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

Grenoble Alpes University Hospital Center (CHU) logo

Grenoble Alpes University Hospital Center (CHU)

Status

Enrolling

Conditions

Stroke
Cognition Disorder
Postural; Defect
Cerebrovascular Disorders
Brain Diseases

Treatments

Other: Virtual Reality , immersion in a virtual titlted room

Study type

Interventional

Funder types

Other

Identifiers

NCT04911738
2020-A02941-38

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

40 participants in 2 patient groups

Plane A for the cross-over (Immersion in a virtual tilted room)
Experimental group
Description:
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.
Treatment:
Other: Virtual Reality , immersion in a virtual titlted room
Plane B for the cross-over (Immersion in a virtual tilted room)
Experimental group
Description:
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.
Treatment:
Other: Virtual Reality , immersion in a virtual titlted room

Trial contacts and locations

1

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Central trial contact

Dominic Pérennou

Data sourced from clinicaltrials.gov

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