Accepted for/Published in: JMIR Research Protocols
Date Submitted: Nov 4, 2025
Date Accepted: Dec 15, 2025
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
HABIT-ILE@home for Adults with Chronic Stroke: Protocol of a Randomized Controlled Trial
ABSTRACT
Background:
Constraint-Induced Movement Therapy (CIMT) has been widely used in stroke rehabilitation, demonstrating significant improvements in arm function and daily life activities. Based on the same therapeutic principles of motor skill learning, Hand and Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) was developed focusing on bimanual coordination and constant concomitant stimulation of trunk control and lower extremities. However, implementation of such high dosage interventions in stroke rehabilitation might face barriers due to limited accessibility, and resource requirements. To overcome these obstacles, we aim to test the efficacy of a home-based HABIT-ILE program. Additionally, the added value of a 9-week specific follow-up program will be tested after high dosage but short-term interventions.
Objective:
The first randomized controlled trial (RCT1) will evaluate the non-inferiority of a high-dosage HABIT-ILE@home program compared to its on-site counterpart. The second RCT (RCT2) will test the superiority of a 9-week specific HABIT-ILE@home follow-up versus a non-specific home program.
Methods:
A total of 48 adults with chronic stroke will participate. HABIT-ILE@home will follow the principles of HABIT-ILE on-site but will be delivered by caregivers with a remote supervision by trained therapists and the use of a dedicated telerehabilitation device to facilitate intervention delivery and remote monitoring (i.e. REAtouch®Lite). The first RCT (RCT1) will assess the non-inferiority of high-dose HABIT-ILE@home versus on-site HABIT-ILE (65h 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 (total 45h, 5h/week). Primary outcomes include the Fugl-Meyer Assessment, while secondary outcomes include feasibility and adherence questionnaires, upper and lower extremities motor function assessments, daily activities and quality of life questionnaires. Assessments will be performed before (T0) and after (T1) the two weeks of high dosage intervention, followed by an assessment after the 9 weeks follow-up (T2).
Results:
In March 2025, all data collections were completed for this study. Data analysis will start soon; we expect to publish results for spring 2026.
Conclusions:
This study will provide evidence on the feasibility and efficacy of delivering HABIT-ILE through a home-based telerehabilitation model for adults with chronic stroke. Demonstrating non-inferiority of HABIT-ILE@home compared to on-site therapy would support wider accessibility to intensive rehabilitation while reducing logistical and human resource constraints. Additionally, showing the added benefit of a structured follow-up could emphasize the importance of continuity of care to sustain and enhance motor recovery after intensive interventions. Clinical Trial: NCT05727111 on https://clinicaltrials.gov/ - REGISTRATION DATE: February 2, 2023
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