Clinical trial NCT01540383: Effectiveness of Intensive Aphasia Therapy Under Routine Clinical Conditions
Official title: From Controlled Experimental Trial to Everyday Communication: How Effective is Intensive Aphasia Therapy Under Routine Clinical Conditions?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphasia
Stroke
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
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
Collaborators: name: Fresenius University of Applied Science
name: Charite University, Berlin, Germany
name: Entwicklungsgruppe Klinische Neuropsychologie, Klinikum Bogenhausen, München
name: Institut für Biometrie und Klinische Epidemiologie, Charité Campus Benjamin Franklin, Berlin
name: RWTH Aachen University
name: Bundesverband für die Rehabilitation der Aphasiker e.V.
name: Universitätsklinikum Leipzig
name: MEDIAN Klinik Grünheide
name: Brandenburgklinik Berlin-Brandenburg GmbH
name: St. Mauritius Therapieklinik
name: Aphasie- und Seniorenzentrum Josef Bergmann Vechta
name: Behandlungs- und Rehabilitationszentrum für Intensiv-Therapie Lindlar
name: Wickerklinik Bad Homburg v.d.H.
name: Asklepios Neurological Clinic Falkenstein
name: Akademische Praxis für Sprachtherapie / Praxis für Rehabilitationswesen Aschaffenburg
name: Städtisches Klinikum München, Klinikum Bogenhausen
name: Schoen Clinic Bad Aibling
name: m&i-Fachklinik Bad Liebenstein
name: m&i-Fachklinik Enzensberg
name: m&i-Fachklinik Herzogenaurach
name: mediclin Klinikum Soltau
name: Moritz Klinik, Bad Klosterlausnitz
name: Klinikum Christophsbad, Göppingen
name: P.A.N.-Zentrum
First posted: 2012-02-28
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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), 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Changes on the Amsterdam Nijmegen Everyday Language Test (ANELT) - A-scale
timeFrame: 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:
measure: morbidity measure: changes in language-systematic aphasia screening (SAPS)
timeFrame: 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)
measure: morbidity measure: changes in communicative-pragmatic screening (KOPS)
timeFrame: 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)
measure: morbidity measure: changes in Modified Rankin Scale
timeFrame: 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)
measure: quality of life measure: changes in German version of the Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39)
timeFrame: 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)
measure: quality of life measure: changes in Communicative Effectiveness Index (CETI) and the ANELT partner communication questionnaire
timeFrame: Baseline is compared to performance 6 months post 3 weeks of intensive language therapy.
measure: morbidity measure: changes in nonverbal cognitive functions
timeFrame: 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)
measure: quality of life measure: changes in Visual analog mood scales (VAMS)
timeFrame: 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)
measure: changes in Amsterdam-Nijmegen Everyday Language Test (ANELT) - B-scale
timeFrame: 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)
measure: changes in Amsterdam-Nijmegen Everyday Language Test (ANELT) - syntactic rating
timeFrame: 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)
measure: changes in Amsterdam-Nijmegen Everyday Language Test (ANELT) - nonverbal communication rating
timeFrame: 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)
Other outcomes:
Locations:
city: Muenster
country: Germany
facility: University of Muenster
state: North Rhine-Westfalia
Study officials:
affiliation: Hochschule Fresenius University of Applied Science
name: Annette Baumgaertner, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Neurology, University of Muenster
name: Caterina Breitenstein, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Neurology, Universitätsmedizin Charite, CCM, Berlin
name: Agnes Floel, MD
role: STUDY_DIRECTOR
affiliation: Clinical Neuropsychology Research Group (EKN), Klinikum Bogenhausen, München
name: Wolfram Ziegler, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hochschule Fresenius University of Applied Sciences
name: Tanja Grewe, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.