NCT07218991

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
21mo left

Started Feb 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress41%
Feb 2025Jan 2028

First Submitted

Initial submission to the registry

February 11, 2025

Completed
10 days until next milestone

Study Start

First participant enrolled

February 21, 2025

Completed
8 months until next milestone

First Posted

Study publicly available on registry

October 21, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2027

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2028

Last Updated

October 28, 2025

Status Verified

October 1, 2025

Enrollment Period

2.3 years

First QC Date

February 11, 2025

Last Update Submit

October 24, 2025

Conditions

Keywords

low visionvisual impairmentblindnessblindvisual aidvisual rehabilitationsensory compensationecholocationparametric soundparametric sound technologywearable echolocation deviceecholocation technologydirectional sound wavesecholocation headphonesassistive deviceecholocation skillsultrasound wavessound wavesadaptive low vision navigation aidlow vision simulation gogglesnavigation aidlow vision simulator

Outcome Measures

Primary Outcomes (4)

  • Change in Stride Length for Visually Impaired Individuals with Implementation of Echolocation Technology

    Stride length will be measured using the Zeno Walkway system, an electronic, pressure-sensitive mat connected to a PC that automates the measurement of spatial and temporal aspects of gait. The walkway's high-resolution sensors capture real-time data as participants walk across it. Each participant will walk on the instrumented mat for approximately 30 minutes, allowing for detailed analysis of stride length. Mean stride length (in meters) will be calculated from multiple trials to assess changes following implementation of echolocation technology.

    Baseline (pre-training) and immediately post-training (same 30 minute session)

  • Change in Cadence for Visually Impaired Individuals with Implementation of Echolocation Technology

    Cadence (steps per minute) will be assessed using the Zeno Walkway system, an electronic, pressure-sensitive mat that captures real-time gait data. Participants will walk across the instrumented walkway for approximately 30 minutes. The system will automatically record and calculate the average number of steps per minute to evaluate changes in cadence following implementation of echolocation technology.

    Baseline (pre-training) and immediately post-training (same 30 minute session)

  • Change in Walking Velocity for Visually Impaired Individuals with Implementation of Echolocation Technology

    Walking velocity will be measured using the Zeno Walkway system, an electronic, pressure-sensitive mat that captures spatial and temporal aspects of gait. Participants will walk across the walkway for approximately 30 minutes. The system will automatically calculate average walking velocity (in meters per second) based on distance and time. This outcome will be used to evaluate improvements in gait speed following implementation of echolocation technology.

    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

    Body Mass Index (BMI) will be calculated using standard anthropometric measures of height and weight (weight in kilograms divided by height in meters squared). Measurements will be taken at each study visit to assess any change in BMI that may occur following implementation of echolocation technology.

    Baseline (pre-training) and immediately post-training (same 30 minute session)

Other Outcomes (1)

  • Participant-Reported Experience with Echolocation Device

    Day 1

Study Arms (2)

Group 1 - Wearing a Low-Vision Simulator without the Wearable Echolocation Device

NO INTERVENTION

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.

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

ACTIVE COMPARATOR

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.

Device: Wearable Echolocation Device

Interventions

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.

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

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555, United States

RECRUITING

Related Publications (7)

  • GBD 2019 Blindness and Vision Impairment Collaborators; Vision Loss Expert Group of the Global Burden of Disease Study. Trends in prevalence of blindness and distance and near vision impairment over 30 years: an analysis for the Global Burden of Disease Study. Lancet Glob Health. 2021 Feb;9(2):e130-e143. doi: 10.1016/S2214-109X(20)30425-3. Epub 2020 Dec 1.

    PMID: 33275950BACKGROUND
  • Varadaraj V, Ehrlich JR, Swenor BK. Vision Impairment Has Implications for Aging and Health Outcomes, Beyond Ophthalmology. JAMA Netw Open. 2022 May 2;5(5):e2214610. doi: 10.1001/jamanetworkopen.2022.14610. No abstract available.

    PMID: 35608864BACKGROUND
  • Ong SR, Crowston JG, Loprinzi PD, Ramulu PY. Physical activity, visual impairment, and eye disease. Eye (Lond). 2018 Aug;32(8):1296-1303. doi: 10.1038/s41433-018-0081-8. Epub 2018 Apr 3.

    PMID: 29610523BACKGROUND
  • Thaler L, Goodale MA. Echolocation in humans: an overview. Wiley Interdiscip Rev Cogn Sci. 2016 Nov;7(6):382-393. doi: 10.1002/wcs.1408. Epub 2016 Aug 19.

    PMID: 27538733BACKGROUND
  • Swenor BK, Ehrlich JR. Ageing and vision loss: looking to the future. Lancet Glob Health. 2021 Apr;9(4):e385-e386. doi: 10.1016/S2214-109X(21)00031-0. Epub 2021 Feb 16. No abstract available.

    PMID: 33607013BACKGROUND
  • Sohl-Dickstein J, Teng S, Gaub BM, Rodgers CC, Li C, DeWeese MR, Harper NS. A Device for Human Ultrasonic Echolocation. IEEE Trans Biomed Eng. 2015 Jun;62(6):1526-1534. doi: 10.1109/TBME.2015.2393371. Epub 2015 Jan 16.

    PMID: 25608301BACKGROUND
  • Norman LJ, Dodsworth C, Foresteire D, Thaler L. Human click-based echolocation: Effects of blindness and age, and real-life implications in a 10-week training program. PLoS One. 2021 Jun 2;16(6):e0252330. doi: 10.1371/journal.pone.0252330. eCollection 2021.

    PMID: 34077457BACKGROUND

Related Links

MeSH Terms

Conditions

Vision, LowVision DisordersBlindnessEcholocation

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsAnimal CommunicationBehavior, AnimalBehavior

Study Officials

  • Praveena M Gupta, PhD OD FAAO

    University of Texas

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Praveena Gupta, PhD OD FAAO

CONTACT

Stacy M Schreiber Lopez, AA BS MA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Subjects will be randomly assigned to one of two groups. Both groups will perform identical study activities, though the order of activities will be different. Group assignment will not be provided to the outcomes assessor so as to avoid influencing the analysis of the data.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Subjects will be divided into two groups who will both perform identical study activities, performing a trial with the study device and another without the study device, however, in a different order.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2025

First Posted

October 21, 2025

Study Start

February 21, 2025

Primary Completion (Estimated)

June 14, 2027

Study Completion (Estimated)

January 31, 2028

Last Updated

October 28, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations