VR-Based Mobility Training for Low Vision
(VR-IOMS Trial)
Trial Summary
What is the purpose of this trial?
The human subject research is a randomized, controlled training trial that tests the effectiveness of three Virtual Reality-based Intelligent Orientation and Mobility Specialists (VR-IOMSs) in teaching orientation and mobility (O\&M) task skills to low vision patients. It will be conducted on two sites, University of Alabama at Birmingham (UAB) and Alabama Institute for Deaf and Blind (AIDB). The same protocol will be used on both sites. UAB will be the sIRB for the trial. Three O\&M tasks will be studied, timing to cross a signalized street using the near lane parallel traffic surge skill, timing to cross an uncontrolled street using the traffic gap judgment skill and learning outdoor numbering system. A VR-IOMS will be develop for each task. The training does not involve research subjects walking into street traffic. Low vision subjects who have difficulties with these O\&M tasks due to their impaired vision will be randomized into three groups, learning the task from a VR-IOMS (experimental group), from a human Certified Orientation \& Mobility Specialist (COMS) in real streets (active control group) and not learning the task but spending the same amount of time watching low vision education videos (placebo group). All subjects will be evaluated by COMSs in real streets around the two study sites before training (pre-training), within 3 days after the completion of training (post-training) and 3 months after the completion of training (follow up). Their ability to perform the O\&M tasks will be assess quantitatively using objective methods. COMSs who conduct these evaluations will be blinded for subject training assignment. The primary outcome measure is the training effect, the difference in task performance between the pre-training and post-training real street evaluations. The training effects of the 3 groups will be compared to determine the training effectiveness of the VR-IOMS relative to human COMS. Secondary outcome measures include the retainment of the training effect. Objective assessment of the VR-IOMS training process and trainee subjective evaluation of the VR-IOMS training will also be analyzed.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you are under aggressive treatment for ocular diseases, such as receiving VEGF injections, you may not be eligible to participate.
What data supports the effectiveness of the treatment VR-Based Mobility Training for Low Vision?
Research shows that orientation and mobility training helps people with low vision maintain their independence by teaching them new skills to navigate their environment. Additionally, head-mounted display technology, which is similar to virtual reality, has been found to improve mobility and orientation in people with low vision.12345
Is VR-based mobility training safe for people with low vision?
How is the VR-Based Mobility Training for Low Vision treatment different from other treatments?
Research Team
Lei Liu, PhD
Principal Investigator
University of Alabama at Birmingham
Eligibility Criteria
This trial is for individuals with low vision who have not had formal orientation and mobility (O&M) training, can hear normally or with correction, aim to improve O&M skills, and have stable late-onset visual impairment. They should be able to perform basic tasks like using a mouse or joystick and walking short distances. People with rapidly progressing eye diseases, aggressive treatments ongoing, congenital impairments, existing mastery of the skills being taught, difficulty speaking English, or a history of seizures/motion sickness cannot join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Pre-training Evaluation
Participants are evaluated by COMSs in real streets to assess baseline O&M task performance
Training
Participants undergo training using VR-IOMS, human COMS, or watch educational videos
Post-training Evaluation
Participants are evaluated by COMSs in real streets to assess O&M task performance after training
Follow-up
Participants are monitored for retention of training effects and safety in O&M tasks
Treatment Details
Interventions
- No Orientation and Mobility Training
- Orientation and Mobility Training with COMS
- Orientation and Mobility Training with VR-IOMSs
Orientation and Mobility Training with VR-IOMSs is already approved in United States for the following indications:
- Teaching orientation and mobility task skills to low vision patients
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alabama at Birmingham
Lead Sponsor