In the Driver’s Seat: A Randomized, Crossover Clinical Trial Protocol Comparing Home and Community Use of the Permobil Explorer Mini and a Modified Ride-On Car by Children With Cerebral Palsy

Abstract

Abstract Objective The aims of this study are 2-fold: (1) to evaluate a powered mobility intervention to promote developmental, activity, and participation outcomes of young children aged 12 to 36 months who have cerebral palsy; and (2) to compare the use patterns (frequency, duration, environment) of 2 different powered mobility options. Methods This study is a multisite, mixed-methods, doubly counterbalanced, randomized, crossover clinical trial, where intervention A is the Permobil Explorer Mini and intervention B is a modified ride-on toy car. The study will take place in rural and urban home and community settings surrounding 3 sites (Washington, Oregon, and Michigan). There will be 24 child-caregiver dyads in the study (8 dyads per site). Primary outcome measures include the Bayley Scale of Infant and Toddler Development, the Youth and Children’s Participation and Environment Measure, the Assessment for Learning Power mobility use, automated device use tracking logs, caregiver semistructured interviews, and the Acceptability, Feasibility, and Intervention Appropriateness Measures. Secondary measures include the Child Engagement in Daily Life and caregiver diaries. Impact The use of powered mobility devices for young children with cerebral palsy has gained traction, with evidence that the use of powered mobility at young ages complements (rather than detracts from) other interventions focused on more traditional mobility skills such as crawling and walking. However, research is limited, and often comprised of low-level evidence. Given the clearance of the first powered mobility device for infants, the Permobil Explorer Mini, and the recent popularity of modified ride-on toy cars as an alternative for powered mobility for young children with disabilities, this study will contribute to rigorous examination of the developmental outcomes, use patterns, and caregiver perceptions of these novel devices.