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The Effects of Lower Right Limb Orthopedic Immobilization on Driving Performance

The Effects of Lower Right Limb Orthopedic Immobilization on Driving Performance: an Experimental Study During Simulated Driving in Healthy Volunteers.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00950729
Enrollment
48
Registered
2009-08-03
Start date
2007-03-31
Completion date
2007-09-30
Last updated
2015-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Walking Cast Right Leg Immobilisation Effects, Aircast Right Leg Immobilisation Effects

Keywords

car driving simulator, orthopedic leg immobilisation, braking time, braking force

Brief summary

Abstract Background: Effects of orthopedic immobilizations of the lower right limb on driving performances are unknown. Therefore, clinicians and legislators cannot put forth recommendations for road safety for patients requiring such immobilizations. The objective of the present study was to evaluate the effects of different orthopedic immobilizations on braking performances in simulated driving conditions. Methods: The braking performances of 48 healthy volunteers were evaluated under 3 conditions: wearing their running shoes, and 2 types of orthopedic immobilizations of the lower right limb, a walking cast and an Aircast walker. A computerized driving simulator was used to measure the maximum force applied on the brake pedal during braking, the braking reaction time and the total braking time during emergency braking with and without a distracter.

Interventions

PROCEDUREDriving with running shoes

Participant was asked to do all the experiments with their own running shoes

PROCEDUREPlaster cast

The participant was ask to do all the experiments with a plaster cast molded on his right leg

PROCEDUREDriving with Aircast

The participant was ask to do all the experiments with a aircast on his right leg

Sponsors

BSN Medical Inc
CollaboratorINDUSTRY
Université de Sherbrooke
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
25 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy subjects between 25 and 60 years old * Valid Québec driving license * Driving for at least five years * Must used exclusively the right foot for accelerating and braking

Exclusion criteria

* Non-compensated visual acuity deficits or other visual problems * Drug or alcohol abuse * Use of psychotropic drugs * Central nervous system illnesses such as epilepsy * Sleep issues * Metabolic problems * Cardiovascular disease * Cerebrovascular disease * Peripheral vascular disease * Psychiatric illness * Renal disease * Musculoskeletal disease * Motion sickness and * Simulator sickness

Design outcomes

Primary

MeasureTime frameDescription
Mean Breaking Time Measured on a Driving Car SimulatorJune 2007 to September 2007computerized driving simulator was used to measure the braking reaction time and the total braking time during emergency braking with and without a distracter.
Mean Breaking Force Measured on a Driving Car SimulatorJune 2007 to September 2007computerized driving simulator was used to measure the braking force during emergency braking with and without distractor

Countries

Canada

Participant flow

Recruitment details

march 2007 to june 2007 recruitment was done at the CHUS

Participants by arm

ArmCount
Healthy Subjects48
Total48

Baseline characteristics

CharacteristicHealthy Subjects
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
48 Participants
Age, Continuous42.27 years
STANDARD_DEVIATION 10.06
Region of Enrollment
Canada
48 participants
Sex: Female, Male
Female
24 Participants
Sex: Female, Male
Male
24 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 48
serious
Total, serious adverse events
0 / 48

Outcome results

Primary

Mean Breaking Force Measured on a Driving Car Simulator

computerized driving simulator was used to measure the braking force during emergency braking with and without distractor

Time frame: June 2007 to September 2007

ArmMeasureValue (MEAN)Dispersion
Healthy SubjectsMean Breaking Force Measured on a Driving Car Simulator293.8 poundsStandard Deviation 75.2
Primary

Mean Breaking Time Measured on a Driving Car Simulator

computerized driving simulator was used to measure the braking reaction time and the total braking time during emergency braking with and without a distracter.

Time frame: June 2007 to September 2007

ArmMeasureValue (MEAN)Dispersion
Healthy SubjectsMean Breaking Time Measured on a Driving Car Simulator0.58 secondsStandard Deviation 0.041

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026