Functional Electrical Stimulation Cycling, Goal-Directed Training, And Adapted Cycling For Children With Cerebral Palsy: A Randomized Controlled Trial

Aim To test the efficacy of functional electrical stimulation (FES) cycling, goal-directed training, and adapted cycling, compared with usual care, to improve function in children with cerebral palsy (CP). Method The intervention was delivered between 2017 and 2019 and included three sessions per week for 8 weeks (2x1h sessions at a children's hospital, and 1h home programme/week). Hospital sessions included 30 minutes of FES cycling and 30 minutes of goal-directed training. Home programmes included goal-directed training and adapted cycling. The comparison group continued usual care. Primary outcomes were gross motor function assessed by the Gross Motor Function Measure (GMFM) and goal performance/satisfaction assessed using the Canadian Occupational Performance Measure (COPM). Secondary outcomes were sit-to-stand and activity capacity, participation in home, school, and community activities, and power output. Linear regression was used to determine the between-group mean difference immediately post-training completion after adjusting for baseline scores. Results This randomized controlled trial included 21 participants (mean age=10y 3mo, standard deviation [SD]=3y; Gross Motor Function Classification System level: II=7, III=6, IV=8) who were randomized to the intervention (n=11) or usual care group (n=10). Between-group differences at T2 favoured the intervention group for GMFM-88 (mean difference=7.4; 95% confidence interval [CI]: 2.3-12.6;p=0.007), GMFM-66 (mean difference=5.9; 95% CI: 3.1-8.8;p<0.001), COPM performance (mean difference=4.4; 95% CI: 3.9-5.3;p<0.001) and satisfaction (mean difference=5.2; 95% CI: 4.0-6.4;p<0.001). Interpretation Children with CP achieved meaningful functional improvements after FES cycling, goal-directed training, and adapted cycling training. Cycling programmes for children with CP should be individualized and goal directed.