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Personalised Health Motor and Cognitive Assistance System for RehAbilitation (PHRASE)

RecruitingNAAges 18 Years - anyAllEodyne Systems SL
NCT06885502 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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, d

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📋 Eligibility rules (as published)
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.
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What it tests

  • RGS
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Where

2 sites
RoNeuro Institute for Neurological Research and Diagnostics
Cluj-Napoca, Romania
Hospital Universitari Joan XXIII de Tarragona
Tarragona, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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