Blindness
Conditions
Brief summary
This is a feasibility study involving a small number of blind subject to evaluate the effectiveness of using a software and associated hardware components to assist the blind in identifying and locating objects of interests and to assist in way finding tasks. After the system has been successfully tested by the blindfolded engineers, it will be evaluated in a small number of blind subjects.
Detailed description
This is primarily an engineering project to develop computer vision algorithms for an integrated system comprising of a laptop computer, webcam, gps, digital compass, microphone, and stereo earphones. The system will be voice controlled. The algorithm will be trained to identify and located objects and navigationally landmarks in real-time, previously selected by sighted developers. After the system has passed objective engineering milestones, blind subjects will be tested to determine whether the novel system will improve the ability of the blind to travel over a test course in a hospital setting.
Interventions
DEVICEinitial system
The computer vision system is used to assist blind subject to navigate an extended path with multiple turns within a hospital setting.The initial prototype system would have been successfully tested for outdoor navigation and basic object recognition tasks.
DEVICEmodified system
The problems associated with the initial system were identified and modified. This modified system was tested with a second separate group of subjects. The redesigned system is used to assist blind subject to navigate the same extended path with multiple turns within a hospital setting.
Sponsors
VA Office of Research and Development
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* age 18 and over * legally blind
Exclusion criteria
* decreased hearing * unable to understand or follow instructions * inability to walk and stand for 10 minutes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Device Failures Per Attempt to Complete a Navigation Course | The subject is given as much time as needed to complete the task | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ability to Meet the Subjective Travel Needs of the Blind Subject | no time limit | This 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Initial 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. | 8 |
| Modified 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. | 8 |
| Total | 16 |
Baseline characteristics
| Characteristic | Modified System | Initial System | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 7 Participants | 14 Participants |
| Age, Continuous | 52 years | 43 years | 48 years |
| Region of Enrollment United States | 8 participants | 8 participants | 16 participants |
| Sex: Female, Male Female | 5 Participants | 3 Participants | 8 Participants |
| Sex: Female, Male Male | 3 Participants | 5 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 8 | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 |
Outcome results
Primary
Frequency of Device Failures Per Attempt to Complete a Navigation Course
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.
Time frame: The subject is given as much time as needed to complete the task
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Initial System | Frequency of Device Failures Per Attempt to Complete a Navigation Course | 4.1 number of device failures per attempt | Standard Error 1.2 |
| Modified System | Frequency of Device Failures Per Attempt to Complete a Navigation Course | 2 number of device failures per attempt | Standard Error 0.82 |
Secondary
Ability to Meet the Subjective Travel Needs of the Blind Subject
This 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.
Time frame: no time limit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Initial System | Ability to Meet the Subjective Travel Needs of the Blind Subject | 3.0 units on a scale | Standard Error 0.3 |
| Modified System | Ability to Meet the Subjective Travel Needs of the Blind Subject | 2.3 units on a scale | Standard Error 0.36 |