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

NCT04911738 | Recruiting

• 1 other identifier: 2020-A02941-38
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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). To this end, the investigators will conduct a within-person randomized trial including post-stroke patients and healthy participants.

Conditions

Stroke; Brain Diseases; Cerebrovascular Disorders; Postural; Defect; Cognition Disorder

Keywords

Lateropulsion; Verticality representation; Virtual reality; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  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.

  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.

  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.

  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.

  Days 2 and 4 if assignment to plane A or days 1 and 3 if assignment to plane B of the W2

Study Arms (2)

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.

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.

Other: Virtual Reality , immersion in a virtual titlted room

Interventions

Virtual Reality , immersion in a virtual titlted room OTHER

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

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• healthy participants
• No history of stroke or others neurological pathologies
• No balance disorders
• No history of vestibular or dizzissness disorders

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Fondation Paul Bennetot: collaborator

Study Sites (1)

University Hospital Grenoble

Grenoble, 38000, France

RECRUITING

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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. doi: 10.1136/bmjopen-2024-092406.

  PMID: 40533218 DERIVED

MeSH Terms

Conditions

Stroke; Brain Diseases; Cerebrovascular Disorders; Cognition Disorders

Interventions

Immersion

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Dominic Pérennou

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominic Pérennou

CONTACT

+33 476766084; DPerennou@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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)
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: * 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.

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: June 3, 2021
• Study Start: June 15, 2021
• Primary Completion: March 31, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: At the end of the study
• Access Criteria: 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

Locations

FR (1)