Effects of Right Lower Limb Orthopedic Immobilization on Braking Function

This study has been completed.

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: June 4, 2015

Last verified: June 2015

History of Changes

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 Francois Cabana, Université de Sherbrooke:

Primary Outcome Measures:

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.


Enrollment:	14
Study Start Date:	September 2008
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 (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

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 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


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:	June 4, 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

ClinicalTrials.gov processed this record on July 26, 2017

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