V-NAV Usability Study: End Users Trying the Vortant Indoor Navigation Tool

NCT ID: NCT05647694

Last Updated: 2024-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2025-04-30

Brief Summary

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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

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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.

Conditions

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Blindness and Low Vision

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Participants will compare the value of the prototype app to their previous navigational experience without the app.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

The use of the app will not be masked.

Study Groups

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V-NAV users

Users who try the V-NAV for navigation tasks.

Group Type EXPERIMENTAL

V-NAV indoor navigation prototype

Intervention Type OTHER

Users will use the V-NAV prototype as an augmentation to their indoor navigation activities.

Interventions

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V-NAV indoor navigation prototype

Users will use the V-NAV prototype as an augmentation to their indoor navigation activities.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vortant Technologies, LLC

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philip R Schaefer, M.S.E

Role: PRINCIPAL_INVESTIGATOR

Vortant Technologies, LLC

Locations

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Vortant Technologies

Weaverville, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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NEI-VNAV-2C

Identifier Type: -

Identifier Source: org_study_id

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