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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-21

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Stroke Stroke Rehabilitation Chronic Stroke Patients Post Stroke Recovery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Due to the nature of the intervention, participants and clinicians involved in the intervention (except those conducting the clinical assessments) will be aware of the group allocation. Outcome assessors conducting the clinical evaluations at T0 (baseline), T2 (end-intervention), and T3 (follow-up) will remain blinded to the group allocation to minimize assessment bias.

Study Groups

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Experimental Group (RGS)

The standardized intervention schedule consists of daily 20-30-minute training sessions with the RGSapp, conducted at home, including weekends, for 6 weeks. This intervention is provided in addition to the prescribed conventional therapy (Standard of Care, SoC).

Group Type EXPERIMENTAL

RGS

Intervention Type DEVICE

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.

Control Group

The control group participants will be assessed at Baseline (T0), Week 6/End of Treatment (T2), and Follow-up at Week 14 (T3). The outcome measures will be the same as in the intervention group, including assessments of motor function, cognitive function, depression, activity participation, usability, and healthcare costs. No VR or AR-based interventions will be provided to the control group during the study period.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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RGS

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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No