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Collision Warning Device for Blind and Visually Impaired

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ClinicalTrials.gov Identifier: NCT03057496
Recruitment Status : Recruiting
First Posted : February 20, 2017
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Alexandra Bowers, Massachusetts Eye and Ear Infirmary

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 2 months. 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
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
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019


Arm Intervention/treatment
Experimental: Intervention
Participants will use the collision warning device as much as possible for two months 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. 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. As the time to collision decreases, the rhythm of auditory beeps and the tactile vibrations will increase. 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 Outcome Measures :
  1. Number of collision incidents in everyday device use [ Time Frame: Number of collision incidents during the two-month period of device use ]
    The primary outcome measure will be the difference in the number of collision incidents in the active and silent modes during everyday device use.


Secondary Outcome Measures :
  1. Indoor obstacle course - number of contacts [ Time Frame: Assessed at the final study visit (week 8) ]
    The number of obstacle contacts will be recorded on a high-density, indoor obstacle course. The difference in the number of contacts when using the device and when not using the device will be compared.

  2. Indoor obstacle course - preferred walking speed [ Time Frame: Assessed at the final study visit (week 8) ]
    Walking speed on the obstacle course will be quantified in terms of the percentage of preferred walking speed (PPWS) relative to walking on an obstacle-free path. The PPWS when using the device and when not using the device will be compared

  3. Independent mobility questionnaire [ Time Frame: Administered once at baseline without the device and once at the final study visit (week 8) ]
    Perceived level of mobility difficulties quantified using the Independent Mobility Questionnaire (rates level of difficulty with mobility in various situations on a 5-point scale)



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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

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


Contacts
Contact: Alex Bowers, PhD 617-912-2512 alex_bowers@meei.harvard.edu

Locations
United States, Massachusetts
Schepens Eye Research Institute Recruiting
Boston, Massachusetts, United States, 02114
Contact: Moona Abdulkerim    617-912-2505    visiontrials@meei.harvard.edu   
Sponsors and Collaborators
Massachusetts Eye and Ear Infirmary
Investigators
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

Responsible Party: Alexandra Bowers, Associate Professor of Ophthalmology, Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT03057496     History of Changes
Other Study ID Numbers: 1007377
First Posted: February 20, 2017    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Vision Disorders
Retinitis
Retinitis Pigmentosa
Cone-Rod Dystrophies
Blindness
Hemianopsia
Retinal Diseases
Eye Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms