BlindnessPhase 1NCT00920231
Computer Vision System for the Blind Veteran
A Phase 1 study testing initial system and modified system in people with Blindness, run by VA Office of Research and Development at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Blindness
- What is being tested?
- initial system and modified system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2011to Sep 2015
- Phase
- Phase 1
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 and over
- legally blind
Who cannot join
- decreased hearing
- unable to understand or follow instructions
- inability to walk and stand for 10 minutes
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201
Atlanta VA Medical and Rehab Center, Decatur
Decatur, Georgia, 30033
About this study
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.
Read the 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.
- Conditions
- Blindness
- Being tested
- initial system, modified system
- Medical subject headings
- Blindness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
initial systemDevice
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.
modified systemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 initial system | Experimental | 8 blind subjects are asked to use a prototype computer vision system to determine the challenges facing computer vision based indoor navigation.
Subjects are asked to travel through the hallways of a large hospital from the front entrance to a side entrance. The pathway consists of 9 segments including corners, four-way intersections, and doorways, and the total length of the route was approximately 200 meters. This challenging route was designed to stress the capabilities of the navigation system. It is a route that even sighted persons may find difficult to follow without practice. Pedestrian traffic was present throughout the route and lighting conditions could change in two of the segments where there were windows and doors. Receives: Device: initial system |
| Arm 2 modified system | Experimental | The system is redesigned in response to problems identified from the first phase of the study. The redesigned system is tested by a second set of 8 blind subjects in the same indoor path as used in Arm 1. Receives: Device: modified system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The subject is given as much time as needed to complete the task
Secondary outcomes (1)
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.
Measured: no time limit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2009 (estimated)
- Study startNov 2011
- Primary completionDec 2013
- Study completionSep 2015
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.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Cha-Min Tang, PhD MD, Principal investigator, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00920231
- Sponsor's protocol ID
- C6731-R
- Status last verified
- Dec 2015
- First submitted
- 11 Jun 2009
- Last updated
- 22 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer Vision System for the Blind Veteran
- ClinicalTrials.gov ID
- NCT00920231
- Acronym / sponsor ID
- C6731-R
- Conditions
- Blindness
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Nov 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 15 Jun 2009 (estimated)
- Results
- Posted 2 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 initial system | Experimental | Device: initial system8 blind subjects are asked to use a prototype computer vision system to determine the challenges facing computer vision based indoor navigation. Subjects are asked to travel through the hallways of a large hospital from the front entrance to a side entrance. The pathway consists of 9 segments including corners, four-way intersections, and doorways, and the total length of the route was approximately 200 meters. This challenging route was designed to stress the capabilities of the navigation system. It is a route that even sighted persons may find difficult to follow without practice. Pedestrian traffic was present throughout the route and lighting conditions could change in two of the segments where there were windows and doors. |
| Arm 2 modified system | Experimental | Device: modified systemThe system is redesigned in response to problems identified from the first phase of the study. The redesigned system is tested by a second set of 8 blind subjects in the same indoor path as used in Arm 1. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age 18 and over
- legally blind
Key exclusion criteria (3 listed)
- decreased hearing
- unable to understand or follow instructions
- inability to walk and stand for 10 minutes
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 |
|---|---|---|
| initial systemThe 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. | Device | Arm 1 initial system |
| modified systemThe 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. | Device | Arm 2 modified system |
Primary outcome
Frequency of Device Failures Per Attempt to Complete a Navigation Course
Time frame: 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.
1 secondary outcome
Ability to Meet the Subjective Travel Needs of the Blind Subject
Time frame: no time limit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2016.
- 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.
Cha-Min Tang, PhD MD principal investigator
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing initial system and modified system in people with Blindness, run by VA Office of Research and Development at 2 sites 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 2 inclusion and 3 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 22 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Apr 2015). 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?
Frequency of Device Failures Per Attempt to Complete a Navigation Course (time frame: The subject is given as much time as needed to complete the task). 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 22 Jan 2016.