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

Sponsor
Université Catholique de Louvain (Other)
Overall Status
Recruiting
CT.gov ID
NCT04694833
Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain (Other)
400
1
2
23.7
16.9

Study Details

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 :
  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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Motor and cognitive virtual reality-based assessments
  • Behavioral: Motor and cognitive virtual reality-based serious games
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Studies will be conducted in a single group of (a) stroke patients and (b) healthy subjectsStudies will be conducted in a single group of (a) stroke patients and (b) healthy subjects
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Self-assessment and Telerehabilitation Using Virtual Reality Devices and Serious Games to Improve Motor and Cognitive Impairments in Stroke Patients
Actual Study Start Date :
Oct 23, 2020
Anticipated Primary Completion Date :
Aug 30, 2022
Anticipated Study Completion Date :
Oct 15, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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).

  2. 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.

  3. The Bells Test [Through study completion, on average 24 weeks]

    A cancellation task, permits a quantitative and qualitative evaluation of visual neglect

  4. 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).

  5. 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

Secondary Outcome Measures

  1. 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.

  2. 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.

  3. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cliniques universitaires Saint-Luc Brussels Woluwé Belgium 1200

Sponsors and Collaborators

  • Université Catholique de Louvain
  • Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT04694833
Other Study ID Numbers:
  • ROBIGAME
  • 1810108
First Posted:
Jan 5, 2021
Last Update Posted:
Jun 15, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 15, 2022