Virtual Reality-Base Intelligent Orientation and Mobility Specialists Trial

Summary

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

Interventions

BEHAVIORAL

Orientation and Mobility Training with VR-IOMSs

Learning Orientation and Mobility skills from virtual-reality-based, automated, intelligent computer training programs - VR-IOMSs

BEHAVIORAL

Orientation and Mobility Training with COMS

Learning Orientation and Mobility skills from human Certified Orientation and Mobility Specialists (COMS)

BEHAVIORAL

No Orientation and Mobility Training

No Orientation and Mobility training. Watch low vision education videos and discuss low vision issues not related to O\&M with COMS

Sponsors & Collaborators

• New Jersey Institute of Technology

  collaborator OTHER

• National Eye Institute (NEI)

  collaborator NIH

• University of Alabama at Birmingham

  lead OTHER

Principal Investigators

• Lei Liu, PhD · University of Alabama at Birmingham

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

13 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-08-15

Primary Completion

2025-06-30

Completion

2025-06-30

Countries

• United States

Study Locations