The Effects of Lower Right Limb Orthopedic Immobilization on Driving Performance

June 18, 2015 updated by: Université de Sherbrooke

The Effects of Lower Right Limb Orthopedic Immobilization on Driving Performance: an Experimental Study During Simulated Driving in Healthy Volunteers.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

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 4C4
        • Research Centre on Aging, Sherbrooke Geriatric University Institute (IUGS),

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 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

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: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Breaking Time Measured on a Driving Car Simulator
Time Frame: June 2007 to September 2007
computerized driving simulator was used to measure the braking reaction time and the total braking time during emergency braking with and without a distracter.
June 2007 to September 2007
Mean Breaking Force Measured on a Driving Car Simulator
Time Frame: June 2007 to September 2007
computerized driving simulator was used to measure the braking force during emergency braking with and without distractor
June 2007 to September 2007

Collaborators and Investigators

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

Sponsor

Université de Sherbrooke

Collaborators

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

March 1, 2007

Primary Completion (ACTUAL)

June 1, 2007

Study Completion (ACTUAL)

September 1, 2007

Study Registration Dates

First Submitted

March 2, 2009

First Submitted That Met QC Criteria

June 16, 2009

First Posted (ESTIMATE)

August 3, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

July 15, 2015

Last Update Submitted That Met QC Criteria

June 18, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Socrate

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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