Table 15: Studies of Bracing Interventions Combined with FES in SCI

Author Year; Country
Score
Research Design
Sample Size

Methods

Outcomes

Marsolais et al. 2000;

USA

Post-test
N=6

Population: 6 subjects; age 22-50 yrs; all subjects 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. Subjects who were unable to use RGO alone could ambulate with hybrid system. 3 subjects 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. 2 of the subjects were capable of stair-climbing with the hybrid system.

Solomonow et al. 1997;

USA

Post-test

N=70

Population: 70 subjects; age 16-50 yrs; all subjects 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
N=5

Population: 5 subjects; age 24-37 yrs; all subjects 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. 1 subject (AIS C) was already a community ambulator and showed most frequent use of RGO but across all subjects, RGO-use was variable, intermittent and generally poor.

Sykes et al. 1996b;

UK

Post-test

N=5

Population: 5 subjects; age 24-37 yrs; all subjects had a diagnosis ofAIS 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, subjects’ 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
N=3

Population: 3 subjects; age 28-42 yrs; subjects 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 subjects walked with the RGO+FES, average walking speed was 13% faster and stride length was 5% longer.

Thoumie et al. 1995;

France

Post-test
N=26

Population: 26 subjects; age 20-53 yrs; all subjects 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)
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