NCT06885502Recruiting
Personalised Health Motor and Cognitive Assistance System for RehAbilitation (PHRASE)
Personalised Health Motor and Cognitive Assistance System for RehAbilitation (PHRASE): A Randomized Clinical Trial
Source: ClinicalTrials.gov · Last updated 6 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 6 Mar 2025
- Start date
- 21 Feb 2025
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- Eodyne Systems SL
- Diseases
- Stroke
- NCT number
- NCT06885502
What you commit to
- Study type: Interventional
- Planned participants: 70
- From 21 Feb 2025 to the primary completion date, 30 Jun 2026
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
- Pre-stroke history of upper limb motor disability.
Other
- Severe cognitive capabilities that prevent the execution of the study, evaluated by the MoCA \< 19 or based on the clinician's opinion.
- Unable to use the RGS independently, according to the clinician's observations, and needing more support from a caregiver to use the RGS.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitari Joan XXIII de Tarragona Coordinator of this site? Confirm its status | Tarragona | Spain | Recruiting |
| RoNeuro Institute for Neurological Research and Diagnostics Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.