Virtual Reality-Base Intelligent Orientation and Mobility Specialists Trial

Description

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.

Conditions

Low Vision, Both Eyes

Study Overview

Study Details

Study overview

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.

Automated Orientation & Mobility Training in Virtual Reality for Low Vision Rehabilitation

Virtual Reality-Base Intelligent Orientation and Mobility Specialists Trial

Condition
Low Vision, Both Eyes
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham, Birmingham, Alabama, United States, 35226

Talladega

Alabama Institute for Deaf and Blind, Talladega, Alabama, United States, 35160

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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.

Ages Eligible for Study

13 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Alabama at Birmingham,

Lei Liu, PhD, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

Study Record Dates

2025-06-30