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
  Purpose

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.


Condition Intervention
Walking Cast Right Leg Immobilisation Effects
Aircast Right Leg Immobilisation Effects
Procedure: Driving with running shoes
Procedure: Plaster cast
Procedure: Driving with Aircast

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: The Effects of Lower Right Limb Orthopedic Immobilization on Driving Performance: an Experimental Study During Simulated Driving in Healthy Volunteers.

Further study details as provided by Université de Sherbrooke:

Primary Outcome Measures:
  • 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 ]

Enrollment: 48
Study Start Date: March 2007
Study Completion Date: September 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Driving with Running Shoes Procedure: Driving with running shoes
Participant was asked to do all the experiments with their own running shoes
Active Comparator: Driving with Plaster cast Procedure: Plaster cast
The participant was ask to do all the experiments with a plaster cast molded on his right leg
Active Comparator: Driving with Aircast Procedure: Driving with Aircast
The participant was ask to do all the experiments with a aircast on his right leg

  Eligibility

Ages Eligible for Study:   25 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00950729

Locations
Canada, Quebec
Research Centre on Aging, Sherbrooke Geriatric University Institute (IUGS),
Sherbrooke, Quebec, Canada, J1H 4C4
Sponsors and Collaborators
Université de Sherbrooke
BSN Medical Inc
Investigators
Principal Investigator: François Cabana, MD Centre Hospitalier Universitaire de Sherbrooke
  More Information

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

Keywords provided by Université de Sherbrooke:
car driving simulator
orthopedic leg immobilisation
braking time
braking force

ClinicalTrials.gov processed this record on October 01, 2014