Clinical trial NCT04911738: VIrtual Reality Glasses Use to Improve Lateropulsion and the Post-stroke Postural Vertical
Official title: VIrtual Reality Glasses Use to Improve Lateropulsion and the Post-stroke Postural Vertical (VIRGIL)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Brain Diseases
Cerebrovascular Disorders
Postural; Defect
Cognition Disorder
Keywords: Lateropulsion
Verticality representation
Virtual reality
Rehabilitation
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Fondation Paul Bennetot
First posted: 2021-06-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: * 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 purpose: TREATMENT

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.

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.

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)

Primary outcomes:
measure: Changes in the postural perception of the vertical (PV) before and during the immersion in a virtual tilted room, in stroke and healthy participants.
timeFrame: Days 1 and 3 if assignment to plane A or days 2 and 4 if assignment to plane B of the W2
Secondary outcomes:
measure: Changes in the visual perception of the vertical (VV) before and during the immersion in a virtual tilted room, in stroke and healthy participants.
timeFrame: Days 1 and 3 if assignment to plane A or days 2 and 4 if assignment to plane B of the W2
measure: Post-effect on PV. Change from baseline in PV orientation that continues after the immersion in virtual reality, in stroke and healthy participants.
timeFrame: Days 1 and 3 if assignment to plane A or days 2 and 4 if assignment to plane B of the W2
measure: Post-effect on VV. Change from baseline in VV orientation that continues after the immersion in virtual reality, in stroke and healthy participants.
timeFrame: Days 1 and 3 if assignment to plane A or days 2 and 4 if assignment to plane B of the W2
measure: 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.
timeFrame: Days 2 and 4 if assignment to plane A or days 1 and 3 if assignment to plane B of the W2
measure: 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.
timeFrame: Days 2 and 4 if assignment to plane A or days 1 and 3 if assignment to plane B of the W2
measure: 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.
timeFrame: Days 2 and 4 if assignment to plane A or days 1 and 3 if assignment to plane B of the W2
measure: 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.
timeFrame: 45 minutes every Friday during the protocol (W0, W1, W2, W3).
measure: 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
timeFrame: 45 minutes every Friday during the protocol (W0, W1, W2, W3).
measure: Responders to virtual reality. Proportion of participants in whom the immersion in a virtual tilted room modulates PV (at least 2 degrees).
timeFrame: Days 1 and 3 if assignment to plane A or days 2 and 4 if assignment to plane B of the W2
measure: 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.
timeFrame: Days 2 and 4 if assignment to plane A or days 1 and 3 if assignment to plane B of the W2
measure: 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.
timeFrame: Days 2 and 4 if assignment to plane A or days 1 and 3 if assignment to plane B of the W2
measure: 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)
timeFrame: Days 2 and 4 if assignment to plane A or days 1 and 3 if assignment to plane B of the W2
measure: 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).
timeFrame: Days 2 and 4 if assignment to plane A or days 1 and 3 if assignment to plane B of the W2
measure: Quantification of a possible Virtual reality sickness.
timeFrame: Days 1, 2, 3 and 4 of the W2
measure: Description of symptoms in case of Virtual reality sickness.
timeFrame: Days 1, 2, 3 and 4 of the W2
measure: Influence of verbal instruction on standing posture
timeFrame: Days 1, 2, 3 and 4 of the W2
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital Grenoble
Study officials:
affiliation: University Hospital, Grenoble
name: Dominic Pérennou
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.