Low Vision
Conditions
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
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
Detailed description
The objective of this project is to study visually impaired individuals' ability to develop echolocation skills using simple, wearable, echolocation devices that will not be cost prohibitive to most Americans and that would allow for greater availability to the visually impaired community. These echolocation devices emit parametric sound, a directional beam of ultrasound waves that interact with sound waves and surrounding objects, through goggles, watches, lanyards or even walking canes. This allows the visually impaired individual to detect sound waves as they reflect off their surroundings and return to the patient's ears in unique patterns resembling their external environment. This device would enable individuals to create a raw mental image of their surroundings and any obstacles along their path. The primary endpoint for this pilot study is to assess the feasibility of such echolocation devices as an adaptive low vision navigation aid on healthy subjects using low vision simulation goggles. Several metrics will be observed and recorded to measure how well echolocation technology addresses challenges associated with visual impairment and downstream factors. These metrics will include gait initiation, termination analysis via the Zeno-Walkway system, electromyography (EMG) of key muscles involved in gait termination, participant preference of echolocation wearable device modularity, and general survey questions. The secondary study endpoint is to implement the use of echolocation technology among members of the blind or visually impaired population as a clinical aid and study the impact that this technology has on their quality of life and added downstream health implications longitudinally. A final objective of this study is to seek feedback, not only on the use of any echolocation device to navigate but, to obtain feedback on subjects' experience with the specific study device, the Wearable Echolocation Device.
Interventions
DEVICEWearable 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.
Sponsors
The University of Texas Medical Branch, Galveston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Stride Length for Visually Impaired Individuals with Implementation of Echolocation Technology | Baseline (pre-training) and immediately post-training (same 30 minute session) | 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. |
| Change in Cadence for Visually Impaired Individuals with Implementation of Echolocation Technology | Baseline (pre-training) and immediately post-training (same 30 minute session) | 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. |
| Change in Walking Velocity for Visually Impaired Individuals with Implementation of Echolocation Technology | Baseline (pre-training) and immediately post-training (same 30 minute session) | 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. |
| Change in Body Mass Index (BMI) for Visually Impaired Individuals with Implementation of Echolocation Technology | Baseline (pre-training) and immediately post-training (same 30 minute session) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Participant-Reported Experience with Echolocation Device | Day 1 | Participants will complete the Wearable Echolocation Aids Using Parametric Sound: Post-Trials Survey to evaluate their experience using the echolocation device during the study. |
Countries
United States
Contacts
Primary ContactPraveena Gupta, PhD OD FAAO
Backup ContactStacy M Schreiber Lopez, AA BS MA
Outcome results
None listed