Virtual Reality-Base Intelligent Orientation and Mobility Specialists Trial

NCT04639531 | Completed

• 2 other identifiers: IRB-3000038741R01EY030470
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Orientation & Mobility; Virtual Reality; Intelligent Tutoring; Low Vision

Outcome Measures

Primary Outcomes (2)

• Training effectiveness

  Performance in Orientation and Mobility task in real streets before training (Percent of success)

  Within 3 days before commencement of Orientation and Mobility training

• Training effectiveness

  Performance in Orientation and Mobility task in real streets after training (Percent of success)

  Within 3 days after completion of Orientation and Mobility training

Secondary Outcomes (4)

• Training effect retainment

  Within 3 days after completion of Orientation and Mobility training

• Training effect retainment

  At 3 months after completion of orientation and mobility training

• Subjective learning experience with VR-IOMS

  Within 30 minutes after completion of VR-IOMS training

• Training duration

  From the commencement of orientation & mobility training to its completion (may spread in multiple days) / within one week

Study Arms (3)

Orientation and Mobility Training with VR-IOMSs

EXPERIMENTAL

Low vision subjects with Orientation and Mobility (O\&M) difficulties learning O\&M skills from Virtual Reality-base Intelligent O\&M Specialists (VR-IOMSs). VR-IOMSs are intelligent, computer-controlled automatic O\&M skill training programs in virtual streets.

Behavioral: Orientation and Mobility Training with VR-IOMSs

Orientation and Mobility Training with COMS

ACTIVE COMPARATOR

Low vision subjects with Orientation and Mobility (O\&M) difficulties learning O\&M skills from human Certified O\&M Specialists (COMS) in real streets

Behavioral: Orientation and Mobility Training with COMS

No Orientation and Mobility Training

PLACEBO COMPARATOR

Low vision subjects with Orientation and Mobility (O\&M) difficulties watching low vision education videos and discuss low vision issues not related to O\&M with COMSs.

Behavioral: No Orientation and Mobility Training

Interventions

Orientation and Mobility Training with VR-IOMSs BEHAVIORAL

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

Orientation and Mobility Training with VR-IOMSs

Orientation and Mobility Training with COMS BEHAVIORAL

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

Orientation and Mobility Training with COMS

No Orientation and Mobility Training BEHAVIORAL

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

No Orientation and Mobility Training

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• New Jersey Institute of Technology: collaborator
• Alabama Institute for Deaf and Blind: collaborator

Study Sites (2)

University of Alabama at Birmingham

Birmingham, Alabama, 35226, United States

Location

Alabama Institute for Deaf and Blind

Talladega, Alabama, 35160, United States

Location

MeSH Terms

Conditions

Vision, Low; Orientation, Spatial

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spatial Behavior; Behavior

Study Officials

• Lei Liu, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Separate Certified Orientation \& Mobility Specialists (COMS) conduct training and outcome evaluation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: randomized, controlled training trial with experimental, active control and placebo groups

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: November 20, 2020
• Study Start: August 15, 2023
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)