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')
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Number of Collision Incidents (All Contacts)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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;
排除标准
- •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
结局指标
主要结局
Number of Collision Incidents (All Contacts)
时间窗: 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.
次要结局
- Number of Body Contacts(During the one-month period of device use)
- Device Questionnaire(During the one-month period of device use)
研究者
Alexandra Bowers
Associate Professor of Ophthalmology
Massachusetts Eye and Ear Infirmary