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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 is a NA study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 117 participants.
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
Interventions
- BEHAVIORAL Orientation and Mobility Training with VR-IOMSs
- BEHAVIORAL Orientation and Mobility Training with COMS
- BEHAVIORAL No Orientation and Mobility Training
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 117 participants |
| Start Date | 2023-08-15 |
| Est. Completion | 2025-06-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04639531
The ClinicalTrials.gov registry entry for NCT04639531 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 117 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Orientation and Mobility Training with VR-IOMSs is the first listed.
NCT04639531 reports 0 study locations.
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.
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