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

Primary Purpose

Stroke, Hemiparesis, Cognitive Impairment

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Motor and cognitive virtual reality-based assessments
Motor and cognitive virtual reality-based serious games
Sponsored by
Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Cliniques universitaires Saint-LucRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Stroke patients

Healthy subjects

Arm Description

Stroke patients with hemiparesis and/or cognitive impairments (such as apraxia, aphasia and hemineglect)

Subjects who do not suffer from any pathology that could affect upper-limb motor function or cognition

Outcomes

Primary Outcome Measures

Upper Extremity Fugl-Meyer Assessment
Highly recommended scale that assess upper limb motor function (0% = worse outcome; 100% best outcome).
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.
The Bells Test
A cancellation task, permits a quantitative and qualitative evaluation of visual neglect
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).
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

Secondary Outcome Measures

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.
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.
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)

Full Information

First Posted
November 26, 2020
Last Updated
June 14, 2022
Sponsor
Université Catholique de Louvain
Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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1. Study Identification

Unique Protocol Identification Number
NCT04694833
Brief Title
Telerehabilitation Through Serious Games in Virtual Reality in a Stroke Population (AutoRReVi)
Acronym
AutoRReVi
Official Title
Self-assessment and Telerehabilitation Using Virtual Reality Devices and Serious Games to Improve Motor and Cognitive Impairments in Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 23, 2020 (Actual)
Primary Completion Date
August 30, 2022 (Anticipated)
Study Completion Date
October 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Université Catholique de Louvain
Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 : 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiparesis, Cognitive Impairment, Healthy Subjects

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Studies will be conducted in a single group of (a) stroke patients and (b) healthy subjects
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stroke patients
Arm Type
Experimental
Arm Description
Stroke patients with hemiparesis and/or cognitive impairments (such as apraxia, aphasia and hemineglect)
Arm Title
Healthy subjects
Arm Type
Experimental
Arm Description
Subjects who do not suffer from any pathology that could affect upper-limb motor function or cognition
Intervention Type
Behavioral
Intervention Name(s)
Motor and cognitive virtual reality-based assessments
Intervention Description
Motor and cognitive testing in virtual reality
Intervention Type
Behavioral
Intervention Name(s)
Motor and cognitive virtual reality-based serious games
Intervention Description
Serious games implemented in virtual reality to rehabilitate motor and cognitive impairments.
Primary Outcome Measure Information:
Title
Upper Extremity Fugl-Meyer Assessment
Description
Highly recommended scale that assess upper limb motor function (0% = worse outcome; 100% best outcome).
Time Frame
Through study completion, on average 24 weeks
Title
Box and Block Test
Description
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.
Time Frame
Through study completion, on average 24 weeks
Title
The Bells Test
Description
A cancellation task, permits a quantitative and qualitative evaluation of visual neglect
Time Frame
Through study completion, on average 24 weeks
Title
Action Research Arm Test
Description
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).
Time Frame
Through study completion, on average 24 weeks
Title
System Usability Scale
Description
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
Time Frame
Through study completion, on average 24 weeks
Secondary Outcome Measure Information:
Title
Upper limb 3D position
Description
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.
Time Frame
Through study completion, on average 24 weeks
Title
Upper limb peak velocity
Description
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.
Time Frame
Through study completion, on average 24 weeks
Title
Upper limb smoothness
Description
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)
Time Frame
Through study completion, on average 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gauthier Everard, MSc, PT
Phone
+32472500158
Email
gauthier.everard@uclouvain.be
First Name & Middle Initial & Last Name or Official Title & Degree
Khawla Ajana, MSc
Email
khawla.ajana@uclouvain.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thierry Lejeune, MD, PhD
Organizational Affiliation
Cliniques universitaires Saint-Luc - UCLouvain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cliniques universitaires Saint-Luc
City
Brussels
State/Province
Woluwé
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thierry Lejeune, Pr
Email
thierry.lejeune@uclouvain.be
First Name & Middle Initial & Last Name & Degree
Thierry Lejeune, Pr
First Name & Middle Initial & Last Name & Degree
Gaëtan Stoquart, Pr
First Name & Middle Initial & Last Name & Degree
Martin Edwards, Pr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35065678
Citation
Everard G, Otmane-Tolba Y, Rosselli Z, Pellissier T, Ajana K, Dehem S, Auvinet E, Edwards MG, Lebleu J, Lejeune T. Concurrent validity of an immersive virtual reality version of the Box and Block Test to assess manual dexterity among patients with stroke. J Neuroeng Rehabil. 2022 Jan 22;19(1):7. doi: 10.1186/s12984-022-00981-0.
Results Reference
derived

Learn more about this trial

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

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