Condition category
Signs and Symptoms
Date applied
12/10/2006
Date assigned
12/10/2006
Last edited
16/05/2011
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

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 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

Ethics approval received from the local medical ethics committee

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

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

04/09/2006

Overall trial end date

04/12/2008

Reason abandoned

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

Patient

Age group

Adult

Gender

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

Trial 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

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1 2006 results in Hagelstein, M. RATS-2: De effectiviteit van cognitief linguÏstische therapie in de acute fase van afasie: een gerandomiseerde gecontroleerde trial. Afasiologie, 28 (4), 62-64.
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/20935327

Publication citations

  1. Results

    de Jong-Hagelstein M, van de Sandt-Koenderman WM, Prins ND, Dippel DW, Koudstaal PJ, Visch-Brink EG, Efficacy of early cognitive-linguistic treatment and communicative treatment in aphasia after stroke: a randomised controlled trial (RATS-2)., J. Neurol. Neurosurg. Psychiatr., 2011, 82, 4, 399-404, doi: 10.1136/jnnp.2010.210559.

Additional files

Editorial Notes