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

Not Applicable

• Conditions: Stroke; Cognitive Impairment; Healthy Subjects; Hemiparesis
• Interventions: Behavioral: Motor and cognitive virtual reality-based assessments; Behavioral: Motor and cognitive virtual reality-based serious games

• Registration Number: NCT04694833
• Lead Sponsor: Université Catholique de Louvain

Brief Summary

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 :

1. to develop and validate relevant self-assessments tools in virtual reality

2. to propose auto-adaptative virtual reality-based therapies based on the link between motor and cognitive functions.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-23
• Study First Submitted: 2020-11-26
• Study First Submitted QC: 2021-01-04
• Study First Posted: 2021-01-05
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-14
• Last Update Posted: 2022-06-15
• Primary Completion: 2022-08-30
• Study Completion: 2022-10-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy subjects	Motor and cognitive virtual reality-based assessments	Subjects who do not suffer from any pathology that could affect upper-limb motor function or cognition
Stroke patients	Motor and cognitive virtual reality-based assessments	Stroke patients with hemiparesis and/or cognitive impairments (such as apraxia, aphasia and hemineglect)
Stroke patients	Motor and cognitive virtual reality-based serious games	Stroke patients with hemiparesis and/or cognitive impairments (such as apraxia, aphasia and hemineglect)
Healthy subjects	Motor and cognitive virtual reality-based serious games	Subjects who do not suffer from any pathology that could affect upper-limb motor function or cognition

Primary Outcome Measures

Name	Time	Method
Upper Extremity Fugl-Meyer Assessment	Through study completion, on average 24 weeks	Highly recommended scale that assess upper limb motor function (0% = worse outcome; 100% best outcome).
The Bells Test	Through study completion, on average 24 weeks	A cancellation task, permits a quantitative and qualitative evaluation of visual neglect
System Usability Scale	Through study completion, on average 24 weeks	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
Box and Block Test	Through study completion, on average 24 weeks	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.
Action Research Arm Test	Through study completion, on average 24 weeks	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).

Secondary Outcome Measures

Name	Time	Method
Upper limb 3D position	Through study completion, on average 24 weeks	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.
Upper limb peak velocity	Through study completion, on average 24 weeks	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.
Upper limb smoothness	Through study completion, on average 24 weeks	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)

Trial Locations

Locations (1)

Cliniques universitaires Saint-Luc; 🇧🇪 Brussels, Woluwé, Belgium