Using Virtual Reality to Train Children in Pedestrian Safety

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
David Schwebel, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00850759
First received: February 24, 2009
Last updated: October 28, 2013
Last verified: October 2013
Results First Received: June 17, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Street-crossing Ability
Pedestrian Safety
Interventions: Device: virtual pedestrian environment
Device: computer and video
Behavioral: streetside training

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
recruitment from a variety of community sources between October 2009 and September 2011

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
9 excluded prior to group assignment, for these reasons: Not meeting inclusion criteria; child of incorrect age (n = 3) Not meeting inclusion criteria; child unable to understand protocol (n = 3) Did not complete baseline assessment (n = 3)

Reporting Groups
  Description
Virtual Reality street-crossing training in a virtual pedestrian environment
Computer and Video exposure to training in pedestrian safety via computer software, internet games, and television videos
Streetside Training one-on-one training in street-crossing skills by an adult, at a streetside location
No-contact Control no-contact control group.

Participant Flow:   Overall Study
    Virtual Reality     Computer and Video     Streetside Training     No-contact Control  
STARTED     59     57     57     58  
COMPLETED     52     52     52     55  
NOT COMPLETED     7     5     5     3  
Lost to Follow-up                 7                 5                 5                 3  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Virtual Reality street-crossing training in a virtual pedestrian environment
Computer and Video exposure to training in pedestrian safety via computer software, internet games, and television videos
Streetside Training one-on-one training in street-crossing skills by an adult, at a streetside location
No-contact Control no-contact control group.
Total Total of all reporting groups

Baseline Measures
    Virtual Reality     Computer and Video     Streetside Training     No-contact Control     Total  
Number of Participants  
[units: participants]
  59     57     57     58     231  
Age  
[units: participants]
         
<=18 years     59     57     57     58     231  
Between 18 and 65 years     0     0     0     0     0  
>=65 years     0     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  7.9  ± 0.67     8.1  ± 0.63     7.9  ± 0.68     8.1  ± 0.63     8.0  ± 0.65  
Gender  
[units: participants]
         
Female     32     35     35     30     132  
Male     27     22     22     28     99  
Region of Enrollment  
[units: participants]
         
United States     59     57     57     58     231  



  Outcome Measures

1.  Primary:   Street-crossing Ability   [ Time Frame: post-training and again 6 months later ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT 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 Schwebel
Organization: UAB
phone: 205-934-8745
e-mail: schwebel@uab.edu


Publications:

Responsible Party: David Schwebel, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00850759     History of Changes
Other Study ID Numbers: F080715010, R01HD058573-01A1
Study First Received: February 24, 2009
Results First Received: June 17, 2013
Last Updated: October 28, 2013
Health Authority: United States: Federal Government