Effectiveness of Intensive Aphasia Therapy Under Routine Clinical Conditions (FCET2EC)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Hochschule Fresenius, Fachbereich Gesundheit, Hamburg and Idstein
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.
Tagesklinik für kognitive Neurologie, Universitätsklinikum Leipzig
MEDIAN Klinik Grünheide
Brandenburg Klinik Bernau
St. Mauritius Therapieklinik
Aphasie- und Seniorenzentrum Josef Bergmann Vechta
Behandlungs- und Rehabilitationszentrum für Intensiv-Therapie Lindlar
Wickerklinik Bad Homburg v.d.H.
Asklepios Neurologische Klinik 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
Information provided by (Responsible Party):
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT01540383
First received: February 6, 2012
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

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).


Condition Intervention
Aphasia
Stroke
Behavioral: Intensive integrative aphasia therapy
Behavioral: Waiting list control group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: From Controlled Experimental Trial to Everyday Communication: How Effective is Intensive Aphasia Therapy Under Routine Clinical Conditions?

Resource links provided by NLM:


Further study details as provided by University Hospital Muenster:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    Mean gain in ANELT understandability scores (ANELT A-scale; using the parallel versions ANELT-I and ANELT-II)


Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

    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).


  • 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) ] [ Designated as safety issue: No ]

    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


  • 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) ] [ Designated as safety issue: No ]

    Changes from pre- to post therapy of scores in:

    the degree of disability or dependence in daily activities


  • 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) ] [ Designated as safety issue: No ]

    Changes from pre- to post therapy of scores on:

    Health-related quality of life questionnaire adapted for persons with aphasia


  • 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. ] [ Designated as safety issue: No ]

    Changes from pre- to post therapy of scores on:

    ratings of functional communication ability by relatives of persons with aphasia


  • 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) ] [ Designated as safety issue: No ]

    Changes from pre- to post therapy of scores on:

    • general speed of cognitive processing ("Inspection time test")
    • Nonverbal Learning Test (NVLT)
    • Trail Making Test
    • Verbal Fluency Test

  • 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) ] [ Designated as safety issue: No ]

    Changes from pre- to post therapy of scores on:

    assessment of mood visual analog scales (adapted for persons with aphasia)


  • 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) ] [ Designated as safety issue: No ]
    Mean gain in ANELT intelligibility scores (ANELT B-scale; using the parallel versions ANELT-I and ANELT-II)

  • 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) ] [ Designated as safety issue: No ]
    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)

  • 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) ] [ Designated as safety issue: No ]
    Mean gain in nonverbal rating scores (criteria based on "Scenario Test") for the ANELT scenarios (using the parallel versions ANELT-I and ANELT-II)


Estimated Enrollment: 126
Study Start Date: April 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intensive aphasia therapy group
Group starts intensive language therapy within 3 workdays (or as soon as possible) after baseline exam
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 Behavioral: Waiting list control group
Control group starts intensive language therapy after a 3-week waiting period.

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01540383

Locations
Germany
University of Muenster
Muenster, North Rhine-Westfalia, Germany, 48149
Sponsors and Collaborators
University Hospital Muenster
Hochschule Fresenius, Fachbereich Gesundheit, Hamburg and Idstein
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.
Tagesklinik für kognitive Neurologie, Universitätsklinikum Leipzig
MEDIAN Klinik Grünheide
Brandenburg Klinik Bernau
St. Mauritius Therapieklinik
Aphasie- und Seniorenzentrum Josef Bergmann Vechta
Behandlungs- und Rehabilitationszentrum für Intensiv-Therapie Lindlar
Wickerklinik Bad Homburg v.d.H.
Asklepios Neurologische Klinik 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
Investigators
Principal Investigator: Annette Baumgaertner, PhD Hochschule Fresenius University of Applied Science
Principal Investigator: Caterina Breitenstein, PhD Neurology, University of Muenster
Study Director: Agnes Floel, MD Neurology, Universitätsmedizin Charite, CCM, Berlin
Principal Investigator: Wolfram Ziegler, PhD Clinical Neuropsychology Research Group (EKN), Klinikum Bogenhausen, München
Principal Investigator: Tanja Grewe, PhD Hochschule Fresenius University of Applied Sciences
  More Information

No publications provided by University Hospital Muenster

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital Muenster
ClinicalTrials.gov Identifier: NCT01540383     History of Changes
Other Study ID Numbers: EA1/234/11
Study First Received: February 6, 2012
Last Updated: May 20, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by University Hospital Muenster:
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

Additional relevant MeSH terms:
Aphasia
Communication Disorders
Language Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Speech Disorders

ClinicalTrials.gov processed this record on October 29, 2014