VIrtual Reality Glasses Use to Improve Lateropulsion and the Post-stroke Postural Vertical

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-15

Study Completion Date

2026-05-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Stroke Brain Diseases Cerebrovascular Disorders Postural; Defect Cognition Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

* 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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Participants know the intervention condition but not the effect expected. Assessor knows the intervention condition for the primary outcome change in PV, and the secondary outcomes, changes in VV, body orientation, and weight bearing asymmetry.

Assessor blind of the intervention condition for the assessment of the secondary criteria lateropulsion (SCALA) and balance in daily life (PASS)

Study Groups

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Plane A for the cross-over (Immersion in a virtual tilted room)

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.

Group Type EXPERIMENTAL

Virtual Reality , immersion in a virtual titlted room

Intervention Type OTHER

The immersion in virtual reality will be based on the HTC VIVE® device and the software developed by the Virtualis Society.

Plane B for the cross-over (Immersion in a virtual tilted room)

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.

Group Type EXPERIMENTAL

Virtual Reality , immersion in a virtual titlted room

Intervention Type OTHER

The immersion in virtual reality will be based on the HTC VIVE® device and the software developed by the Virtualis Society.

Interventions

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Virtual Reality , immersion in a virtual titlted room

The immersion in virtual reality will be based on the HTC VIVE® device and the software developed by the Virtualis Society.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

* No history of stroke or others neurological pathologies
* No balance disorders
* No history of vestibular or dizzissness disorders

Exclusion Criteria

* 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

* 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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes