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BlindnessNCT00829036

Wayfinding Information Access System for People With Vision Loss

A study testing Wayfinding Prototype in people with Blindness, run by US Department of Veterans Affairs at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Blindness
What is being tested?
Wayfinding Prototype
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited States
Study dates
Oct 2012to Dec 2012
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • N/A

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Atlanta VA Medical and Rehab Center, Decatur

    Decatur, Georgia, 30033

Other trials in United States

About this study

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.

Read the detailed 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.
Conditions
Blindness
Being tested
Wayfinding Prototype
Keywords
Rehabilitation, Sensory Aid
Medical subject headings
Blindness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Wayfinding PrototypeDevice

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

Study groups in NCT00829036
Study groupRoleWhat they receive
Wayfinding PrototypeExperimentalA Wayfinding Prototype is evaluated in terms of the time it takes subjects to use this device to walk to specific indoor locations versus baseline walking time.
Receives: Device: Wayfinding Prototype

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2009 (estimated)
  2. Study startOct 2012
  3. Primary completionDec 2012
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00829036
Sponsor's protocol ID
C6690-R
Status last verified
Feb 2014
First submitted
22 Jan 2009
Last updated
2 Apr 2014
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Wayfinding Prototype in people with Blindness, run by US Department of Veterans Affairs at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Percent (Prototype / Baseline) Time (time frame: 2 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2014.

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