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 well-being that could be targeted for assessment in future SCI trials.
Lyndhurst Centre, Toronto Rehabilitation Institute - University Health Network , Toronto, Ontario , Canada.
Sander L
SL
Hitzig
B Catharine
BC
Craven
Aliza
A
Panjwani
Naaz
N
Kapadia
Lora M
LM
Giangregorio
Kieva
K
Richards
Kei
K
Masani
Milos R
MR
Popovic
activities of daily living; community participation; exercise; functional electrical stimulation; qualitative research; quality of life; spinal cord injuries; therapy; walking