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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:
Université de Sherbrooke
ClinicalTrials.gov Identifier:
NCT00950729
First received: March 2, 2009
Last updated: August 13, 2009
Last verified: August 2009

March 2, 2009
August 13, 2009
March 2007
June 2007   (final data collection date for primary outcome measure)
  • Mean Breaking Time Measured on a Driving Car Simulator [ Time Frame: June 2007 to September 2007 ] [ Designated as safety issue: No ]
  • Mean Breaking Force Measured on a Driving Car Simulator [ Time Frame: June 2007 to September 2007 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00950729 on ClinicalTrials.gov Archive Site
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The Effects of Lower Right Limb Orthopedic Immobilization on Driving Performance
The Effects of Lower Right Limb Orthopedic Immobilization on Driving Performance: an Experimental Study During Simulated Driving in Healthy Volunteers.

Abstract Background: Effects of orthopedic immobilizations of the lower right limb on driving performances are unknown. Therefore, clinicians and legislators cannot put forth recommendations for road safety for patients requiring such immobilizations. The objective of the present study was to evaluate the effects of different orthopedic immobilizations on braking performances in simulated driving conditions.

Methods: The braking performances of 48 healthy volunteers were evaluated under 3 conditions: wearing their running shoes, and 2 types of orthopedic immobilizations of the lower right limb, a walking cast and an Aircast walker. A computerized driving simulator was used to measure the maximum force applied on the brake pedal during braking, the braking reaction time and the total braking time during emergency braking with and without a distracter.

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Interventional
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Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Walking Cast Right Leg Immobilisation Effects
  • Aircast Right Leg Immobilisation Effects
  • Procedure: Driving with running shoes
    Participant was asked to do all the experiments with their own running shoes
  • Procedure: Plaster cast
    The participant was ask to do all the experiments with a plaster cast molded on his right leg
  • Procedure: Driving with Aircast
    The participant was ask to do all the experiments with a aircast on his right leg
  • Active Comparator: Driving with Running Shoes
    Intervention: Procedure: Driving with running shoes
  • Active Comparator: Driving with Plaster cast
    Intervention: Procedure: Plaster cast
  • Active Comparator: Driving with Aircast
    Intervention: Procedure: Driving with Aircast
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
September 2007
June 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy subjects between 25 and 60 years old
  • Valid Québec driving license
  • Driving for at least five years
  • Must used exclusively the right foot for accelerating and braking

Exclusion Criteria:

  • Non-compensated visual acuity deficits or other visual problems
  • Drug or alcohol abuse
  • Use of psychotropic drugs
  • Central nervous system illnesses such as epilepsy
  • Sleep issues
  • Metabolic problems
  • Cardiovascular disease
  • Cerebrovascular disease
  • Peripheral vascular disease
  • Psychiatric illness
  • Renal disease
  • Musculoskeletal disease
  • Motion sickness and
  • Simulator sickness
Both
25 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00950729
Socrate
No
Francois Cabana, Centre hospitalier universitaire de Sherbrooke (CHUS)
Université de Sherbrooke
BSN Medical Inc
Principal Investigator: François Cabana, MD Centre Hospitalier Universitaire de Sherbrooke
Université de Sherbrooke
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP