Effects of Right Lower Limb Orthopedic Immobilization on Braking Function

Study Overview
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Brief Summary
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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.

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

Conditions
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Automobile Driving With an Aircast Walker, Automobile Driving With a Walking Cast

Intervention / Treatment
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* Procedure: Driving with an Aircast Walker
* Procedure: Driving with a walking cast
* Procedure: Driving with a running shoe


Participation Criteria
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Eligibility Criteria
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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

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: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aircast Walker<br>Automobile driving with an Aircast Walker applied to each participant's right lower extremity | Procedure: Driving with an Aircast Walker<br> <br> |
| Experimental: Walking cast<br>Automobile driving with a walking cast applied to each participant's right lower extremity | Procedure: Driving with a walking cast<br> <br> |
| Active Comparator: Running shoe<br>Automobile driving with a running shoe applied to each participant's right lower extremity | Procedure: Driving with a running shoe<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Braking performances during real-time driving. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Automobile Driving, Fracture Fixation/instrumentation, Lower Extremity, Orthopedic Fixation Devices, Orthopedic Procedures, Reaction Time, Task Performance and Analysis, Time Factors