Automobile Driving With an Aircast WalkerNCT01171287
Effects of Right Lower Limb Orthopedic Immobilization on Braking Function
A study testing Driving with an Aircast Walker, Driving with a walking cast and Driving with a running shoe in people with Automobile Driving With an Aircast Walker and Automobile Driving With a Walking Cast, run by Université de Sherbrooke at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Automobile Driving With an Aircast Walker, Automobile Driving With a Walking Cast
- What is being tested?
- Driving with an Aircast Walker, Driving with a walking cast and Driving with a running shoe
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesCanada
- Study dates
- Sep 2008to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- Cardiovascular disease
- Cerebrovascular disease
- Peripheral vascular disease
- Psychiatric illness
- Renal disease
- Musculoskeletal disease
- Motion sickness
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Centre de recherche sur le vieillissement
Sherbrooke, Quebec, J1H 4C4
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
About this study
Official title: 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.
- Being tested
- Driving with an Aircast Walker, Driving with a walking cast, Driving with a running shoe
- Keywords
- Automobile Driving, Fracture Fixation/instrumentation, Lower Extremity, Orthopedic Fixation Devices, Orthopedic Procedures, Reaction Time, Task Performance and Analysis, Time Factors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Driving with an Aircast WalkerProcedure or surgery
Driving with a walking castProcedure or surgery
Driving with a running shoeProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Aircast Walker | Experimental | Automobile driving with an Aircast Walker applied to each participant's right lower extremity Receives: Procedure: Driving with an Aircast Walker |
| Walking cast | Experimental | Automobile driving with a walking cast applied to each participant's right lower extremity Receives: Procedure: Driving with a walking cast |
| Running shoe | Active comparator | Automobile driving with a running shoe applied to each participant's right lower extremity Receives: Procedure: Driving with a running shoe |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2010 (estimated)
- Study startSep 2008
- Primary completionOct 2008
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Automobile Driving With an Aircast WalkerStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Fonds de la Recherche en Santé du Québec, BSN Medical Inc
- Responsible party
- Principal investigator, Francois Cabana, Université de Sherbrooke
- Investigators
- Francois Cabana, MD, Principal investigator, Centre de recherche du Centre hospitalier universitaire de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01171287
- Sponsor's protocol ID
- Erica 02
- Status last verified
- Jun 2015
- First submitted
- 19 Jul 2010
- Last updated
- 8 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Right Lower Limb Orthopedic Immobilization on Braking Function : An On-the-Road Experimental Study by Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01171287
- Acronym / sponsor ID
- Erica 02
- Keywords
- Automobile Driving, Fracture Fixation/instrumentation, Lower Extremity, Orthopedic Fixation Devices, Orthopedic Procedures, Reaction Time, Task Performance and Analysis, Time Factors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Fonds de la Recherche en Santé du Québec, BSN Medical Inc
- Study start
- Sep 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 28 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aircast Walker | Experimental | Procedure: Driving with an Aircast WalkerAutomobile driving with an Aircast Walker applied to each participant's right lower extremity |
| Walking cast | Experimental | Procedure: Driving with a walking castAutomobile driving with a walking cast applied to each participant's right lower extremity |
| Running shoe | Active comparator | Procedure: Driving with a running shoeAutomobile driving with a running shoe applied to each participant's right lower extremity |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Driving with an Aircast Walker | Procedure or surgery | Aircast Walker |
| Driving with a walking cast | Procedure or surgery | Walking cast |
| Driving with a running shoe | Procedure or surgery | Running shoe |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francois Cabana, MD principal investigator
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Driving with an Aircast Walker, Driving with a walking cast and Driving with a running shoe in people with Automobile Driving With an Aircast Walker and Automobile Driving With a Walking Cast, run by Université de Sherbrooke at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Braking performances during real-time driving. (time frame: Two years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2015.