Effects of Right Lower Limb Orthopedic Immobilization on Braking Function

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Fonds de la Recherche en Santé du Québec
BSN Medical Inc
Information provided by (Responsible Party):
Francois Cabana, Université de Sherbrooke
ClinicalTrials.gov Identifier:
NCT01171287
First received: July 19, 2010
Last updated: April 29, 2014
Last verified: April 2014
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: 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

Further study details as provided by Université de Sherbrooke:

Primary Outcome Measures:
  • Braking performances during real-time driving. [ Time Frame: Two years. ] [ Designated as safety issue: No ]
    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.


Enrollment: 14
Study Start Date: September 2008
Estimated Study Completion Date: April 2014
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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 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
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: NCT01171287

Locations
Canada, Quebec
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4
Centre de recherche sur le vieillissement
Sherbrooke, Quebec, Canada, J1H 4C4
Sponsors and Collaborators
Université de Sherbrooke
Fonds de la Recherche en Santé du Québec
BSN Medical Inc
Investigators
Principal Investigator: Francois Cabana, MD Centre Hospitalier Universitaire de Sherbrooke
  More Information

No publications provided

Responsible Party: Francois Cabana, Doctor, Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT01171287     History of Changes
Other Study ID Numbers: Erica 02
Study First Received: July 19, 2010
Last Updated: April 29, 2014
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on August 20, 2014