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

Recruiting now · Not applicable

Conditions studied: Stroke, Stroke Rehabilitation, Chronic Stroke Patients, Post Stroke Recovery

In brief

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.

Key facts

Study ID

NCT06885502

Run by

Eodyne Systems SL

People needed

70

Starts

2025-02-21

Expected to finish

2026-06-30

Last updated by the study team

2026-01-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• RoNeuro Institute for Neurological Research and Diagnostics — Cluj-Napoca, Romania (enrolling)
• Hospital Universitari Joan XXIII de Tarragona — Tarragona, Spain (enrolling)

Full record on ClinicalTrials.gov

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