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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list