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Using Virtual Reality to Train Children in Pedestrian Safety

This study has been completed.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
David Schwebel, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00850759
First received: February 24, 2009
Last updated: December 1, 2014
Last verified: December 2014
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 
Overall Participants Analyzed 
[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 ( US NIH Grant/Contract Award Number )
Study First Received: February 24, 2009
Results First Received: June 17, 2013
Last Updated: December 1, 2014
Health Authority: United States: Federal Government