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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03057496|
Recruitment Status : Recruiting
First Posted : February 20, 2017
Last Update Posted : March 12, 2018
|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)|
|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|
|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|
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.
- 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.
- 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)
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
|Contact: Alex Bowers, PhDfirstname.lastname@example.org|
|United States, Massachusetts|
|Schepens Eye Research Institute||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Jordyn Hanover 617-912-2505 email@example.com|
|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|