Actively Recruiting
Led by Eodyne Systems SL · Updated on 2026-01-06
70
Participants Needed
2
Research Sites
N/A
Total Duration
This research aims to evaluate the use of digital technology, specifically a smartphone application with virtual reality (VR) and augmented reality (AR) features, 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. It compares the Rehabilitation Gaming System (RGS) application with conventional therapy to see how well they improve upper limb motor function and cognitive recovery in stroke survivors aged over 18. Participants will be randomly assigned to one of two groups: one group will use the RGSapp daily for 20-30 minutes at home for six weeks alongside their usual therapy, including 4 to 6 exercises per session with weekly updates to keep training engaging. The other group will receive standard care without VR or AR interventions. Some participants may also use a smartwatch to monitor upper arm use. Regular clinician check-ins will support adherence and safety. Throughout the study, participants will be assessed at the start, after three weeks, at the end of six weeks, and at a 14-week follow-up. Assessments will measure motor and cognitive function, depression, activity levels, usability of the RGSapp, and healthcare costs. The main outcome is improvement in upper limb motor function using the Action Research Arm Test (ARAT). Researchers will also evaluate the app's usability and the validity of remote assessments, aiming to validate this digital rehabilitation approach in real-world settings.
CONDITIONS
Personalised Health Motor and Cognitive Assistance System for RehAbilitation (PHRASE)
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants in the experimental group use the Rehabilitation Gaming System (RGS) app at home with daily 20-30 minute training sessions, alongside their prescribed conventional therapy, for 6 weeks. Participants in the control group continue with their conventional therapy without the RGS intervention.
Daily home training sessions with regular check-ins by clinicians
Duration - 8 weeks after intervention ends
Participants are assessed to evaluate motor and cognitive recovery, mood changes, activity participation, and usability of the RGS app at 14 weeks after starting the intervention.
1 visit (in-person) at Week 14 follow-up
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
S
Santiago Brandi
A
Anna Mura
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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