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NCT04639531 · ClinicalTrials.gov registry record · NA

Virtual Reality-Base Intelligent Orientation and Mobility Specialists Trial

A NA study, sponsored by University of Alabama at Birmingham.

Completed
Registry status
NA
Development phase
117
Enrollment target

NCT04639531: Completed NA study, sponsored by University of Alabama at Birmingham.

NCT04639531 is a NA study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 117 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04639531, a NA study, has completed, sponsored by University of Alabama at Birmingham.

COMPLETED
Registry status
NA
Development phase
117 participants
Enrollment target

Study 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 t

Primary Outcome

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

Interventions

  • BEHAVIORAL Orientation and Mobility Training with VR-IOMSs
  • BEHAVIORAL Orientation and Mobility Training with COMS
  • BEHAVIORAL No Orientation and Mobility Training

Trial Details

FieldValue
Enrollment Target 117 participants
Start Date 2023-08-15
Est. Completion 2025-06-30
Phase NA
University of Alabama at Birmingham

1,160 total trials

What the finished NCT04639531 record still lists

NCT04639531 is an interventional study that assigns participants to a tested intervention. The registered 117 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 3 interventions - of which Orientation and Mobility Training with VR-IOMSs is the first listed.

NCT04639531 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04639531 about?

NCT04639531 is a clinical study titled "Virtual Reality-Base Intelligent Orientation and Mobility Specialists Trial". 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 si...

What is the current status of trial NCT04639531?

This trial is currently completed. It is a NA study. The enrollment target is 117 participants. The study started on 2023-08-15. Estimated completion is 2025-06-30.

What interventions are being tested in trial NCT04639531?

The interventions under investigation include: Orientation and Mobility Training with VR-IOMSs (BEHAVIORAL), Orientation and Mobility Training with COMS (BEHAVIORAL), No Orientation and Mobility Training (BEHAVIORAL).

Who is sponsoring clinical trial NCT04639531?

This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04639531's enrollment target sits among peer trials

117 807th of 2000 higher than 1,193 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04639531, the US trial registry maintained by the National Library of Medicine. NCT04639531 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.