Effects of Right Lower Limb Orthopedic Immobilization on Braking Function

Not Applicable

Completed

• Conditions: Automobile Driving With an Aircast Walker; Automobile Driving With a Walking Cast
• Interventions: Procedure: Driving with a walking cast; Procedure: Driving with an Aircast Walker; Procedure: Driving with a running shoe

• Registration Number: NCT01171287
• Lead Sponsor: Université de Sherbrooke

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Primary Completion: 2008-10
• Study First Submitted: 2010-07-19
• Study First Submitted QC: 2010-07-27
• Study First Posted: 2010-07-28
• Study Completion: 2014-04
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-04
• Last Update Posted: 2015-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Walking cast	Driving with a walking cast	Automobile driving with a walking cast applied to each participant's right lower extremity
Aircast Walker	Driving with an Aircast Walker	Automobile driving with an Aircast Walker applied to each participant's right lower extremity
Running shoe	Driving with a running shoe	Automobile driving with a running shoe applied to each participant's right lower extremity

Primary Outcome Measures

Name	Time	Method
Braking performances during real-time driving.	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.

Trial Locations

Locations (2)

Centre de recherche sur le vieillissement; 🇨🇦 Sherbrooke, Quebec, Canada

Centre Hospitalier Universitaire de Sherbrooke; 🇨🇦 Sherbrooke, Quebec, Canada