Effects of Right Lower Limb Orthopedic Immobilization on Braking Function

NCT ID: NCT01171287

Last Updated: 2015-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2014-04-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Aircast Walker

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

Group Type: EXPERIMENTAL

Driving with an Aircast Walker

Intervention Type: PROCEDURE

Walking cast

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

Group Type: EXPERIMENTAL

Driving with a walking cast

Intervention Type: PROCEDURE

Running shoe

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

Group Type: ACTIVE_COMPARATOR

Driving with a running shoe

Intervention Type: PROCEDURE

Interventions

Driving with an Aircast Walker

Intervention Type: PROCEDURE

Driving with a walking cast

Intervention Type: PROCEDURE

Driving with a running shoe

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fonds de la Recherche en Santé du Québec

OTHER_GOV

Sponsor Role: collaborator

BSN Medical Inc

INDUSTRY

Sponsor Role: collaborator

Université de Sherbrooke

OTHER

Sponsor Role: lead

Responsible Party

Francois Cabana

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Francois Cabana, MD

Role: PRINCIPAL_INVESTIGATOR

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Locations

Centre de recherche sur le vieillissement

Sherbrooke, Quebec, Canada

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Countries

Canada

Other Identifiers

Erica 02

Identifier Type: -

Identifier Source: org_study_id