Rotterdam Aphasia Therapy Study - 2
| ISRCTN | ISRCTN67723958 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67723958 |
| Secondary identifying numbers | 1; NTR736 |
- Submission date
- 12/10/2006
- Registration date
- 12/10/2006
- Last edited
- 16/05/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms M Hagelstein
Scientific
Scientific
Erasmus Medical Center
P.O. Box 2040
Rotterdam
3015 GD
Netherlands
| Phone | +31 (0)10 4087414 |
|---|---|
| m.hagelstein@erasmusmc.nl |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | RATS-2 |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 04/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 85 Years |
| Sex | Both |
| Target number of participants | 160 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 04/09/2006 |
| Date of final enrolment | 04/12/2008 |
Locations
Countries of recruitment
- Belgium
- Netherlands
Study participating centre
Erasmus Medical Center
Rotterdam
3015 GD
Netherlands
3015 GD
Netherlands
Sponsor information
Erasmus Medical Center (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
"ROR" |
https://ror.org/018906e22 |
|---|
Funders
Funder type
Research organisation
The Nuts-Ohra Foundation (Stichting Nuts Ohra [SNO]) (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2011 | Yes | No |
