COMPLETED

Virtual Reality-Base Intelligent Orientation and Mobility Specialists Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-08-15
Study Completion:2025-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT04639531

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:13 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Have stable, late-onset visual impairment.
  2. * 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.
  3. * Following visual function requirements for the three studied O\&M tasks
  4. * Task NLPT: best corrected visual acuity of 20/650 or worse
  5. * Task TGJ:
  6. * central vision loss - acuity 20/100-20/300, radius of field 50-80 deg
  7. * peripheral vision loss - acuity 20/15-20/100, radius of field 5-55 deg
  8. * Task ONS: visual function requirements for both Tasks NLPT \& TGJ
  9. * Possess sufficient functional vision to learn the O\&M tasks (evaluated by COMS in real streets)
  10. * Have O\&M as a rehabilitation goal
  11. * Normal or corrected to normal hearing
  12. * No cognitive impairment (Montreal Cognitive Assessment (MoCA) or MoCA-blind (MoCA-B) score exceeds education-adjusted cutoffs)
  13. * Dexterity to operate a pointing mouse or a joystick
  14. * 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
  1. * Patients in the rapid progression phase of ocular diseases, such as wet macular degeneration
  2. * Patients under aggressive treatment of ocular diseases, such as VEGF injection for retinal diseases
  3. * Patients with congenital visual impairment will be excluded.
  4. * Participants will be excluded from the training for the skills that they already master.
  5. * Participants who have a history of epileptic seizure or are prone to motion sickness will be excluded.
  6. * Have difficulty in verbal communication in English.

Contacts and Locations

Principal Investigator

Lei Liu, PhD
PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35226
United States
Alabama Institute for Deaf and Blind
Talladega, Alabama, 35160
United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

  • Lei Liu, PhD, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-15
Study Completion Date2025-06-30

Study Record Updates

Study Start Date2023-08-15
Study Completion Date2025-06-30

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Low Vision, Both Eyes