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Effects of Right Lower Limb Orthopedic Immobilization on Braking Function

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ClinicalTrials.gov Identifier: NCT01171287
Recruitment Status : Completed
First Posted : July 28, 2010
Last Update Posted : June 8, 2015
Sponsor:
Collaborators:
Fonds de la Recherche en Santé du Québec
BSN Medical Inc
Information provided by (Responsible Party):
Francois Cabana, Université de Sherbrooke

Study Description
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Brief Summary:
Research on the implications of orthopedic injury and surgery on automobile driving ability has been limited. Only a handful of orthopedic issues have been studied to date, especially the safe postoperative resumption of driving. However, effects of orthopedic immobilizations of the lower right limb on fitness to drive are largely unknown, and the physician is left with little guidance. Only one study (Tremblay et al. 2009) have looked at the impact of wearing such devices on braking performances. The results have shown a statistically significant increase of braking times while wearing a removable Aircast walker and a walking cast in healthy subjects under simulated driving conditions. Despite this, the study have not demonstrated that driving with orthopedic immobilization is dangerous since the increase in braking times were minimal. Limitations of this study include the important fact that driving simulation is not real-time driving. In order to assess the validity of the driving simulator used in this study, a similar experimental study during real-time driving was thus devised.

Condition or disease Intervention/treatment Phase
Automobile Driving With an Aircast Walker Automobile Driving With a Walking Cast Procedure: Driving with an Aircast Walker Procedure: Driving with a walking cast Procedure: Driving with a running shoe Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effects of Right Lower Limb Orthopedic Immobilization on Braking Function : An On-the-Road Experimental Study by Healthy Volunteers
Study Start Date : September 2008
Actual Primary Completion Date : October 2008
Actual Study Completion Date : April 2014
Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Aircast Walker
Automobile driving with an Aircast Walker applied to each participant's right lower extremity
 Procedure: Driving with an Aircast Walker
Experimental: Walking cast
Automobile driving with a walking cast applied to each participant's right lower extremity
 Procedure: Driving with a walking cast
Active Comparator: Running shoe
Automobile driving with a running shoe applied to each participant's right lower extremity
 Procedure: Driving with a running shoe


Outcome Measures
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Primary Outcome Measures :
  1. Braking performances during real-time driving. [ Time Frame: Two years. ]
    The braking performances are assessed using (1) the median foot movement time, (2) the median brake reaction time and (3) the median total braking time.


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects between 25 to 60 years old
  • Possession of a valid Quebec driver's license
  • Driving for at least 5 years
  • Exclusively use the right foot for accelerating and braking

Exclusion Criteria:

  • Visual acuity deficits or other visual problems uncompensated
  • History of drug or alcohol abuse
  • Use of psychotropic drugs
  • Any illness of the central nervous system such as epilepsy
  • Sleep disorders
  • Metabolic problems
  • Cardiovascular disease
  • Cerebrovascular disease
  • Peripheral vascular disease
  • Psychiatric illness
  • Renal disease
  • Musculoskeletal disease
  • Motion sickness
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01171287


Locations
Canada, Quebec
Centre de recherche sur le vieillissement
Sherbrooke, Quebec, Canada, J1H 4C4
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
Université de Sherbrooke
Fonds de la Recherche en Santé du Québec
BSN Medical Inc
Investigators
Principal Investigator: Francois Cabana, MD Centre de recherche du Centre hospitalier universitaire de Sherbrooke
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Francois Cabana, Doctor, Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT01171287     History of Changes
Other Study ID Numbers: Erica 02
First Posted: July 28, 2010    Key Record Dates
Last Update Posted: June 8, 2015
Last Verified: June 2015

Keywords provided by Francois Cabana, Université de Sherbrooke:
Automobile Driving
Fracture Fixation/instrumentation
Lower Extremity
Orthopedic Fixation Devices
 Orthopedic Procedures
Reaction Time
Task Performance and Analysis
Time Factors