Peer-reviewed article
HABIT-ILE@home for Children With Bilateral Cerebral Palsy: Protocol for Noninferiority and Superiority Randomized Controlled Trials.
Rosselli Z, Somville M, Ducoffre E, Arnould C, Bleyenheuft Y et al. ·
Summary
Written by AI, not yet AICS's view · claude-haiku-4-5-20251001This is a protocol for two randomized controlled trials testing a home-based telerehabilitation version of HABIT-ILE, an intensive motor therapy for children with bilateral cerebral palsy aged 5-18 years. The first trial will compare home-based therapy to the standard on-site 2-week camp format, while the second will test whether a 9-week follow-up program adds value. The study uses virtual technology and therapist remote supervision to make intensive therapy accessible to families who cannot attend in-person camps.
Key points
- HABIT-ILE@home is delivered at home with caregiver involvement and remote therapist supervision using a virtual device (REAtouch Lite)
- RCT1 tests noninferiority of high-dose home-based therapy (65 hours over 2 weeks, 6.5 hours per day) compared to on-site HABIT-ILE
- RCT2 tests superiority of a 9-week HABIT-ILE@home follow-up program (45 hours total, 5 hours per week) versus nonspecific home follow-up
- Primary outcome is the Gross Motor Function Measure-66 (GMFM-66); secondary outcomes include motor function, activities of daily living, self-esteem, participation, and neuroimaging
- Recruitment completed June 2024, all interventions performed by November 2024, data analysis completed May 2025
Limitations
This is a protocol document, not a results paper, so it cannot tell us whether the interventions are actually effective or how families engaged with the technology in practice. The countries where the trials are being conducted are not specified in the document.
Abstract
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.