NCT00333879

Brief Summary

This is a two-year proof-of-concept study to evaluate a new Virtual Reality (VR) "holographic" sound system for use as an audiological Orientation and Mobility (O\&M) training tool

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2009

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

June 2, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 6, 2006

Completed
2.7 years until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
4.6 years until next milestone

Results Posted

Study results publicly available

November 19, 2013

Completed
Last Updated

December 16, 2013

Status Verified

November 1, 2013

Enrollment Period

Same day

First QC Date

June 2, 2006

Results QC Date

September 16, 2013

Last Update Submit

November 20, 2013

Conditions

Keywords

RehabilitationSensory Aid

Outcome Measures

Primary Outcomes (1)

  • Accuracy in Judging Direction of Traffic at Traffic Intersection

    Standing at an intersection subject indicates when traffic is moving left to right and right to left in front of him, versus traffic moving to and away on the street parallel to his path. Subject can respond in only two ways: 1) traffic is moving on the street in front of me, or 2) traffic is moving on the street beside me. Each trial lasts 5 minutes with a 2 minute and 30 second break between trials. Traffic stops and starts 5 times over the 5 minutes, each time moving in one of two randomly selected directions: 1) left and right in front of the subject, or 2) forward and back along the street beside the subject. The participant must correctly state the direction of traffic at least 4 out of five times for the equipment under test to be counted as efficacious for presenting accurate 3D sound information to the participant.

    4 trials over 30 minutes after 30 minutes of training

Secondary Outcomes (1)

  • Accuracy in Selecting Appropriate Time to Cross Street

    4 trials over 30 minutes after 30 minutes of training

Study Arms (1)

Virtual Sound System

OTHER

Efficacy of using a virtual sound system to simulate street crossing conditions.

Device: Virtual Sound System

Interventions

Virtual Sound System is tested for efficacy in its ability to realistically simulate Street Crossings sounds in a safe indoor environment. If efficacious, Blind students will be able to practice crossing streets in safety indoors.

Also known as: 3-D Sound Simulation System
Virtual Sound System

Eligibility Criteria

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

You may qualify if:

  • Must have little or no light perception
  • OMCT (Orientation-Memory Concentration Test) of 10 or less
  • Must have been independently and regularly crossing busy intersections for at least 3 years
  • Ambulatory and able to walk for at least 10 minutes at a time without resting
  • Auditory function at 25 db HL

You may not qualify if:

  • Imbalance between ears - HL difference of 20 db HL or more

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

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed. Technical problems with Virtual Sound System. None of the first 4 Subjects could distinguish between sounds in front versus sounds beside them.

Results Point of Contact

Title
David Ross
Organization
Atlanta VA Rehab R&D Center

Study Officials

  • David A Ross, MSEE Med

    Atlanta VA Medical and Rehab Center, Decatur

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

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

June 2, 2006

First Posted

June 6, 2006

Study Start

March 1, 2009

Primary Completion

March 1, 2009

Study Completion

April 1, 2009

Last Updated

December 16, 2013

Results First Posted

November 19, 2013

Record last verified: 2013-11

Locations