Actively Recruiting
Personalised Health Motor and Cognitive Assistance System for RehAbilitation (PHRASE)
Led by Eodyne Systems SL · Updated on 2026-01-06
70
Participants Needed
2
Research Sites
70 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Personalised Health Motor and Cognitive Assistance System for RehAbilitation (PHRASE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients presenting an ischemic or intracerebral haemorrhagic stroke, 63 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 will not qualify if you...
- 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.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
RoNeuro Institute for Neurological Research and Diagnostics
Cluj-Napoca, Romania, 400354
Actively Recruiting
2
Hospital Universitari Joan XXIII de Tarragona
Tarragona, Spain, 43005
Actively Recruiting
Research Team
S
Santiago Brandi
CONTACT
A
Anna Mura
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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