Status:
RECRUITING
Personalised Health Motor and Cognitive Assistance System for RehAbilitation (PHRASE)
Lead Sponsor:
Eodyne Systems SL
Conditions:
Stroke
Stroke Rehabilitation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 rehabil...
Detailed Description
Stroke-induced motor and cognitive impairments often worsen after hospital discharge due to limited access to rehabilitation, creating a cycle of non-use and functional loss ("rehabilitation in vain")...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06885502
Start Date
February 21 2025
End Date
June 30 2026
Last Update
January 6 2026
Active Locations (2)
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1
RoNeuro Institute for Neurological Research and Diagnostics
Cluj-Napoca, Romania, 400354
2
Hospital Universitari Joan XXIII de Tarragona
Tarragona, Spain, 43005