RecruitingNot ApplicableNCT06885502

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

Personalised Health Motor and Cognitive Assistance System for RehAbilitation (PHRASE): A Randomized Clinical Trial

Sponsor

Eodyne Systems SL

Enrollment

70 participants

Start Date

Feb 21, 2025

Study Type

INTERVENTIONAL

Conditions

Stroke Rehabilitation Stroke Chronic Stroke Patients Post Stroke Recovery

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria8

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 Criteria4

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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Interventions

DEVICERGS

The standardized intervention schedule consists of 20-30-minute daily training sessions (including weekends) for 6 weeks, in addition to the prescribed conventional therapy (Standard of Care, SoC). Each session includes 4 to 6 exercises, each lasting approximately 5 minutes. To promote variability and engagement, at least one exercise will be replaced every week based on the participant's progress. Participants are encouraged to train more than the prescribed duration if desired. The RGSapp training will take place at home, and patients will use a smartphone. An optional wearable device (smartwatch) will be used to remotely monitor the use of the paretic upper arm for the duration of the trial. Regular check-ins by clinicians will monitor adherence, adjust the intervention if needed, and ensure the participants' safety.