title: 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.
abstract: Treatment guidelines for aphasia recommend intensive speech and language therapy for chronic (≥6 months) aphasia after stroke, but large-scale, class 1 randomised controlled trials on treatment effectiveness are scarce. We aimed to examine whether 3 weeks of intensive speech and language therapy under routine clinical conditions improved verbal communication in daily-life situations in people with chronic aphasia after stroke.
  
  
  
  In this multicentre, parallel group, superiority, open-label, blinded-endpoint, randomised controlled trial, patients aged 70 years or younger with aphasia after stroke lasting for 6 months or more were recruited from 19 inpatient or outpatient rehabilitation centres in Germany. An external biostatistician used a computer-generated permuted block randomisation method, stratified by treatment centre, to randomly assign participants to either 3 weeks or more of intensive speech and language therapy (≥10 h per week) or 3 weeks deferral of intensive speech and language therapy. The primary endpoint was between-group difference in the change in verbal communication effectiveness in everyday life scenarios (Amsterdam-Nijmegen Everyday Language Test A-scale) from baseline to immediately after 3 weeks of treatment or treatment deferral. All analyses were done using the modified intention-to-treat population (those who received 1 day or more of intensive treatment or treatment deferral). This study is registered with ClinicalTrials.gov, number NCT01540383.
  
  
  
  We randomly assigned 158 patients between April 1, 2012, and May 31, 2014. The modified intention-to-treat population comprised 156 patients (78 per group). Verbal communication was significantly improved from baseline to after intensive speech and language treatment (mean difference 2·61 points [SD 4·94]; 95% CI 1·49 to 3·72), but not from baseline to after treatment deferral (-0·03 points [4·04]; -0·94 to 0·88; between-group difference Cohen's d 0·58; p=0·0004). Eight patients had adverse events during therapy or treatment deferral (one car accident [in the control group], two common cold [one patient per group], three gastrointestinal or cardiac symptoms [all intervention group], two recurrent stroke [one in intervention group before initiation of treatment, and one before group assignment had occurred]); all were unrelated to study participation.
  
  
  
  3 weeks of intensive speech and language therapy significantly enhanced verbal communication in people aged 70 years or younger with chronic aphasia after stroke, providing an effective evidence-based treatment approach in this population. Future studies should examine the minimum treatment intensity required for meaningful treatment effects, and determine whether treatment effects cumulate over repeated intervention periods.
  
  
  
  German Federal Ministry of Education and Research and the German Society for Aphasia Research and Treatment.
authors.affiliation: Department of General Neurology (formerly Department of Neurology), University of Münster, Münster, Germany. Electronic address: caterina.breitenstein@uni-muenster.de.
authors.forename: Caterina
authors.initials: C
authors.lastname: Breitenstein
authors.affiliation: Faculty of Health and Social Sciences, Fresenius University of Applied Sciences, Idstein and Hamburg, Germany.
authors.forename: Tanja
authors.initials: T
authors.lastname: Grewe
authors.affiliation: NeuroCure Clinical Research Center, Charité-Universitätsmedizin Berlin, Berlin, Germany; Center for Stroke Research Berlin, Charité-Universitätsmedizin Berlin, Berlin, Germany; Department of Neurology, Charité-Universitätsmedizin Berlin, Berlin, Germany; Department of Neurology, University of Greifswald, Greifswald, Germany.
authors.forename: Agnes
authors.initials: A
authors.lastname: Flöel
authors.affiliation: Clinical Neuropsychology Research Group, Institute of Phonetics and Speech Processing, Ludwig-Maximilians-University, Munich, Germany.
authors.forename: Wolfram
authors.initials: W
authors.lastname: Ziegler
authors.affiliation: Clinical and Cognitive Neuroscience, Department of Neurology, University Hospital, RWTH Aachen University, Aachen, Germany.
authors.forename: Luise
authors.initials: L
authors.lastname: Springer
authors.affiliation: Institute for Clinical Epidemiology and Applied Biostatistics, University of Tübingen, Tübingen, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Martus
authors.affiliation: Clinical and Cognitive Neuroscience, Department of Neurology, University Hospital, RWTH Aachen University, Aachen, Germany.
authors.forename: Walter
authors.initials: W
authors.lastname: Huber
authors.affiliation: Neuropsychology, Department of Neurology, University Hospital, RWTH Aachen University, Aachen, Germany.
authors.forename: Klaus
authors.initials: K
authors.lastname: Willmes
authors.affiliation: Department of General Neurology (formerly Department of Neurology), University of Münster, Münster, Germany.
authors.forename: E Bernd
authors.initials: EB
authors.lastname: Ringelstein
authors.affiliation: Center for Stroke Research Berlin, Charité-Universitätsmedizin Berlin, Berlin, Germany; Department of Neurology, Charité-Universitätsmedizin Berlin, Berlin, Germany.
authors.forename: Karl Georg
authors.initials: KG
authors.lastname: Haeusler
authors.affiliation: Neuropsychology, Department of Neurology, University Hospital, RWTH Aachen University, Aachen, Germany; School of Biological Sciences, University of Manchester, Manchester, UK.
authors.forename: Stefanie
authors.initials: S
authors.lastname: Abel
authors.affiliation: Neuropsychological Department, Bogenhausen Hospital, Munich, Germany.
authors.forename: Ralf
authors.initials: R
authors.lastname: Glindemann
authors.affiliation: Institute of Germanic Linguistics, University of Marburg, Marburg, Germany.
authors.forename: Frank
authors.initials: F
authors.lastname: Domahs
authors.affiliation: Clinic of Cognitive Neurology, University of Leipzig and Max Planck Institute for Cognitive and Brain Sciences, Leipzig, Germany.
authors.forename: Frank
authors.initials: F
authors.lastname: Regenbrecht
authors.affiliation: m&i Fachklinik Enzensberg, Fuessen, Germany.
authors.forename: Klaus-Jürgen
authors.initials: KJ
authors.lastname: Schlenck
authors.affiliation: Department of General Neurology (formerly Department of Neurology), University of Münster, Münster, Germany.
authors.forename: Marion
authors.initials: M
authors.lastname: Thomas
authors.affiliation: Clinic of Cognitive Neurology, University of Leipzig and Max Planck Institute for Cognitive and Brain Sciences, Leipzig, Germany.
authors.forename: Hellmuth
authors.initials: H
authors.lastname: Obrig
authors.affiliation: Reha-Centre Passauer Wolf, Bad Griesbach, Germany.
authors.forename: Ernst
authors.initials: E
authors.lastname: de Langen
authors.affiliation: Department of General Neurology (formerly Department of Neurology), University of Münster, Münster, Germany.
authors.forename: Roman
authors.initials: R
authors.lastname: Rocker
authors.affiliation: Department of General Neurology (formerly Department of Neurology), University of Münster, Münster, Germany.
authors.forename: Franziska
authors.initials: F
authors.lastname: Wigbers
authors.affiliation: Department of General Neurology (formerly Department of Neurology), University of Münster, Münster, Germany.
authors.forename: Christina
authors.initials: C
authors.lastname: Rühmkorf
authors.affiliation: Department of General Neurology (formerly Department of Neurology), University of Münster, Münster, Germany.
authors.forename: Indra
authors.initials: I
authors.lastname: Hempen
authors.affiliation: NeuroCure Clinical Research Center, Charité-Universitätsmedizin Berlin, Berlin, Germany; Center for Stroke Research Berlin, Charité-Universitätsmedizin Berlin, Berlin, Germany; Department of Neurology, Charité-Universitätsmedizin Berlin, Berlin, Germany.
authors.forename: Jonathan
authors.initials: J
authors.lastname: List
authors.affiliation: Faculty of Health and Social Sciences, Fresenius University of Applied Sciences, Idstein and Hamburg, Germany.
authors.forename: Annette
authors.initials: A
authors.lastname: Baumgaertner
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001037:Aphasia / Q000209:etiology / Q000534:rehabilitation*; D002908:Chronic Disease; D006801:Humans; D007808:Language Therapy / Q000379:methods*; D008875:Middle Aged; D013070:Speech Therapy / Q000379:methods*; D020521:Stroke / Q000150:complications*; D000071939:Stroke Rehabilitation