NCT00920231

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2011

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

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

June 11, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 15, 2009

Completed
2.4 years until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

April 2, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

January 22, 2016

Status Verified

December 1, 2015

Enrollment Period

2.1 years

First QC Date

June 11, 2009

Results QC Date

January 14, 2015

Last Update Submit

December 18, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    no time limit

Study Arms (2)

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.

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.

Device: modified system

Interventions

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.

Arm 1 initial 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.

Arm 2 modified system

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18 and over
  • legally blind

You may not qualify if:

  • decreased hearing
  • unable to understand or follow instructions
  • inability to walk and stand for 10 minutes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Atlanta VA Medical and Rehab Center, Decatur

Decatur, Georgia, 30033, United States

Location

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Blindness

Condition Hierarchy (Ancestors)

Vision DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr Cha-Min Tang
Organization
Baltimore VA MC

Study Officials

  • Cha-Min Tang, PhD MD

    Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2009

First Posted

June 15, 2009

Study Start

November 1, 2011

Primary Completion

December 1, 2013

Study Completion

September 1, 2015

Last Updated

January 22, 2016

Results First Posted

April 2, 2015

Record last verified: 2015-12

Locations