Caterina Breitenstein1, Tanja Grewe2, Agnes Flöel3, Wolfram Ziegler4, Luise Springer5, Peter Martus6, Walter Huber5, Klaus Willmes7, E Bernd Ringelstein8, Karl Georg Haeusler9, Stefanie Abel10, Ralf Glindemann11, Frank Domahs12, Frank Regenbrecht13, Klaus-Jürgen Schlenck14, Marion Thomas8, Hellmuth Obrig13, Ernst de Langen15, Roman Rocker8, Franziska Wigbers8, Christina Rühmkorf8, Indra Hempen8, Jonathan List16, Annette Baumgaertner2. 1. Department of General Neurology (formerly Department of Neurology), University of Münster, Münster, Germany. Electronic address: caterina.breitenstein@uni-muenster.de. 2. Faculty of Health and Social Sciences, Fresenius University of Applied Sciences, Idstein and Hamburg, Germany. 3. 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. 4. Clinical Neuropsychology Research Group, Institute of Phonetics and Speech Processing, Ludwig-Maximilians-University, Munich, Germany. 5. Clinical and Cognitive Neuroscience, Department of Neurology, University Hospital, RWTH Aachen University, Aachen, Germany. 6. Institute for Clinical Epidemiology and Applied Biostatistics, University of Tübingen, Tübingen, Germany. 7. Neuropsychology, Department of Neurology, University Hospital, RWTH Aachen University, Aachen, Germany. 8. Department of General Neurology (formerly Department of Neurology), University of Münster, Münster, Germany. 9. Center for Stroke Research Berlin, Charité-Universitätsmedizin Berlin, Berlin, Germany; Department of Neurology, Charité-Universitätsmedizin Berlin, Berlin, Germany. 10. Neuropsychology, Department of Neurology, University Hospital, RWTH Aachen University, Aachen, Germany; School of Biological Sciences, University of Manchester, Manchester, UK. 11. Neuropsychological Department, Bogenhausen Hospital, Munich, Germany. 12. Institute of Germanic Linguistics, University of Marburg, Marburg, Germany. 13. Clinic of Cognitive Neurology, University of Leipzig and Max Planck Institute for Cognitive and Brain Sciences, Leipzig, Germany. 14. m&i Fachklinik Enzensberg, Fuessen, Germany. 15. Reha-Centre Passauer Wolf, Bad Griesbach, Germany. 16. 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.
Abstract
BACKGROUND: 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. METHODS: 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. FINDINGS: 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. INTERPRETATION: 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. FUNDING: German Federal Ministry of Education and Research and the German Society for Aphasia Research and Treatment.
RCT Entities:
BACKGROUND: 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. METHODS: 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. FINDINGS: 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. INTERPRETATION: 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. FUNDING: German Federal Ministry of Education and Research and the German Society for Aphasia Research and Treatment.
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