Virtual Reality Mobility Training System for Veterans With Vision Loss

Sponsor
US Department of Veterans Affairs (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT00333879
Collaborator
(none)
4
1
1
1
3.9

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Device: Virtual Sound System
N/A

Detailed Description

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. This new system avoids the limitations of other technologies (i.e., binaural recordings and existing VR sound systems) that have been employed with limited success for audiological training. Four advancements in the state-of-the-art represented by this new holographic system provide new promise for audiological O&M training. First, unlike binaural systems, the new system allows the person to move their head in a natural fashion to localize sounds. Second, a spherical microphone array is used to record sound environments so as to retain the direction from which each ambient sound originated. When these recorded sound environments are later presented through head-tracking headphones in a VR environment, real-time software maintains the directionality of the sound so that it remains true no matter how the person moves or turns their head. Third, this new system models the actual physical acoustic structure of each person's head and ears to present sounds as they would be heard by that particular person in the recorded setting. Fourth, this system uses software algorithms to isolate specific sounds (i.e., of a moving vehicle) so that during virtual playback, these sounds can be inserted into the virtual sound field at will and in a customizable fashion to create truly unique and flexible virtual sound presentations.

There are two study hypotheses. First, when using sounds to negotiate traffic intersections, skills employed by experienced travelers in real environments will readily transfer to the proposed VR environment to the extent that audiological tasks performed in real environments are just as easily performed in the VR environment. Second, when the VR environment is enhanced to emphasize critical sound cues and eliminate distracting or confusing noises and sounds, performance by skilled travelers in the VR environment will be significantly better than in the actual environment.

The objectives are to: (1) adapt the existing spherical microphone array and digital recording software algorithms to best suit the capture of critical intersection sounds used for intersection negotiations; (2) develop software algorithms to deconstruct intersection sounds, isolating each sound for the VR construction of specific environments of varying complexity; (3) determine the level of sound detail necessary for negotiating intersections successfully; (4) expand the existing system to obtain the desired level of detail; (5) develop software to provide the ability to control the relative emphasis of a variety of sound elements being presented so as to simplify the auditory task; and (6) employ study participants to compare performance in the VR environment with outdoor performance.

Once validated, this system should be able to: (1) leverage instructor time by providing students with an effective means of practicing audiological skills on their own, (2) provide instructors with a means of introducing concepts in a graduated learning sequence that is not dependent on the happenstance availability of specific sounds and conditions found in real environments, and (3) provide audiological training for environments not located in the vicinity of the training site, but which do represent the veteran's home community.

Research will be conducted in collaboration with investigators in the Perceptual Interfaces and Reality Laboratory (PIRL) at the University of Maryland who initially conceived and developed this holographic VR sound system.

COMPARISONS: Outdoor O&M training exclusively

Study Design

Study Type:
Interventional
Actual Enrollment :
4 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Official Title:
Virtual Reality Mobility Training System for Veterans With Vision Loss
Study Start Date :
Mar 1, 2009
Actual Primary Completion Date :
Mar 1, 2009
Actual Study Completion Date :
Apr 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Other: Virtual Sound System

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

Device: Virtual Sound System
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.
Other Names:
  • 3-D Sound Simulation System
  • Outcome Measures

    Primary Outcome Measures

    1. Accuracy in Judging Direction of Traffic at Traffic Intersection [4 trials over 30 minutes after 30 minutes of training]

      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.

    Secondary Outcome Measures

    1. Accuracy in Selecting Appropriate Time to Cross Street [4 trials over 30 minutes after 30 minutes of training]

      Subject is able to state when it is safe to cross the street based on traffic on the street beside him accelerating into motion after traffic on the street in front of him coming to a stop. Subject must state is it safe to cross within 5 seconds of the cars on the street beside him accelerating into motion. The system under test will be considered efficacious if the subject is correct at least 4 out of 5 times. This counts as being efficacious for that one subject.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • 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

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Atlanta VA Medical and Rehab Center, Decatur Decatur Georgia United States 30033

    Sponsors and Collaborators

    • US Department of Veterans Affairs

    Investigators

    • Principal Investigator: David A Ross, MSEE Med, Atlanta VA Medical and Rehab Center, Decatur

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    US Department of Veterans Affairs
    ClinicalTrials.gov Identifier:
    NCT00333879
    Other Study ID Numbers:
    • C4188-R
    First Posted:
    Jun 6, 2006
    Last Update Posted:
    Dec 16, 2013
    Last Verified:
    Nov 1, 2013
    Keywords provided by US Department of Veterans Affairs
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details The 4 totally blind Participants were recruited over three months (April - June) 2009 from the Atlanta Center for Visual Impairment.
    Pre-assignment Detail All 4 subjects were accepted for the study. None were excluded.
    Arm/Group Title Virtual Sound System
    Arm/Group Description Efficacy of using a virtual sound system to simulate street crossing conditions.
    Period Title: Overall Study
    STARTED 4
    COMPLETED 4
    NOT COMPLETED 0

    Baseline Characteristics

    Arm/Group Title Virtual Sound System
    Arm/Group Description Efficacy of using a virtual sound system to simulate street crossing conditions.
    Overall Participants 4
    Age (Count of Participants)
    <=18 years
    0
    0%
    Between 18 and 65 years
    4
    100%
    >=65 years
    0
    0%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    43
    (14.7)
    Sex: Female, Male (Count of Participants)
    Female
    2
    50%
    Male
    2
    50%
    Region of Enrollment (participants) [Number]
    United States
    4
    100%

    Outcome Measures

    1. Primary Outcome
    Title Accuracy in Judging Direction of Traffic at Traffic Intersection
    Description 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.
    Time Frame 4 trials over 30 minutes after 30 minutes of training

    Outcome Measure Data

    Analysis Population Description
    Initial pilot study design called for 16 subjects to provide data of significance based on a power analysis. Study terminated at 4 subjects when none of the subjects could identify the location of traffic vehicles when using the intervention across multiple (4) trials.
    Arm/Group Title Virtual Sound System
    Arm/Group Description Efficacy of using a virtual sound system to simulate street crossing conditions.
    Measure Participants 4
    Number [participants]
    0
    0%
    2. Secondary Outcome
    Title Accuracy in Selecting Appropriate Time to Cross Street
    Description Subject is able to state when it is safe to cross the street based on traffic on the street beside him accelerating into motion after traffic on the street in front of him coming to a stop. Subject must state is it safe to cross within 5 seconds of the cars on the street beside him accelerating into motion. The system under test will be considered efficacious if the subject is correct at least 4 out of 5 times. This counts as being efficacious for that one subject.
    Time Frame 4 trials over 30 minutes after 30 minutes of training

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Virtual Sound System
    Arm/Group Description Efficacy of using a virtual sound system to simulate street crossing conditions.
    Measure Participants 4
    Number [participants]
    0
    0%

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Virtual Sound System
    Arm/Group Description Efficacy of using a virtual sound system to simulate street crossing conditions.
    All Cause Mortality
    Virtual Sound System
    Affected / at Risk (%) # Events
    Total / (NaN)
    Serious Adverse Events
    Virtual Sound System
    Affected / at Risk (%) # Events
    Total 0/4 (0%)
    Other (Not Including Serious) Adverse Events
    Virtual Sound System
    Affected / at Risk (%) # Events
    Total 0/4 (0%)

    Limitations/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.

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title David Ross
    Organization Atlanta VA Rehab R&D Center
    Phone 404-321-6111 ext 6817
    Email rosss0128@bellsouth.net
    Responsible Party:
    US Department of Veterans Affairs
    ClinicalTrials.gov Identifier:
    NCT00333879
    Other Study ID Numbers:
    • C4188-R
    First Posted:
    Jun 6, 2006
    Last Update Posted:
    Dec 16, 2013
    Last Verified:
    Nov 1, 2013