Personalised Health Motor and Cognitive Assistance System for RehAbilitation (PHRASE)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEodyne Systems SL
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
RGS
DeviceThe 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.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Experimental Group (RGS)Experimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Upper Limb Function (Motor Recovery)
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.
Time frame
Assessments will be conducted at Baseline (T0), End of Treatment (T2, Week 6), and Follow-up (T3, Week 14, 2-months follow-up)Secondary outcomes
1
Cognitive Function
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.
Time frame
Baseline (T0), End of Treatment (T2, Week 6), Follow-up (T3, Week 14)2
Depression and Mood Changes
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.
Time frame
Baseline (T0), End of Treatment (T2, Week 6), Follow-up (T3, Week 14)3
Activity and Participation domain
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.
Time frame
Baseline (T0), End of Treatment (T2, Week 6), Follow-up (T3, Week 14)4
Usability of RGSapp
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.
Time frame
End of Treatment (T2, Week 6)Sponsors and contacts
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Source ClinicalTrials.gov