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.
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.
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.
Crossover
Audiovisual Stimulation
DeviceThe 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.)
Changes from baseline in braking response (sec)
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 #)
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)
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)
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 visual attention and speed using Re:ViewD
This vision test will be completed within the VR headset and will measure visual processing speed, sustained visual attention, and divided visual attention. This is a VR version of the Useful Field of View (UFoV) test which has been extensively used to measure visual attention in healthy individuals and older adults with low vision. Outcome measures are time of display (ms) for 75% of correct responses.
Changes from baseline in visual fields
Visual fields are evaluated with the automated Humphrey Field Analysis III using Esterman binocular field test procedure at Toronto Western Hospital. Outcome measures are number of points seen among 120 points.
Simulator Sickness Questionnaire (SSQ)
The SSQ will be administered after each driving session to capture any feelings related to simulator sickness. The SSQ is a validated 16-item questionnaire that assesses various symptom categories of simulator sickness. Responses are made on a 4-point scale ranging from "not at all" (total score = 0) to "severe" (total score =235.62). A total score (TS) ≥ 150 corresponds to mild to severe symptoms. Three subscales within the SSQ specifically targeting feelings of nausea (SSQ-N), oculomotor disturbances (SSQ-O), and disorientation (SSQ-D) as well as a total score (SSQ-TS) can be calculated based on pre-defined factor weightings.
Virtual-Reality Induced Symptoms and Effects (VRISE) - initial screening
This questionnaire is made up of five (5) questions related to possible cybersickness symptoms and will be completed within the VR headset by using the hand controller. Participants will complete the VRISE immediately after being trained on how to use the VR intervention at the initial visit. The VRISE score ranges from 5 (very intense level of symptoms and effects) to 35 (very low level of symptom and effects).
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