Accepted for/Published in: JMIR Research Protocols
Date Submitted: Dec 18, 2025
Date Accepted: Jun 3, 2026
Implementation protocol of HABIT-ILE@home for children with bilateral cerebral palsy: non-inferiority and superiority randomized controlled trials.
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 extremities functions as well as in bimanual performance and activities of daily living in children with cerebral palsy (CP). However, the typical delivery of HABIT-ILE as a two-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 "HABIT-ILE@home" protocol aims to evaluate the effectiveness of this approach through two randomized controlled trials.
Methods:
A total of 44 children with bilateral CP (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 (REAtouchLite®). The first RCT (RCT1) will assess the non-inferiority of high-dose HABIT-ILE@home versus on-site HABIT-ILE (65 hours over two weeks, 6.5h/day). The second RCT (RCT2) will assess the superiority of a HABIT-ILE@home follow-up program delivered over nine weeks compared to non-specific home follow-up (45 hours in total, 5h/week). GMFM-66 is the primary outcome. Secondary outcomes include feasibility and adherence questionnaires, motor and functional outcome measures, as well as daily life activities questionnaires, self-esteem, participation in life situations, and neuroimaging. Evaluations will be conducted before (T0) and after (T1) the two weeks of therapy, followed by a final assessment after the follow-up (T2).
Results:
Recruitment was completed in 2024. All interventions were performed by the participants. Data analysis is planned for spring 2026.
Conclusions:
The results will first confirm or not the non-inferior efficacy of a telerehabilitation HABIT-ILE@home program compared to its typical on-site delivery. Secondly, the results will determine the added value of a specific HABIT-ILE@home follow-up after such high dosage motor learning based interventions. Clinical Trial: NCT05740605 - REGISTRATION DATE : March 6, 2023
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.