Clinical trial NCT01171287: Effects of Right Lower Limb Orthopedic Immobilization on Braking Function
Official title: Effects of Right Lower Limb Orthopedic Immobilization on Braking Function : An On-the-Road Experimental Study by Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Automobile Driving With an Aircast Walker
Automobile Driving With a Walking Cast
Keywords: Automobile Driving
Fracture Fixation/instrumentation
Lower Extremity
Orthopedic Fixation Devices
Orthopedic Procedures
Reaction Time
Task Performance and Analysis
Time Factors
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Fonds de la Recherche en Santé du Québec
name: BSN Medical Inc
First posted: 2010-07-28
Enrollment: 14
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Braking performances during real-time driving.
timeFrame: Two years.
Secondary outcomes:
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre de recherche sur le vieillissement
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
Study officials:
affiliation: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
name: Francois Cabana, MD
role: PRINCIPAL_INVESTIGATOR
References: