Trial Outcomes & Findings for Computer Vision System for the Blind Veteran (NCT NCT00920231)
NCT ID: NCT00920231
Last Updated: 2016-01-22
Results Overview
device failures were defined as any failure to provide correct location and direction information at thre appropriate time, resulting in a mistake that needed the initial prototype's ability to meet their travel needs at a good to excellent range.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
The subject is given as much time as needed to complete the task
Results posted on
2016-01-22
Participant Flow
Participant milestones
| Measure |
Initial Computer Vision System
a group of 8 blind subjects were tested with a prototype computer vision system build for outdoor navigation that relied on combination of GPS and location recognition for navigation information.
the task was a wayfinding task starting from one point in the hospital and go to a point at another point in the hospital while navigating negotiating a number of turns over multiple corridors.
|
Modified Computer Vision System
a second group of 8 blind subjects were tested with a modified computer vision system.
same task as the initial group with improved computer vision algorithm.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Computer Vision System for the Blind Veteran
Baseline characteristics by cohort
| Measure |
Initial System
n=8 Participants
a group of 8 blind subjects were tested with a prototype computer vision system build for outdoor navigation that relied on combination of GPS and location recognition for navigation information.
the task was a wayfinding task starting from one point in the hospital and go to a point at another point in the hospital while navigating negotiating a number of turns over multiple corridors.
|
Modified System
n=8 Participants
a second group of 8 blind subjects were tested with a modified computer vision system.
same task as the initial group with improved computer vision algorithm.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
43 years
n=5 Participants
|
52 years
n=7 Participants
|
48 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: The subject is given as much time as needed to complete the taskdevice failures were defined as any failure to provide correct location and direction information at thre appropriate time, resulting in a mistake that needed the initial prototype's ability to meet their travel needs at a good to excellent range.
Outcome measures
| Measure |
Initial System
n=8 Participants
The subjects were asked to travel over a novel path in the hospital after given instructions how to reach the final destination. the computer vision system was used to provide additional information as when to turn and in what direction. the subjects were allowed to also use their white cane
|
Modified System
n=8 Participants
a second group of 8 subjects were tested with a system that incorporated modifications identified by the first group using the initial prototype system.
|
|---|---|---|
|
Frequency of Device Failures Per Attempt to Complete a Navigation Course
|
4.1 number of device failures per attempt
Standard Error 1.2
|
2 number of device failures per attempt
Standard Error 0.82
|
SECONDARY outcome
Timeframe: no time limitThis is a subjective rating that incorporates user friendliness of the system and the specific needs of the subject. The subject is asked to rate whether the device meets his or her travel needs on a 1 to 7 scale with 1 being excellent and 7 being very poor.
Outcome measures
| Measure |
Initial System
n=8 Participants
The subjects were asked to travel over a novel path in the hospital after given instructions how to reach the final destination. the computer vision system was used to provide additional information as when to turn and in what direction. the subjects were allowed to also use their white cane
|
Modified System
n=8 Participants
a second group of 8 subjects were tested with a system that incorporated modifications identified by the first group using the initial prototype system.
|
|---|---|---|
|
Ability to Meet the Subjective Travel Needs of the Blind Subject
|
3.0 units on a scale
Standard Error 0.30
|
2.3 units on a scale
Standard Error 0.36
|
Adverse Events
Arm 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place