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Collision Warning Device for Blind and Visually Impaired

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ClinicalTrials.gov Identifier: NCT03057496
Recruitment Status : Completed
First Posted : February 20, 2017
Results First Posted : December 21, 2020
Last Update Posted : February 10, 2021
Sponsor:
Information provided by (Responsible Party):
Alexandra Bowers, Massachusetts Eye and Ear Infirmary

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hemianopia Hemianopsia Peripheral Visual Field Defect Blindness Retinitis Pigmentosa Glaucoma Device: Collision warning device Not Applicable

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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: The device will operate in two modes: active mode (intervention condition), when it gives warnings and, silent mode (control condition), when it does not give warnings. The device will be programmed to generate a different randomized active/silent schedule for each subject. Participants will not know whether it is in the active or silent mode.
Masking: None (Open Label)
Masking Description: Although this is a single-arm study, participants will be masked in the sense that they will not know whether the device is operating in the active mode (intervention condition), when it gives warnings, or the silent mode (control condition), when it does not give warnings. The device will be programmed to generate a different randomized active/silent schedule for each subject. The investigator conducting the statistical analyses will also be masked as to whether the device was in the active or silent mode
Primary Purpose: Other
Official 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')
Actual Study Start Date : January 22, 2018
Actual Primary Completion Date : November 8, 2019
Actual Study Completion Date : December 5, 2019

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Arms and Interventions
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Arm Intervention/treatment
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03057496


Locations
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United States, Massachusetts
Schepens Eye Research Institute
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts Eye and Ear Infirmary
Investigators
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Principal Investigator: Alex Bowers, PhD Schepens Eye Research Institute, Mass Eye and Ear
Principal Investigator: Gang Luo, PhD Schepens Eye Research Institute, Mass Eye and Ear
  Study Documents (Full-Text)

Documents provided by Alexandra Bowers, Massachusetts Eye and Ear Infirmary:
Informed Consent Form  [PDF] January 26, 2019
Study Protocol and Statistical Analysis Plan  [PDF] January 12, 2021

More Information
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Publications:

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Responsible Party: Alexandra Bowers, Associate Professor of Ophthalmology, Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT03057496    
Other Study ID Numbers: 1007377
First Posted: February 20, 2017    Key Record Dates
Results First Posted: December 21, 2020
Last Update Posted: February 10, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Blindness
Hemianopsia
Retinitis
Retinitis Pigmentosa
Eye Diseases
Retinal Diseases
Eye Diseases, Hereditary
 Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases