Effects of a training programme of functional electrical stimulation (FES) powered cycling, recreational cycling and goal-directed exercise training on children with cerebral palsy: a randomised controlled trial protocol

INTRODUCTION: Children with cerebral palsy (CP) experience declines in gross motor ability as they transition from childhood to adolescence, which can result in the loss of ability to perform sit-to-stand transfers, ambulate or participate in leisure activities such as cycling. Functional electrical stimulation (FES) cycling is a novel technology that may provide opportunities for children with CP to strengthen their lower limbs, improve functional independence and increase physical activity participation. The proposed randomised controlled trial will test the efficacy of a training package of FES cycling, adapted cycling and goal-directed functional training to usual care in children with CP who are susceptible to functional declines. METHODS AND ANALYSIS: Forty children with CP (20 per group), aged 6–8 years and classified as Gross Motor Function Classification System (GMFCS) levels II–IV will be recruited across South East Queensland. Participants will be randomised to either an immediate intervention group, who will undertake 8 weeks of training, or a waitlist control group. The training group will attend two 1 hour sessions per week with a physiotherapist, consisting of FES cycling and goal-directed, functional exercises and a 1 hour home exercise programme per week, consisting of recreational cycling. Primary outcomes will be the gross motor function measure and Canadian occupational performance measure, and secondary outcomes will include the five times sit-to-stand test, habitual physical activity (accelerometry), power output during cycling and Participation and Environment Measure-Children and Youth. Outcomes will be assessed at baseline, postintervention (8 weeks) and 8 weeks following the intervention (retention). ETHICS AND DISSEMINATION: Ethical approval has been obtained from Griffith University (2018/037) and the Children’s Health Queensland Hospital and Health Service (CHQHHS) Human Research Ethics Committee (HREC/17/QRCH/88). Site-specific approval was obtained from CHQHHS research governance (SSA/17/QRCH/145). Results from this trial will be disseminated via publication in relevant peer-reviewed journals. TRIAL REGISTRATION NUMBER: ACTRN12617000644369p.