Virtual Reality-Base Intelligent Orientation and Mobility Specialists Trial

Completed · Not applicable · Has a placebo group

Conditions studied: Low Vision, Both Eyes

In brief

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.

Key facts

Study ID: NCT04639531
Run by: University of Alabama at Birmingham
People needed: 117
Starts: 2023-08-15
Expected to finish: 2025-06-30
Last updated by the study team: 2026-05-20

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Have stable, late-onset visual impairment.
Not have had formal O\&M training. Potential participants will be taken to real streets by COMS and their performance on the 3 studied tasks will be evaluated.
Following visual function requirements for the three studied O\&M tasks
Task NLPT: best corrected visual acuity of 20/650 or worse
Task TGJ:
central vision loss - acuity 20/100-20/300, radius of field 50-80 deg
peripheral vision loss - acuity 20/15-20/100, radius of field 5-55 deg
Task ONS: visual function requirements for both Tasks NLPT \& TGJ
Possess sufficient functional vision to learn the O\&M tasks (evaluated by COMS in real streets)
Have O\&M as a rehabilitation goal
Normal or corrected to normal hearing
No cognitive impairment (Montreal Cognitive Assessment (MoCA) or MoCA-blind (MoCA-B) score exceeds education-adjusted cutoffs)
Dexterity to operate a pointing mouse or a joystick
Physical stamina to walk a few street blocks under guidance of COMSs and to stand or sit for 30-min training sessions on the street or in the VR simulator

You may not qualify if…

Patients in the rapid progression phase of ocular diseases, such as wet macular degeneration
Patients under aggressive treatment of ocular diseases, such as VEGF injection for retinal diseases
Patients with congenital visual impairment will be excluded.
Participants will be excluded from the training for the skills that they already master.
Participants who have a history of epileptic seizure or are prone to motion sickness will be excluded.
Have difficulty in verbal communication in English.

Where it is running

University of Alabama at Birmingham — Birmingham, Alabama, United States
Alabama Institute for Deaf and Blind — Talladega, Alabama, United States

Full record on ClinicalTrials.gov

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