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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Université Catholique de Louvain

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 23, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 26, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 15, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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