Trial document





This trial has been registered retrospectively.
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  DRKS00018057

Trial Description

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Title

lnvestigations on Intensive Language-Action Therapy in Post-Stroke Aphasia II: larger-scale single RCT

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The Intensive Language-Action Therapy (ILAT, also known as Constraint Induced Aphasia Therapy, CIAT) is an established aphasia treatment approach. Its effectiveness in chronic aphasia has been confirmed in a range of studies. One hallmark of ILAT is that language is trained in the context of everyday communicative interactions. Since first results showed that this characteristic might particularly contribute to the success of ILAT, we here investigate this in a larger clinical trial. Patients are treated with one out of the following two treatment methods: (i) a standard protocol of ILAT with language use being embedded in relevant communicative actions; (ii) a conventional aphasia therapy focusing on naming and comprehension of words without language-embedding into everyday actions, delivered in the same high intensity as ILAT. We expect more pronounced language improvements after (i) ILAT than after (ii) intensive naming therapy.

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Brief Summary in Scientific Language

The present randomized-controlled trial (RCT) investigates whether embedding of language use into relevant everyday communicative actions and action sequences particularly contributes to the success of intensive aphasia therapy. First results from a cross-over RCT demonstrated that language-action embedding appears to be an important characteristic of ILAT. Here, we investigate this in a parallel-group design and a larger sample. There are two treatment groups in which chronic aphasia patients receive either (i) a standard protocol of ILAT with language use being embedded in relevant communicative actions; (ii) a conventional therapy delivered in the same high intensity as ILAT, but focusing on utterance-centered naming and comprehension treatment.

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Organizational Data

  •   DRKS00018057
  •   2019/08/23
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  •   yes
  •   Approved
  •   EA1/382/16, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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Health Condition or Problem studied

  •   R47.0 -  Dysphasia and aphasia
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Interventions/Observational Groups

  •   Standard protocol of ILAT with language-action embedding;
    Intensity: 5 sessions per week à 2.5 hours daily for 10 consecutive working days; total: 25 hours of therapy
  •   Intensive conventional naming and comprehension therapy;
    Intensity: 5 sessions per week à 2.5 hours daily for 10 consecutive working days; total: 25 hours of therapy
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, assessor
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Standardized language test: Aachen Aphasia Test (AAT), assessment pre and post therapy

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Secondary Outcome

(1) EEG; dependent variables: event-related potentials, measured pre and post therapy
(2) Amsterdam-Nijmegen Everyday Language Test (ANELT), assessment pre and post therapy
(3) Rating scale/questionnaire: Communication Activity Log (CAL), assessment pre and post therapy
(4) language test: Communicative-pragmatic naming and requesting test, assessment pre and post therapy
(5) Depression scale/questionnaire: Beck's Depression Inventory, assessment pre and post therapy

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2017/01/02
  •   42
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

ability to give consent;
diagnosis of aphasia;
time post stroke at least 1 year at enrollment into the study;
vascular origin of lesion;
left hemispheric lesion;
German native speaker;
normal (corrected) vision and hearing

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Exclusion Criteria

severe visual or auditory impairment;
severe apraxia or agnosia;
multiple strokes;
additional neurological diseases;
withdrawal of consent

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Addresses

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    • Freie Universität Berlin; Brain Language Laboratory
    • Mr.  Prof. Dr. Dr.  Friedemann  Pulvermüller 
    • Habelschwerdter Allee
    • 14195  Berlin
    • Germany
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    • Freie Universität Berlin; Brain Language Laboratory
    • Ms.  Lea  Doppelbauer 
    • Habelschwerdter Allee 45
    • 14195  Berlin
    • Germany
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    • Freie Universität Berlin; Brain Language Laboratory
    • Ms.  Verena  Büscher 
    • Habelschwerdter Allee 45
    • 14195  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft (DFG)
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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