VIrtual Reality Glasses Use to Improve Lateropulsion and the Post-stroke Postural Vertical
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity Hospital, Grenoble
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
20 stroke participants
Hospitalized in neurorehabilitation
Hemisphere stroke (Right or left)
Stroke delay < 6 months
Disqualifiers
All
History of psychiatric disorders
Nyctophobia
Advanced heart failure
Trial design
Design model
Crossover
Treatments tested in this trial
Virtual Reality , immersion in a virtual titlted room
Other interventionThe immersion in virtual reality will be based on the HTC VIVE® device and the software developed by the Virtualis Society.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Plane A for the cross-over (Immersion in a virtual tilted room)Experimental treatment 1 intervention
Group B: Plane B for the cross-over (Immersion in a virtual tilted room)Experimental treatment 1 intervention
Trial outcomes
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.
Time frame
Days 1 and 3 if assignment to plane A or days 2 and 4 if assignment to plane B of the W2Secondary 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.
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.
Time frame
Days 1 and 3 if assignment to plane A or days 2 and 4 if assignment to plane B of the W22
Post-effect on PV. Change from baseline in PV orientation that continues after the immersion in virtual reality, in stroke and healthy participants.
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.
Time frame
Days 1 and 3 if assignment to plane A or days 2 and 4 if assignment to plane B of the W23
Post-effect on VV. Change from baseline in VV orientation that continues after the immersion in virtual reality, in stroke and healthy participants.
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.
Time frame
Days 1 and 3 if assignment to plane A or days 2 and 4 if assignment to plane B of the W24
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.
Comparison between active vertical trunk orientation assessed by inertial captors at baseline and active vertical trunk orientation during the virtual reality immersion.
Time frame
Days 2 and 4 if assignment to plane A or days 1 and 3 if assignment to plane B of the W2Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Grenoble
Lead sponsor
Fondation Paul Bennetot
Collaborator
Source ClinicalTrials.gov