HABIT-ILE@home for Children With Bilateral Cerebral Palsy: Protocol for Noninferiority and Superiority Randomized Controlled Trials.

BACKGROUND: Intensive motor learning interventions, such as Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE), have demonstrated significant improvements in upper and lower extremity functions, as well as in bimanual performance and activities of daily living in children with cerebral palsy. However, the typical delivery of HABIT-ILE as a 2-week on-site camp can be inaccessible to families living in remote areas or with travel difficulties. Offering HABIT-ILE as a home-based telerehabilitation program could overcome these barriers. OBJECTIVE: The study aims to evaluate the effectiveness of this approach through 2 randomized controlled trials. METHODS: A total of 44 children with bilateral cerebral palsy (aged 5-18 years) will participate. HABIT-ILE@home will follow the principles of HABIT-ILE on-site but will be delivered at home with the involvement of caregivers and remote supervision by trained therapists. A dedicated virtual device will facilitate intervention delivery and remote monitoring (REAtouch Lite). The first randomized controlled trial (RCT), RCT1, will assess the noninferiority of high-dose HABIT-ILE@home vs on-site HABIT-ILE (65 h over 2 weeks, 6.5 h/d). The second RCT (RCT2) will assess the superiority of a HABIT-ILE@home follow-up program delivered over 9 weeks compared to a nonspecific home follow-up (45 h in total, 5 h/wk). The Gross Motor Function Measure-66 (GMFM-66) is the primary outcome. Secondary outcomes include feasibility and adherence questionnaires, motor and functional outcome measures, as well as activities of daily living questionnaires, self-esteem, participation in life situations, and neuroimaging. Evaluations will be conducted before (T0) and after (T1) the 2 weeks of therapy, followed by a final assessment after the follow-up (T2). RESULTS: Recruitment was completed in June 2024. All interventions were performed by November 2024. Data analysis was completed in May 2025. CONCLUSIONS: The results will first confirm or refute the noninferior efficacy of a telerehabilitation HABIT-ILE@home program compared to its typical on-site delivery. Second, the results will determine the added value of a specific HABIT-ILE@home follow-up after such high-dosage motor learning-based interventions.