To investigate the differences in driving performance and safety between CD patients and healthy controls in a driving simulator. To compare the subjective evaluation of the difficulty of various aspects of the driving task driving in CD patients…
ID
Source
Brief title
DriveID-study
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Driving performance, driving safety and the Fitness To Drive Screening. Driving
performance is measured as the standard deviation of the lateral position in
the lane, time to lane crossing, and number of lane crossings. Driving safety
is measured by the number of (near) crashes and other traffic conflicts such as
near crashes and rule violations. Data will be retrieved from the driving
simulator
Secondary outcome
Range of motion and movement speed of the head will be measured with a portable
device that uses motion sensors that combines a gyroscope, accelero- and
magnetometer to capture a complete three-dimensional spectrum of the head
movements.
Gaze behaviour by filming the driver*s face while driving. The drivers face
will be captured by a HD camera (Sony HDR CX 210E) mounted on top of the
simulator in front of the driver. In order to analyze the gaze behavior, video
recordings of participants* face are coded and analyzed. The Drivers face is
manually labeled with ELAN, a tool used to make complex annotations on videos.
Perceived fatigue of the neck and shoulder aera and driving effort will be
rated just before and just after the simulated drive, using the Borg CR-10
scale. The Borg CR-10 scale is an 11 point rating scale, ranging from 0 to 10
on which monitors perceived fatigue and driving effort during the performance
of a driving task.
Background summary
Cervical Dystonia (CD) is characterized by involuntary muscle contraction of
the neck and abnormal positions of the head that affects daily life activities
and social life of patients. For most people, being able to drive a vehicle is
a very important part of their daily life. However, it is likely that driving
performance and driving safety are affected due to the involuntary muscle
contractions and abnormal postures. Although Botulinum Toxin (BTX) treatment
improves motor symptoms and head postures in 70-92% of CD patients, many
patients still have difficulties with the execution of voluntary and controlled
movements of the neck and head. Up to date, there is no literature available
about driving performance and driving safety in CD patients.
Study objective
To investigate the differences in driving performance and safety between CD
patients and healthy controls in a driving simulator. To compare the subjective
evaluation of the difficulty of various aspects of the driving task driving in
CD patients and healthy controls with the Fitness To Drive Screening.
Study design
The study will be performed as an explorative case-control study.
Study burden and risks
Some persons might experience some dizziness or nausea while driving in the
simulator. This is mainly caused by the fact that movement is seen but not
felt. When a person gets dizzy or nauseous, the simulator will be stopped.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
- 30 years or older
- Stable on Botulinum Toxin for at least 1 year
- 30 years of age or older
- Having a drivers license
- Have given written informed consent for participation
- Able to drive
- Have driven in the last 12 months
Exclusion criteria
- Secondary (including psychogenic) dystonia
- Hereditary (dominant) forms of dystonia
- Segmental, hemi-, multifocal or generalized dystonia
- Patients who underwent neurosurgery
- Inability to understand written and spoken Dutch language
- Motion sickness
- Medication that is known to influence driving performance
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL45887.042.13 |
| Other | NTR |
| OMON | NL-OMON28122 |