{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,10]],"date-time":"2026-09-10T22:42:37Z","timestamp":1789080157333,"version":"build-2803163510"},"reference-count":68,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2025,10,14]],"date-time":"2025-10-14T00:00:00Z","timestamp":1760400000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Neurol."],"abstract":"<jats:sec><jats:title>Background<\/jats:title><jats:p>Stroke remains a leading cause of disability globally, creating significant challenges for healthcare systems. Early intensive rehabilitation is recommended (NICE2023) for functional recovery; but standard therapy may not cover all patients\u2019 needs. Stroke survivors should continue active task practice outside of scheduled therapy sessions (self-directed, or semi-supervised by family and caregivers), possibly by sustainable technological solutions. However, most technology-based ecosystems are not designed for healthcare. To test a digital stroke rehab ecosystem Randomized Clinical Trials (RCTs) are the gold standard, but present ethical and logistical challenges, particularly in blinding and participant adherence. This study protocol (<jats:uri>ClinicalTrials.gov<\/jats:uri>; NCT06728020; March 21 st, 2025) employs a cohort multiple RCT (cmRCT) innovative design, suitable for comparing usual care to interventions in studies with multiple interventions: cmRCT enrols a large observational cohort, allowing random selection of participants for individual trials rather than random allocation for all subjects, alongside a patient-centered approach to information and consent.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>A certified device including a multimedia monitor with virtual reality cognitive and motor rehabilitation exercises (VRRS) will be enriched with educational videos and rehabilitation contents, developed by co-creation involving stroke patients, caregivers and rehabilitation professionals (VRRS1). A dynamic cohort of post-acute stroke inpatients will then be prospectively enrolled in a cmRCT: first, the VRRS1 will be randomly proposed to and tested with 70 subjects, while 70 other eligible patients will be randomized to Usual Care (UC) - controls (ROOMMATE 1st); then, the VRRS1, integrated with a set of inertial sensors (BMR4ROOMMATE) (VRRS2), will be tested in a pilot RCT on 30 patients (while 30 other eligible patients will be randomized as controls - ROOMMATE 2nd). The primary outcome will be the Modified Barthel Index, while secondary outcomes will include measures of motor and cognitive functions, as well as feasibility, usability, and device wearability.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>By combining sensor-based assessment, expert coaching on digital literacy, and the active involvement of patients, caregivers, and healthcare professionals ROOMMATE aims to co-create an innovative digital ecosystem for Stroke rehabilitation. By rigorously verifying its impact by a cmRCT, it seeks evidence to enhance stroke recovery beyond usual care.<\/jats:p><\/jats:sec>","DOI":"10.3389\/fneur.2025.1568728","type":"journal-article","created":{"date-parts":[[2025,10,14]],"date-time":"2025-10-14T04:16:17Z","timestamp":1760415377000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":1,"title":["Development of a cohort multiple randomized clinical trial to test an integrated system of sensors and multimedia monitors technology, for stroke rehabilitation: the ROOMMATE study 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