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Rotterdam Aphasia Therapy Study - 2.


- candidate number2175
- NTR NumberNTR736
- ISRCTNISRCTN67723958
- Date ISRCTN created12-okt-2006
- date ISRCTN requested11-okt-2006
- Date Registered NTR21-jul-2005
- Secondary IDs
- Public TitleRotterdam Aphasia Therapy Study - 2.
- Scientific TitleThe efficacy of cognitive linguistic therapy in the acute stage of aphasia: a randomized controlled trial.
- ACRONYMRATS-2
- hypothesis1. Cognitive linguistic therapy (CLT) is more effective than no-CLT; 2. CLT applied 0-3 months post onset is more effective than applied 3-6 m.p.o.
- Healt Condition(s) or Problem(s) studiedAphasia
- Inclusion criteria1. Aphasia due to stroke; 2. Within 3 weeks post onset; 3. Age 18-85 years; 4. Language near native Dutch; 5. Life expectancy > 6 months.
- Exclusion criteria1. Severe dysarthria; 2. Premorbid dementia; 3. Illiteracy; 4. Severe developmental dyslexia; 5. Severe visual perceptual disorders; 6.Existing aphasia; 7. Subarachnoidal haemorrhage; 8. Recent psychiatric disorder.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type[default]
- Studytypeintervention
- planned startdate 4-sep-2006
- planned closingdate4-dec-2008
- Target number of participants160
- InterventionsAssessment: - Amsterdam-Nijmegen Everyday Language Test (ANELT), scale A - ScreeLing - Semantic Association Test (SAT), verbal version - Semantic Association words with low imageability (PALPA) - semantic word fluency (animals, professions) - Nonwords Repetition (PALPA) - Auditory Lexical Decision (PALPA) - letter fluency (D, A, T) - Boston Naming Test - Token Test (short version) - Spontaneous Speech - Partner Communication Questionnaire - Aachen Aphasia Test - EuroQol - Rankin - Barthel Therapy: - CLT: cognitive linguistic therapy using BOX or FIKS or a combination of the two, depending on how the language disorder manifests itself in each patient. BOX is a lexical semantic treatment program, focused on the interpretation of the semantic features of written words, sentences, and texts. FIKS is a phonological treatment program focused on sound structure and word form, consisting of exercises for selecting and sequencing speech sounds on word-, sentence- and text level. Both the paper versions (for individual therapy) and the computerized versions (for additional therapy with homework) can be used. - no-CLT: all therapy tasks other than cognitive linguistic exercises are allowed. Treatment focused on the linguistic levels (phonology, semantics and syntax) is not permitted. In practice, this means that the control therapy will contain exercises aimed at improving communicative strategies.
- Primary outcomeThe score at 6 months post onset on the Amsterdam Nijmegen Everyday Language Test (ANELT), scale A (Understandability).
- Secondary outcome- Proportion of patients in each treatment group who improve at least 7 points on the ANELT - A categorization of the ANELT into severe (score, 10-29) and moderate to mild (score, 30-48) communication deficits - ScreeLing; Semantic Association Test (SAT), verbal version; Semantic Association words with low imageability, Nonwords Repetition and Auditory Lexical Decision (PALPA); semantic word fluency; letter fluency.
- Timepoints
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES M. Hagelstein
- CONTACT for SCIENTIFIC QUERIES E.G. Visch-Brink
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Stichting Nuts Ohra
- PublicationsHagelstein, M. (in press). RATS-2: De effectiviteit van cognitief lingu´stische therapie in de acute fase van afasie: een gerandomiseerde gecontroleerde trial. Afasiologie.
- Brief summaryAim: to evaluate the effect of semantic and phonological treatment on verbal communication in patients with aphasia after stroke. The study consists of two parts. In Part 1, CLT (BOX and/or FIKS) will be compared with no-CLT (nonspecific aphasia therapy directed to functional language behavior). 80 aphasic patients with semantic and/or phonological disorders will receive treatment 0-6 months post onset. Diagnostic or evaluative tests will be administered pre-therapy, after 3 months and after 6 months. The ANELT is the primary outcome measure. In addition, semantic and phonological tests will be administered. Hypothesis: CLT is more effective than no-CLT. Depending on the results of Part 1, the intervention contrast will be changed in Part 2. Aphasic patients with semantic and/or phonological disorders (n=80) will be randomized into 2 groups: (1) CLT from 0-3 months, followed by 3 months of no-CLT; (2) no-CLT from 0-3 months, followed by 3 months of CLT. Hypothesis: application in the acute stage, from 0-3 months, enhances the efficacy of CLT.
- Main changes (audit trail)
- RECORD21-jul-2006 - 16-aug-2009


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