A feasibility randomised controlled trial of an exergaming device aimed at improving mobility in children with cerebral palsy

Aim: A novel interactive exergaming device enables children with cerebral palsy (CP) to exercise whilst standing. A small study showed gains in ankle motion after training with the device. This study explores the feasibility of a community-based randomised controlled trial (RCT) using this device to improve mobility in children with CP (Registered ISRCTN80878394). Method: Fifteen children with CP Gross Motor Function Classification System (GMFCS) levels I-III were randomised 1:1 to either 10-weeks training with the device or usual care. Two potential primary outcome measures were assessed at 10-weeks with 20-week follow up: motion of the centre-of-mass estimate while stepping (Next Step) and Pediatric Balance Scale (PBS). Results: Twenty-one children were assessed for eligibility, three declined to participate, two withdrew and one did not receive the intervention but remained in follow-up. Two serious adverse events occurred (n=2). Participant recruitment was 1.2 per month, limited by device availability. Completion of PBS and Next Step was 100% and 87% at baseline, dropping to 75% and 65% respectively at 10-weeks. The intervention group showed clinically meaningful changes in median (interquartile range) PBS at 10-weeks 2.7 (1) compared to the control 1.7 (0.67). Conclusion: This study found multiple feasibility issues and further work is needed prior to implementing a RCT. There were signs of efficacy of the intervention, but findings are limited by small sample size.