Condition category
Nervous System Diseases
Date applied
27/03/2006
Date assigned
02/05/2006
Last edited
22/12/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.refonet.de/projekte/laufendeprojekte_5010.php

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

http://www.refonet.de/

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

Publication citations

Additional files

Editorial Notes