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Behavioural Intervention
AV-Stimulation in VR for Vision Impairment (Re:DriVR Trial)
N/A
Waitlist Available
Led By Michael Reber, PhD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Visual field defects due to TBI or stroke
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up initial visit (day 0), end of period 1 (day 43), end of period 2 (day 86)
Awards & highlights
Re:DriVR Trial Summary
This trial will test if a 6-week VR-based program can improve driving performance in people who have lost their license due to vision issues. #ClinicalTrial #VR #DrivingPerfomance
Who is the study for?
This trial is for adults over 25 who've lost their driver's license due to vision problems from a stroke or brain injury. They must have had a valid license, be able to follow the program, pass an online hearing test, and have home Wi-Fi. People with certain cognitive conditions, drug use, vertigo, prior vision therapy, severe visual neglect or epilepsy can't join.Check my eligibility
What is being tested?
The study tests if a 6-week immersive VR program can improve visual perception and driving skills in people with vision loss. Participants are split into two groups: one starts training immediately and the other waits six weeks before starting. Their driving performance and visual abilities are tested before, halfway through, and after the program.See study design
What are the potential side effects?
Potential side effects aren't specified but may include discomfort from VR such as dizziness or nausea especially in individuals prone to motion sickness or those with pre-existing vestibular disorders.
Re:DriVR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have vision problems because of a brain injury or stroke.
Re:DriVR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ initial visit (day 0), end of period 1 (day 43), end of period 2 (day 86)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~initial visit (day 0), end of period 1 (day 43), end of period 2 (day 86)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes from baseline in braking response (sec)
Changes from baseline in collisions (total #)
Changes from baseline in lane keeping (meters of deviations/departures)
+2 moreSecondary outcome measures
Changes from baseline in visual attention and speed using Re:ViewD
Changes from baseline in visual fields
Simulator Sickness Questionnaire (SSQ)
+2 moreRe:DriVR Trial Design
2Treatment groups
Experimental Treatment
Group I: Waitlist GroupExperimental Treatment1 Intervention
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.
Group II: VR Intervention FirstExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Audiovisual Stimulation
2019
N/A
~110
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,468 Previous Clinical Trials
484,460 Total Patients Enrolled
Michael Reber, PhDPrincipal InvestigatorUniversity Health Network, Toronto
2 Previous Clinical Trials
80 Total Patients Enrolled
Lora Appel, PhDPrincipal InvestigatorYork University
2 Previous Clinical Trials
107 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I can see, hear, and follow instructions well.I have undergone vision rehabilitation.You have a condition that makes it unsafe for you to use a driving simulator or virtual reality.I used to have a valid driving license and drove regularly.I cannot perform tasks during tests and training.I have vision problems because of a brain injury or stroke.I am older than 25 years.You have difficulty paying attention to things on one side of your vision.You have passed an online hearing test for the 125 Hz frequency.Your VRISE scores have been consistently low (less than 25) for the past three times you were checked.I have experienced vertigo or dizziness in the past.You use drugs for fun or for medical reasons that affect your mind.You have epilepsy triggered by flashing lights or patterns.Both of my eyes have a condition that affects my vision.Your vision is at least 20/50.You have access to Wi-Fi at home.
Research Study Groups:
This trial has the following groups:- Group 1: Waitlist Group
- Group 2: VR Intervention First
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment still taking place for this research?
"This trial, which was first posted on March 1st 2023 and last updated a month later, is not currently enrolling. Nevertheless, 1234 other medical trials are recruiting participants at this moment."
Answered by AI
What primary goals is this clinical trial attempting to accomplish?
"This research study will span from day 0 to day 86, and the main outcomes being measured are changes in collisions. Secondary results include alterations of visual fields, scores on the Simulator Sickness Questionnaire (SSQ) ranging from no symptoms (0 points) to severe ones (235.62), and Virtual-Reality Induced Symptoms and Effects (VRISE) assessments at the initial screening stage with a score range of 5 to 35 depending on symptom intensity."
Answered by AI
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