Collision Warning Device for Blind and Visually Impaired

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-22

Study Completion Date

2019-12-05

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Hemianopia Hemianopsia Peripheral Visual Field Defect Blindness Retinitis Pigmentosa Glaucoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

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

Study Groups

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Intervention

Participants will use the collision warning device as much as possible for about one month during everyday activities, when walking indoors and outdoors.

Group Type EXPERIMENTAL

Collision warning device

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes