Randomized trial of functional electrical stimulation therapy for walking in incomplete spinal cord injury: effects on quality of life and community participation

Background: Functional electrical stimulation (FES) therapy has been applied to achieve functional benefits post spinal cord injury (SCI), but little is known about its effects on well-being. Objective: Using a parallel-group randomized controlled trial (RCT) design (NCT00201968), the effects of a FES-assisted walking intervention on quality of life and participation post SCI were compared to a non-FES exercise program. Methods: Individuals with chronic (≥18 months) incomplete SCI (level C2 to T12, AIS C or D) were randomized to a FES-assisted walking (intervention) or aerobic/resistance training (control) sessions 3 times a week for 16 weeks. The Spinal Cord Independence Measure (SCIM), Satisfaction With Life Scale, Lawton Instrumental Activities of Daily Living, Craig Handicap and Assessment Reporting Technique, Reintegration to Normal Living Index, and perceptions of intervention(s) outcomes were completed at baseline, 4, 6, and 12 months. Repeated measures general linear models were used to assess between-group differences. Perceptions of intervention(s) were analyzed using qualitative content analysis. Results: Thirty-four individuals were randomized (17 per group); 27 remained at 12 months. The FES group had a significant increase (P < .01) on SCIM mobility subscores (mean [SD] = 17.27 [7.2] to 21.33 [7.6]) compared to the exercise group (mean [SD] = 19.9 [17.1] to 17.36 [5.5] ). Although no significant between-group differences were detected for other outcomes, both groups reported positive gains in well-being from trial participation. Conclusions: The present study provides insight into the perceived benefits acquired by participating in an RCT comparing exercise to FES therapy and serves as a model for pinpointing domains of wellbeing that could be targeted for assessment in future SCI trials.