Effectiveness of Intensive Aphasia Therapy Under Routine Clinical Conditions

Stroke Clinical Trial

— FCET2EC  

Official title:

From Controlled Experimental Trial to Everyday Communication: How Effective is Intensive Aphasia Therapy Under Routine Clinical Conditions?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01540383
• Other study ID #: EA1/234/11
• Status: Completed
• Phase: N/A
• First received: February 6, 2012
• Last updated: September 25, 2017
• Start date: April 2012
• Est. completion date: January 2015

Study information

• Verified date: September 2017
• Source: University Hospital Muenster
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Aphasia
• Stroke

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Germany	University of Muenster	Muenster	North Rhine-Westfalia

Sponsors (25)

Lead Sponsor

Collaborator

University Hospital Muenster

Akademische Praxis für Sprachtherapie / Praxis für Rehabilitationswesen Aschaffenburg, Aphasie- und Seniorenzentrum Josef Bergmann Vechta, Asklepios Neurologische Klinik Falkenstein, Behandlungs- und Rehabilitationszentrum für Intensiv-Therapie Lindlar, Brandenburgklinik Berlin-Brandenburg GmbH, Bundesverband für die Rehabilitation der Aphasiker e.V., Charite University, Berlin, Germany, Entwicklungsgruppe Klinische Neuropsychologie, Klinikum Bogenhausen, München, Fresenius University of Applied Science, Institut für Biometrie und Klinische Epidemiologie, Charité Campus Benjamin Franklin, Berlin, Klinikum Christophsbad, Göppingen, m&i-Fachklinik Bad Liebenstein, m&i-Fachklinik Enzensberg, m&i-Fachklinik Herzogenaurach, MEDIAN Klinik Grünheide, mediclin Klinikum Soltau, Moritz Klinik, Bad Klosterlausnitz, P.A.N.-Zentrum Berlin, RWTH Aachen University, Schoen Clinic Bad Aibling, St. Mauritius Therapieklinik, Städtisches Klinikum München, Klinikum Bogenhausen, Universitätsklinikum Leipzig, Wickerklinik Bad Homburg v.d.H.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	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	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).	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	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	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	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	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	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	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	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	Baseline is compared to performance 6 months post 3 weeks of intensive language therapy.
Secondary	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	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	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)	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	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)	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	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)	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	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)	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)