Clinical trial NCT05647694: V-NAV Usability Study: End Users Trying the Vortant Indoor Navigation Tool
Official title: V-NAV: Advanced Indoor Navigation Aid for Individuals With Visual Impairments, End User Evaluation
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Blindness and Low Vision
Keywords: blindness, indoor navigation
Lead sponsor: Vortant Technologies, LLC
Sponsor class: OTHER
First posted: 2022-12-12
Enrollment: 16
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants will compare the value of the prototype app to their previous navigational experience without the app.
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: V-NAV effectiveness
timeFrame: 4 weeks
Secondary outcomes:
measure: V-NAV usability
timeFrame: 1 day
Other outcomes:
Locations:
city: Weaverville
country: United States
facility: Vortant Technologies
state: North Carolina
Study officials:
affiliation: Vortant Technologies, LLC
name: Philip R Schaefer, M.S.E
role: PRINCIPAL_INVESTIGATOR
References: