Study Stopped
Intervention worsened performance for first 17 of 24 planned participants.
Emergency Egress and Information System for Persons With Vision Loss
1 other identifier
interventional
17
1 country
1
Brief Summary
The purpose of the research project is to develop and evaluate an emergency egress system for persons with visual impairment, which would use existing lighted exit signage to provide egress information at a distance of up to 100 feet.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2008
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2005
CompletedFirst Posted
Study publicly available on registry
December 6, 2005
CompletedStudy Start
First participant enrolled
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedResults Posted
Study results publicly available
February 11, 2014
CompletedFebruary 11, 2014
January 1, 2014
3 months
December 2, 2005
September 17, 2013
January 14, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to Exit Building
Subjects are walked into a building to a specific location and then asked to find their way out of the building. Time to Exit Building is measured. This is protocol is performed twice, and the times averaged to obtain the outcome measure.
30 minutes total, 15 minutes for each of two timed trials
Study Arms (2)
Egress Badge Performance
EXPERIMENTALBlind subjects are walked into a building to a specific location, and then are asked to find their way out of the building.
Baseline Egress Performance
NO INTERVENTIONBlind subjects are walked into a building to a particular location and then asked to find their way out of the building.
Interventions
Egress Badge is worn by subjects who are asked to use the badge to exit the building. The badge indicates the direction of each exit sign on route to an exit.
Eligibility Criteria
You may qualify if:
- Must Be Blind with no better vision than light perception
- Must be able to walk the necessary distances, i.e., three hours of intermittent indoor walking
- OMCT (Orientation-Memory Concentration Test) of 10 or less
You may not qualify if:
- Patients currently being treated at Atlanta VA Medical Center
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Atlanta VA Medical and Rehab Center, Decatur
Decatur, Georgia, 30033, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Trials were terminated early with just 17 Participants of the planned 24, as the intervention was NOT providing measurable benefit.
Results Point of Contact
- Title
- David A. Ross
- Organization
- Atlanta VA Rehabilitation R&D Center of Excellence
Study Officials
- PRINCIPAL INVESTIGATOR
David A Ross, MSEE Med
Atlanta VA Medical and Rehab Center, Decatur
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2005
First Posted
December 6, 2005
Study Start
September 1, 2008
Primary Completion
December 1, 2008
Study Completion
April 1, 2009
Last Updated
February 11, 2014
Results First Posted
February 11, 2014
Record last verified: 2014-01