StrokeAutoRReViNCT04694833
Telerehabilitation Through Serious Games in Virtual Reality in a Stroke Population (AutoRReVi)
A study testing Motor and cognitive virtual reality-based assessments and Motor and cognitive virtual reality-based serious games in people with Stroke and Hemiparesis, run by Université Catholique de Louvain at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Hemiparesis, Cognitive Impairment
- What is being tested?
- Motor and cognitive virtual reality-based assessments and Motor and cognitive virtual reality-based serious games
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteBelgium
- Study dates
- 23 Oct 2020to 15 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Stroke patients (with hemiparesis or cognitive impairment such as apraxia, aphasia or hemineglect) OR healthy subjects
- Able to undersand simple instructions
Who cannot join
- Other disease that could affect upper limb motor function or cognition
Trial locations and contacts
1 site in 1 country.
Khawla Ajana, MSc contact
Belgium1 site, 1 recruiting
- Recruiting
Cliniques universitaires Saint-Luc
Brussels, Woluwé, 1200
Thierry Lejeune, Pr, thierry.lejeune@uclouvain.be
Thierry Lejeune, Pr
About this study
Official title: 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 :
- 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.
- Conditions
- Stroke, Hemiparesis, Cognitive Impairment, Healthy Subjects
- Being tested
- Motor and cognitive virtual reality-based assessments, Motor and cognitive virtual reality-based serious games
- Medical subject headings
- Stroke, Paresis, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor and cognitive virtual reality-based assessmentsBehavioural
Motor and cognitive testing in virtual reality
Motor and cognitive virtual reality-based serious gamesBehavioural
Serious games implemented in virtual reality to rehabilitate motor and cognitive impairments.
| Study group | Role | What they receive |
|---|---|---|
| Stroke patients | Experimental | Stroke patients with hemiparesis and/or cognitive impairments (such as apraxia, aphasia and hemineglect) Receives: Behavioral: Motor and cognitive virtual reality-based assessments; Behavioral: Motor and cognitive virtual reality-based serious games |
| Healthy subjects | Experimental | Subjects who do not suffer from any pathology that could affect upper-limb motor function or cognition Receives: Behavioral: Motor and cognitive virtual reality-based assessments; Behavioral: Motor and cognitive virtual reality-based serious games |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper Extremity Fugl-Meyer Assessment
Highly recommended scale that assess upper limb motor function (0% = worse outcome; 100% best outcome).
Measured: Through study completion, on average 24 weeks
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.
Measured: Through study completion, on average 24 weeks
The Bells Test
A cancellation task, permits a quantitative and qualitative evaluation of visual neglect
Measured: Through study completion, on average 24 weeks
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).
Measured: Through study completion, on average 24 weeks
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
Measured: Through study completion, on average 24 weeks
Secondary outcomes (3)
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.
Measured: Through study completion, on average 24 weeks
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.
Measured: Through study completion, on average 24 weeks
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)
Measured: Through study completion, on average 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start23 Oct 2020
- Primary completion30 Aug 2022 (estimated)
- Study completion15 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Studies will be conducted in a single group of (a) stroke patients and (b) healthy subjects
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thierry Lejeune, MD, PhD, Principal investigator, Cliniques universitaires Saint-Luc - UCLouvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04694833
- Sponsor's protocol ID
- ROBIGAME
- Other IDs
- 1810108
- Acronym
- AutoRReVi
- Status last verified
- Jun 2022
- First submitted
- 26 Nov 2020
- Last updated
- 15 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 41408291Everard 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 40053708Ajana 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 39973878Everard 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 38491540Burton 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 36463219Everard 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-assessment and Telerehabilitation Using Virtual Reality Devices and Serious Games to Improve Motor and Cognitive Impairments in Stroke Patients
- ClinicalTrials.gov ID
- NCT04694833
- Acronym / sponsor ID
- AutoRReVi / ROBIGAME
- Conditions
- Stroke, Hemiparesis, Cognitive Impairment, Healthy Subjects
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Collaborators
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Study start
- 23 Oct 2020 (actual)
- Primary completion
- 30 Aug 2022 (estimated)
- Study completion
- 15 Oct 2022 (estimated)
- First posted
- 5 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Studies will be conducted in a single group of (a) stroke patients and (b) healthy subjects
| Arm | Type | Receives |
|---|---|---|
| Stroke patients | Experimental | Behavioral: Motor and cognitive virtual reality-based assessments, Behavioral: Motor and cognitive virtual reality-based serious gamesStroke patients with hemiparesis and/or cognitive impairments (such as apraxia, aphasia and hemineglect) |
| Healthy subjects | Experimental | Behavioral: Motor and cognitive virtual reality-based assessments, Behavioral: Motor and cognitive virtual reality-based serious gamesSubjects who do not suffer from any pathology that could affect upper-limb motor function or cognition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Stroke patients (with hemiparesis or cognitive impairment such as apraxia, aphasia or hemineglect) OR healthy subjects
- Able to undersand simple instructions
Key exclusion criteria (1 listed)
- Other disease that could affect upper limb motor function or cognition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motor and cognitive virtual reality-based assessmentsMotor and cognitive testing in virtual reality | Behavioural | Healthy subjects, Stroke patients |
| Motor and cognitive virtual reality-based serious gamesSerious games implemented in virtual reality to rehabilitate motor and cognitive impairments. | Behavioural | Healthy subjects, Stroke patients |
Primary outcome
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).
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.
The Bells Test
Time frame: Through study completion, on average 24 weeks
A cancellation task, permits a quantitative and qualitative evaluation of visual neglect
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).
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
3 secondary outcomes
Upper limb 3D position
Time frame: Through study completion, on average 24 weeks
Upper limb peak velocity
Time frame: Through study completion, on average 24 weeks
Upper limb smoothness
Time frame: Through study completion, on average 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
- Derived from this study: PubMed 41408291Sorrentino 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.
- Derived from this study: PubMed 40053708Everard 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.
- Derived from this study: PubMed 39973878Ajana 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.
- Derived from this study: PubMed 38491540Everard 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.
- Derived from this study: PubMed 36463219Burton 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.
- Derived from this study: PubMed 35065678Everard 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Khawla Ajana, MSc contact
Thierry Lejeune, MD, PhD principal investigator
Cliniques universitaires Saint-Luc - UCLouvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor and cognitive virtual reality-based assessments and Motor and cognitive virtual reality-based serious games in people with Stroke and Hemiparesis, run by Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gauthier Everard, MSc, PT (+32472500158, gauthier.everard@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper Extremity Fugl-Meyer Assessment (time frame: Through study completion, on average 24 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04694833, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2022.