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.
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
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:
- 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?
- 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:
- Determine what kinds of information are needed according to (a) a characterization of individual needs, O\&M abilities, and degree of useful residual vision;
- 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.;
- Develop an optimal user interface for the control and delivery of needed information adaptable to the individual needs of the participants;
- 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
- 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 group | Role | What they receive |
|---|---|---|
| Wayfinding Prototype | Experimental | A 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.
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.
- First posted26 Jan 2009 (estimated)
- Study startOct 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BlindnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- David A Ross, MSEE Med, Principal investigator, Atlanta VA Medical and Rehab Center, Decatur
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wayfinding Information Access System for People With Vision Loss
- ClinicalTrials.gov ID
- NCT00829036
- Acronym / sponsor ID
- C6690-R
- Conditions
- Blindness
- Keywords
- Rehabilitation, Sensory Aid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Oct 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 26 Jan 2009 (estimated)
- Results
- Posted 2 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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?
- 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:
- Determine what kinds of information are needed according to (a) a characterization of individual needs, O\&M abilities, and degree of useful residual vision;
- 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.;
- Develop an optimal user interface for the control and delivery of needed information adaptable to the individual needs of the participants;
- 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
- Construct and Evaluate a Wayfinding Prototype as specified by the results of the above objectives.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wayfinding Prototype | Experimental | Device: Wayfinding PrototypeA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Must be blind with no better vision than light perception and must be able to do 3 hours of walking (with many breaks)
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wayfinding PrototypeA Wayfinding Prototype is used by subjects to determine any advantages over current standard of rehabilitation. | Device | Wayfinding Prototype |
Primary outcome
Mean Percent (Prototype / Baseline) Time
Time frame: 2 hours
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David A Ross, MSEE Med principal investigator
Atlanta VA Medical and Rehab Center, Decatur
1 site in 1 country: see every site and its status.
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.