Effectiveness of Intensive Aphasia Therapy Under Routine Clinical Conditions
NCT ID: NCT01540383
Last Updated: 2017-09-26
Study Results
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Basic Information
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COMPLETED
NA
156 participants
INTERVENTIONAL
2012-04-30
2015-01-31
Brief Summary
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Detailed Description
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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), 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intensive aphasia therapy group
Group starts intensive integrative aphasia therapy within 3 workdays (or as soon as possible) after baseline exam
Intensive integrative aphasia therapy
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 group
Group starts intensive integrative aphasia therapy after a waiting period of at least three weeks
Waiting list control group
Control group starts intensive language therapy after a 3-week waiting period.
Interventions
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Intensive integrative aphasia therapy
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 group
Control group starts intensive language therapy after a 3-week waiting period.
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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Fresenius University of Applied Science
OTHER
Charite University, Berlin, Germany
OTHER
Entwicklungsgruppe Klinische Neuropsychologie, Klinikum Bogenhausen, München
UNKNOWN
Institut für Biometrie und Klinische Epidemiologie, Charité Campus Benjamin Franklin, Berlin
UNKNOWN
RWTH Aachen University
OTHER
Bundesverband für die Rehabilitation der Aphasiker e.V.
UNKNOWN
Universitätsklinikum Leipzig
OTHER
MEDIAN Klinik Grünheide
UNKNOWN
Brandenburgklinik Berlin-Brandenburg GmbH
UNKNOWN
St. Mauritius Therapieklinik
UNKNOWN
Aphasie- und Seniorenzentrum Josef Bergmann Vechta
UNKNOWN
Behandlungs- und Rehabilitationszentrum für Intensiv-Therapie Lindlar
UNKNOWN
Wickerklinik Bad Homburg v.d.H.
UNKNOWN
Asklepios Neurological Clinic Falkenstein
OTHER
Akademische Praxis für Sprachtherapie / Praxis für Rehabilitationswesen Aschaffenburg
UNKNOWN
Städtisches Klinikum München, Klinikum Bogenhausen
UNKNOWN
Schoen Clinic Bad Aibling
OTHER
m&i-Fachklinik Bad Liebenstein
UNKNOWN
m&i-Fachklinik Enzensberg
UNKNOWN
m&i-Fachklinik Herzogenaurach
UNKNOWN
mediclin Klinikum Soltau
UNKNOWN
Moritz Klinik, Bad Klosterlausnitz
UNKNOWN
Klinikum Christophsbad, Göppingen
UNKNOWN
P.A.N.-Zentrum
OTHER
University Hospital Muenster
OTHER
Responsible Party
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Principal Investigators
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Annette Baumgaertner, PhD
Role: PRINCIPAL_INVESTIGATOR
Hochschule Fresenius University of Applied Science
Caterina Breitenstein, PhD
Role: PRINCIPAL_INVESTIGATOR
Neurology, University of Muenster
Agnes Floel, MD
Role: STUDY_DIRECTOR
Neurology, Universitätsmedizin Charite, CCM, Berlin
Wolfram Ziegler, PhD
Role: PRINCIPAL_INVESTIGATOR
Clinical Neuropsychology Research Group (EKN), Klinikum Bogenhausen, München
Tanja Grewe, PhD
Role: PRINCIPAL_INVESTIGATOR
Hochschule Fresenius University of Applied Sciences
Locations
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University of Muenster
Münster, North Rhine-Westfalia, Germany
Countries
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References
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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.
Baumgaertner 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.
Other Identifiers
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EA1/234/11
Identifier Type: -
Identifier Source: org_study_id