The Effects of Lower Right Limb Orthopedic Immobilization on Driving Performance

NCT ID: NCT00950729

Last Updated: 2015-07-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2007-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Walking Cast Right Leg Immobilisation Effects Aircast Right Leg Immobilisation Effects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Driving with Running Shoes

Group Type ACTIVE_COMPARATOR

Driving with running shoes

Intervention Type PROCEDURE

Participant was asked to do all the experiments with their own running shoes

Driving with Plaster cast

Group Type ACTIVE_COMPARATOR

Plaster cast

Intervention Type PROCEDURE

The participant was ask to do all the experiments with a plaster cast molded on his right leg

Driving with Aircast

Group Type ACTIVE_COMPARATOR

Driving with Aircast

Intervention Type PROCEDURE

The participant was ask to do all the experiments with a aircast on his right leg

Interventions

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Driving with running shoes

Participant was asked to do all the experiments with their own running shoes

Intervention Type PROCEDURE

Plaster cast

The participant was ask to do all the experiments with a plaster cast molded on his right leg

Intervention Type PROCEDURE

Driving with Aircast

The participant was ask to do all the experiments with a aircast on his right leg

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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BSN Medical Inc

INDUSTRY

Sponsor Role collaborator

Université de Sherbrooke

OTHER

Sponsor Role lead

Responsible Party

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Centre hospitalier universitaire de Sherbrooke (CHUS)

Principal Investigators

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François Cabana, MD

Role: PRINCIPAL_INVESTIGATOR

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Locations

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

Sherbrooke, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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Socrate

Identifier Type: -

Identifier Source: org_study_id

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