Contact information
Type
Scientific
Contact name
Ms M Hagelstein
ORCID ID
Contact details
Erasmus Medical Center
P.O. Box 2040
Rotterdam
3015 GD
Netherlands
+31 (0)10 4087414
m.hagelstein@erasmusmc.nl
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
1; NTR736
Study information
Scientific title
Acronym
RATS-2
Study hypothesis
1. Cognitive linguistic therapy (CLT) is more effective than no-CLT
2. CLT applied zero to three months post onset is more effective than applied three to six months post-onset
Ethics approval(s)
Ethics approval received from the local medical ethics committee
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study type
Treatment
Patient information sheet
Condition
Aphasia
Intervention
Assessment:
1. Amsterdam-Nijmegen Everyday Language Test (ANELT), scale A
2. ScreeLing: semantic, phonological and syntactic deficits
3. Semantic Association Test (SAT), verbal version
4. Semantic Association words with low imageability (Psycholinguistic Assessment of Language Processing in Aphasia [PALPA])
5. Semantic word fluency (animals, professions)
6. Nonwords Repetition (PALPA)
7. Auditory Lexical Decision (PALPA)
8. Letter fluency (D, A, T)
9. Boston Naming Test
10. Token Test (short version)
11. Spontaneous Speech
12. Partner Communication Questionnaire
13. Aachen Aphasia Test
14. EuroQol quality of life instrument
15. Modified Rankin Scale
16. Barthel Index
Therapy:
Group one: Cognitive Linguistic Therapy (CLT) 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 computerised versions (for additional therapy with homework) can be used.
Group two: 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.
Intervention type
Other
Primary outcome measure
The score at six months post onset on the Amsterdam Nijmegen Everyday Language Test (ANELT), scale A (understandability).
Secondary outcome measures
1. Proportion of patients in each treatment group who improve at least seven points on the ANELT with a categorisation of the ANELT into severe (score: ten to 29) and moderate to mild (score: 30-48) communication deficits (ScreeLing)
2. Semantic Association Test (SAT), verbal version
3. Semantic Association words with low imageability, Nonwords Repetition and Auditory Lexical Decision (PALPA)
4. Semantic word fluency
5. Letter fluency
Overall study start date
04/09/2006
Overall study end date
04/12/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aphasia due to stroke
2. Within three weeks post onset
3. Age 18 to 85 years
4. Language near native Dutch
5. Life expectancy more than six months
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Upper age limit
85 Years
Sex
Both
Target number of participants
160
Participant 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
Recruitment start date
04/09/2006
Recruitment end date
04/12/2008
Locations
Countries of recruitment
Belgium, Netherlands
Study participating centre
Erasmus Medical Center
Rotterdam
3015 GD
Netherlands
Sponsor information
Organisation
Erasmus Medical Center (The Netherlands)
Sponsor details
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
Sponsor type
Hospital/treatment centre
Website
ROR
Funders
Funder type
Research organisation
Funder name
The Nuts-Ohra Foundation (Stichting Nuts Ohra [SNO]) (The Netherlands)
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2011 | Yes | No |