Condition category
Injury, Occupational Diseases, Poisoning
Date applied
01/08/2003
Date assigned
27/10/2003
Last edited
14/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Peter Frommelt

ORCID ID

Contact details

Medical Director
Asklepios Klinik Schaufling
Haustein 2
Schaufling
94571
Germany
+49 (0)9904 775571
p.frommelt@asklepios.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

B8

Study information

Scientific title

Acronym

Study hypothesis

A randomised controlled trial on neuropsychological rehabilitation

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Severe head trauma, stroke

Intervention

Compensatory skills training versus retraining basic cognitive impairments (either memory skills training or problemsolving)
addititional for both therapies
"living with neuropsychological impairment" and attention training

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

01/04/2002

Overall trial end date

30/04/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Neuropsychological impairments in at least two of the cognitive domains (cf. International Classification of Functioning, Disability and Health [ICF], World Health Organisation [WHO]): attention, memory, or problem solving
2. Age 16 to 55 years
3. Participation in the therapy programme for 5 weeks
4. Barthel Index at least summary score 40

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Not provided at time of registration.

Participant exclusion criteria

1. Prior brain injury to the actual trauma
2. Psychiatric disorder before trauma medically documented
3. Substance abuse
The participants are all inpatients at the neuropsychological rehabilitation centres. They are no longer in emergency units but in therapeutic care for the reintegration in job, family and daily life.

Recruitment start date

01/04/2002

Recruitment end date

30/04/2005

Locations

Countries of recruitment

Germany

Trial participating centre

Medical Director
Schaufling
94571
Germany

Sponsor information

Organisation

Bavarian Network for Rehabilitation Research (Rehabilitationswissenschaftlicher Forschungsverbund Bayern) (Germany)

Sponsor details

RFB-Geschäftsstelle
Wilmar Igl
c/o Institut für Psychotherapie und Medizinische Psychologie der Universität Würzburg
Marcusstr.9-11
Würzburg
97070
Germany

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

Bavarian Network for Rehabilitation Research (Rehabilitationswissenschaftlicher Forschungsverbund Bayern) (Germany)

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