Trial document




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  DRKS00007829

Trial Description

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Title

Intensive Language-Action Therapy (ILAT): How does high training intensity affect speech and language recovery in stroke patients with chronic aphasia?

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Trial Acronym

BILAT II

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URL of the Trial

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Brief Summary in Lay Language

Intensive Language-Action Therapy (ILAT) is one of the few treatment programs in speech and language neurorehabilitation that have proven effective in a number of clinical trials. One critical feature of ILAT is the high intensity of the training. The current randomized controlled trial seeks to investigate whether or not high training intensity contributes to the efficacy of the program in stroke patients with speech and language disorders. To address this question, patients are randomly assigned to (i) standard ILAT with high training intensity or (ii) a modified, less intensive form of ILAT. We predict a particular benefit on standardized clinical tests resulting from (ii) standard ILAT compared to (ii) modified ILAT. The expected results will hopefully provide insight into whether high training intensity is crucial for the efficacy of ILAT.

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Brief Summary in Scientific Language

The current randomized controlled trial aims to investigate the role of training intensity in Intensive Language-Action Therapy (ILAT) in left-hemisphere stroke patients with chronic aphasia. Patients are randomly assigned to (i) standard ILAT with high training intensity or (ii) a modified, less intensive form of ILAT.

Note: This study is part of a larger clinical trial, consisting of two separate projects. The first project (BILAT1) addresses the role of action and communication in intensive aphasia therapy, whereas the second project (BILAT2) is concerned with the possible effect of training intensity on the outcome of the treatment.

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Organizational Data

  •   DRKS00007829
  •   2015/02/20
  •   [---]*
  •   yes
  •   Approved
  •   EA4/122/12, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  •   U1111-1167-4363 
  •   /DRKS00005482  (Teilprojekt 1 / Project part 1)
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Health Condition or Problem studied

  •   F80.1 -  Expressive language disorder
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Interventions/Observational Groups

  •   The current randomized controlled trial aims to investigate the role of training intensity in Intensive Language-Action Therapy (ILAT) in left-hemisphere stroke patients with chronic aphasia. Patients are randomly assigned to

    (a) standard ILAT with high training intensity (intensity: three weekly training sessions; duration of each session: 4 hours; overall length of the treatment: 4 weeks)

    or
  •   (b) a modified, less intensive form of ILAT (intensity: three weekly training sessions; duration of each session: 2 hours; overall length of the treatment: 4 weeks)
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Characteristics

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

Standardized aphasia battery: Aachen Aphasia Test (AAT), performed at four different points in time:

(T0) 2 weeks before the onset of the treatment

(T1) 1 day prior to the onset of the treatment

(T2) 2 weeks after the onset of the treatment

(T3) 4 weeks after the onset of the treatment (end of therapy)

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Secondary Outcome

Questionnaires:
Motivation;
Beck's Depression Inventory (BDI);
Selbstwirksamkeitserwartung (SWE);
Fragebogen zur Sozialen Unterstützung (FSozU);
Montgomery-Åsberg Depression Rating Scale (MADRS);
Activities of Daily Living (ADL);
Communication Activity Log (CAL)

Communicative-pragmatic request and naming task:
Action Communication Test (ACT)

IQ assessment:
Raven's Standard Progressive Matrices (SPM)

EEG:
Lexical decision task and oddball paradigm; dependent variables: event-related potentials, error rates, reaction times

fMRI:
Lexical decision task; dependent variables: event-related potentials, error rates, reaction times

Each clinical variable is assessed at four different points in time (T0, T1, T2, T3; see above).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2015/03/02
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Patients are able to give informed consent;

diagnosis of aphasia;

patients are more than one year post-infarction;

German native speakers;

no visual or auditory impairments

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Exclusion Criteria

severe visual or auditory impairments;

severe apraxia of speech or agnosia;

reinfarctions;

additional neurological disorders

major depression or psychosis

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Freie Universität Berlin Brain Language Laboratory
    • Mr.  Prof. Dr. Dr.  Friedemann  Pulvermüller 
    • Habelschwerdter Allee 45
    • 14195  Berlin
    • Germany
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    • Freie Universität Berlin Brain Language Laboratory
    • Mr.  Dr.  Benjamin  Stahl 
    • Habelschwerdter Allee 45
    • 14195  Berlin
    • Germany
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    • Freie Universität Berlin Brain Language Laboratory
    • Mr.  Dr.  Benjamin  Stahl 
    • Habelschwerdter Allee 45
    • 14195  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/09/30
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Trial Publications, Results and other Documents

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