NCT06885502 Personalised Health Motor and Cognitive Assistance System for RehAbilitation (PHRASE)
| NCT ID | NCT06885502 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Eodyne Systems SL |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2025-02-21 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2025-02-21 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is a multicentric randomized controlled trial evaluating the effectiveness of digital technology, specifically a smartphone with integrated VR-and AR-based intervention, for at-home rehabilitation after stroke. The study focuses on combined motor and cognitive training for patients in the late subacute and chronic phases post-stroke. The intervention is provided through the Rehabilitation Gaming System application RGSapp, a goal-oriented, first-person virtual reality (VR) and augmented reality (AR) mobile application for upper limb rehabilitation. A total of seventy participants will be randomly assigned (1:1 ratio) to either the RGSapp intervention or conventional therapy/standard of care for six weeks. The primary outcome is motor function improvement (upper limb), assessed using the Action Research Arm Test (ARAT). Secondary outcomes include changes in cognitive function, depression, usability, adherence, validity of remote assessments, and healthcare costs.
Eligibility Criteria
Inclusion Criteria: * Patients presenting an ischemic or intracerebral haemorrhagic stroke, ≥ 3 months post-stroke. * Age \> 18 years old * Moderate to mild proximal upper limb motor impairment Medical Research Council Scale (MRC \>2). * ARAT: \<50, inclusive, to avoid ceiling effects while allowing room for improvement. * Able to sit on a chair or a wheelchair to interact with the RGS system. * Minimal experience with smartphone technology based on the clinician's opinion * Willing to participate and agree to comply with the trial scheme and procedures * Must sign an Informed Consent Form (ICF) indicating that they understand the purpose and the procedures of the study. Exclusion Criteria: * Presence of a condition or abnormality that, in the opinion of the investigator, would compromise the safety of the patient or the quality of the data. * Severe cognitive capabilities that prevent the execution of the study, evaluated by the MoCA \< 19 or based on the clinician's opinion. * Pre-stroke history of upper limb motor disability. * Unable to use the RGS independently, according to the clinician's observations, and needing more support from a caregiver to use the RGS.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06885502 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06885502 currently recruiting?
Yes, NCT06885502 is actively recruiting participants. Contact the research team at contact@eodyne.com for enrollment information.
Where is the NCT06885502 trial being conducted?
This trial is being conducted at Cluj-Napoca, Romania, Tarragona, Spain.
Who is sponsoring the NCT06885502 clinical trial?
NCT06885502 is sponsored by Eodyne Systems SL. The trial plans to enroll 70 participants.
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