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OpenTrials
Completed

NCT Number: NCT00950729

The Effects of Lower Right Limb Orthopedic Immobilization on Driving Performance

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.

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Key information

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Research Centre on Aging, Sherbrooke Geriatric University Institute (IUGS),

Sherbrooke, Quebec, J1H 4C4, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Driving with running shoes

Procedure

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

plaster cast

Procedure

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

Driving with Aircast

Procedure

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

Primary outcomes

  1. Mean Breaking Time Measured on a Driving Car Simulator

    Time frame: June 2007 to September 2007

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

  2. Mean Breaking Force Measured on a Driving Car Simulator

    Time frame: June 2007 to September 2007

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

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Collaborators

  • BSN Medical Inc

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Aug 3, 2009
Registry last updated
Jul 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.