Trial Outcomes & Findings for Wayfinding Information Access System for People With Vision Loss (NCT NCT00829036)
NCT ID: NCT00829036
Last Updated: 2014-04-02
Results Overview
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.
COMPLETED
NA
24 participants
2 hours
2014-04-02
Participant Flow
Participant milestones
| Measure |
Prototype vs. Baseline
Prototype:
Subjects are trained for 20 minutes in the use of the prototype (1) in open spaces and (2) in hallways. They are taught how to select a destination, and obtain turn-by-turn navigation directions to walk to the selected destination. Subjects are then asked to walk to 12 different unknown locations, one location in each of 12 timed trials. Half of these locations are in open spaces and half in hallways. Walking time is the performance measure.
Baseline:
An Orientation and Mobility (O\&M) specialist first teaches the subject how to find (walk to) each of the same 12 locations, though in a different order. Again, 6 of these are in open spaces and 6 in hallways. Then, over 12 trials, subjects are asked to independently walk to each of the specified locations, one location per trial. Again, walking time is the performance measure.
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Wayfinding Information Access System for People With Vision Loss
Baseline characteristics by cohort
| Measure |
Baseline Wayfinding Performance
n=24 Participants
An Orientation and Mobility specialist teaches subjects (1) how to find each of 4 specific locations in an open space from a random starting location, and (2) how to navigate hallways from a known starting location to find each of 8 specific locations in the hallways of the Atlanta VA Medical Center. Subjects are then (1) brought to a random start point in the open space and asked to walk to the same 4 specific locations they were taught to find and (2) brought to a known starting point in the hallways of the VA Medical Center and asked to walk to the same 8 specific locations they were taught to find.
|
|---|---|
|
Age, Continuous
|
50.9 years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 hoursPopulation: Power Analysis: Using Repeated Measures ANOVA for the 24 participants assuming a minimum correlation between repeated measures of .7, we chose our analyses will be sensitive to a medium between factor effect size of f=.33 with power set to .80 and alpha level set to .05.
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.
Outcome measures
| Measure |
Prototype vs. Baseline
n=24 Participants
Prototype:
Subjects are trained for 20 minutes in the use of the prototype (1) in open spaces and (2) in hallways. They are taught how to select a destination, and obtain turn-by-turn navigation directions to walk to the selected destination. Subjects are then asked to walk to 12 different unknown locations, one location in each of 12 timed trials. Half of these locations are in open spaces and half in hallways. Walking time is the performance measure.
Baseline:
An Orientation and Mobility (O\&M) specialist first teaches the subject how to find (walk to) each of the same 12 locations, though in a different order. Again, 6 of these are in open spaces and 6 in hallways. Then, over 12 trials, subjects are asked to independently walk to each of the specified locations, one location per trial. Again, walking time is the performance measure.
|
|---|---|
|
Mean Percent (Prototype / Baseline) Time
|
78.7 Percentage of Baseline Performance Time
Standard Deviation 68.6
|
Adverse Events
Wayfinding: Prototype vs. Baseline
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
David A. Ross
Atlanta VA Rehab R&D Center of Excellence
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place