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Completed Not applicable Interventional

Virtual Reality-Base Intelligent Orientation and Mobility Specialists Trial

ClinicalTrials.gov ID: NCT04639531

Public ClinicalTrials.gov record NCT04639531. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 1, 2026, 9:35 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04639531
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Enrollment
117 participants

Conditions and interventions

Eligibility (public fields only)

Age range
13 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 14, 2023
Primary completion
Jun 29, 2025
Completion
Jun 29, 2025
Last update posted
May 19, 2026

2023 – 2025

United States locations

U.S. sites
2
U.S. states
1
U.S. cities
2
Facility City State ZIP Site status
University of Alabama at Birmingham Birmingham Alabama 35226
Alabama Institute for Deaf and Blind Talladega Alabama 35160

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04639531, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 19, 2026 · Synced Sep 1, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04639531 live on ClinicalTrials.gov.

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