Collision Warning Device for Blind and Visually Impaired
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03057496|
Recruitment Status : Completed
First Posted : February 20, 2017
Results First Posted : December 21, 2020
Last Update Posted : February 10, 2021
|Condition or disease||Intervention/treatment||Phase|
|Hemianopia Hemianopsia Peripheral Visual Field Defect Blindness Retinitis Pigmentosa Glaucoma||Device: Collision warning device||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 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|
|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|
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.
- 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.
- 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.
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
|United States, Massachusetts|
|Schepens Eye Research Institute|
|Boston, Massachusetts, United States, 02114|
|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|