An interventional study of Intensive integrative aphasia therapy and Waiting list control group in Aphasia and Stroke, sponsored by University Hospital Muenster. Completed at 1 site in Germany. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-04-30.
Sponsored by University Hospital Muenster · Not applicable, Interventional, and Treatment
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).
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.
338 studies on the registry are indexed under Aphasia; 95 are open to participants now.
This study's enrollment of 156 is above the median of 30 across 298 interventional studies indexed under Aphasia.
Browse Aphasia studies →University Hospital Muenster is the lead sponsor of 192 studies on the registry; 20 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Group starts intensive integrative aphasia therapy within 3 workdays (or as soon as possible) after baseline exam
Behavioral: Intensive integrative aphasia therapy
Group starts intensive integrative aphasia therapy after a waiting period of at least three weeks
Behavioral: Waiting list control group
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
Control group starts intensive language therapy after a 3-week waiting period.
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)
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 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).
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)
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
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
Changes from pre- to post therapy of scores in: the degree of disability or dependence in daily activities
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)
Changes from pre- to post therapy of scores on: Health-related quality of life questionnaire adapted for persons with aphasia
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
Changes from pre- to post therapy of scores on: ratings of functional communication ability by relatives of persons with aphasia
Time frame: 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
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)
Changes from pre- to post therapy of scores on: assessment of mood visual analog scales (adapted for persons with aphasia)
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
Mean gain in ANELT intelligibility scores (ANELT B-scale; using the parallel versions ANELT-I and ANELT-II)
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
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)
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
Mean gain in nonverbal rating scores (criteria based on "Scenario Test") for the ANELT scenarios (using the parallel versions ANELT-I and ANELT-II)
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)
The record gives a start of Apr 2012, a primary completion of Jan 2015 and a completion of Jan 2015. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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