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Completed

NCT Number: NCT03057496

Collision Warning Device for Blind and Visually Impaired

This study evaluates a novel collision warning device to help people with severe vision impairment or blindness avoid collisions with obstacles. The main hypothesis to be tested is that the device reduces the number of collisions with obstacles in everyday activities.

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Key information

Conditions

Hemianopia Blindness Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Glaucoma Hemianopsia Nervous System Diseases Neurologic Manifestations Ocular Hypertension Pathological Conditions, Signs and Symptoms Peripheral Visual Field Defect Retinal Degeneration Retinal Diseases Retinal Dystrophies Retinitis Pigmentosa Sensation Disorders Signs and Symptoms Vision Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Schepens Eye Research Institute

Boston, Massachusetts, 02114, United States

About this study

Participants with blindness or severe visual field loss (hemianopia or tunnel vision) will be trained to use a collision warning device that alerts them to impending collisions. Participants will use the device at home during everyday mobility for about 1 month. The device is designed to supplement existing mobility devices, such as a long cane or dog guide. The device will provide warnings about potential collisions with mid- or high-level obstacles (which are typically not detected by a long cane).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Blindness (or very limited vision with visual acuity no better than "counting fingers"),
  • Or severe peripheral field loss / tunnel vision (≤ 40° remaining visual field) with visual acuity of at least 20/200,
  • Or homonymous hemianopia with visual acuity of at least 20/200;
  • Able to walk independently either with or without mobility aids such as a long cane or guide dog (but without the aid of a sighted guide);
  • Reports at least minor bumps or collisions within the last 3 months;

Exclusion criteria

  • Currently participating in a mobility training program
  • Diagnosed dementia
  • Significant cognitive decline
  • Participants with hemianopia will be excluded if they have hemianopia for less than 3 months and/or have spatial neglect

Treatment and study plan

Collision warning device

Device

The collision warning device is a pocket-sized, electronic system that includes a micro-computer, a clip-on miniature camera, a gyro-sensor, an accelerometer, and a rechargeable battery, all contained within a shoulder bag. It is about the size of a smart phone. When a potential collision is detected by the device it emits a warning to the user, either in the form of an audible beep or a tactile warning through bracelets worn on the wrist. The time to collision will be coded in both the auditory and tactile domains. The device is designed to only give warnings about high risk collisions, so the users will not be continually bombarded by warnings for every potential collision object in the environment.

Primary outcomes

  1. Number of Collision Incidents (All Contacts)

    Time frame: During the one-month period of device use

    Collision incidents recorded by the device in everyday use, including long cane contacts and body contacts with surrounding objects in the environment.

Secondary outcomes

  1. Number of Body Contacts

    Time frame: During the one-month period of device use

    Collision incidents with body contacts recorded by the device

  2. Device Questionnaire

    Time frame: During the one-month period of device use

    Questionnaire addressing participants' experiences of using the device. Scores were on a 5-point rating scale (1 to 5) with higher scores representing a better score. Questions were grouped into four main categories: i) overall satisfaction, ii) comfort, iii) mobility benefit, and iv) ease of operation. An average score was computed for questions within each category.

Sponsors and collaborators

Lead sponsor

Massachusetts Eye and Ear Infirmary

Other

Registry information

Official study title

Wearable Collision Warning Device for Blind and Visually Impaired: Clinical Trial (As Part of: 'Development of a Vision Assistive Device for Veterans With Traumatic Brain Injury-Associated Visual Dysfunctions')

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 20, 2017
Registry last updated
Feb 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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