Condition category
Signs and Symptoms
Date applied
27/11/2006
Date assigned
03/01/2007
Last edited
05/01/2007
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 Jutta Küst

ORCID ID

Contact details

NRZ Godeshoehe
Waldstrasse 2-10
Bonn
53177
Germany
j.kuest@godeshoehe.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

05004

Study information

Scientific title

Acronym

FUATAC

Study hypothesis

1. 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

Ethik-Kommission of Medizinische Fakultät Bonn (Germany), date of approval: 09/08/2006 (ref: 107/06).

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

Aphasia

Intervention

Intervention:
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 type

Other

Phase

Not Specified

Drug names

Primary outcome measures

To establish efficacy of FUAT in the acute phase

Secondary outcome measures

1. 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 trial start date

01/07/2006

Overall trial end date

31/07/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Left hemispheric cerebro-vascular accident maximally three months post-onset
2. Aphasia (by clinical diagnosis and standardised aphasia screening)
3. Monolingual German native speaker

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

52

Participant exclusion criteria

1. Aphasia mainly characterised by automatisms
2. Severe jargon
3. Severe apraxia of speech
4. Severe neuropsychological and/or psychiatric disorders

Recruitment start date

01/07/2006

Recruitment end date

31/07/2008

Locations

Countries of recruitment

Germany

Trial participating centre

NRZ Godeshoehe
Bonn
53177
Germany

Sponsor information

Organisation

Refonet (Germany)

Sponsor details

c/o Dr H Pollmann
Postfach 10 07 63
Bad Neuenahr-Ahrweiler
53177
Germany
+49 (0)2641 9062-12
service@refonet.de

Sponsor type

Research organisation

Website

http://www.refonet.de/

Funders

Funder type

Research organisation

Funder name

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

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