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临床试验/NCT05647694
NCT05647694暂停不适用

V-NAV: Advanced Indoor Navigation Aid for Individuals With Visual Impairments, End User Evaluation

Vortant Technologies, LLC2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2025年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
入组人数
16
试验地点
2
主要终点
V-NAV effectiveness

研究概览

简要总结

The study will begin with an explanatory/training session where individuals with low vision will learn to use the V-NAV (Vortant NAVigation tool) indoor navigation app, and will have the opportunity to try it for a few representative tasks. The main activity includes a take-home trial, an extended unstructured period to emulate the post-purchase experience of users, during which participants will have the opportunity to use the V-NAV in their everyday lives. Data will be collected from the users to measure the relative advantage of V-NAV compared to the user's current indoor navigation method.

详细描述

The introductory session, emphasizing real-world experiences, will involve a brief training session followed by simulated navigation experiences in a convenient location to the users. Participants will use V-NAV to record approximately 8 locations, then will be given instructions to find these locations again. The V-NAV prototype's logging software will measure distance walked and task time. Participants will complete a study-specific tool covering the relevant attributes of the V-NAV prototype, as well as a standardized tool, the NASA TLX (Task Load Index).

Subsequently, participants will complete a take-home trial, during which they will be encouraged to use the V-NAV features regularly to support their everyday community navigation activities. Participants will be contacted approximately weekly with a "check-in" to answer questions and resolve any emergent technical problems. At the conclusion of the trial, a product-specific tool and an appropriate standardized tool, the PIADS (Psychosocial Impact of Assistive Devices Scale) will be administered.

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

The use of the app will not be masked.

入排标准

年龄范围
12 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • AFB "visually impaired" definition, acuity 20/70 or worse or field loss of 140 degrees

排除标准

  • Any health condition that may affect safety of individual to participate
  • Any physical, mental, or behavioral impairment that would provide more than minimal risk or hindering ability to comprehend the purpose of the device or otherwise to be a potential user of the V-NAV hardware or app.

结局指标

主要结局

V-NAV effectiveness

时间窗: 4 weeks

A measurement of user impressions as to the value of the V-NAV navigation aid. Use of e.g., PIADS survey.

次要结局

  • V-NAV usability(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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