Walking Cast Right Leg Immobilisation EffectsNCT00950729
The Effects of Lower Right Limb Orthopedic Immobilization on Driving Performance
A study testing Driving with running shoes, Plaster cast and Driving with Aircast in people with Walking Cast Right Leg Immobilisation Effects and Aircast Right Leg Immobilisation Effects, run by Université de Sherbrooke at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Walking Cast Right Leg Immobilisation Effects, Aircast Right Leg Immobilisation Effects
- What is being tested?
- Driving with running shoes, Plaster cast and Driving with Aircast
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2007to Sep 2007
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 and 60 years old
- Valid Québec driving license
- Driving for at least five years
- Must used exclusively the right foot for accelerating and braking
Who cannot join
- 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
Show all 14Show fewer
- Cardiovascular disease
- Cerebrovascular disease
- Peripheral vascular disease
- Psychiatric illness
- Renal disease
- Musculoskeletal disease
- Motion sickness and
- Simulator sickness
Trial locations and contacts
1 site in 1 country.
Canada1 site
Research Centre on Aging, Sherbrooke Geriatric University Institute (IUGS),
Sherbrooke, Quebec, J1H 4C4
About this study
Official title: The Effects of Lower Right Limb Orthopedic Immobilization on Driving Performance: an Experimental Study During Simulated Driving in Healthy Volunteers.
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.
- Being tested
- Driving with running shoes, Plaster cast, Driving with Aircast
- Keywords
- car driving simulator, orthopedic leg immobilisation, braking time, braking force
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Driving with running shoesProcedure or surgery
Participant was asked to do all the experiments with their own running shoes
Plaster castProcedure or surgery
The participant was ask to do all the experiments with a plaster cast molded on his right leg
Driving with AircastProcedure or surgery
The participant was ask to do all the experiments with a aircast on his right leg
| Study group | Role | What they receive |
|---|---|---|
| Driving with Running Shoes | Active comparator | Not described Receives: Procedure: Driving with running shoes |
| Driving with Plaster cast | Active comparator | Not described Receives: Procedure: Plaster cast |
| Driving with Aircast | Active comparator | Not described Receives: Procedure: Driving with Aircast |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: June 2007 to September 2007
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2009 (estimated)
- Study startMar 2007
- Primary completionJun 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Walking Cast Right Leg Immobilisation EffectsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- BSN Medical Inc
- Investigators
- François Cabana, MD, Principal investigator, Centre de recherche du Centre hospitalier universitaire de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00950729
- Sponsor's protocol ID
- Socrate
- Status last verified
- Jun 2015
- First submitted
- 2 Mar 2009
- Last updated
- 15 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Lower Right Limb Orthopedic Immobilization on Driving Performance: an Experimental Study During Simulated Driving in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT00950729
- Acronym / sponsor ID
- Socrate
- Keywords
- car driving simulator, orthopedic leg immobilisation, braking time, braking force
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- BSN Medical Inc
- Study start
- Mar 2007
- Primary completion
- Jun 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 3 Aug 2009 (estimated)
- Results
- Posted 3 Aug 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
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 and 60 years old
- Valid Québec driving license
- Driving for at least five years
- Must used exclusively the right foot for accelerating and braking
Key exclusion criteria (14 listed)
- 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
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 running shoesParticipant was asked to do all the experiments with their own running shoes | Procedure or surgery | Driving with Running Shoes |
| Plaster castThe participant was ask to do all the experiments with a plaster cast molded on his right leg | Procedure or surgery | Driving with Plaster cast |
| Driving with AircastThe participant was ask to do all the experiments with a aircast on his right leg | Procedure or surgery | Driving with Aircast |
Primary outcome
Mean Breaking Time Measured on a Driving Car Simulator
Time frame: June 2007 to September 2007
computerized driving simulator was used to measure the braking reaction time and the total braking time during emergency braking with and without a distracter.
Mean Breaking Force Measured on a Driving Car Simulator
Time frame: June 2007 to September 2007
computerized driving simulator was used to measure the braking force during emergency braking with and without distractor
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
François Cabana, MD principal investigator
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Driving with running shoes, Plaster cast and Driving with Aircast in people with Walking Cast Right Leg Immobilisation Effects and Aircast Right Leg Immobilisation Effects, run by Université de Sherbrooke at 1 site 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 14 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 15 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 3 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Breaking Time Measured on a Driving Car Simulator (time frame: June 2007 to September 2007). The study lists 2 primary outcomes in all. 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 15 Jul 2015.