Effects of Right Lower Limb Orthopedic Immobilization on Braking Function

June 4, 2015 updated by: Francois Cabana, Université de Sherbrooke

Effects of Right Lower Limb Orthopedic Immobilization on Braking Function : An On-the-Road Experimental Study by Healthy Volunteers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Centre Hospitalier Universitaire de Sherbrooke
      • Sherbrooke, Quebec, Canada, J1H 4C4
        • Centre de recherche sur le vieillissement

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Two years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Sherbrooke

Collaborators

Fonds de la Recherche en Santé du Québec
BSN Medical Inc

Investigators

  • Principal Investigator: François Cabana, MD, Centre de recherche du Centre hospitalier Universitaire de Sherbrooke

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (ACTUAL)

October 1, 2008

Study Completion (ACTUAL)

April 1, 2014

Study Registration Dates

First Submitted

July 19, 2010

First Submitted That Met QC Criteria

July 27, 2010

First Posted (ESTIMATE)

July 28, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

June 8, 2015

Last Update Submitted That Met QC Criteria

June 4, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Erica 02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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