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The Effects of Lower Right Limb Orthopedic Immobilization on Driving Performance

This study has been completed.
Sponsor:
Collaborator:
BSN Medical Inc
Information provided by:
Universitaire de Sherbrooke
ClinicalTrials.gov Identifier:
NCT00950729
First received: March 2, 2009
Last updated: August 13, 2009
Last verified: August 2009
History of Changes
Results First Received: March 2, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Basic Science
Conditions: Walking Cast Right Leg Immobilisation Effects
Aircast Right Leg Immobilisation Effects
Interventions: Procedure: Driving with running shoes
Procedure: Plaster cast
Procedure: Driving with Aircast

  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
march 2007 to june 2007 recruitment was done at the CHUS

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Healthy Subjects No text entered.

Participant Flow for 3 periods

 Period 1:   Driving With Running Shoes
    Healthy Subjects  
STARTED     48 [1]
COMPLETED     48 [2]
NOT COMPLETED     0  
[1] March 2007
[2] June 2007

Period 2:   Driving With Plaster Cast
    Healthy Subjects  
STARTED     48  
COMPLETED     48  
NOT COMPLETED     0  

Period 3:   Driving With Aircast
    Healthy Subjects  
STARTED     48  
COMPLETED     48  
NOT COMPLETED     0  



  Baseline Characteristics
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Reporting Groups
  Description
Healthy Subjects No text entered.

Baseline Measures
    Healthy Subjects  
Number of Participants  
[units: participants]
 		  48  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     48  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation 		  42.27  ± 10.06  
Gender  
[units: participants]
 		 
Female     24  
Male     24  
Region of Enrollment  
[units: participants]
 		 
Canada     48  



  Outcome Measures
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1.  Primary:   Mean Breaking Time Measured on a Driving Car Simulator   [ Time Frame: June 2007 to September 2007 ]
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Measure Type Primary
Measure Title Mean Breaking Time Measured on a Driving Car Simulator
Measure Description computerized driving simulator was used to measure the braking reaction time and the total braking time during emergency braking with and without a distracter.
Time Frame June 2007 to September 2007  
Safety Issue No  

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
Healthy Subjects No text entered.

Measured Values
    Healthy Subjects  
Number of Participants Analyzed  
[units: participants]
 		  48  
Mean Breaking Time Measured on a Driving Car Simulator  
[units: seconds]
Mean ± Standard Deviation 		  0.58  ± .041  

No statistical analysis provided for Mean Breaking Time Measured on a Driving Car Simulator



2.  Primary:   Mean Breaking Force Measured on a Driving Car Simulator   [ Time Frame: June 2007 to September 2007 ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: François Cabana
Organization: Centre hospitalier universitaire de Sherbrooke (CHUS)
phone: 1-819-346-1110 ext 14233
e-mail: francois.cabana@usherbrooke.ca


No publications provided


Responsible Party: Francois Cabana, Centre hospitalier universitaire de Sherbrooke (CHUS)
ClinicalTrials.gov Identifier: NCT00950729     History of Changes
Other Study ID Numbers: Socrate
Study First Received: March 2, 2009
Results First Received: March 2, 2009
Last Updated: August 13, 2009
Health Authority: Canada: Ethics Review Committee