Stroke Clinical Trial
— Re:DriVROfficial title:
Effectiveness of Audiovisual Stimulation in Immersive Virtual Reality to Improve Visual Perception and Driving Performance: a Pilot Study
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.
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | December 1, 2024 |
Est. primary completion date | December 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 25 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | KITE Research Institute, UHN | Toronto | Ontario |
Canada | Toronto Western Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto |
Canada,
Richards E, Bennett PJ, Sekuler AB. Age related differences in learning with the useful field of view. Vision Res. 2006 Nov;46(25):4217-31. doi: 10.1016/j.visres.2006.08.011. Epub 2006 Oct 5. — View Citation
Saredakis D, Szpak A, Birckhead B, Keage HAD, Rizzo A, Loetscher T. Factors Associated With Virtual Reality Sickness in Head-Mounted Displays: A Systematic Review and Meta-Analysis. Front Hum Neurosci. 2020 Mar 31;14:96. doi: 10.3389/fnhum.2020.00096. eCo — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Initial visit (day 0), End of Period 1 (day 43), End of Period 2 (day 86) | |
Primary | 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. | Initial visit (day 0), End of Period 1 (day 43), End of Period 2 (day 86) | |
Primary | 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. | Initial visit (day 0), End of Period 1 (day 43), End of Period 2 (day 86) | |
Primary | 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. | Initial visit (day 0), End of Period 1 (day 43), End of Period 2 (day 86) | |
Primary | Changes from baseline in road rule violations (# and type) | Driving performance will be assessed at the DriverLab, a driving simulator located at KITE-UHN under the supervision of the research team members. | Initial visit (day 0), End of Period 1 (day 43), End of Period 2 (day 86) | |
Secondary | 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. |
Initial visit (day 0), End of Period 1 (day 43), End of Period 2 (day 86) | |
Secondary | 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. |
Initial visit (day 0), End of Period 1 (day 43), End of Period 2 (day 86) | |
Secondary | 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. |
Initial visit (day 0), End of Period 1 (day 43), End of Period 2 (day 86) | |
Secondary | 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). | Initial visit (day 0) | |
Secondary | Virtual-Reality Induced Symptoms and Effects (VRISE) - intervention period | 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). | Every other day with training session (Weeks 1-6 for Intervention-First Group, Weeks 7-12 for Waitlist Group) |
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