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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00829036
Other study ID # C6690-R
Secondary ID
Status Completed
Phase N/A
First received January 22, 2009
Last updated February 18, 2014
Start date October 2012
Est. completion date December 2012

Study information

Verified date February 2014
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

The purpose of the project is to find out what kinds of information are most useful to visually impaired people when they are moving around indoors and what kinds of controls will make it easy for visually impaired people to control a device to help orient them to an unfamiliar indoor space.


Description:

The greatest mobility problems for people with severe visual impairment are caused by gaps in available information about the environment -- environmental cues needed for orienting to salient landmarks in the surrounding environment and for wayfinding. Such informational cues are of great import because persons with severe visual impairment can become hopelessly lost if they cannot keep track of where they are at any given moment as they move along.

A newly developed long-range Radio Frequency Identification (RFID) tag reader might completely solve this problem. Previously, passive (i.e., not battery powered) RFID tags could only be read from a distance of 16 inches or less. This new tag reader can read multiple tags up to 18 feet away, and indicate the direction and range of each tag. At a cost of under 10 each, 250 RFID tags would have to be placed around an environment to equal the cost of 1 Braille sign ($25), yet the value-added in terms of available information at a distance is incredible: every object (landmark, door, water fountain, exit sign, chair, table, etc.) within a range of 18 feet would be able to "announce" its presence.

Visible signage equivalency could be achieved overnight. Further, Interface, Inc., a commercial floor manufacturer is now adhering RFID tags to the protected underside their 50X50 cm floor tiles. Using such flooring and the new long-range readers, a very elegant and affordable indoor GPS-like guidance system can be realized through triangulation of these RFID floor tiles. In the long run, as this RFID flooring infrastructure fills in, the most ideal solution could result, as it would enable the development of easily-managed building databases containing everything users would need to know to orient to new buildings and find their way around with ease. Users would never be lost, as they would always know their current location and heading. In addition, such a building database would be much easier to maintain, as opposed to updating individual RFID tags, when building tenants move or renovations take place. Interface is very interested in supporting our research, and is donating 2500 square feet of their RFID flooring to the VA for this purpose.

The Research Questions to be answered by the herein proposed research are:

1. How should environmental information be organized and parsed according to actual needs so that persons can be provided with needed information without inundating them with useless and/or distracting information in the process?

2. How should a user interface be structured to offer needed information in an easily controlled and useable fashion?

To address these Questions, the following Research Objectives have been established:

1. Determine what kinds of information are needed according to (a) a characterization of individual needs, O&M abilities, and degree of useful residual vision;

2. Develop a structured database of information parsed and organized according to information associated with specific participant characterization clusters as associated with individual needs, residual vision, etc.;

3. Develop an optimal user interface for the control and delivery of needed information adaptable to the individual needs of the participants;

4. Develop an RFID reader antenna that can triangulate RFID tags in flooring to determine the user's current location and heading, as well as identify the information and location of other tags of interest on objects in the surround; and

5. Construct and Evaluate a Wayfinding Prototype as specified by the results of the above objectives.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Must be blind with no better vision than light perception and must be able to do 3 hours of walking (with many breaks)

Exclusion Criteria:

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Device:
Wayfinding Prototype
A Wayfinding Prototype is used by subjects to determine any advantages over current standard of rehabilitation.

Locations

Country Name City State
United States Atlanta VA Medical and Rehab Center, Decatur Decatur Georgia

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean Percent (Prototype / Baseline) Time The outcome measure for each subject is the mean of the (Prototype Time / Baseline Time) across 12 trials. The outcome measure for the experiment is the mean of 24 individual subject mean scores. This mean outcome measure is expressed as a percentage of the mean Baseline Time, where improved performance is represented by a percentage that is less than 100 percent of the Baseline Time. The lower the percentage, the better the performance improvement. 2 hours No
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