Driving ability after neurological diseases: driving behavior and therapy
| ISRCTN | ISRCTN36275372 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36275372 |
| Secondary identifying numbers | 05010 |
- Submission date
- 27/03/2006
- Registration date
- 02/05/2006
- Last edited
- 22/12/2006
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Dr. Hans Karbe
Scientific
Scientific
Neurological Rehabilitation Center Godeshoehe e.V.
Section Neuropsychology
Waldstr. 2-10
Bonn
53177
Germany
| Phone | +49 (0)228 381207 |
|---|---|
| h.karbe@godeshoehe.de |
Study information
| Study design | Randomised clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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(s) | University of Bonn, Medical Faculty (under review as of 02/05/2006) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/04/2006 |
| Completion date | 31/05/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 60 participants (30 group A, 30 group B) |
| Key inclusion criteria | Neurological, annuity assured patients (phase d, Barthel-Index >80) with stroke or brain injury and written informed consent. |
| Key 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) |
| Date of first enrolment | 01/04/2006 |
| Date of final enrolment | 31/05/2006 |
Locations
Countries of recruitment
- Germany
Study participating centre
Neurological Rehabilitation Center Godeshoehe e.V.
Bonn
53177
Germany
53177
Germany
Sponsor information
Refonet (Germany)
Research organisation
Research organisation
c/o Dr. Hartmut Pollmann
Postfach 10 07 63
Bad Neuenahr-Ahrweiler
53445
Germany
| Phone | +49 (0)264 1906212 |
|---|---|
| service@refonet.de | |
| Website | http://www.refonet.de/ |
"ROR" |
https://ror.org/04yeh2x21 |
Funders
Funder type
Research organisation
Rehabilitations - Research Network of the German Pension Insurance Fund Rhineland - Refonet Germany (Forschungsnetzwerk der Deutschen Rentenversicherung Rheinland - Refonet) Project number: 05010
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
