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NCT Number: NCT04911738

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

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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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Cognition Disorder Cognition Disorders Mental Disorders Nervous System Diseases Neurocognitive Disorders Postural; Defect Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Grenoble

Grenoble, 38000, France

Location status: Recruiting

Location contact

Dominic Perennou

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

    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.

Secondary outcomes

  1. 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

    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.

  2. 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

    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.

  3. 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

    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.

  4. 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

    Comparison between active vertical trunk orientation assessed by inertial captors at baseline and active vertical trunk orientation during the virtual reality immersion.

  5. 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

    Comparison between active vertical pelvis orientation assessed by inertial captors at baseline and active vertical pelvis orientation during the virtual reality immersion.

  6. 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

    Comparison between active vertical head orientation assessed by inertial captors at baseline and active vertical head orientation during the virtual reality immersion.

  7. 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).

    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).

  8. 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).

    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).

  9. 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

    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

  10. 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

    Weight-bearing asymmetry assessed by posturography at baseline and during virtual reality, in patients and healthy participants. Comparison of both conditions.

  11. 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

    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])

  12. 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

    Active vertical body orientation measures and weight-bearing asymetry before virtual reality.

  13. 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

    Active vertical body orientation measures and weight-bearing asymetry during virtual reality.

  14. Quantification of a possible Virtual reality sickness.

    Time frame: Days 1, 2, 3 and 4 of the W2

    Systematic evaluation of virtual reality sickness with a visual analogical scale (ad-hoc scale, from 0 to 10, higher scores mean a worse outcome).

  15. Description of symptoms in case of Virtual reality sickness.

    Time frame: Days 1, 2, 3 and 4 of the W2

    Systematic evaluation of virtual reality sickness with a structured interview.

  16. Influence of verbal instruction on standing posture

    Time frame: Days 1, 2, 3 and 4 of the W2

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dominic Pérennou

CONTACT

[email protected]

+33 476766084

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • Fondation Paul Bennetot

Registry information

Official study title

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

Acronym: VIRGIL

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jun 3, 2021
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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