Trial Outcomes & Findings for The Effects of Lower Right Limb Orthopedic Immobilization on Driving Performance (NCT NCT00950729)

Results Overview

computerized driving simulator was used to measure the braking reaction time and the total braking time during emergency braking with and without a distracter.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

48 participants

Primary outcome timeframe

June 2007 to September 2007

Results posted on

2015-07-15

Participant Flow

march 2007 to june 2007 recruitment was done at the CHUS

Participant milestones

Participant milestones
Measure	Healthy Subjects
Driving With Running Shoes STARTED	48
Driving With Running Shoes COMPLETED	48
Driving With Running Shoes NOT COMPLETED	0
Driving With Plaster Cast STARTED	48
Driving With Plaster Cast COMPLETED	48
Driving With Plaster Cast NOT COMPLETED	0
Driving With Aircast STARTED	48
Driving With Aircast COMPLETED	48
Driving With Aircast NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effects of Lower Right Limb Orthopedic Immobilization on Driving Performance

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healthy Subjects n=48 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	48 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	42.27 years STANDARD_DEVIATION 10.06 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants
Region of Enrollment Canada	48 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Healthy Subjects n=48 Participants
Mean Breaking Time Measured on a Driving Car Simulator	0.58 seconds Standard Deviation .041

PRIMARY outcome

Timeframe: June 2007 to September 2007

computerized driving simulator was used to measure the braking force during emergency braking with and without distractor

Outcome measures

Outcome measures
Measure	Healthy Subjects n=48 Participants
Mean Breaking Force Measured on a Driving Car Simulator	293.8 pounds Standard Deviation 75.2

Adverse Events

Healthy Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

François Cabana

Centre hospitalier universitaire de Sherbrooke (CHUS)

Phone: 1-819-346-1110

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place