Effectiveness of virtual reality on functional mobility during treadmill training in children with cerebral palsy: a single-blind, two-arm parallel group randomised clinical trial (VirtWalkCP Project).

Introduction: Treadmill training and virtual reality have been investigated in children with cerebral palsy. However, few studies have assessed the effectiveness of the combination of both treatments on children's functional and balance activities. The project aims to compare the effects of treadmill training with and without virtual reality on walking endurance and speed, static and dynamic balance, gross motor function, functional independence, quality of life and occupational participation in children with spastic cerebral palsy between the ages of 4 and 12 years classified at levels I, II and III of the Gross Motor Function Classification System.

Methods And Analysis: This study is a single-blind, two-arm parallel group, randomised, controlled clinical trial. Participants will be recruited at the Pediatric Department of the Vic Hospital Consortium, and the research will be conducted at the University of Vic - Central University of Catalonia. The participants will be randomly allocated into two groups: (1) the experimental group, which will receive the treadmill training at the same time as the virtual reality; and (2) the control group, which will undertake treadmill gait training alone. The training will be provided in 10 sessions over 2 weeks with 30 min for each session. Assessments will be performed on three occasions: 1 week before the intervention, 1 week following the intervention and 1 month after the end of the intervention. The evaluations will involve the 6 min walk test, stabilometry, the Berg Balance Scale, the 10 m walk test, the Gross Motor Function Measure, the Functional Independence Measure, the paediatric quality of life inventory and the Children Participation Questionnaire. For between-within group comparison, a mixed-effect linear model will be used.

Ethics And Dissemination: The study has been approved by the Clinical Research Ethics Committee of the Osona Foundation for Health Research and Education (2021061). Results will be published in peer-reviewed journals and presented at international conferences.

Trial Registration Number: NCT05131724.