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ID
Source
Brief title
Health condition
1. Experimental condition: CLT 0-6 m.p.o
Control condition: no-CLT 0-6 m.p.o
2. Experimental condition: CLT 0-3 m.p.o. followed by no-CLT 3-6 m.p.o.
Control condition: no-CLT 0-3 m.p.o. followed by CLT 3-6 m.p.o.
Sponsors and support
Intervention
Outcome measures
Primary outcome
The 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.
Background summary
Aim: 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.
Study objective
1. 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.
Intervention
Assessment:
- 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.
M. Hagelstein
Rotterdam 3015 GD
The Netherlands
+31 (0)10 4087414
m.hagelstein@erasmusmc.nl
M. Hagelstein
Rotterdam 3015 GD
The Netherlands
+31 (0)10 4087414
m.hagelstein@erasmusmc.nl
Inclusion criteria
1. 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 criteria
1. 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL726 |
| NTR-old | NTR736 |
| Other | : 1 |
| ISRCTN | ISRCTN67723958 |