JMIR Res Protoc. 2026 Feb 10;15:e87035. doi: 10.2196/87035.
ABSTRACT
BACKGROUND: Intensive therapies based on motor skill learning have been widely used in stroke rehabilitation for improving upper extremity abilities, 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, the implementation of such high-dosage interventions in stroke rehabilitation might face barriers due to limited accessibility and high resource requirements. Delivering HABIT-ILE therapy at home (HABIT-ILE@home) via telerehabilitation may reduce logistical barriers while maintaining efficacy. In addition, the added value of a 9-week specific follow-up program will be tested after high dosage interventions.
OBJECTIVE: The first randomized controlled trial (RCT1) aims to evaluate the noninferiority of a high-dosage HABIT-ILE@home program compared to its on-site counterpart. The second randomized controlled trial (RCT2) aims to test the superiority of a 9-week specific HABIT-ILE@home follow-up vs a nonspecific home program.
METHODS: A total of 48 adults with chronic stroke will be randomized to either HABIT-ILE@home or HABIT-ILE on-site group (RCT1, 65 hours over 2 weeks). HABIT-ILE@home will follow the same principles as HABIT-ILE on-site but will be delivered by caregivers with remote supervision by trained therapists and the use of a dedicated telerehabilitation device to facilitate intervention delivery and remote monitoring (ie, REAtouch Lite; Axinesis). All participants will then participate in a HABIT-ILE@home follow-up program or nonspecific follow-up (RCT2, 45 hours over 9 weeks). Primary outcomes will be the change in Fugl-Meyer Assessment (FMA), while secondary outcomes include feasibility and adherence questionnaires, upper and lower extremity motor function assessments, daily activities, and quality of life questionnaires. Assessments will be performed before (T0) and after (T1) the 2 weeks of high dosage intervention, followed by an assessment after the 9-week follow-up (T2).
RESULTS: Recruitment for the trial started in March 2023 and ended in March 2025, and data collection has been completed for this study. Data analysis is planned to start early 2026; we expect to submit the results for publication in 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 noninferiority 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.
PMID:41666310 | DOI:10.2196/87035