A randomized trial of functional electrical stimulation for walking in incomplete spinal cord injury: effects on body composition.

OBJECTIVE: To evaluate the effects of functional electrical stimulation (FES)-assisted walking on body composition, compared to a non-FES exercise program in individuals with a spinal cord injury (SCI). DESIGN: Parallel-group randomized controlled trial. METHODS: Individuals with chronic (≥ 18 months) incomplete SCI (level C2 to T12, AIS C or D) were recruited and randomized to FES-assisted walking (intervention), or aerobic and resistance training (control) sessions thrice-weekly for 16 weeks. Whole body and leg lean mass and whole body fat mass, measured with dual-energy X-ray absorptiometry, and lower-limb muscle cross-sectional area (CSA) and fat CSA, measured with peripheral computed tomography were assessed at baseline, 4 months, and 12 months. Intention-to-treat analyses using repeated measures general linear models were used to assess between-group differences. RESULTS: Thirty-four individuals were randomized (17 per group); 27 remained at 12 months. There were no significant main effects of FES-assisted walking on body composition variables in intention-to-treat analyses with group means. There was a significant group-by-time interaction for muscle area from baseline to 12 months (P = 0.04). Intention-to-treat analysis of muscle area change scores between baseline and 12 months revealed a significant difference between groups (mean (SD) muscle area change score 212 (517) mm(s) for FES, -136 (268) mm(s) for control, P = 0.026). There were 13 side effects or adverse events deemed related to study participation (7 intervention, 5 control); most were resolved with modifications to the protocol. One fainting episode resulted in a hospital visit and study withdrawal. CONCLUSIONS: Thrice-weekly FES-assisted walking exercise over 4 months did not result in a change in body composition in individuals with chronic, motor incomplete C2 to T12 SCI (AIS classification C and D). However, longer-term follow-up revealed that it might maintain muscle area.