais et al. 2000; Solomonow et al. 1997; Sykes et al. 1996a; Thoumie et al. 1995). There does not seem to be further benefit in combining FES with orthosis-use in terms of maximal walking speed (Sykes et al. 1996b; Yang et al. 1996; Thoumie et al. 1995), although greater walking distance may be achieved (Marsolais et al. 2000; Thoumie et al. 1995). Three pretest/posttest studies (Marsolais et al. 2000; Yang et al. 1996; Thoumie et al. 1995); and one posttest study (Sykes et al. 1996b) directly compared the effect of bracing+FES with either FES or bracing alone. When subjects walked with either braces or FES alone, maximum walking distance ranged from 3 to 400 m. When braces were combined with FES, maximum distance increased to 200 to 1400 m (Marsolais et al. 2000; Sykes et al. 1996b; Thoumie et al. 1995).
Biomechanical studies (not included in the summary tables if they did not have a training period) provide some insight into the relative benefits of FES versus bracing. One study that compared FES-alone with bracing-alone found that FES provides a particular advantage in facilitating sit-to-stand movements and donning the system (Bonaroti et al., 1999). However, once standing was achieved, mobility (e.g., walking, stairs) was not found to be different between FES and bracing. For people with incomplete SCI, Kim et al. (2004) found FES produced more benefits in walking speed, and bracing (AFO alone) improved walking distance. However, the combination of AFO with FES improved gait benefits more than either device used alone (Kim et al., 2004).
There is level 4 evidence (Yang et al. 1996) that a combined approach of bracing and FES results in additional benefit to functional ambulation in paraplegic patients with complete SCI. However, in participants who achieve little benefit from bracing alone, the addition of FES appears to help improve standing or short-distance walking function (Marsolais et al. 2000). In incomplete SCI, however, there is some indication that a combination of bracing and FES provides greater ambulatory function than either approach alone (Kim et al. 2004).
