StrokeRe:DriVRNCT05703360
Effectiveness of AV-stimulation in Immersive VR to Improve Visual Perception and Driving Performance
A study testing Audiovisual Stimulation in people with Stroke and Visual Impairment, run by University Health Network, Toronto at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Stroke, Visual Impairment, Low Vision
- What is being tested?
- Audiovisual Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Feb 2025to 1 Dec 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Visual neglect.
- Prior/current vision rehabilitation interventions.
- Photosensitive epilepsy.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Lora Appel, PhD contact
Canada2 sites
KITE Research Institute, UHN
Toronto, Ontario, M5G 2A2
Jennifer Campos, PhD, jennifer.campos@uhn.ca
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
Michael Reber, Ph.D, michael.reber@uhnresearch.ca
About this study
Official 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:
Read more
- Can the 6-week IVR stimulation program help improve driving performance?
- 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.
Read the detailed description
This clinical trial will be an interventional, cross-over, single blind, randomized, supportive care, single-center study lasting 12 weeks with a target recruitment of 30 participants.
SCREENING AND BASELINE TESTS
Potential participants will be identified from patients receiving routine care at Toronto Western Hospital by their ophthalmologist. After obtaining informed consent and screened for inclusion, the research coordinator will set up appointments for each participant to complete baseline tests related to driving performance, visual attention, and visual fields. Participants will also practice the IVR program and be assessed for IVR sensitivity, or cybersickness, using the Virtual-Reality Induced Symptoms and Effects (VRISE) questionnaire.
Participants will be randomized into a Waitlist group or Intervention-First group. The Intervention-First group will be given a head-mounted display (HMD) to take home for training.
INTERVENTION (Week 1 - 12)
Period 1 (Week 1-6):
- Waitlist Group has no intervention
- Intervention-First group trains at home every 2 days using HMD
All participants are booked for their second appointments to repeat baseline tests once Period 1 is complete. Intervention-first group will return their HMD to the researchers and Waitlist group will be given their HMD to take home.
Period 2 (Week 7-12)
- Waitlist Group trains at home every 2 days using HMD
- Intervention-First group has no intervention
All participants are booked for their third appointments to repeat baseline tests once Period 2 is complete. Waitlist group will return their HMD to researchers.
POST-INTERVENTION
Analysis of outcome measures:
- Period 1 (Waitlist Group vs Intervention-First Group)
- Waitlist Group (Period 1 vs Period 2)
- Intervention-First Group (Period 1 vs Period 2)
- Conditions
- Stroke, Visual Impairment, Low Vision, Virtual Reality, Visual Spatial Processing, Visual Field Defect
- Being tested
- Audiovisual Stimulation
- Medical subject headings
- Stroke, Vision Disorders, Vision, Low, Spatial Processing, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audiovisual StimulationDevice
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 group | Role | What they receive |
|---|---|---|
| Waitlist Group | Experimental | Those randomly assigned to the waitlist group will complete initial inclusion tests and baseline tests at Visit 1. They will receive no intervention during Period 1 (week 1-6) and then repeat baseline tests at Visit 2. Next they will perform the VR audiovisual stimulation during Period 2 (week 7-12) and then repeat baseline tests post-intervention at Visit 3. Receives: Device: Audiovisual Stimulation |
| VR Intervention First | Experimental | Those randomly assigned to the intervention-first group will complete initial inclusion tests and baseline tests at Visit 1. They will perform the VR audiovisual stimulation during Period 1 (week 1-6) and then repeat baseline tests at Visit 2. They will receive no intervention during Period 2 (week 7-12) and then repeat baseline tests at Visit 3. Receives: Device: Audiovisual Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Initial visit (day 0), End of Period 1 (day 43), End of Period 2 (day 86)
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.
Measured: Initial visit (day 0), End of Period 1 (day 43), End of Period 2 (day 86)
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.
Measured: Initial visit (day 0), End of Period 1 (day 43), End of Period 2 (day 86)
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.
Measured: Initial visit (day 0), End of Period 1 (day 43), End of Period 2 (day 86)
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.
Measured: Initial visit (day 0), End of Period 1 (day 43), End of Period 2 (day 86)
Secondary outcomes (5)
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.
Measured: Initial visit (day 0), End of Period 1 (day 43), End of Period 2 (day 86)
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.
Measured: Initial visit (day 0), End of Period 1 (day 43), End of Period 2 (day 86)
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.
Measured: Initial visit (day 0), End of Period 1 (day 43), End of Period 2 (day 86)
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).
Measured: Initial visit (day 0)
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).
Measured: Every other day with training session (Weeks 1-6 for Intervention-First Group, Weeks 7-12 for Waitlist Group)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start1 Feb 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Interventional, pragmatic, cross-over, single-blind, multi-centre study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Reber, PhD, Principal investigator, University Health Network, TorontoLora Appel, PhD, Principal investigator, York UniversityJennifer Campos, PhD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05703360
- Sponsor's protocol ID
- 22-5914
- Acronym
- Re:DriVR
- Status last verified
- Dec 2024
- First submitted
- 13 Jan 2023
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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. eCollection 2020.
PubMed 32300295Richards 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.
PubMed 17027061