StrokeVIRGILNCT04911738
VIrtual Reality Glasses Use to Improve Lateropulsion and the Post-stroke Postural Vertical
A study testing Virtual Reality , immersion in a virtual titlted room in people with Stroke and Brain Diseases, run by University Hospital, Grenoble at 1 site in France.
Trial summary
VIRGIL is a monocentric interventional study aiming to investigate the effect of immersion in a virtual tilted room on modulation of the verticality representation (postural vertical [PV] and visual vertical [VV]), which in turn might affect body orientation (head and trunk). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Brain Diseases, Cerebrovascular Disorders
- What is being tested?
- Virtual Reality , immersion in a virtual titlted room
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jun 2021to 30 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 20 stroke participants
- Hospitalized in neurorehabilitation
- Hemisphere stroke (Right or left)
- Stroke delay < 6 months
- Presence of lateropulsion assessed by the Scale for Contraversive Pushing (SCP) > 0.5
- 20 healthy participants
Show all 9Show fewer
- No history of stroke or others neurological pathologies
- No balance disorders
- No history of vestibular or dizzissness disorders
Who cannot join
- All
- History of psychiatric disorders
- Nyctophobia
- Advanced heart failure
- Severe trunk deformation with C7 lateral > 30 mm due to a independant cause beyond the stroke (i.e., scoliosis) or history of postural disorder
- 20 Stroke participants
Show all 12Show fewer
- Medical instability making the assessment impossible
- Comprehension deficits with Boston Diagnostic Aphasia Examination gravity score ≥3
- History of vestibular or dizzissness disorders
- No previous neurological history interfering with balance
- Inability to understand and execute simple orders
- Severe untreated depression (Aphasic Depression Rating Scale (ADRS) score >15)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
University Hospital Grenoble
Grenoble, 38000
Dominic Perennou, dperennou@chu-grenoble.fr
About this study
Official title: VIrtual Reality Glasses Use to Improve Lateropulsion and the Post-stroke Postural Vertical (VIRGIL)
VIRGIL is a monocentric interventional study aiming to investigate the effect of immersion in a virtual tilted room on modulation of the verticality representation (postural vertical [PV] and visual vertical [VV]), which in turn might affect body orientation (head and trunk). To this end, the investigators will conduct a within-person randomized trial including post-stroke patients and healthy participants.
Read the detailed description
This project proposes to test the effect of immersion in a tilted virtual reality on verticality representation in hemisphere stroke patients showing lateropulsion and in healthy participants. The idea is to use the virtual reality as a tool to recalibrate the internal reference of verticality (contralesionally biased) in stroke patients and to experimentally create a bias in verticality perception of healthy participants, then to investigate how this modulation of the internal model of verticality might affect the erect posture. The investigators hypothesize that, in stroke patients, the recalibration of the verticality perception might ameliorate their lateropulsion, whereas in healthy participants, the experimental verticality bias introduced might induce a transient experimental lateropulsion. A transmodal modulation of the verticality perception, both on PV and VV, would imply a modulation by the virtual reality not only at the level of perception but also at the internal model of verticality, advocating for a powerful effect of this technology. The analysis of a post-effect (on verticality perception) that would continue after the intervention (immersion in the virtual titled room) would be a supplementary argument advocating for its clinical use in rehabilitation of post-stroke lateropulsion. To judge the effect of the immersion in tilted virtual reality, the following measures will be considered: (a) PV perception, (b) VV perception, (c) body orientation measured by inertial captors, and (d) weight-bearing asymmetry in erect posture assessed by posturography.
- Being tested
- Virtual Reality , immersion in a virtual titlted room
- Keywords
- Lateropulsion, Verticality representation, Virtual reality, Rehabilitation
- Medical subject headings
- Stroke, Brain Diseases, Cerebrovascular Disorders, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality , immersion in a virtual titlted roomOther
The immersion in virtual reality will be based on the HTC VIVE® device and the software developed by the Virtualis Society.
| Study group | Role | What they receive |
|---|---|---|
| Plane A for the cross-over (Immersion in a virtual tilted room) | Experimental | Half of participants will perform the experiment according the plane A, which corresponds to the following order: verticality perception (Baseline, effect during the intervention, post-effect), then active vertical body orientation (Baseline, effect during the intervention). The intervention is an immersion in a virtual static and tilted environnement (18°).
During the intervention, participants will be immersed in a virtual tilted room for 15 minutes (after 5 minutes of pre -installation adjustments), then verticality perception or active body orientation assessments are performed while the participant is still virtually immersed (approximately 25 minutes). Participants will be immersed in a tilted virtual room for 45 minutes each day. Receives: Other: Virtual Reality , immersion in a virtual titlted room |
| Plane B for the cross-over (Immersion in a virtual tilted room) | Experimental | Half of participants will perform the experiment according the plane B, which corresponds to the following order: active vertical body orientation (Baseline, effect during the intervention), then verticality perception (Baseline, effect during the intervention, post-effect). The intervention is an immersion in a virtual static and tilted environnement (18°).
During the intervention, participants will be immersed in a virtual tilted room for 15 minutes (after 5 minutes of pre -installation adjustments), then verticality perception or active body orientation assessments are performed while the participant is still virtually immersed (approximately 25 minutes). Participants will be immersed in a tilted virtual room for 45 minutes each day. Receives: Other: Virtual Reality , immersion in a virtual titlted room |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the postural perception of the vertical (PV) before and during the immersion in a virtual tilted room, in stroke and healthy participants.
PV consists of testing the whole body orientation in sitting, perceived as vertical by participants, in complete darkness. PV will be tested by a well-validated apparatus and paradigm (Pérennou et al Brain 2008). PV orientation will be the average orientation (in degree) of the 10 trials performed for each condition.
Measured: Days 1 and 3 if assignment to plane A or days 2 and 4 if assignment to plane B of the W2
Secondary outcomes (16)
Changes in the visual perception of the vertical (VV) before and during the immersion in a virtual tilted room, in stroke and healthy participants.
VV consists of testing the direction of a visual line, perceived as vertical by particpants, in complete darkness. VV will be tested by a well-validated apparatus and paradigm (Pérennou et al Brain 2008 ; Piscicelli \& Pérennou 2017). VV orientation will be the average orientation (in degree) of the 10 trials performed for each condition.
Measured: Days 1 and 3 if assignment to plane A or days 2 and 4 if assignment to plane B of the W2
Post-effect on PV. Change from baseline in PV orientation that continues after the immersion in virtual reality, in stroke and healthy participants.
Persistence of PV improvement in stroke participants and persistence of PV change in healthy participants, for at least 20 minutes after the virtual reality is stopped until a maximum of 1 hour.
Measured: Days 1 and 3 if assignment to plane A or days 2 and 4 if assignment to plane B of the W2
Post-effect on VV. Change from baseline in VV orientation that continues after the immersion in virtual reality, in stroke and healthy participants.
Persistence of VV improvement in stroke participants and persistence VV change in healthy participants, for at least 20 minutes after the virtual reality is stopped until a maximum of 1 hour.
Measured: Days 1 and 3 if assignment to plane A or days 2 and 4 if assignment to plane B of the W2
Modulation of active vertical trunk orientation. Change from baseline in active vertical trunk orientation assessed by inertial captors during the modulation of the internal model of verticality by virtual reality, in stroke and healthy participants.
Comparison between active vertical trunk orientation assessed by inertial captors at baseline and active vertical trunk orientation during the virtual reality immersion.
Measured: Days 2 and 4 if assignment to plane A or days 1 and 3 if assignment to plane B of the W2
Modulation of active vertical pelvis orientation. Change from baseline in active vertical trunk orientation assessed by inertial captors during the modulation of the internal model of verticality by virtual reality, in stroke and healthy participants.
Comparison between active vertical pelvis orientation assessed by inertial captors at baseline and active vertical pelvis orientation during the virtual reality immersion.
Measured: Days 2 and 4 if assignment to plane A or days 1 and 3 if assignment to plane B of the W2
Modulation of active vertical head orientation. Change from baseline in active vertical head orientation assessed by inertial captors during the modulation of the internal model of verticality by virtual reality, in stroke and healthy participants.
Comparison between active vertical head orientation assessed by inertial captors at baseline and active vertical head orientation during the virtual reality immersion.
Measured: Days 2 and 4 if assignment to plane A or days 1 and 3 if assignment to plane B of the W2
Effect on lateropulsion. Change from baseline in lateropulsion scores assessed by the SCAle for LAteropulsion after 4 consecutive half days of verticality referential recalibration by virtual reality, in stroke participants.
Comparison of lateropulsion scores assessed by the SCAle for LAteropulsion (SCALA-scale, score from 0 (no lateropulsion) to 50 (severe lateropulsion with pushing); higher scores mean a worse outcome) at the end of each week (Fridays).
Measured: 45 minutes every Friday during the protocol (W0, W1, W2, W3).
Effect on postural capacities. Change from baseline in balance scores assessed by the modified Postural Assessment Scale for Stroke patient after 4 consecutive half days of verticality referential recalibration by virtual reality, in stroke participants
Comparison of balance scores assessed by the modified Postural Assessment Scale for Stroke patient (m-PASS, score from 0 (major postural disorders) to 36 (no postural disorder), higher scores mean a worse outcome) at the end of each week (Fridays).
Measured: 45 minutes every Friday during the protocol (W0, W1, W2, W3).
Responders to virtual reality. Proportion of participants in whom the immersion in a virtual tilted room modulates PV (at least 2 degrees).
Number of participants, stroke and healthy, in whom a change from baseline ≥ 2 degrees in PV orientation was observed during immersion in a virtual tilted room. The investigators hypothesize that the majority of participants (stroke and healthy) will be responders
Measured: Days 1 and 3 if assignment to plane A or days 2 and 4 if assignment to plane B of the W2
Changes in weight-bearing asymmetry. Evaluation of changes in weight-bearing asymmetry in standing posture before and during the immersion in a virtual tilted room, in stroke and healthy participants.
Weight-bearing asymmetry assessed by posturography at baseline and during virtual reality, in patients and healthy participants. Comparison of both conditions.
Measured: Days 2 and 4 if assignment to plane A or days 1 and 3 if assignment to plane B of the W2
Awareness of the changes in active vertical body orientation. Evaluation of participants' awareness of the changes in body orientation and balance in standing posture induced by virtual reality.
Perception of the body orientation change under virtual reality assessed by a 5-point Likert scale (ad-hoc scale, score from -2 [perception of a higher lateropulsion] to + 2 [perception of a less severe lateropulsion])
Measured: Days 2 and 4 if assignment to plane A or days 1 and 3 if assignment to plane B of the W2
Relationship between the trunk tilt (assessed by inertial captors, in degrees) and the weight bearing on the paretic side (in percentage of body weight), at baseline, with average values (2 sessions)
Active vertical body orientation measures and weight-bearing asymetry before virtual reality.
Measured: Days 2 and 4 if assignment to plane A or days 1 and 3 if assignment to plane B of the W2
Relationship between the trunk tilt (assessed by inertial captors, in degrees) and the weight bearing on the paretic side (in percentage of body weight), during the virtual reality, with average values (2 sessions).
Active vertical body orientation measures and weight-bearing asymetry during virtual reality.
Measured: Days 2 and 4 if assignment to plane A or days 1 and 3 if assignment to plane B of the W2
Quantification of a possible Virtual reality sickness.
Systematic evaluation of virtual reality sickness with a visual analogical scale (ad-hoc scale, from 0 to 10, higher scores mean a worse outcome).
Measured: Days 1, 2, 3 and 4 of the W2
Description of symptoms in case of Virtual reality sickness.
Systematic evaluation of virtual reality sickness with a structured interview.
Measured: Days 1, 2, 3 and 4 of the W2
Influence of verbal instruction on standing posture
Active vertical body orientation measures under three verbal conditions: : i) stand comfortably; ii) stand vertical and then iii) stand well symmetrical by distributing the weight equally between the two lower limbs.
Measured: Days 1, 2, 3 and 4 of the W2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start15 Jun 2021
- Primary completion31 Mar 2026 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Randomised
- Intervention model
- Crossover
- Model description
- * 20 stroke participants perform the experiment over 4 weeks (W0, W1, W2, W3). W0 and W1 are devoted to clinical assessments of lateropulsion, balance disorders and other clinical deficits post-stroke. W2 is devoted to the intervention over 4 consecutive half days: 2 for the verticality perception assessments (PV, VV), and 2 for concomitant assessments of lateral body orientation (by inertial captors) and weight-bearing asymmetry (by posturography). These 4 tests are performed before and during virtual reality. A post-effect is investigated only for PV and VV. Each patient is randomly assigned to one of the two following planes: plane A (PV/VV assessment on days 1 and 3 and postural assessment on days 2 and 4) or plane B (postural assessment on days 1 and 3 and PV/VV assessment on days 2 and 4).The W3 is devoted to conventional rehabilitation with only assessment of lateropulsion and balance on Friday (as each week of this protocol). * 20 controls perform the same experiment on 2 days.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Paul Bennetot
- Responsible party
- Sponsor
- Investigators
- Dominic Pérennou, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04911738
- Sponsor's protocol ID
- 2020-A02941-38
- Acronym
- VIRGIL
- Status last verified
- May 2025
- First submitted
- 27 Apr 2021
- Last updated
- 21 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data that support the findings of this study are available from the corresponding author, upon reasonable request, only for authorized research. Their use is subjected to an agreement with the promotor (CHU Grenoble Alpes) and the principal investigator (Pr Dominic Pérennou) of the VIRGIL study. Pseudonymised data that support the findings of this study are available from the promotor (CHU Grenoble Alpes) upon reasonable request, subject to a specific agreement with the promotor (involving the principal investigator) and subject to regulatory proceedings due to data protection applicable laws. Access conditions are to be determined depending on the nature of the request
Publications
Perennou DA, Mazibrada G, Chauvineau V, Greenwood R, Rothwell J, Gresty MA, Bronstein AM. Lateropulsion, pushing and verticality perception in hemisphere stroke: a causal relationship? Brain. 2008 Sep;131(Pt 9):2401-13. doi: 10.1093/brain/awn170. Epub 2008 Aug 4.
PubMed 18678565Piscicelli C, Perennou D. Visual verticality perception after stroke: A systematic review of methodological approaches and suggestions for standardization. Ann Phys Rehabil Med. 2017 Jun;60(3):208-216. doi: 10.1016/j.rehab.2016.02.004. Epub 2016 Apr 11.
PubMed 27079584Odin A, Faletto-Passy D, Assaban F, Perennou D. Modulating the internal model of verticality by virtual reality and body-weight support walking: A pilot study. Ann Phys Rehabil Med. 2018 Sep;61(5):292-299. doi: 10.1016/j.rehab.2018.07.003. Epub 2018 Jul 19.
PubMed 30031891Dai S, Piscicelli C, Clarac E, Baciu M, Hommel M, Perennou D. Balance, Lateropulsion, and Gait Disorders in Subacute Stroke. Neurology. 2021 Apr 27;96(17):e2147-e2159. doi: 10.1212/WNL.0000000000011152. Epub 2020 Nov 11.
PubMed 33177223Dehem S, Piscicelli C, Lhommee E, Gimat R, Dai S, Marquer A, Hugues A, Perennou D. Modulating verticality representation and uprightness by virtual reality: rationale and protocol for a within-person randomised intervention associating a basic study in healthy individuals and a pilot clinical trial in individuals exhibiting post-stroke lateropulsion (VIRGIL). BMJ Open. 2025 Jun 18;15(6):e092406. doi: 10.1136/bmjopen-2024-092406.
PubMed 40533218
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VIrtual Reality Glasses Use to Improve Lateropulsion and the Post-stroke Postural Vertical (VIRGIL)
- ClinicalTrials.gov ID
- NCT04911738
- Acronym / sponsor ID
- VIRGIL / 2020-A02941-38
- Keywords
- Lateropulsion, Verticality representation, Virtual reality, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Fondation Paul Bennetot
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 3 Jun 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.
VIRGIL is a monocentric interventional study aiming to investigate the effect of immersion in a virtual tilted room on modulation of the verticality representation (postural vertical [PV] and visual vertical [VV]), which in turn might affect body orientation (head and trunk). To this end, the investigators will conduct a within-person randomized trial including post-stroke patients and healthy participants.
Detailed description
This project proposes to test the effect of immersion in a tilted virtual reality on verticality representation in hemisphere stroke patients showing lateropulsion and in healthy participants. The idea is to use the virtual reality as a tool to recalibrate the internal reference of verticality (contralesionally biased) in stroke patients and to experimentally create a bias in verticality perception of healthy participants, then to investigate how this modulation of the internal model of verticality might affect the erect posture. The investigators hypothesize that, in stroke patients, the recalibration of the verticality perception might ameliorate their lateropulsion, whereas in healthy participants, the experimental verticality bias introduced might induce a transient experimental lateropulsion. A transmodal modulation of the verticality perception, both on PV and VV, would imply a modulation by the virtual reality not only at the level of perception but also at the internal model of verticality, advocating for a powerful effect of this technology. The analysis of a post-effect (on verticality perception) that would continue after the intervention (immersion in the virtual titled room) would be a supplementary argument advocating for its clinical use in rehabilitation of post-stroke lateropulsion. To judge the effect of the immersion in tilted virtual reality, the following measures will be considered: (a) PV perception, (b) VV perception, (c) body orientation measured by inertial captors, and (d) weight-bearing asymmetry in erect posture assessed by posturography.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- * 20 stroke participants perform the experiment over 4 weeks (W0, W1, W2, W3). W0 and W1 are devoted to clinical assessments of lateropulsion, balance disorders and other clinical deficits post-stroke. W2 is devoted to the intervention over 4 consecutive half days: 2 for the verticality perception assessments (PV, VV), and 2 for concomitant assessments of lateral body orientation (by inertial captors) and weight-bearing asymmetry (by posturography). These 4 tests are performed before and during virtual reality. A post-effect is investigated only for PV and VV. Each patient is randomly assigned to one of the two following planes: plane A (PV/VV assessment on days 1 and 3 and postural assessment on days 2 and 4) or plane B (postural assessment on days 1 and 3 and PV/VV assessment on days 2 and 4).The W3 is devoted to conventional rehabilitation with only assessment of lateropulsion and balance on Friday (as each week of this protocol). * 20 controls perform the same experiment on 2 days.
| Arm | Type | Receives |
|---|---|---|
| Plane A for the cross-over (Immersion in a virtual tilted room) | Experimental | Other: Virtual Reality , immersion in a virtual titlted roomHalf of participants will perform the experiment according the plane A, which corresponds to the following order: verticality perception (Baseline, effect during the intervention, post-effect), then active vertical body orientation (Baseline, effect during the intervention). The intervention is an immersion in a virtual static and tilted environnement (18°). During the intervention, participants will be immersed in a virtual tilted room for 15 minutes (after 5 minutes of pre -installation adjustments), then verticality perception or active body orientation assessments are performed while the participant is still virtually immersed (approximately 25 minutes). Participants will be immersed in a tilted virtual room for 45 minutes each day. |
| Plane B for the cross-over (Immersion in a virtual tilted room) | Experimental | Other: Virtual Reality , immersion in a virtual titlted roomHalf of participants will perform the experiment according the plane B, which corresponds to the following order: active vertical body orientation (Baseline, effect during the intervention), then verticality perception (Baseline, effect during the intervention, post-effect). The intervention is an immersion in a virtual static and tilted environnement (18°). During the intervention, participants will be immersed in a virtual tilted room for 15 minutes (after 5 minutes of pre -installation adjustments), then verticality perception or active body orientation assessments are performed while the participant is still virtually immersed (approximately 25 minutes). Participants will be immersed in a tilted virtual room for 45 minutes each day. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 20 stroke participants
- 20 healthy participants
Key exclusion criteria (12 listed)
- All
- 20 Stroke participants
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 |
|---|---|---|
| Virtual Reality , immersion in a virtual titlted roomThe immersion in virtual reality will be based on the HTC VIVE® device and the software developed by the Virtualis Society. | Other | Plane A for the cross-over (Immersion in a virtual tilted room), Plane B for the cross-over (Immersion in a virtual tilted room) |
Primary outcome
Changes in the postural perception of the vertical (PV) before and during the immersion in a virtual tilted room, in stroke and healthy participants.
Time frame: Days 1 and 3 if assignment to plane A or days 2 and 4 if assignment to plane B of the W2
PV consists of testing the whole body orientation in sitting, perceived as vertical by participants, in complete darkness. PV will be tested by a well-validated apparatus and paradigm (Pérennou et al Brain 2008). PV orientation will be the average orientation (in degree) of the 10 trials performed for each condition.
16 secondary outcomes
Changes in the visual perception of the vertical (VV) before and during the immersion in a virtual tilted room, in stroke and healthy participants.
Time frame: Days 1 and 3 if assignment to plane A or days 2 and 4 if assignment to plane B of the W2
Post-effect on PV. Change from baseline in PV orientation that continues after the immersion in virtual reality, in stroke and healthy participants.
Time frame: Days 1 and 3 if assignment to plane A or days 2 and 4 if assignment to plane B of the W2
Post-effect on VV. Change from baseline in VV orientation that continues after the immersion in virtual reality, in stroke and healthy participants.
Time frame: Days 1 and 3 if assignment to plane A or days 2 and 4 if assignment to plane B of the W2
Modulation of active vertical trunk orientation. Change from baseline in active vertical trunk orientation assessed by inertial captors during the modulation of the internal model of verticality by virtual reality, in stroke and healthy participants.
Time frame: Days 2 and 4 if assignment to plane A or days 1 and 3 if assignment to plane B of the W2
Modulation of active vertical pelvis orientation. Change from baseline in active vertical trunk orientation assessed by inertial captors during the modulation of the internal model of verticality by virtual reality, in stroke and healthy participants.
Time frame: Days 2 and 4 if assignment to plane A or days 1 and 3 if assignment to plane B of the W2
Modulation of active vertical head orientation. Change from baseline in active vertical head orientation assessed by inertial captors during the modulation of the internal model of verticality by virtual reality, in stroke and healthy participants.
Time frame: Days 2 and 4 if assignment to plane A or days 1 and 3 if assignment to plane B of the W2
Effect on lateropulsion. Change from baseline in lateropulsion scores assessed by the SCAle for LAteropulsion after 4 consecutive half days of verticality referential recalibration by virtual reality, in stroke participants.
Time frame: 45 minutes every Friday during the protocol (W0, W1, W2, W3).
Effect on postural capacities. Change from baseline in balance scores assessed by the modified Postural Assessment Scale for Stroke patient after 4 consecutive half days of verticality referential recalibration by virtual reality, in stroke participants
Time frame: 45 minutes every Friday during the protocol (W0, W1, W2, W3).
Responders to virtual reality. Proportion of participants in whom the immersion in a virtual tilted room modulates PV (at least 2 degrees).
Time frame: Days 1 and 3 if assignment to plane A or days 2 and 4 if assignment to plane B of the W2
Changes in weight-bearing asymmetry. Evaluation of changes in weight-bearing asymmetry in standing posture before and during the immersion in a virtual tilted room, in stroke and healthy participants.
Time frame: Days 2 and 4 if assignment to plane A or days 1 and 3 if assignment to plane B of the W2
Awareness of the changes in active vertical body orientation. Evaluation of participants' awareness of the changes in body orientation and balance in standing posture induced by virtual reality.
Time frame: Days 2 and 4 if assignment to plane A or days 1 and 3 if assignment to plane B of the W2
Relationship between the trunk tilt (assessed by inertial captors, in degrees) and the weight bearing on the paretic side (in percentage of body weight), at baseline, with average values (2 sessions)
Time frame: Days 2 and 4 if assignment to plane A or days 1 and 3 if assignment to plane B of the W2
Relationship between the trunk tilt (assessed by inertial captors, in degrees) and the weight bearing on the paretic side (in percentage of body weight), during the virtual reality, with average values (2 sessions).
Time frame: Days 2 and 4 if assignment to plane A or days 1 and 3 if assignment to plane B of the W2
Quantification of a possible Virtual reality sickness.
Time frame: Days 1, 2, 3 and 4 of the W2
Description of symptoms in case of Virtual reality sickness.
Time frame: Days 1, 2, 3 and 4 of the W2
Influence of verbal instruction on standing posture
Time frame: Days 1, 2, 3 and 4 of the W2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Background: PubMed 18678565Perennou DA, Mazibrada G, Chauvineau V, Greenwood R, Rothwell J, Gresty MA, Bronstein AM. Lateropulsion, pushing and verticality perception in hemisphere stroke: a causal relationship? Brain. 2008 Sep;131(Pt 9):2401-13. doi: 10.1093/brain/awn170. Epub 2008 Aug 4.
- Background: PubMed 27079584Piscicelli C, Perennou D. Visual verticality perception after stroke: A systematic review of methodological approaches and suggestions for standardization. Ann Phys Rehabil Med. 2017 Jun;60(3):208-216. doi: 10.1016/j.rehab.2016.02.004. Epub 2016 Apr 11.
- Background: PubMed 30031891Odin A, Faletto-Passy D, Assaban F, Perennou D. Modulating the internal model of verticality by virtual reality and body-weight support walking: A pilot study. Ann Phys Rehabil Med. 2018 Sep;61(5):292-299. doi: 10.1016/j.rehab.2018.07.003. Epub 2018 Jul 19.
- Background: PubMed 33177223Dai S, Piscicelli C, Clarac E, Baciu M, Hommel M, Perennou D. Balance, Lateropulsion, and Gait Disorders in Subacute Stroke. Neurology. 2021 Apr 27;96(17):e2147-e2159. doi: 10.1212/WNL.0000000000011152. Epub 2020 Nov 11.
- Derived from this study: PubMed 40533218Dehem S, Piscicelli C, Lhommee E, Gimat R, Dai S, Marquer A, Hugues A, Perennou D. Modulating verticality representation and uprightness by virtual reality: rationale and protocol for a within-person randomised intervention associating a basic study in healthy individuals and a pilot clinical trial in individuals exhibiting post-stroke lateropulsion (VIRGIL). BMJ Open. 2025 Jun 18;15(6):e092406. doi: 10.1136/bmjopen-2024-092406.
- Individual participant dataSharing planned: Yes. Anonymized data that support the findings of this study are available from the corresponding author, upon reasonable request, only for authorized research. Their use is subjected to an agreement with the promotor (CHU Grenoble Alpes) and the principal investigator (Pr Dominic Pérennou) of the VIRGIL study. Pseudonymised data that support the findings of this study are available from the promotor (CHU Grenoble Alpes) upon reasonable request, subject to a specific agreement with the promotor (involving the principal investigator) and subject to regulatory proceedings due to data protection applicable laws. Access conditions are to be determined depending on the nature of the request
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Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Dominic Pérennou principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality , immersion in a virtual titlted room in people with Stroke and Brain Diseases, run by University Hospital, Grenoble at 1 site in France.
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 9 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 21 May 2025. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dominic Pérennou (+33 476766084, DPerennou@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the postural perception of the vertical (PV) before and during the immersion in a virtual tilted room, in stroke and healthy participants. (time frame: Days 1 and 3 if assignment to plane A or days 2 and 4 if assignment to plane B of the W2). 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 NCT04911738, which also lists 5 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 21 May 2025.