Skip to main content
Clinical Trials/NCT05647694
NCT05647694
Suspended
Not Applicable

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

Vortant Technologies, LLC1 site in 1 country16 target enrollmentJanuary 1, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Blindness and Low Vision
Sponsor
Vortant Technologies, LLC
Enrollment
16
Locations
1
Primary Endpoint
V-NAV effectiveness
Status
Suspended
Last Updated
last year

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2025
End Date
April 30, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

V-NAV effectiveness

Time Frame: 4 weeks

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

Secondary Outcomes

  • V-NAV usability(1 day)

Study Sites (1)

Loading locations...

Similar Trials