Collision Warning Device for Blind and Visually Impaired

Overview

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.

Full Title of Study: “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’)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 8, 2019

Detailed Description

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).

Interventions

  • Device: Collision warning 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.

Arms, Groups and Cohorts

  • Experimental: Intervention
    • Participants will use the collision warning device as much as possible for about one month during everyday activities, when walking indoors and outdoors.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Number of Body Contacts
    • Time Frame: During the one-month period of device use
    • Collision incidents with body contacts recorded by the device
  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Massachusetts Eye and Ear Infirmary
  • Provider of Information About this Clinical Study
    • Principal Investigator: Alexandra Bowers, Associate Professor of Ophthalmology – Massachusetts Eye and Ear Infirmary
  • Overall Official(s)
    • Alex Bowers, PhD, Principal Investigator, Schepens Eye Research Institute, Mass Eye and Ear
    • Gang Luo, PhD, Principal Investigator, Schepens Eye Research Institute, Mass Eye and Ear

References

Pundlik S, Baliutaviciute V, Moharrer M, Bowers AR, Luo G. Data Acquisition, Processing, and Reduction for Home-Use Trial of a Wearable Video Camera-Based Mobility Aid. Transl Vis Sci Technol. 2020 Jun 11;9(7):14. doi: 10.1167/tvst.9.7.14. eCollection 2020 Jun.

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