Audiovisual Stimulation: The device application involves the 3D multiple-object-tracking (3D-MOT) paradigm composed of 8 high-contrast spheres which are adapted to the visual ability of participant (luminosity and size). The initial speed of the spheres is adjustable and determined during the inclusion visit.
One or more of the spheres is temporarily highlighted (target). Then all 8 spheres move for 20 seconds following random linear paths, bouncing on one another and on the walls of a virtual 3D cube when collisions occur. After 20 seconds, the movement stops and the participant is asked to select, using the hand controller, the initially highlighted target(s) among the 8 spheres. If the selection is correct the speed of the spheres in the next trial is increased. If the selection is incorrect the speed of the spheres in the next trial is decreased.
Based on performance, stimulations will be adjusted to change difficulty level (e.g. changing backgrounds, number of cued balls, etc.)
Study summary
The goal of this clinical trial is to evaluate the effectiveness of an immersive virtual-reality (IVR) based stimulation program, in improving visual perception for people who have lost their driver's license due to perceptual or cognitive impairments.
The main questions it aims to answer are:
1. Can the 6-week IVR stimulation program help improve driving performance?
2. Will participants experience improvement in visual detection and perception after training?
Study Design Summary:
* Participants will be randomized into a waitlist group or intervention-first group
* The VR-based intervention will consist of training every 2 days for six weeks
* Waitlist group will wait 6 weeks before starting intervention at study midpoint (week 7)
* Intervention-first group will begin with intervention (week 1-6) and then stop intervention at study midpoint
* Participants will complete tests related to driving performance, visual attention, and visual fields at the start of study, midpoint, and end of study
Researchers will analyze data for changes from baseline in outcome measures.
Eligibility
Sex
ALL
Min age
25 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Male and female \> 25 years old.
* Visual field defects due to TBI or stroke
* BCVA ≥ 20/50.
* Previously held a valid driving license and were active drivers.
* Ability to follow the visual and auditory stimuli and training instructions.
* Online auditory test positive (-5dBHL to 60dBHL range) at 125 Hz (for research purposes only)
* Home Wi-Fi access.
Exclusion Criteria:
* Both eyes with media opacity that impairs visual field testing.
* Inability to perform during testing and training.
* Cognitive/motor condition incompatible with driving simulator and/or VR.
* Recreational or medicinal consumption of psychoactive drugs.
* 3 consecutive VRISE scores \< 25 at inclusion.
* History of vertigo or dizziness.
* Visual neglect.
* Prior/current vision rehabilitation interventions.
* Photosensitive epilepsy.
Primary outcome measure(s)
Changes from baseline in braking response (sec) — Initial visit (day 0), End of Period 1 (day 43), End of Period 2 (day 86) Driving performance will be assessed at the DriverLab, a driving simulator located at KITE-UHN under the supervision of the research team members.
Changes from baseline in collisions (total #) — Initial visit (day 0), End of Period 1 (day 43), End of Period 2 (day 86) Driving performance will be assessed at the DriverLab, a driving simulator located at KITE-UHN under the supervision of the research team members.
Changes from baseline in lane keeping (meters of deviations/departures) — Initial visit (day 0), End of Period 1 (day 43), End of Period 2 (day 86) Driving performance will be assessed at the DriverLab, a driving simulator located at KITE-UHN under the supervision of the research team members.
Changes from baseline in speed variability (km/h) — Initial visit (day 0), End of Period 1 (day 43), End of Period 2 (day 86) Driving performance will be assessed at the DriverLab, a driving simulator located at KITE-UHN under the supervision of the research team members.
Changes from baseline in road rule violations (# and type) — Initial visit (day 0), End of Period 1 (day 43), End of Period 2 (day 86) Driving performance will be assessed at the DriverLab, a driving simulator located at KITE-UHN under the supervision of the research team members.
Trial sites (2)
Facility
City
Region
Status
KITE Research Institute, UHN
Toronto
Ontario
Toronto Western Hospital
Toronto
Ontario
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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