ISRCTN ISRCTN26390986
DOI https://doi.org/10.1186/ISRCTN26390986
Secondary identifying numbers 05004
Submission date
27/11/2006
Registration date
03/01/2007
Last edited
05/01/2007
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Signs and Symptoms
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

Dr Jutta Küst
Scientific

NRZ Godeshoehe
Waldstrasse 2-10
Bonn
53177
Germany

Email j.kuest@godeshoehe.de

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymFUATAC
Study objectives1. Forced Use Aphasia Therapy (FUAT) leads to significant improvements in language skills.
2. FUAT is more effective than ‘classical’ aphasia therapy.
3. Comparable significant improvements in language skills are reached earlier in FUAT.
4. Effects of treatment can be found in both FUAT-group and control group at six months post treatment.
5. Improvements in language skills will also improve communication skills, with FUAT being more effective.
Ethics approval(s)Ethik-Kommission of Medizinische Fakultät Bonn (Germany), date of approval: 09/08/2006 (ref: 107/06).
Health condition(s) or problem(s) studiedAphasia
InterventionIntervention:
Forced-use aphasia therapy is characterised by various aspects:
1. Treatment is group treatment (two to three persons).
2. Treament per day is three to four hours.
3. Treatment is primarily based on communicative aspects.

Control:
In the control group the people with aphasia receive therapy as usual. Control patients will have individual sessions once a day, and therapy is focussed on language/linguistic skills.

Both groups consist of 26 persons. The intervention will take place for six weeks.
Intervention typeOther
Primary outcome measureTo establish efficacy of FUAT in the acute phase
Secondary outcome measures1. To establish efficiency of FUAT as compared to standardised aphasia therapy.
2. To establish long-term effects of aphasia therapy (both FUAT and standard)
Overall study start date01/07/2006
Completion date31/07/2008

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants52
Key inclusion criteria1. Left hemispheric cerebro-vascular accident maximally three months post-onset
2. Aphasia (by clinical diagnosis and standardised aphasia screening)
3. Monolingual German native speaker
Key exclusion criteria1. Aphasia mainly characterised by automatisms
2. Severe jargon
3. Severe apraxia of speech
4. Severe neuropsychological and/or psychiatric disorders
Date of first enrolment01/07/2006
Date of final enrolment31/07/2008

Locations

Countries of recruitment

  • Germany

Study participating centre

NRZ Godeshoehe
Bonn
53177
Germany

Sponsor information

Refonet (Germany)
Research organisation

c/o Dr H Pollmann
Postfach 10 07 63
Bad Neuenahr-Ahrweiler
53177
Germany

Phone +49 (0)2641 9062-12
Email service@refonet.de
Website http://www.refonet.de/
ROR logo "ROR" https://ror.org/04yeh2x21

Funders

Funder type

Research organisation

Rehabilitations-Forschungsnetzwerk der DRV Rheinland (ReFonet) (Germany ) (Project Number: 05004).

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan