- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01171287
Effects of Right Lower Limb Orthopedic Immobilization on Braking Function
June 4, 2015 updated by: Francois Cabana, Université de Sherbrooke
Effects of Right Lower Limb Orthopedic Immobilization on Braking Function : An On-the-Road Experimental Study by Healthy Volunteers
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.
Study Overview
Status
Completed
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Quebec
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Sherbrooke, Quebec, Canada, J1H 5N4
- Centre Hospitalier Universitaire de Sherbrooke
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Sherbrooke, Quebec, Canada, J1H 4C4
- Centre de recherche sur le vieillissement
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 60 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Aircast Walker
Automobile driving with an Aircast Walker applied to each participant's right lower extremity
|
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EXPERIMENTAL: Walking cast
Automobile driving with a walking cast applied to each participant's right lower extremity
|
|
ACTIVE_COMPARATOR: Running shoe
Automobile driving with a running shoe applied to each participant's right lower extremity
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Braking performances during real-time driving.
Time Frame: Two years.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: François Cabana, MD, Centre de recherche du Centre hospitalier Universitaire de Sherbrooke
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2008
Primary Completion (ACTUAL)
October 1, 2008
Study Completion (ACTUAL)
April 1, 2014
Study Registration Dates
First Submitted
July 19, 2010
First Submitted That Met QC Criteria
July 27, 2010
First Posted (ESTIMATE)
July 28, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
June 8, 2015
Last Update Submitted That Met QC Criteria
June 4, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Erica 02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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