NCT00950729

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 2, 2009

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 3, 2009

Completed
Same day until next milestone

Results Posted

Study results publicly available

August 3, 2009

Completed
Last Updated

July 15, 2015

Status Verified

June 1, 2015

Enrollment Period

3 months

First QC Date

March 2, 2009

Results QC Date

March 2, 2009

Last Update Submit

June 18, 2015

Conditions

Walking Cast Right Leg Immobilisation EffectsAircast Right Leg Immobilisation Effects

Keywords

car driving simulatororthopedic leg immobilisationbraking timebraking force

Outcome Measures

Primary Outcomes (2)

  • 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.

    June 2007 to September 2007

  • 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

    June 2007 to September 2007

Study Arms (3)

Driving with Running Shoes

ACTIVE COMPARATOR
Procedure: Driving with running shoes

Driving with Plaster cast

ACTIVE COMPARATOR
Procedure: Plaster cast

Driving with Aircast

ACTIVE COMPARATOR
Procedure: Driving with Aircast

Interventions

Driving with running shoesPROCEDURE

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

Driving with Running Shoes
Plaster castPROCEDURE

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

Driving with Plaster cast
Driving with AircastPROCEDURE

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

Driving with Aircast

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Sherbrooke, Quebec, J1H 4C4, Canada

Location

MeSH Terms

Interventions

Casts, Surgical

Intervention Hierarchy (Ancestors)

External FixatorsOrthopedic Fixation DevicesOrthopedic EquipmentSurgical EquipmentEquipment and SuppliesSurgical Fixation Devices

Results Point of Contact

Title
François Cabana
Organization
Centre hospitalier universitaire de Sherbrooke (CHUS)
francois.cabana@usherbrooke.ca
1-819-346-1110

Study Officials

  • François Cabana, MD

    Centre de recherche du Centre hospitalier universitaire de Sherbrooke

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 2, 2009

First Posted

August 3, 2009

Study Start

March 1, 2007

Primary Completion

June 1, 2007

Study Completion

September 1, 2007

Last Updated

July 15, 2015

Results First Posted

August 3, 2009

Record last verified: 2015-06

Locations

CA(1)