Effects of Right Lower Limb Orthopedic Immobilization on Braking Function

Université de Sherbrooke

Status: Completed

Conditions: Automobile Driving With a Walking Cast; Automobile Driving With an Aircast Walker

Treatments: Procedure: Driving with a running shoe; Procedure: Driving with a walking cast; Procedure: Driving with an Aircast Walker

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01171287

Erica 02

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 25 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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14 participants in 3 patient groups

Aircast Walker

Experimental group

Description:

Automobile driving with an Aircast Walker applied to each participant's right lower extremity

Treatment:

Procedure: Driving with an Aircast Walker

Walking cast

Experimental group

Description:

Automobile driving with a walking cast applied to each participant's right lower extremity

Treatment:

Procedure: Driving with a walking cast

Running shoe

Active Comparator group

Description:

Automobile driving with a running shoe applied to each participant's right lower extremity

Treatment:

Procedure: Driving with a running shoe