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Stand-on ride-on power mobility devices for children with cerebral palsy: pilot study protocol for waitlist-control
Guilherme Manna Cesar1, Ligia Yumi Mochida1, Kira Flanagan1
1Department of Physical Therapy, University of North Florida, Jacksonville, FL, United States.
Background:
Many children with cerebral palsy are often deprived of participation in life activities due to limited postural control and walking capabilities. Ride-on power mobility devices (PMD) allow for the self-generated, active control of mobility. A novel stand-on ride-on device may provide the additional support to maintaining upright posture to improve children's balance and lower extremity strength. This pilot clinical trial aims primarily to assess the feasibility of conducting a full-scale randomized controlled trial, including evaluation of recruitment, retention, adherence to the intervention, and variability in outcome measures. Secondarily, the study will explore biomechanical factors underlying potential changes in balance and mobility function following adapted stand-on PMD use in natural environments.
Methods:
Ten children will participate in this single-arm waitlist-controlled pre-post feasibility trial. Children 4-6 years old with spastic diplegia cerebral palsy (Gross Motor Function Classification System level III) will engage in the intervention with individually adapted stand-on PMD use for three months at home, neighborhood, and family places. Biomechanical assessment will take place at baseline (3 months prior to intervention), at pre-, and at post-intervention. Exploratory outcome measures include center of pressure variables, kinematic variables of full-body coordination, and lower extremity muscle co-contraction during gait, sit-to-stand, and balance tasks.
Discussion:
This pilot clinical trial is the first to evaluate biomechanical factors underlying changes in balance (static and dynamic) and mobility function after stand-on PMD intervention. By collecting key feasibility metrics and quantifying variability in biomechanical outcomes, this study will generate fundamental knowledge to guide the design of a larger, adequately powered trial that can validate PMD interventions in decreasing the lifelong burden of secondary medical conditions that emerge in this population due to impaired balance and limited mobility. Findings will also provide the empirical data supporting the follow-up grant application with larger-scale study design.
Clinical Trial Registration:
ClinicalTrials.gov, identifier NCT06455930.
