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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

Tracking Information
First Submitted Date  ICMJE February 14, 2017
First Posted Date  ICMJE February 20, 2017
Results First Submitted Date  ICMJE October 30, 2020
Results First Posted Date  ICMJE December 21, 2020
Last Update Posted Date February 10, 2021
Actual Study Start Date  ICMJE January 22, 2018
Actual Primary Completion Date November 8, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 15, 2017)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2020)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2017)
  • 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Collision Warning Device for Blind and Visually Impaired
Official Title  ICMJE 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')
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 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Hemianopia
  • Hemianopsia
  • Peripheral Visual Field Defect
  • Blindness
  • Retinitis Pigmentosa
  • Glaucoma
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Device: Collision warning device
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 24, 2020)
49
Original Estimated Enrollment  ICMJE
 (submitted: February 15, 2017)
90
Actual Study Completion Date  ICMJE December 5, 2019
Actual Primary Completion Date November 8, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03057496
Other Study ID Numbers  ICMJE 1007377
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Alexandra Bowers, Massachusetts Eye and Ear Infirmary
Study Sponsor  ICMJE Massachusetts Eye and Ear Infirmary
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Massachusetts Eye and Ear Infirmary
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP