Digital rehabilitation system for stroke recovery
Personalised Health Motor and Cognitive Assistance System for RehAbilitation (PHRASE): A Randomized Clinical Trial
This study is testing a smartphone app that uses virtual and augmented reality to help stroke patients recover at home and see if it works better than regular therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Eodyne Systems SL Industry-sponsored |
| Locations | 2 sites (Cluj-Napoca and 1 other locations) |
| Trial ID | NCT06885502 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a smartphone application that integrates virtual reality (VR) and augmented reality (AR) for at-home rehabilitation of stroke patients. It focuses on providing personalized motor and cognitive training for individuals in the late subacute and chronic phases post-stroke. Participants will be randomly assigned to either the VR/AR intervention or conventional therapy for six weeks, with assessments of motor function, cognitive function, and quality of life at multiple time points. The goal is to validate the PHRASE system's impact on recovery outcomes and its potential as a diagnostic tool.
Who should consider this trial
Good fit: Ideal candidates are stroke survivors over 18 years old, more than three months post-stroke, with mild to moderate upper-limb impairment.
Not a fit: Patients with severe cognitive impairments or other conditions that compromise safety or data quality may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance recovery outcomes for stroke patients by providing accessible and effective rehabilitation at home.
How similar studies have performed: Other studies have shown promise in using VR and AR technologies for rehabilitation, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cluj-Napoca and 1 other locations
- RoNeuro Institute for Neurological Research and Diagnostics — Cluj-Napoca, Romania (Recruiting)
- Hospital Universitari Joan XXIII de Tarragona — Tarragona, Spain (Recruiting)
Study contacts
- Study coordinator: Santiago Brandi
- Email: contact@eodyne.com
- Phone: 34 931389642
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.