Condition category
Nervous System Diseases
Date applied
29/08/2007
Date assigned
03/10/2007
Last edited
03/10/2007
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 Anke Menzel-Begemann

ORCID ID

Contact details

Johanniterstrasse 7
Bad Oeynhausen
32545
Germany
+49 5731 151 773
anke.menzel-begemann@ahb-klinik.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

GfR 06/006

Study information

Scientific title

Acronym

BOMeN

Study hypothesis

The trial studies survivors of stroke or brain injury with a special occupational difficulty concerning the reintegration to work. For these patients return-to-work is accompanied by explicit strains because of the coincidence of physical and cognitive impairments. Furthermore patients with acquired brain injury often focus only on the physical deficits and do not show adequate awareness for cognitive constraints.

Hypotheses:
1. Until 15 months after rehabilitation the ratio of (re-)employed persons in the intervention group is significantly higher than the ratio of (re-)employed persons in the control group
2. Until 15 months after rehabilitation the ratio of (re-)employable persons in the intervention group is significantly higher than the ratio of (re-)employable persons in the control group
3. Patients of the intervention group can be re-integrated significantly quicker than patients of the control group
4. Re-integrated patients who participated in the intervention group show significantly less days of incapacity for work than re-integrated patients who participated in the control group
5. Patients who participated in the intervention group show a significantly higher satisfaction with life and health than patients who participated in the control group
6. Patients who participated in the intervention group show a significantly higher motivation for rehabilitation than patients who participated in the control group
7. The intervention treatment will gain a higher valuation than the control treatment by the parties involved (patients and rehabilitation workers)

Ethics approval

Ethics Committee of the Arztekammer Westfalen-Lippe and the Medical Faculty of the Westfalischen Wilhelms Unitersigy of Munster. Approved on 24th May 2007 (ref: 2007-235-f-S)

Study design

Randomised controlled trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Neurorehabilitation for survivors of stroke and brain injury

Intervention

Intervention group: Patients of the intervention group take part in a newly developed rehabilitation concept called Occupational Orientation in Medical Neurorehabilitation (BOMeN) which consists of nine sessions of 3 hours during a 4-week rehabilitation. In this therapy the patients get to know relevant information about stress, perspectives, motivation and the relevance of attention, memory, planning functions and motor skills for everyday working life. The contents are mediated by patient education, experiments of perception and ergotherapeutic exercises. Furthermore the neuropsychological, socialmedical and ergotherapeutical assessments are more related to work and therapy is integrated in a fixed schedule. Finally different disciplines show a higher degree of interworking.

Control group: Medical Neurorehabilitation (MeN) patients of the control group take part in the conventional rehabilitation concept (MeN) which contains shorter units of assessment and therapy without an explicit relation to work. The average duration of treatment in both groups is controlled.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The following variables are measured by standardized or self-developed questionnaires:
1. Re-employment (patients) 15 months after rehabilitation
2. (Re-)employability (patients) 15 months after rehabilitation
3. Days of incapacity to work (patients), measured using the Indicators of the Status of Rehabilitation questionnaire (Indikatoren des Reha-Status [IRES]) 15 months after rehabilitation
4. Expectations concerning the rehabilitation (patients), measured using the Questionnaire on Expectations and Motivation Concerning Rehabilitation (Fragebogen zu Reha-Erwartungen und Reha-Motivation [FREM]) at the start and end of rehabilitation
5. Motivation for rehabilitation (patients), measured using the Diagnostic Investigation of Motivation Concerning Work questionnaire (Diagnostik von Arbeitsmotivation [DIAMO]) at the start and end of rehabilitation, 6, 12 and 15 months after rehabilitation
6. Satisfaction with life and health (patients) (the 36-item Short Form health survey [SF-36]/the World Health Organization Quality of Life Questionnaire [WHO-QoL-BREF]) at the start and end of rehabilitation, 6, 12 and 15 months after rehabilitation
7. Satisfaction with rehabilitation procedure and contents (patients and rehabilitation workers). Timepoints for patients: at the start and end of rehabilitation, 6, 12 and 15 months after rehabilitation. Timepoints for workers: once in Summer 2008.

Secondary outcome measures

1. Cognitive functional status at the start and end of rehabilitation, 6, 12 and 15 months after rehabilitation
2. Motivation for work at the start and end of rehabilitation, 6, 12 and 15 months after rehabilitation

Overall trial start date

01/07/2007

Overall trial end date

30/06/2010

Reason abandoned

Eligibility

Participant inclusion criteria

All participants must meet all of the following conditions:
1. Positive prognostic estimation of occupational ability
2. Stroke or craniocerebral trauma
3. Estimated Functional Independence Measure (FIM) greater than or equal to 90

Also, all participants must meet at least one of the following conditions:
1. Advice for medical rehabilitation based on paragraph 51.1 of the Social Security Statutes, Book No. 5 (SGB V)
2. Inability to work for 3 months during the last 12 months
3. Ability to work is less than 6 hours
4. Not in paid work before start of rehabilitation
5. Necessary occupational reorientation
6. Application for a pension
7. Risk of early retirement

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

306

Participant exclusion criteria

1. Older than 60 years
2. Acute psychiatric disorder
3. Acute addiction
4. Restrictive aphasic disorder
5. Insufficient knowledge of German language
6. Estimated FIM <90
7. Neurological diseases other than stroke or craniocerebral trauma

Recruitment start date

01/07/2007

Recruitment end date

30/06/2010

Locations

Countries of recruitment

Germany

Trial participating centre

Johanniterstrasse 7
Bad Oeynhausen
32545
Germany

Sponsor information

Organisation

Association for Rehabilitation Sciences Nordrhein-Westfalen e.V. (Germany)

Sponsor details

Königsallee 71
Düsseldorf
40215
Germany

Sponsor type

Not defined

Website

http://www.rehaforschung-nrw.de

Funders

Funder type

Hospital/treatment centre

Funder name

Association for Rehabilitation Sciences Nordrhein-Westfalen e.V. (Gesellschaft für Rehabilitationswissenschaften Nordrhein-Westfalen e.V.) (ref: GfR 06006 / 623-06)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Houses of Holy Order of Johanniter Rehabilitation Centre (Johanniter-Ordenshäuser Bad Oeynhausen gemGmbH) (ref: BOMeN 98410)

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