NCT00829036

Brief Summary

The purpose of the project is to find out what kinds of information are most useful to visually impaired people when they are moving around indoors and what kinds of controls will make it easy for visually impaired people to control a device to help orient them to an unfamiliar indoor space.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 26, 2009

Completed
3.7 years until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

April 2, 2014

Completed
Last Updated

April 2, 2014

Status Verified

February 1, 2014

Enrollment Period

2 months

First QC Date

January 22, 2009

Results QC Date

February 18, 2014

Last Update Submit

February 18, 2014

Conditions

Keywords

RehabilitationSensory Aid

Outcome Measures

Primary Outcomes (1)

  • Mean Percent (Prototype / Baseline) Time

    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.

    2 hours

Study Arms (1)

Wayfinding Prototype

EXPERIMENTAL

A Wayfinding Prototype is evaluated in terms of the time it takes subjects to use this device to walk to specific indoor locations versus baseline walking time.

Device: Wayfinding Prototype

Interventions

A Wayfinding Prototype is used by subjects to determine any advantages over current standard of rehabilitation.

Wayfinding Prototype

Eligibility Criteria

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

You may qualify if:

  • Must be blind with no better vision than light perception and must be able to do 3 hours of walking (with many breaks)

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atlanta VA Medical and Rehab Center, Decatur

Decatur, Georgia, 30033, 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
David A. Ross
Organization
Atlanta VA Rehab R&D Center of Excellence

Study Officials

  • David A Ross, MSEE Med

    Atlanta VA Medical and Rehab Center, Decatur

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2009

First Posted

January 26, 2009

Study Start

October 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

April 2, 2014

Results First Posted

April 2, 2014

Record last verified: 2014-02

Locations