Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Prof Dr. Hans Karbe
ORCID ID
Contact details
Neurological Rehabilitation Center Godeshoehe e.V.
Section Neuropsychology
Waldstr. 2-10
Bonn
53177
Germany
+49 (0)228 381207
h.karbe@godeshoehe.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
05010
Study information
Scientific title
Acronym
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.
Ethics approval
University of Bonn, Medical Faculty (under review as of 02/05/2006)
Study design
Randomised clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Stroke, brain injury
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/04/2006
Overall trial end date
31/05/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Neurological, annuity assured patients (phase d, Barthel-Index >80) with stroke or brain injury and written informed consent.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60 participants (30 group A, 30 group B)
Participant 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)
Recruitment start date
01/04/2006
Recruitment end date
31/05/2006
Locations
Countries of recruitment
Germany
Trial participating centre
Neurological Rehabilitation Center Godeshoehe e.V.
Bonn
53177
Germany
Sponsor information
Organisation
Refonet (Germany)
Sponsor details
c/o Dr. Hartmut Pollmann
Postfach 10 07 63
Bad Neuenahr-Ahrweiler
53445
Germany
+49 (0)264 1906212
service@refonet.de
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Rehabilitations - Research Network of the German Pension Insurance Fund Rhineland - Refonet Germany (Forschungsnetzwerk der Deutschen Rentenversicherung Rheinland - Refonet) Project number: 05010
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary