Effects of Right Lower Limb Orthopedic Immobilization on Braking Function
This study has been completed.
Sponsor:
Université de Sherbrooke
Collaborators:
Fonds de la Recherche en Santé du Québec
BSN Medical Inc
Information provided by (Responsible Party):
Francois Cabana, Université de Sherbrooke
ClinicalTrials.gov Identifier:
NCT01171287
First received: July 19, 2010
Last updated: June 4, 2015
Last verified: June 2015
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Automobile Driving With an Aircast Walker Automobile Driving With a Walking Cast |
Procedure: Driving with an Aircast Walker Procedure: Driving with a walking cast Procedure: Driving with a running shoe |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Effects of Right Lower Limb Orthopedic Immobilization on Braking Function : An On-the-Road Experimental Study by Healthy Volunteers |
Further study details as provided by Université de Sherbrooke:
Primary Outcome Measures:
- Braking performances during real-time driving. [ Time Frame: Two years. ] [ Designated as safety issue: No ]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.
| Enrollment: | 14 |
| Study Start Date: | September 2008 |
| Study Completion Date: | April 2014 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Aircast Walker
Automobile driving with an Aircast Walker applied to each participant's right lower extremity
|
Procedure: Driving with an Aircast Walker |
|
Experimental: Walking cast
Automobile driving with a walking cast applied to each participant's right lower extremity
|
Procedure: Driving with a walking cast |
|
Active Comparator: Running shoe
Automobile driving with a running shoe applied to each participant's right lower extremity
|
Procedure: Driving with a running shoe |
Eligibility| Ages Eligible for Study: | 25 Years to 60 Years (Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01171287
Please refer to this study by its ClinicalTrials.gov identifier: NCT01171287
Locations
| Canada, Quebec | |
| Centre de recherche sur le vieillissement | |
| Sherbrooke, Quebec, Canada, J1H 4C4 | |
| Centre Hospitalier Universitaire de Sherbrooke | |
| Sherbrooke, Quebec, Canada, J1H 5N4 | |
Sponsors and Collaborators
Université de Sherbrooke
Fonds de la Recherche en Santé du Québec
BSN Medical Inc
Investigators
| Principal Investigator: | Francois Cabana, MD | Centre de recherche du Centre hospitalier universitaire de Sherbrooke |
More Information
| Responsible Party: | Francois Cabana, Doctor, Université de Sherbrooke |
| ClinicalTrials.gov Identifier: | NCT01171287 History of Changes |
| Other Study ID Numbers: | Erica 02 |
| Study First Received: | July 19, 2010 |
| Last Updated: | June 4, 2015 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by Université de Sherbrooke:
|
Automobile Driving Fracture Fixation/instrumentation Lower Extremity Orthopedic Fixation Devices |
Orthopedic Procedures Reaction Time Task Performance and Analysis Time Factors |
ClinicalTrials.gov processed this record on September 23, 2016