Personalised Health Motor and Cognitive Assistance System for RehAbilitation (PHRASE) (PHRASE-2024)

  • STATUS
    Recruiting
  • End date
    Jun 30, 2026
  • participants needed
    70
  • sponsor
    Eodyne Systems SL
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Updated on 27 March 2026
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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 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.

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"). The PHRASE system aims to counteract this by providing patient-tailored, continuous rehabilitation at home using the Rehabilitation Gaming System (RGS). This integrated approach leverages VR/AR technology, prognostic tools, and data-driven decision-making to improve motor and cognitive function, reduce costs, and enhance patient independence.

The study seeks to validate the effectiveness of the PHRASE system, focusing on its impact on motor and cognitive recovery and its use as a diagnostic and prognostic tool. It hypothesizes that combining the RGS application with conventional therapy will lead to better recovery outcomes compared to conventional therapy alone.

This randomized clinical trial (RCT) will compare the RGS-based intervention to conventional therapy in stroke patients in Spain and Romania. Participants will undergo a six-week intervention involving daily 20-30-minute RGS sessions. Assessments are at baseline, mid-study (3 weeks), end of study (6 weeks) and follow-up (14 weeks). Data will be collected on motor and cognitive function, quality of life, usability, and patient/therapist experiences.

Participants must be stroke survivors (>3 months post-stroke), aged >18, with mild to moderate upper-limb impairment (ARAT <50) and minimal smartphone experience.

The RGS-based PHRASE approach offers a scalable, cost-effective solution for continuous rehabilitation, improving patient recovery, quality of life, and reducing healthcare costs. The study aims to validate its clinical validity in real-world settings.

Details
Condition Stroke, Stroke Rehabilitation, Chronic Stroke Patients, Post Stroke Recovery
Age 18years or above
Clinical Study IdentifierNCT06885502
SponsorEodyne Systems SL
Last Modified on27 March 2026

Eligibility

 Yes No Not Sure

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
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