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Status unknownNCT04694833AutoRReViUpdated Jun 15, 2022

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

An interventional study of Motor and cognitive virtual reality-based assessments and Motor and cognitive virtual reality-based serious games in Stroke, Hemiparesis and Cognitive Impairment, sponsored by Université Catholique de Louvain. Status unknown at 1 site in Belgium. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-15.

Sponsored by Université Catholique de Louvain · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
400
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.
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Conditions studied

  • Stroke
  • Hemiparesis
  • Cognitive Impairment
  • Healthy Subjects
03

In context

Stroke

7,441 studies on the registry are indexed under Stroke; 2,012 are open to participants now.

This study's planned enrollment of 400 is above the median of 50 across 5,482 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Université Catholique de Louvain is the lead sponsor of 151 studies on the registry; 57 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Other disease that could affect upper limb motor function or cognition
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
400 participants (estimated)

Study arms

  • 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 · Behavioral: Motor and cognitive virtual reality-based serious games

  • 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 · Behavioral: Motor and cognitive virtual reality-based serious games

Interventions

  • BehavioralMotor and cognitive virtual reality-based assessments

    Motor and cognitive testing in virtual reality

  • BehavioralMotor and cognitive virtual reality-based serious games

    Serious games implemented in virtual reality to rehabilitate motor and cognitive impairments.

06

What researchers measure

Primary outcomes

  1. Upper Extremity Fugl-Meyer Assessment

    Highly recommended scale that assess upper limb motor function (0% = worse outcome; 100% best outcome).

    Time frame: Through study completion, on average 24 weeks

  2. 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.

    Time frame: Through study completion, on average 24 weeks

  3. The Bells Test

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

    Time frame: Through study completion, on average 24 weeks

  4. 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).

    Time frame: Through study completion, on average 24 weeks

  5. 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

    Time frame: Through study completion, on average 24 weeks

Secondary outcomes

  1. 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.

    Time frame: Through study completion, on average 24 weeks

  2. 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.

    Time frame: Through study completion, on average 24 weeks

  3. 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)

    Time frame: Through study completion, on average 24 weeks

07

Study locations

1 of 1 sites recruiting
  • Cliniques universitaires Saint-Luc
    Brussels, Woluwé 1200, Belgium
    • Thierry Lejeune, Pr · Contact · thierry.lejeune@uclouvain.be
    • Thierry Lejeune, Pr · Principal investigator
    • Gaëtan Stoquart, Pr · Principal investigator
    • Martin Edwards, Pr · Principal investigator
    Recruiting
08

References and documents

Publications

  • Sorrentino G, Edwards MG, Baldini N, Mustile M, Lejeune T, Everard G. REAsmash-ET: a methodological framework for combined cognitive and motor assessment through eye-tracking and kinematic metrics in immersive VR search-and-reach task. J Neuroeng Rehabil. 2025 Dec 17;23(1):25. doi: 10.1186/s12984-025-01844-0. PubMed 41408291 ↗
  • Everard G, Declerck L, Lejeune T, Edwards MG, Bogacki J, Reiprich C, Delvigne K, Legrain N, Batcho CS. A Self-Adaptive Serious Game to Improve Motor Learning Among Older Adults in Immersive Virtual Reality: Short-Term Longitudinal Pre-Post Study on Retention and Transfer. JMIR Aging. 2025 Mar 3;8:e64004. doi: 10.2196/64004. PubMed 40053708 ↗
  • Ajana K, Everard G, Lejeune T, Edwards MG. An immersive virtual reality serious game set for the clinical assessment of spatial attention impairments: Effects of avatars on perspective? Technol Health Care. 2025 Jul;33(4):1626-1644. doi: 10.1177/09287329241296380. Epub 2025 Jan 17. PubMed 39973878 ↗
  • Everard G, Burton Q, Van de Sype V, Bibentyo TN, Auvinet E, Edwards MG, Batcho CS, Lejeune T. Extended reality to assess post-stroke manual dexterity: contrasts between the classic box and block test, immersive virtual reality with controllers, with hand-tracking, and mixed-reality tests. J Neuroeng Rehabil. 2024 Mar 15;21(1):36. doi: 10.1186/s12984-024-01332-x. PubMed 38491540 ↗
  • Burton Q, Lejeune T, Dehem S, Lebrun N, Ajana K, Edwards MG, Everard G. Performing a shortened version of the Action Research Arm Test in immersive virtual reality to assess post-stroke upper limb activity. J Neuroeng Rehabil. 2022 Dec 3;19(1):133. doi: 10.1186/s12984-022-01114-3. PubMed 36463219 ↗
  • 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. PubMed 35065678 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04694833
Responsible party
Sponsor
First posted
Jan 5, 2021
Start date
Oct 23, 2020
Primary completion
Aug 30, 2022 (estimated)
Completion
Oct 15, 2022 (estimated)
Last update
Jun 15, 2022

Study contacts

Gauthier Everard, MSc, PT
Contact
gauthier.everard@uclouvain.be
+32472500158
Khawla Ajana, MSc
Contact
khawla.ajana@uclouvain.be
Thierry Lejeune, MD, PhD
principal investigator · Cliniques universitaires Saint-Luc - UCLouvain

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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