|- candidate number||16507|
|- NTR Number||NTR4446|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||19-feb-2014|
|- Secondary IDs||NL45887.042.13 |
|- Public Title||Driving performance in cervical dystonia|
|- Scientific Title||Driving performance in cervical dystonia; a driving simulator pilot studie|
|- ACRONYM||DriveID study|
|- hypothesis||Driving a motor vehicle is a functional task requiring a complex interaction of visual, cognitive and motor skills. A wide range of acute and chronic medical conditions may impair driving performance and safety. Since CD is characterized by involuntary movements and /or abnormal postures of the neck and head it might affect driving performance and safety.|
|- Healt Condition(s) or Problem(s) studied||Cervical dystonia, Spasmodic torticollis|
|- Inclusion criteria||- 30 years or older
- Stable on BTX for at least 1 year
- Able to drive
- Have driven in the last 12 months
- Have given written and informed consent
|- Exclusion criteria||- Secondary (including psychogenic) dystonia
- Hereditary (dominant) forms of dystonia
- Segmental, hemi-, multifocal or generalized dystonia
- Subjects who underwent neurosurgery
- Inability to understand written and spoken Dutch language
- Motion sickness
|- mec approval received||no|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-apr-2014|
|- planned closingdate||1-apr-2015|
|- Target number of participants||20|
|- Interventions||6 drives in a driving simulator|
|- Primary outcome||- Driving performance (standard deviation of
lateral position on the road)
- Driving safety (The number of crashes and
other traffic conflicts such as near crashes.
Rule violations like not giving right of way
and driving hindrance which includes
norm violations like travelling under the
speed limit or stopping unreasonably far
away from a stop line or traffic light
- Fitness To Drive Screening measure|
|- Secondary outcome||- Range of motion and kinematics of the head
- Gaze behaviour
- Perceived fatigue and Driving effort|
|- Timepoints||measurements will only be performed just after the simulation drives|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| J. Dool, van den|
|- CONTACT for SCIENTIFIC QUERIES|| J. Dool, van den|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG)|
(Source(s) of Monetary or Material Support)
|Fonds Nuts-Ohra, Jacques & Gloria Gossweiler Foundation, Hogeschool van Amsterdam/Amsterdam University of Applied Sciences, Wetenschapsfonds Dystonie|
|- Brief summary||Background: 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 objectives: 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 in subjects with CD patients and healthy controls with the Fitness To Drive Screening.
Study design: The study will be performed as an explorative case-control pilot study.
Study population: 10 subjects patients with idiopathic cervical dystonia and 10 healthy age and sex matched controls.
Primary outcomes: 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.
Measurements: Measurements will be performed eight to ten weeks after BTX injections. All subjects will fill in the Fitness To Drive Screening and perform three driving tests in a driving simulator. The first test consists of a swing drive where patient drive a winding route. The second test consists of a route involving intersections and the third consists of a highway route with a merging task.
Expected results: It is expected that subjects with CD patients perform less well than healthy controls with respect to driving performance and driving safety. We expect limitations in tasks requiring movements opposite to the personal dystonic posturing of the patients.
|- Main changes (audit trail)|
|- RECORD||19-feb-2014 - 8-apr-2014|