NCT01171287

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2010

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 28, 2010

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

June 8, 2015

Status Verified

June 1, 2015

Enrollment Period

1 month

First QC Date

July 19, 2010

Last Update Submit

June 4, 2015

Conditions

Automobile Driving With an Aircast WalkerAutomobile Driving With a Walking Cast

Keywords

Automobile DrivingFracture Fixation/instrumentationLower ExtremityOrthopedic Fixation DevicesOrthopedic ProceduresReaction TimeTask Performance and AnalysisTime Factors

Outcome Measures

Primary Outcomes (1)

  • Braking performances during real-time driving.

    The braking performances are assessed using (1) the median foot movement time, (2) the median brake reaction time and (3) the median total braking time.

    Two years.

Study Arms (3)

Aircast Walker

EXPERIMENTAL

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

Procedure: Driving with an Aircast Walker

Walking cast

EXPERIMENTAL

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

Procedure: Driving with a walking cast

Running shoe

ACTIVE COMPARATOR

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

Procedure: Driving with a running shoe

Interventions

Driving with an Aircast WalkerPROCEDURE
Aircast Walker
Driving with a walking castPROCEDURE
Walking cast
Driving with a running shoePROCEDURE
Running shoe

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre de recherche sur le vieillissement

Sherbrooke, Quebec, J1H 4C4, Canada

Location

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Study Officials

  • Francois Cabana, MD

    Centre de recherche du Centre hospitalier universitaire de Sherbrooke

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

July 19, 2010

First Posted

July 28, 2010

Study Start

September 1, 2008

Primary Completion

October 1, 2008

Study Completion

April 1, 2014

Last Updated

June 8, 2015

Record last verified: 2015-06

Locations

CA(2)