ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effects of Lower Right Limb Orthopedic Immobilization on Driving Performance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00950729
Recruitment Status : Completed
First Posted : August 3, 2009
Results First Posted : August 3, 2009
Last Update Posted : July 15, 2015
Sponsor:
Collaborator:
BSN Medical Inc
Information provided by:
Université de Sherbrooke

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (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
Enrollment 48
Recruitment Details march 2007 to june 2007 recruitment was done at the CHUS
Pre-assignment Details  
Arm/Group Title Healthy Subjects
Hide Arm/Group Description [Not Specified]
Period Title: Driving With Running Shoes
Started 48 [1]
Completed 48 [2]
Not Completed 0
[1]
March 2007
[2]
June 2007
Period Title: Driving With Plaster Cast
Started 48
Completed 48
Not Completed 0
Period Title: Driving With Aircast
Started 48
Completed 48
Not Completed 0
Arm/Group Title Healthy Subjects
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 48
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants
<=18 years
0
   0.0%
Between 18 and 65 years
48
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 48 participants
42.27  (10.06)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants
Female
24
  50.0%
Male
24
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 48 participants
48
1.Primary Outcome
Title Mean Breaking Time Measured on a Driving Car Simulator
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Healthy Subjects
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 48
Mean (Standard Deviation)
Unit of Measure: seconds
0.58  (.041)
2.Primary Outcome
Title Mean Breaking Force Measured on a Driving Car Simulator
Hide Description computerized driving simulator was used to measure the braking force during emergency braking with and without distractor
Time Frame June 2007 to September 2007
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Healthy Subjects
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 48
Mean (Standard Deviation)
Unit of Measure: pounds
293.8  (75.2)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Healthy Subjects
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Healthy Subjects
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Healthy Subjects
Affected / at Risk (%)
Total   0/48 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Healthy Subjects
Affected / at Risk (%)
Total   0/48 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: François Cabana
Organization: Centre hospitalier universitaire de Sherbrooke (CHUS)
Phone: 1-819-346-1110 ext 14233
Responsible Party: Francois Cabana, Centre hospitalier universitaire de Sherbrooke (CHUS)
ClinicalTrials.gov Identifier: NCT00950729     History of Changes
Other Study ID Numbers: Socrate
First Submitted: March 2, 2009
First Posted: August 3, 2009
Results First Submitted: March 2, 2009
Results First Posted: August 3, 2009
Last Update Posted: July 15, 2015