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Recruiting NCT04911738

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

No phase Interventional Stroke Brain Diseases Cerebrovascular Disorders Postural; Defect

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Virtual Reality , immersion in a virtual titlted room.
Who it may be relevant to
Registry conditions: Stroke, Brain Diseases, Cerebrovascular Disorders, Postural; Defect. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Other 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.

Primary outcome measures

  • 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]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Treatment

Study locations

France · 1 center
  • University Hospital Grenoble — Grenoble

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. PMID 18678565
  • Piscicelli 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. PMID 27079584
  • Odin 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. PMID 30031891
  • Dai 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. PMID 33177223
  • Dehem 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. d PMID 40533218

Identifiers

NCT: NCT04911738 · 2020-A02941-38

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗