Clinical Trial: Collision Warning Device for Blind and Visually Impaired

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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 Dysf

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.

Detailed Summary: 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).
Sponsor: Massachusetts Eye and Ear Infirmary

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.
  • 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
  • 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)


Original Secondary Outcome: Same as current

Information By: Massachusetts Eye and Ear Infirmary

Dates:
Date Received: February 14, 2017
Date Started: May 2017
Date Completion: September 2019
Last Updated: April 19, 2017
Last Verified: April 2017