AphasiaFCET2ECNCT01540383
Effectiveness of Intensive Aphasia Therapy Under Routine Clinical Conditions
A study testing Intensive integrative aphasia therapy in people with Aphasia and Stroke, run by University Hospital Muenster at 1 site in Germany.
Trial summary
The purpose of this study is to examine whether 3 weeks of intensive language therapy provided in clinical in- and outpatient settings is effective in improving everyday communication in postacute/chronic post-stroke aphasia, as measured by performance on the Amsterdam Nijmegen Everyday Language Test (ANELT). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- What is being tested?
- Intensive integrative aphasia therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2012to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- presence of aphasia for at least 6 months after non-hemorrhagic or hemorrhagic cortical or subcortical-cortical stroke
- native language German
- participant's comprehension ability needs to be sufficiently high to give informed consent
- participant's language abilities have to allow the administration of the Aachen Aphasia Test (AAT)
Who cannot join
- aphasia due to non-vascular etiology
- no evidence for aphasia (based on AAT subtests 'Token Test' and 'Written Language'
- severe untreated medical conditions which prohibit participation in intensive language therapy
- severe vision or hearing problems (uncorrected)
- participation in another interventional or language therapy study within four weeks before potential enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: From Controlled Experimental Trial to Everyday Communication: How Effective is Intensive Aphasia Therapy Under Routine Clinical Conditions?
The purpose of this study is to examine whether 3 weeks of intensive language therapy provided in clinical in- and outpatient settings is effective in improving everyday communication in postacute/chronic post-stroke aphasia, as measured by performance on the Amsterdam Nijmegen Everyday Language Test (ANELT).
Read the detailed description
Aims of the study:
This multicenter randomized placebo-controlled study aims to examine whether integrative intensive (> 10 hours/week for at least 3 weeks) language and communication therapy administered under routine clinical conditions translates into a statistically significant functional improvement of everyday communication in patients with chronic aphasia (i.e., aphasia persisting for 6 or more months after the stroke). A further aim is to examine whether therapy-induced improvements are still maintained over a period of six months. The study's results may lead to more targeted treatment regimens and thus to an enhancement of health-related quality of life in persons with chronic aphasia. The data will further provide evidence-based guidelines of best practice in the rehabilitation of persons with chronic aphasia.
Methods:
Fourteen in- and outpatient rehabilitation centres across Germany participate in the study. Via a digital randomization procedure, patients are allocated to one of two groups: an experimental group, starting as soon as feasible with treatment lasting 3 to 6 weeks, and a waiting list control group, whose therapy begins after a three-week delay. Both groups receive a combination of language systematic and communicative-pragmatic language therapy. Everyday language ability will be examined with a standardized outcome measure, and compared between groups at several points: immediately before as well as immediately after and 6 months after completion of (3-6 weeks) intensive language therapy.
Statistical analyses:
The primary analysis compares the changes in functional communication ability (as indicated by changes of pre- to post-therapy functional communication scores on the primary outcome measure, the ANELT) between the experimental and the waiting list control group in an intention-to-treat (ITT) design. To balance for unequal treatment durations across patient ("naturalistic treatment setting"), the critical pre- to post therapy interval is fixed at three weeks, with the option of extension of therapy (provided it is granted by the sickness fund) and re-test after termination of therapy. The long-term stability of potential treatment gains will be re-evaluated 6 months post therapy.
Further exploratory analyses will examine therapy-induced changes in secondary outcome measures (see below) in the experimental compared to the waiting list control group.
Considering that age, gender, time post stroke onset, aphasia type (fluent, non-fluent), aphasia severity (based on the Aachen Aphasia Test [AAT] profile score), baseline cognitive status, the total hours of therapy provided, type of stroke (cortical strokes with or without subcortical involvement), the amount of therapy-concomitant self-administered language practice (e.g. computer-aided practice), and concurrent physio- and neuropsychological therapies might influence functional outcome, the above factors will be included in a multivariate analysis with variable selection. The amount of outpatient therapy provided after discharge from intensive treatment will be statistically controlled by covariate analyses.
Finally, the investigators expect that therapy effects in the waiting list control group will be comparable to those of the experimental group. Thus, after initiation of therapy in the control group after a three-week delay, outcome data will be collected in analogy to the experimental group, and will serve to replicate potential effects of intensive language therapy under routine clinical conditions.
- Being tested
- Intensive integrative aphasia therapy, Waiting list control group
- Keywords
- Communication, Language, Treatment, Intervention, Therapy, Efficacy, Maintenance, Recovery, Outcome, Rehabilitation, Treatment Intensity, Language Impairment, Intensive Language Therapy, Functional Communication, Functional Improvement, Evidence-Based Intervention, High-Frequency
- Medical subject headings
- Aphasia, Stroke, Communication, Language, Language Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive integrative aphasia therapyBehavioural
Intensive language therapy (3 weeks, 5 days/week, >=2 hours/day) provided in regular clinical setting and consisting of a combination of language systematic and communicative-pragmatic treatment
Waiting list control groupBehavioural
Control group starts intensive language therapy after a 3-week waiting period.
| Study group | Role | What they receive |
|---|---|---|
| Intensive aphasia therapy group | Experimental | Group starts intensive integrative aphasia therapy within 3 workdays (or as soon as possible) after baseline exam Receives: Behavioral: Intensive integrative aphasia therapy |
| Waiting list control group | Other | Group starts intensive integrative aphasia therapy after a waiting period of at least three weeks Receives: Behavioral: Waiting list control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes on the Amsterdam Nijmegen Everyday Language Test (ANELT) - A-scale
Mean gain in ANELT understandability scores (ANELT A-scale; using the parallel versions ANELT-I and ANELT-II)
Measured: Baseline is compared to performance immediately and 6 months post 3 weeks of intensive language therapy. Patients with at least 5 weeks of therapy, performance will also be assessed after therapy completion (on average 6 weeks)
Secondary outcomes (10)
morbidity measure: changes in language-systematic aphasia screening (SAPS)
Changes from pre- to post therapy of scores on:
a (yet unpublished) test to assess language performance in 2 language modalities (perception, production) and 3 language levels (phonological, lexical, morphosyntactic). There are 3 different levels of complexity for each combination of modality and language level. Performance is thus assessed in 18 language domains (2x3x3).
Measured: Baseline is compared to performance immediately and 6 months post 3 weeks of intensive language therapy. Patients with at least 5 weeks of therapy, performance will also be assessed after therapy completion (on average 6 weeks)
morbidity measure: changes in communicative-pragmatic screening (KOPS)
Changes from pre- to post therapy of scores on:
an (yet unpublished) test measuring verbal and nonverbal performance in daily life communicative activities of increasing complexity
Measured: Baseline is compared to performance immediately and 6 months post 3 weeks of intensive language therapy. Patients with at least 5 weeks of therapy, performance will also be assessed after therapy completion (on average 6 weeks)
morbidity measure: changes in Modified Rankin Scale
Changes from pre- to post therapy of scores in:
the degree of disability or dependence in daily activities
Measured: Baseline is compared to performance immediately and 6 months post 3 weeks of intensive language therapy. Patients with at least 5 weeks of therapy, performance will also be assessed after therapy completion (on average 6 weeks)
quality of life measure: changes in German version of the Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39)
Changes from pre- to post therapy of scores on:
Health-related quality of life questionnaire adapted for persons with aphasia
Measured: Baseline is compared to performance immediately and 6 months post 3 weeks of intensive language therapy. Patients with at least 5 weeks of therapy, performance will also be assessed after therapy completion (on average 6 weeks)
quality of life measure: changes in Communicative Effectiveness Index (CETI) and the ANELT partner communication questionnaire
Changes from pre- to post therapy of scores on:
ratings of functional communication ability by relatives of persons with aphasia
Measured: Baseline is compared to performance 6 months post 3 weeks of intensive language therapy.
morbidity measure: changes in nonverbal cognitive functions
Changes from pre- to post therapy of scores on:
- Nonverbal Learning Test (NVLT)
- Trail Making Test
- Verbal Fluency Test
Measured: Baseline is compared to performance immediately and 6 months post 3 weeks of intensive language therapy. Patients with at least 5 weeks of therapy, performance will also be assessed after therapy completion (on average 6 weeks)
quality of life measure: changes in Visual analog mood scales (VAMS)
Changes from pre- to post therapy of scores on:
assessment of mood visual analog scales (adapted for persons with aphasia)
Measured: Baseline is compared to performance immediately and 6 months post 3 weeks of intensive language therapy. Patients with at least 5 weeks of therapy, performance will also be assessed after therapy completion (on average 6 weeks)
changes in Amsterdam-Nijmegen Everyday Language Test (ANELT) - B-scale
Mean gain in ANELT intelligibility scores (ANELT B-scale; using the parallel versions ANELT-I and ANELT-II)
Measured: Baseline is compared to performance immediately and 6 months post 3 weeks of intensive language therapy. Patients with at least 5 weeks of therapy, performance will also be assessed after therapy completion (on average 6 weeks)
changes in Amsterdam-Nijmegen Everyday Language Test (ANELT) - syntactic rating
Mean gain in syntactic rating scores (syntax rating criteria based on AAT subtest "spontaneous speech") for the ANELT scenarios (using the parallel versions ANELT-I and ANELT-II)
Measured: Baseline is compared to performance immediately and 6 months post 3 weeks of intensive language therapy. Patients with at least 5 weeks of therapy, performance will also be assessed after therapy completion (on average 6 weeks)
changes in Amsterdam-Nijmegen Everyday Language Test (ANELT) - nonverbal communication rating
Mean gain in nonverbal rating scores (criteria based on "Scenario Test") for the ANELT scenarios (using the parallel versions ANELT-I and ANELT-II)
Measured: Baseline is compared to performance immediately and 6 months post 3 weeks of intensive language therapy. Patients with at least 5 weeks of therapy, performance will also be assessed after therapy completion (on average 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2012 (estimated)
- Study startApr 2012
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AphasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Collaborators
- Fresenius University of Applied Science, Charite University, Berlin, Germany, Entwicklungsgruppe Klinische Neuropsychologie, Klinikum Bogenhausen, München, Institut für Biometrie und Klinische Epidemiologie, Charité Campus Benjamin Franklin, Berlin, RWTH Aachen University, Bundesverband für die Rehabilitation der Aphasiker e.V., Universitätsklinikum Leipzig, MEDIAN Klinik Grünheide, Brandenburgklinik Berlin-Brandenburg GmbH, St. Mauritius Therapieklinik, Aphasie- und Seniorenzentrum Josef Bergmann Vechta, Behandlungs- und Rehabilitationszentrum für Intensiv-Therapie Lindlar, Wickerklinik Bad Homburg v.d.H., Asklepios Neurological Clinic Falkenstein, Akademische Praxis für Sprachtherapie / Praxis für Rehabilitationswesen Aschaffenburg, Städtisches Klinikum München, Klinikum Bogenhausen, Schoen Clinic Bad Aibling, m&i-Fachklinik Bad Liebenstein, m&i-Fachklinik Enzensberg, m&i-Fachklinik Herzogenaurach, mediclin Klinikum Soltau, Moritz Klinik, Bad Klosterlausnitz, Klinikum Christophsbad, Göppingen, P.A.N.-Zentrum
- Responsible party
- Sponsor
- Investigators
- Annette Baumgaertner, PhD, Principal investigator, Hochschule Fresenius University of Applied ScienceCaterina Breitenstein, PhD, Principal investigator, Neurology, University of MuensterAgnes Floel, MD, Study director, Neurology, Universitätsmedizin Charite, CCM, BerlinWolfram Ziegler, PhD, Principal investigator, Clinical Neuropsychology Research Group (EKN), Klinikum Bogenhausen, MünchenTanja Grewe, PhD, Principal investigator, Hochschule Fresenius University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01540383
- Sponsor's protocol ID
- EA1/234/11
- Acronym
- FCET2EC
- Status last verified
- Apr 2026
- First submitted
- 6 Feb 2012
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Breitenstein C, Grewe T, Floel A, Ziegler W, Springer L, Martus P, Huber W, Willmes K, Ringelstein EB, Haeusler KG, Abel S, Glindemann R, Domahs F, Regenbrecht F, Schlenck KJ, Thomas M, Obrig H, de Langen E, Rocker R, Wigbers F, Ruhmkorf C, Hempen I, List J, Baumgaertner A; FCET2EC study group. Intensive speech and language therapy in patients with chronic aphasia after stroke: a randomised, open-label, blinded-endpoint, controlled trial in a health-care setting. Lancet. 2017 Apr 15;389(10078):1528-1538. doi: 10.1016/S0140-6736(17)30067-3. Epub 2017 Mar 1.
PubMed 28256356Baumgaertner A, Grewe T, Ziegler W, Floel A, Springer L, Martus P, Breitenstein C. FCET2EC (From controlled experimental trial to = 2 everyday communication): How effective is intensive integrative therapy for stroke-induced chronic aphasia under routine clinical conditions? A study protocol for a randomized controlled trial. Trials. 2013 Sep 23;14:308. doi: 10.1186/1745-6215-14-308.
PubMed 24059983
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From Controlled Experimental Trial to Everyday Communication: How Effective is Intensive Aphasia Therapy Under Routine Clinical Conditions?
- ClinicalTrials.gov ID
- NCT01540383
- Acronym / sponsor ID
- FCET2EC / EA1/234/11
- Keywords
- Communication, Language, Treatment, Intervention, Therapy, Efficacy, Maintenance, Recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Collaborators
- Fresenius University of Applied Science, Charite University, Berlin, Germany, Entwicklungsgruppe Klinische Neuropsychologie, Klinikum Bogenhausen, München, Institut für Biometrie und Klinische Epidemiologie, Charité Campus Benjamin Franklin, Berlin, RWTH Aachen University, Bundesverband für die Rehabilitation der Aphasiker e.V., Universitätsklinikum Leipzig, MEDIAN Klinik Grünheide, Brandenburgklinik Berlin-Brandenburg GmbH, St. Mauritius Therapieklinik, Aphasie- und Seniorenzentrum Josef Bergmann Vechta, Behandlungs- und Rehabilitationszentrum für Intensiv-Therapie Lindlar, Wickerklinik Bad Homburg v.d.H., Asklepios Neurological Clinic Falkenstein, Akademische Praxis für Sprachtherapie / Praxis für Rehabilitationswesen Aschaffenburg, Städtisches Klinikum München, Klinikum Bogenhausen, Schoen Clinic Bad Aibling, m&i-Fachklinik Bad Liebenstein, m&i-Fachklinik Enzensberg, m&i-Fachklinik Herzogenaurach, mediclin Klinikum Soltau, Moritz Klinik, Bad Klosterlausnitz, Klinikum Christophsbad, Göppingen, P.A.N.-Zentrum
- Study start
- Apr 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 28 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine whether 3 weeks of intensive language therapy provided in clinical in- and outpatient settings is effective in improving everyday communication in postacute/chronic post-stroke aphasia, as measured by performance on the Amsterdam Nijmegen Everyday Language Test (ANELT).
Detailed description
Aims of the study:
This multicenter randomized placebo-controlled study aims to examine whether integrative intensive (> 10 hours/week for at least 3 weeks) language and communication therapy administered under routine clinical conditions translates into a statistically significant functional improvement of everyday communication in patients with chronic aphasia (i.e., aphasia persisting for 6 or more months after the stroke). A further aim is to examine whether therapy-induced improvements are still maintained over a period of six months. The study's results may lead to more targeted treatment regimens and thus to an enhancement of health-related quality of life in persons with chronic aphasia. The data will further provide evidence-based guidelines of best practice in the rehabilitation of persons with chronic aphasia.
Methods:
Fourteen in- and outpatient rehabilitation centres across Germany participate in the study. Via a digital randomization procedure, patients are allocated to one of two groups: an experimental group, starting as soon as feasible with treatment lasting 3 to 6 weeks, and a waiting list control group, whose therapy begins after a three-week delay. Both groups receive a combination of language systematic and communicative-pragmatic language therapy. Everyday language ability will be examined with a standardized outcome measure, and compared between groups at several points: immediately before as well as immediately after and 6 months after completion of (3-6 weeks) intensive language therapy.
Statistical analyses:
The primary analysis compares the changes in functional communication ability (as indicated by changes of pre- to post-therapy functional communication scores on the primary outcome measure, the ANELT) between the experimental and the waiting list control group in an intention-to-treat (ITT) design. To balance for unequal treatment durations across patient ("naturalistic treatment setting"), the critical pre- to post therapy interval is fixed at three weeks, with the option of extension of therapy (provided it is granted by the sickness fund) and re-test after termination of therapy. The long-term stability of potential treatment gains will be re-evaluated 6 months post therapy.
Further exploratory analyses will examine therapy-induced changes in secondary outcome measures (see below) in the experimental compared to the waiting list control group.
Considering that age, gender, time post stroke onset, aphasia type (fluent, non-fluent), aphasia severity (based on the Aachen Aphasia Test [AAT] profile score), baseline cognitive status, the total hours of therapy provided, type of stroke (cortical strokes with or without subcortical involvement), the amount of therapy-concomitant self-administered language practice (e.g. computer-aided practice), and concurrent physio- and neuropsychological therapies might influence functional outcome, the above factors will be included in a multivariate analysis with variable selection. The amount of outpatient therapy provided after discharge from intensive treatment will be statistically controlled by covariate analyses.
Finally, the investigators expect that therapy effects in the waiting list control group will be comparable to those of the experimental group. Thus, after initiation of therapy in the control group after a three-week delay, outcome data will be collected in analogy to the experimental group, and will serve to replicate potential effects of intensive language therapy under routine clinical conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive aphasia therapy group | Experimental | Behavioral: Intensive integrative aphasia therapyGroup starts intensive integrative aphasia therapy within 3 workdays (or as soon as possible) after baseline exam |
| Waiting list control group | Other | Behavioral: Waiting list control groupGroup starts intensive integrative aphasia therapy after a waiting period of at least three weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- presence of aphasia for at least 6 months after non-hemorrhagic or hemorrhagic cortical or subcortical-cortical stroke
- native language German
- participant's comprehension ability needs to be sufficiently high to give informed consent
- participant's language abilities have to allow the administration of the Aachen Aphasia Test (AAT)
Key exclusion criteria (5 listed)
- aphasia due to non-vascular etiology
- no evidence for aphasia (based on AAT subtests 'Token Test' and 'Written Language'
- severe untreated medical conditions which prohibit participation in intensive language therapy
- severe vision or hearing problems (uncorrected)
- participation in another interventional or language therapy study within four weeks before potential enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive integrative aphasia therapyIntensive language therapy (3 weeks, 5 days/week, >=2 hours/day) provided in regular clinical setting and consisting of a combination of language systematic and communicative-pragmatic treatment | Behavioural | Intensive aphasia therapy group |
| Waiting list control groupControl group starts intensive language therapy after a 3-week waiting period. | Behavioural | Waiting list control group |
Primary outcome
Changes on the Amsterdam Nijmegen Everyday Language Test (ANELT) - A-scale
Time frame: Baseline is compared to performance immediately and 6 months post 3 weeks of intensive language therapy. Patients with at least 5 weeks of therapy, performance will also be assessed after therapy completion (on average 6 weeks)
Mean gain in ANELT understandability scores (ANELT A-scale; using the parallel versions ANELT-I and ANELT-II)
10 secondary outcomes
morbidity measure: changes in language-systematic aphasia screening (SAPS)
Time frame: Baseline is compared to performance immediately and 6 months post 3 weeks of intensive language therapy. Patients with at least 5 weeks of therapy, performance will also be assessed after therapy completion (on average 6 weeks)
morbidity measure: changes in communicative-pragmatic screening (KOPS)
Time frame: Baseline is compared to performance immediately and 6 months post 3 weeks of intensive language therapy. Patients with at least 5 weeks of therapy, performance will also be assessed after therapy completion (on average 6 weeks)
morbidity measure: changes in Modified Rankin Scale
Time frame: Baseline is compared to performance immediately and 6 months post 3 weeks of intensive language therapy. Patients with at least 5 weeks of therapy, performance will also be assessed after therapy completion (on average 6 weeks)
quality of life measure: changes in German version of the Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39)
Time frame: Baseline is compared to performance immediately and 6 months post 3 weeks of intensive language therapy. Patients with at least 5 weeks of therapy, performance will also be assessed after therapy completion (on average 6 weeks)
quality of life measure: changes in Communicative Effectiveness Index (CETI) and the ANELT partner communication questionnaire
Time frame: Baseline is compared to performance 6 months post 3 weeks of intensive language therapy.
morbidity measure: changes in nonverbal cognitive functions
Time frame: Baseline is compared to performance immediately and 6 months post 3 weeks of intensive language therapy. Patients with at least 5 weeks of therapy, performance will also be assessed after therapy completion (on average 6 weeks)
quality of life measure: changes in Visual analog mood scales (VAMS)
Time frame: Baseline is compared to performance immediately and 6 months post 3 weeks of intensive language therapy. Patients with at least 5 weeks of therapy, performance will also be assessed after therapy completion (on average 6 weeks)
changes in Amsterdam-Nijmegen Everyday Language Test (ANELT) - B-scale
Time frame: Baseline is compared to performance immediately and 6 months post 3 weeks of intensive language therapy. Patients with at least 5 weeks of therapy, performance will also be assessed after therapy completion (on average 6 weeks)
changes in Amsterdam-Nijmegen Everyday Language Test (ANELT) - syntactic rating
Time frame: Baseline is compared to performance immediately and 6 months post 3 weeks of intensive language therapy. Patients with at least 5 weeks of therapy, performance will also be assessed after therapy completion (on average 6 weeks)
changes in Amsterdam-Nijmegen Everyday Language Test (ANELT) - nonverbal communication rating
Time frame: Baseline is compared to performance immediately and 6 months post 3 weeks of intensive language therapy. Patients with at least 5 weeks of therapy, performance will also be assessed after therapy completion (on average 6 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Derived from this study: PubMed 28256356Breitenstein C, Grewe T, Floel A, Ziegler W, Springer L, Martus P, Huber W, Willmes K, Ringelstein EB, Haeusler KG, Abel S, Glindemann R, Domahs F, Regenbrecht F, Schlenck KJ, Thomas M, Obrig H, de Langen E, Rocker R, Wigbers F, Ruhmkorf C, Hempen I, List J, Baumgaertner A; FCET2EC study group. Intensive speech and language therapy in patients with chronic aphasia after stroke: a randomised, open-label, blinded-endpoint, controlled trial in a health-care setting. Lancet. 2017 Apr 15;389(10078):1528-1538. doi: 10.1016/S0140-6736(17)30067-3. Epub 2017 Mar 1.
- Derived from this study: PubMed 24059983Baumgaertner A, Grewe T, Ziegler W, Floel A, Springer L, Martus P, Breitenstein C. FCET2EC (From controlled experimental trial to = 2 everyday communication): How effective is intensive integrative therapy for stroke-induced chronic aphasia under routine clinical conditions? A study protocol for a randomized controlled trial. Trials. 2013 Sep 23;14:308. doi: 10.1186/1745-6215-14-308.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annette Baumgaertner, PhD principal investigator
Hochschule Fresenius University of Applied Science
Caterina Breitenstein, PhD principal investigator
Neurology, University of Muenster
Agnes Floel, MD study director
Neurology, Universitätsmedizin Charite, CCM, Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive integrative aphasia therapy in people with Aphasia and Stroke, run by University Hospital Muenster at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes on the Amsterdam Nijmegen Everyday Language Test (ANELT) - A-scale (time frame: Baseline is compared to performance immediately and 6 months post 3 weeks of intensive language therapy. Patients with at least 5 weeks of therapy, performance will also be assessed after therapy completion (on average 6 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01540383, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.