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

June 14, 2022 updated by: Université Catholique de Louvain

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
    • Woluwé
      • Brussels, Woluwé, Belgium, 1200
        • Recruiting
        • Cliniques universitaires Saint-Luc
        • Contact:
        • Principal Investigator:
          • Thierry Lejeune, Pr
        • Principal Investigator:
          • Gaëtan Stoquart, Pr
        • Principal Investigator:
          • Martin Edwards, Pr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stroke patients
Stroke patients with hemiparesis and/or cognitive impairments (such as apraxia, aphasia and hemineglect)
Behavioral: Motor and cognitive virtual reality-based assessments
Motor and cognitive testing in virtual reality
Behavioral: Motor and cognitive virtual reality-based serious games
Serious games implemented in virtual reality to rehabilitate motor and cognitive impairments.
Experimental: Healthy subjects
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
Motor and cognitive testing in virtual reality
Behavioral: Motor and cognitive virtual reality-based serious games
Serious games implemented in virtual reality to rehabilitate motor and cognitive impairments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Upper Extremity Fugl-Meyer Assessment
Time Frame: Through study completion, on average 24 weeks
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
Time Frame: 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.
Through study completion, on average 24 weeks
The Bells Test
Time Frame: Through study completion, on average 24 weeks
A cancellation task, permits a quantitative and qualitative evaluation of visual neglect
Through study completion, on average 24 weeks
Action Research Arm Test
Time Frame: 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).
Through study completion, on average 24 weeks
System Usability Scale
Time Frame: 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
Through study completion, on average 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Upper limb 3D position
Time Frame: 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.
Through study completion, on average 24 weeks
Upper limb peak velocity
Time Frame: 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.
Through study completion, on average 24 weeks
Upper limb smoothness
Time Frame: 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)
Through study completion, on average 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université Catholique de Louvain

Collaborators

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

  • Principal Investigator: Thierry Lejeune, MD, PhD, Cliniques universitaires Saint-Luc - UCLouvain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 23, 2020

Primary Completion (Anticipated)

August 30, 2022

Study Completion (Anticipated)

October 15, 2022

Study Registration Dates

First Submitted

November 26, 2020

First Submitted That Met QC Criteria

January 4, 2021

First Posted (Actual)

January 5, 2021

Study Record Updates

Last Update Posted (Actual)

June 15, 2022

Last Update Submitted That Met QC Criteria

June 14, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ROBIGAME
  • 1810108 (Other Grant/Funding Number: Région Wallonne - Economié Emploi Recherche - Win2Wal)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on Motor and cognitive virtual reality-based assessments

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe