Effectiveness of Audiovisual Stimulation in Immersive Virtual Reality to Improve Visual Perception and Driving Performance: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Changes from baseline in braking response (sec)
研究概览
简要总结
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:
- 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.
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female > 25 years old.
- •Visual field defects due to TBI or stroke
- •BCVA ≥ 20/
- •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.
排除标准
- •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.
研究组 & 干预措施
Waitlist Group
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.
干预措施: Audiovisual Stimulation (Device)
VR Intervention First
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.
干预措施: Audiovisual Stimulation (Device)
结局指标
主要结局
Changes from baseline in braking response (sec)
时间窗: 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 #)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- Changes from baseline in visual fields(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(Initial visit (day 0))
- Changes from baseline in visual attention and speed using Re:ViewD(Initial visit (day 0), End of Period 1 (day 43), End of Period 2 (day 86))
- Simulator Sickness Questionnaire (SSQ)(Initial visit (day 0), End of Period 1 (day 43), End of Period 2 (day 86))
- Virtual-Reality Induced Symptoms and Effects (VRISE) - intervention period(Every other day with training session (Weeks 1-6 for Intervention-First Group, Weeks 7-12 for Waitlist Group))