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

Not Applicable

Recruiting

• Conditions: Stroke; Stroke Rehabilitation; Chronic Stroke Patients; Post Stroke Recovery

• Registration Number: NCT06885502
• Lead Sponsor: Eodyne Systems SL

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2025-02-21
• Status Verified: 2025-03
• Study First Submitted: 2025-03-06
• Study First Submitted QC: 2025-03-12
• Last Update Submitted: 2025-03-12
• Study First Posted: 2025-03-20
• Last Update Posted: 2025-03-20
• Primary Completion: 2025-08-29
• Study Completion: 2025-08-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Upper Limb Function (Motor Recovery)	Assessments will be conducted at Baseline (T0), End of Treatment (T2, Week 6), and Follow-up (T3, Week 14, 2-months follow-up)	The primary objective of this study is to assess the effect of a mobile technology (RGSapp) intervention on upper limb motor function compared to Standard of Care (SoC). Upper limb function will be evaluated using the Action Research Arm Test (ARAT).; Action Research Arm Test (ARAT) (Lyle, 1981): It is a functional assessment tool comprising 19 items, with a maximum score of 57. These items are organized into four subscales: grasp, grip, pinch, and gross movement. Each item is scored on a 4-point ordinal scale: 0 (cannot perform the task) to 3 (performs the task normally). Higher scores indicate better outcomes, reflecting greater arm function.

Secondary Outcome Measures

Name	Time	Method
Validity of Remote Assessments Using RGSapp	Baseline (T0), End of Treatment (T2, Week 6), Follow-up (T3, Week 14)	This outcome will assess the correlation between remote assessments using RGSapp and standard clinical evaluations of motor and cognitive function. Specifically, performance data collected through RGSapp will be compared with established clinical assessment tools, including the Action Research Arm Test (ARAT), Fugl-Meyer Assessment for Upper Extremity (FMA-UE), and Test for Attentional Performance (TAP) subtests.
Cognitive Function	Baseline (T0), End of Treatment (T2, Week 6), Follow-up (T3, Week 14)	Post-stroke cognitive impairment, particularly deficits in attention, processing speed, executive function, and visual perception, which are key factors in long-term disability \[Lesniak M. et al., 2008\].; Test of Attentional Performance (TAP) (Zimmermann \& Fimm, 2004): It is a comprehensive battery designed to assess various aspects of attentional performance, including sustained attention, selective attention, and cognitive flexibility. It includes multiple subtests, with each scored based on accuracy and response time. Higher scores indicate better attentional capacity, providing detailed insights into different attention processes and cognitive functioning.
Depression and Mood Changes	Baseline (T0), End of Treatment (T2, Week 6), Follow-up (T3, Week 14)	This outcome will assess depression and mood changes using the following validated tool: Hamilton Depression Rating Scale (HDRS) (Hamilton, 1960): It is a clinician-administered questionnaire used to evaluate the severity of depressive symptoms over the previous week, based on a structured or unstructured interview. The scale consists of 17 items, with scores ranging from 0 to 53. Higher scores indicate more severe depression, with 0-7 considered normal, 8-16 indicating mild depression, 17-23 indicating moderate depression, and 24 or above indicating severe depression.
Activity and Participation domain	Baseline (T0), End of Treatment (T2, Week 6), Follow-up (T3, Week 14)	We will further assess the impact of stroke on parameters that strongly influence activity and participation (Activities of daily living, mobility, emotion, strength, and communication). We will use: Quality of Life (EQ-5D-5L) (Devlin \& Brooks, 2017): It is a standardized tool for measuring health-related quality of life. It includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on a 5-point scale (1 - no problems to 5 - extreme problems). The final score is based on the combination of responses across dimensions, with higher scores reflecting better overall quality of life.; Fatigue Severity Scale (FSS) (Krupp et al., 1988): It is a 9-item self-report questionnaire used to assess fatigue severity in individuals with chronic diseases. Each item is rated on a 1 to 7 scale, where 1 indicates no fatigue and 7 represents severe fatigue. Higher scores indicate more severe fatigue.
Usability of RGSapp	End of Treatment (T2, Week 6)	This outcome will assess the usability of the RGSapp using the System Usability Scale (SUS).; System Usability Scale (SUS) (Brooke, 1996): It is a 10-item questionnaire using a five-point Likert scale (Strongly Agree to Strongly Disagree) to assess the usability of products and services, including hardware, software, mobile devices, websites, and applications. Scores range from 0 to 100, with higher scores indicating better usability. A score above 68 is considered above average, below 50 suggests poor usability, and a score above 80 indicates excellent usability.

Trial Locations

Locations (2)

RoNeuro Institute for Neurological Research and Diagnostics; 🇷🇴 Cluj-Napoca, Romania

Hospital Universitari Joan XXIII de Tarragona; 🇪🇸 Tarragona, Spain