The Effects of Lower Right Limb Orthopedic Immobilization on Driving Performance

Study Overview
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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.

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

Conditions
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Walking Cast Right Leg Immobilisation Effects, Aircast Right Leg Immobilisation Effects

Intervention / Treatment
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* Procedure: Driving with running shoes
* Procedure: Plaster cast
* Procedure: Driving with Aircast


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Driving with Running Shoes<br> | Procedure: Driving with running shoes<br>* Participant was asked to do all the experiments with their own running shoes<br>|
| Active Comparator: Driving with Plaster cast<br> | Procedure: Plaster cast<br>* The participant was ask to do all the experiments with a plaster cast molded on his right leg<br>|
| Active Comparator: Driving with Aircast<br> | Procedure: Driving with Aircast<br>* The participant was ask to do all the experiments with a aircast on his right leg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Breaking Time Measured on a Driving Car Simulator | 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 | computerized driving simulator was used to measure the braking force during emergency braking with and without distractor | June 2007 to September 2007 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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car driving simulator, orthopedic leg immobilisation, braking time, braking force