Telerehabilitation Through Serious Games in Virtual Reality in a Stroke Population (AutoRReVi)

Study Overview
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Brief Summary
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After a stroke, individuals present with motor and/or cognitive impairments. These impairments limit activity, restrict participation and affect quality of life. Therefore, rehabilitation programs are provided from the earliest days. However, an important proportion of patients do not achieve the recommended amount of rehabilitation therapy (even in institutional systems). In fact, patients do not always have access to healthcare systems. Moreover, hospital resources and healthcare systems are often limited (especially in poor countries) which has led to the development of new cost-effective rehabilitation methods such as self-rehabilitation and tele-rehabilitation. This study aims : to develop and validate relevant self-assessments tools in virtual reality to propose auto-adaptative virtual reality-based therapies based on the link between motor and cognitive functions.

Official Title
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Self-assessment and Telerehabilitation Using Virtual Reality Devices and Serious Games to Improve Motor and Cognitive Impairments in Stroke Patients

Conditions
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Stroke, Hemiparesis, Cognitive Impairment, Healthy Subjects

Intervention / Treatment
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* Behavioral: Motor and cognitive virtual reality-based assessments
* Behavioral: Motor and cognitive virtual reality-based serious games


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stroke patients (with hemiparesis or cognitive impairment such as apraxia, aphasia or hemineglect) OR healthy subjects Able to undersand simple instructions Exclusion Criteria: Other disease that could affect upper limb motor function or cognition

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Studies will be conducted in a single group of (a) stroke patients and (b) healthy subjects
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stroke patients<br>Stroke patients with hemiparesis and/or cognitive impairments (such as apraxia, aphasia and hemineglect) | Behavioral: Motor and cognitive virtual reality-based assessments<br>* Motor and cognitive testing in virtual reality<br>Behavioral: Motor and cognitive virtual reality-based serious games<br>* Serious games implemented in virtual reality to rehabilitate motor and cognitive impairments.<br>|
| Experimental: Healthy subjects<br>Subjects who do not suffer from any pathology that could affect upper-limb motor function or cognition | Behavioral: Motor and cognitive virtual reality-based assessments<br>* Motor and cognitive testing in virtual reality<br>Behavioral: Motor and cognitive virtual reality-based serious games<br>* Serious games implemented in virtual reality to rehabilitate motor and cognitive impairments.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Upper Extremity Fugl-Meyer Assessment | Highly recommended scale that assess upper limb motor function (0% = worse outcome; 100% best outcome). | Through study completion, on average 24 weeks | 
| Box and Block Test | A measure of manual dexterity and activity that requires repeatedly moving 1-inch blocks from one side of a box to another in 60 seconds. | Through study completion, on average 24 weeks | 
| The Bells Test | A cancellation task, permits a quantitative and qualitative evaluation of visual neglect | Through study completion, on average 24 weeks | 
| Action Research Arm Test | A 19 item observational measure used by physical therapists and other health care professionals to assess upper extremity performance (coordination, dexterity and functioning). Items are categorized into four subscales (grasp, grip, pinch and gross movement) and arranged in order of decreasing difficulty, with the most difficult task examined first, followed by the least difficult task. Task performance is rated on a 4-point scale, ranging from 0 (no movement) to 3 (movement performed normally). | Through study completion, on average 24 weeks | 
| System Usability Scale | Reliable tool for measuring the usability. It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree | Through study completion, on average 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Upper limb 3D position | Upper limb 3D position will be measured with different virtual reality devices (Oculus Quest, htc Vive, REAtouch). This will be done thanks to the headset's infra-red camera or the controller's inertial measurement units. | Through study completion, on average 24 weeks | 
| Upper limb peak velocity | Upper limb peak velocity will be measured with different virtual reality devices (Oculus Quest, htc Vive, REAtouch). This will be done by deriving 3D position (obtained previously thanks to the headset's infra-red camera or the controller's inertial measurement units) and extracting highest value. | Through study completion, on average 24 weeks | 
| Upper limb smoothness | Upper limb smoothness will be measured with different virtual reality devices (Oculus Quest, htc Vive, REAtouch). This will be done by deriving three times 3D position (obtained previously thanks to the headset's infra-red camera or the controller's inertial measurement units) and converting it to a logarithmic dimensionless jerk. Second option is to measure a spectral arc length (also computed from 3D position) | Through study completion, on average 24 weeks |