Recruiting

Assistive Device

Sponsor:

The University of Texas Medical Branch, Galveston

Code:

NCT07218991

Conditions

Low Vision

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Wearable Echolocation Device

Study Details

Brief summary:

The objective of this study is to study a novel device designed to aid patients with impaired vision to safely navigate their environment. Subjects for this study will be individuals with normal vision, either with or without correction. The subjects will wear a device to simulate impaired vision and will be asked to walk a path with randomly placed obstacles during two trials. One of the trials will consist of the subject wearing the simulator alone. The other trial will consist of the subject wearing the simulator and the study device. The study device is designed to be worn by the study subject and will emit tones to indicate obstacles in the environment as the subject walks on the path with random obstacles. The tones will indicate that there is an obstacle in the individual's path and will increase in intensity as the subject moves closer to the object.Invest

Conditions

Low Vision

Study ID

NCT07218991

Start date

Feb 21, 2025

Status verified date

Oct, 2025

Completion date

Jan 31, 2028

Anticipated

Primary completion date

Jun 14, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Subject has provided informed consent in a manner approved by the Institutional Review Board (IRB) and is willing and able to comply with the trial procedures.
  • Adults at least 18 years of age and no older than 100 years of age at the time of consent.
  • Individuals in good health who can perform daily activities without assistance and can walk independently.
  • Normal vision (with or without corrective lenses) if there is no uncorrectable visual impairment.

Exclusion Criteria:

  • History of gait problems.
  • Foot or leg impairments.
  • Hearing impairment.
  • Vertigo or other balance problems.
  • Pregnant individuals.
  • Any medical condition that, in the opinion of the investigator, would place the subject at increased risk for participation.
  • Medications that may cause dizziness or weakness.
  • Concurrent participation on another research study.
  • Use of an investigational agent in the 30 days prior to signing informed consent.
  • History of prior non-compliance.
  • Presence or history of psychiatric condition (including anxiety, psychosis, drug, or alcohol addiction) that would, in the opinion of the investigator, make it difficult for the subject to comply with the study procedures or follow the investigators instructions.
  • Non-English-speaking individuals.
  • Individuals from special or vulnerable populations (i.e., adults unable to consent, minors, incarcerated individuals).
  • Body weight greater than 700 pounds.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

no intervention: Group 1 - Wearing a Low-Vision Simulator without the Wearable Echolocation Device

The participant will be wearing a low-vision simulator and navigating a pathway randomly populated with obstacles. They will then perform the same trial, wearing the low vision simulator, navigating the same pathway with obstacles randomly rearranged; however, the participants will use the Wearable Echolocation Device to assist with navigation.

active comparator: Group 2- Wearing a Low-Vision Simulator with the Wearable Echolocation Device

The participants will be wearing the low-vision simulator and the wearable echolocation Device for the first test to assist with navigating the pathway randomly populated with obstacles. The participant will then perform the same test, wearing the low-vision simulator without the Wearable Echolocation Device, navigating the same pathway with randomly rearranged obstacles.

Interventions

Wearable Echolocation Device

The device features many parametric speakers housed in a plastic case. The parametric speakers emit directional sound waves that return to the source with varying wavelengths depending on the distance of the surrounding objects. The device is designed to be worn by the subject either using a lanyard on the subject's neck, or on the subject's wrist.

Primary outcome measure

  • Change in Stride Length for Visually Impaired Individuals with Implementation of Echolocation Technology [ Time Frame: Baseline (pre-training) and immediately post-training (same 30 minute session) ]
  • Change in Cadence for Visually Impaired Individuals with Implementation of Echolocation Technology [ Time Frame: Baseline (pre-training) and immediately post-training (same 30 minute session) ]
  • Change in Walking Velocity for Visually Impaired Individuals with Implementation of Echolocation Technology [ Time Frame: Baseline (pre-training) and immediately post-training (same 30 minute session) ]
  • Change in Body Mass Index (BMI) for Visually Impaired Individuals with Implementation of Echolocation Technology [ Time Frame: Baseline (pre-training) and immediately post-training (same 30 minute session) ]

Central Contacts and Locations

Central contacts

Praveena Gupta, PhD OD FAAO

(409) 747-5823prgupta@utmb.edu

Stacy M Schreiber Lopez, AA BS MA

2814602704smschrei@UTMB.EDU

Locations

University of Texas Medical Branch

Recruiting

Galveston, Texas, United States, 77555

Contacts

Praveena Gupta, PhD OD FAAO

409-747-5823prgupta@utmb.edu

Stacy M Schreiber Lopez, AA BS MA

2814602704smschrei@UTMB.EDU

More Information

Sponsor

The University of Texas Medical Branch, Galveston

Last update posted

Oct 28, 2025

Last verified

Oct, 2025

Keywords

  • low vision
  • visual impairment
  • blindness
  • blind
  • visual aid
  • visual rehabilitation
  • sensory compensation
  • echolocation
  • parametric sound
  • parametric sound technology
  • wearable echolocation device
  • echolocation technology
  • directional sound waves
  • echolocation headphones
  • assistive device
  • echolocation skills
  • ultrasound waves
  • sound waves
  • adaptive low vision navigation aid
  • low vision simulation goggles
  • navigation aid
  • low vision simulator

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Medical Branch, Galveston on 2025-10-28.