Wearable Echolocation Aids Using Parametric Sound
ConditionLow Vision
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorThe University of Texas Medical Branch, Galveston
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
History of gait problems.
Foot or leg impairments.
Hearing impairment.
Vertigo or other balance problems.
Trial design
Design model
Parallel
Treatments tested in this trial
Wearable Echolocation Device
DeviceThe 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Group 1 - Wearing a Low-Vision Simulator without the Wearable Echolocation DeviceNo intervention 0 interventions
Group B: Group 2- Wearing a Low-Vision Simulator with the Wearable Echolocation DeviceActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (pre-training) and immediately post-training (same 30 minute session)2
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.
Time frame
Baseline (pre-training) and immediately post-training (same 30 minute session)3
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.
Time frame
Baseline (pre-training) and immediately post-training (same 30 minute session)4
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.
Time frame
Baseline (pre-training) and immediately post-training (same 30 minute session)Other outcomes
1
Participant-Reported Experience with Echolocation Device
Participants will complete the "Wearable Echolocation Aids Using Parametric Sound: Post-Trials Survey" to evaluate their experience using the echolocation device during the study.
Time frame
Day 1Sponsors and contacts
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Source ClinicalTrials.gov