|
ISRCTN
|
ISRCTN36275372
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Driving ability after neurological diseases: driving behavior and therapy
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
05010
|
|
Study hypothesis
|
Driving ability, measured by a test of driving behavior after the intervention, improves more after a neuropsychological training with additional individual driving training than after a neuropsychological training with placebo intervention.
|
|
Lay summary
|
|
|
Ethics approval
|
University of Bonn, Medical Faculty (under review as of 02/05/2006)
|
|
Study design
|
Randomised clinical trial
|
|
Countries of recruitment
|
Germany
|
|
Disease/condition/study domain
|
Stroke, brain injury
|
|
Participants - inclusion criteria
|
Neurological, annuity assured patients (phase d, Barthel-Index >80) with stroke or brain injury and written informed consent.
|
|
Participants - exclusion criteria
|
1. Hemiparesis
2. Seizure disorder
3. Visual field failures in terms of driving licence ordinance (FeV appendix 6)
4. Psychiatric history and important cognitive impairment as orientation disorder and a lack of understanding of instructions
5. Patients with extreme abnormal driving experience (no car driving in the last year or more than 70,000 km per year)
|
|
Anticipated start date
|
01/04/2006
|
|
Anticipated end date
|
31/05/2006
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
60 participants (30 group A, 30 group B)
|
|
Interventions
|
Group A: Individual driving training and neuropsychological training
Group B: Neuropsychological training and placebo intervention (computer education)
Pre/post: test of driving behavior and neuropsychological assessment.
Additional post: interview with patient about compensational strategies and interview with driving instructor concerning patients performance during driving lessons.
|
|
Primary outcome measure(s)
|
Not provided at time of registration
|
|
Secondary outcome measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
Rehabilitations - Research Network of the German Pension Insurance Fund Rhineland - Refonet Germany (Forschungsnetzwerk der Deutschen Rentenversicherung Rheinland - Refonet) Project number: 05010
|
|
Trial website
|
http://www.refonet.de/projekte/laufendeprojekte_5010.php
|
|
Publications
|
|
|
Contact name
|
Prof
Dr. Hans
Karbe
|
|
Address
|
Neurological Rehabilitation Center Godeshoehe e.V.
Section Neuropsychology
Waldstr. 2-10
|
|
City/town
|
Bonn
|
|
Zip/Postcode
|
53177
|
|
Country
|
Germany
|
|
Tel
|
+49 (0)228 381207
|
|
Fax
|
+49 (0)228 381350
|
|
Email
|
h.karbe@godeshoehe.de
|
|
Sponsor
|
Refonet (Germany)
|
|
Address
|
c/o Dr. Hartmut Pollmann
Postfach 10 07 63
|
|
City/town
|
Bad Neuenahr-Ahrweiler
|
|
Zip/Postcode
|
53445
|
|
Country
|
Germany
|
|
Tel
|
+49 (0)264 1906212
|
|
Fax
|
+49 (0)264 1906220
|
|
Email
|
service@refonet.de
|
|
Sponsor website:
|
http://www.refonet.de/
|
|
Date applied
|
27/03/2006
|
|
Last edited
|
22/12/2006
|
|
Date ISRCTN assigned
|
02/05/2006
|
