A randomized controlled trial of functional electrical stimulation powered cycling, goaldirected training and adapted cycling in children with cerebral palsy

Abstract

Objective: Children with cerebral palsy (CP) can experience a decline in gross motor ability from childhood to adolescence, affecting functional tasks, ambulation and participation in leisure activities such as cycling. This randomized controlled trial tested the efficacy of a training package of Functional Electrical Stimulation (FES) powered cycling, adapted cycling and goal-directed exercises to improve gross motor function, sit-to-stand capacity and cycling ability in children with CP, compared to care as usual (CAU). Design: Randomised controlled trial. Method: Twenty-one children with CP (10±3.2y; GMFCS level: II=7, III=6, IV=8; hemiplegia=5, diplegia=7, quadriplegia= 9) participated in the study at a tertiary children's hospital. Eleven participants were randomised to the intervention group (9.5±3.5y; GMFCS level: II=4, III=3, IV=4) and ten to CAU (10.6±2.76y; GMFCS level: II=3, III=3, IV=4). The intervention group completed 2×1-hour hospital-based sessions and a 1-hour home program each week for 8 weeks (totalling 24 hours). The waitlist control group continued usual care. Hospital-based sessions included 30 minutes of FES-powered cycling and 30 minutes of goal-directed exercises. Home programs included similar functional exercises, in addition to adapted recreational cycling. Primary outcomes were the Gross Motor Function Measure (GMFM-88, 66 and goal-score) and Canadian Occupational Performance Measure (COPM). Secondary outcomes included the five-times sit-tostand test (5TSTS), the Pediatric Evaluation of Disability Inventory (Pedi-CAT) and power output achieved during a stationary cycling test. Separate general linear models were used to compare outcome measures between groups at 8 weeks, with baseline measures entered as covariates using SPSS (ver25). Results: The intervention group had significantly improved GMFM-66 scores (mean difference (MD)=5.9, 95% CI=3.1- 8.8, p<0.01); GMFM-88 (MD=7.4, 95% CI=2.3-12.6, p<0.01); GMFM goal-score (MD=13.5, 95% CI=5.9-21.0, p<0.01); COPM performance (MD= 4.4, 95% CI=3.4-5.4, p<0.01) and COPM satisfaction (MD=5.2, 95% CI=3.9-6.4, p<0.01) for goals relating to cycling and mobility. 5TSTS approached, but did not reach statistical significance (MD=11.9, 95% CI= 2.7-21.2,p=0.0145). No between-group differences for the four Pedi-CAT domains or cycling power were observed. Adverse events included mild muscle soreness, chaffing and a fall (no injury sustained) while cycling at home. Conclusion: A goal directed training package of functional exercise training, FES-powered cycling and recreational cycling is an efficacious approach to improve gross motor function and the performance of cycling and mobility goals in children with CP. These clinically important results provide an alternative therapy approach for children with CP who are susceptible to functional decline.L6316058382020-05-04 <br />