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

Launched by EODYNE SYSTEMS SL · Mar 12, 2025

Keywords

ClinConnect Summary

The PHRASE trial is studying a new way to help people recover from a stroke using digital technology. Specifically, it will test a smartphone app that uses virtual reality (VR) and augmented reality (AR) to assist with rehabilitation at home. This program focuses on helping patients improve both their movement and thinking skills after a stroke, especially for those who are recovering months after the event. The study will involve 70 participants who will be randomly divided into two groups: one group will use the app for six weeks, while the other will receive standard therapy. Researchers will measure how well the app improves upper limb movement and other aspects like cognitive function and mood.

To be eligible for this trial, participants must be at least 18 years old and have experienced a stroke at least three months prior. They should have moderate to mild difficulties with arm movement and be able to sit independently to use the app. Participants should also be comfortable using a smartphone, even if they don’t have a lot of experience. If you or a loved one meets these criteria and is interested in helping improve stroke recovery methods, this study might be a good opportunity.

Gender

ALL

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.