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A randomized control trial of intensive aphasia therapy after acute stroke: The Very Early Rehabilitation for SpEech (VERSE) study

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posted on 11.08.2021, 03:13 by E Godecke, E Armstrong, T Rai, N Ciccone, Miranda RoseMiranda Rose, S Middleton, A Whitworth, A Holland, F Ellery, GJ Hankey, DA Cadilhac, J Bernhardt
Background: Effectiveness of early intensive aphasia rehabilitation after stroke is unknown. The Very Early Rehabilitation for SpEech trial (VERSE) aimed to determine whether intensive aphasia therapy, beginning within 14 days after stroke, improved communication recovery compared to usual care. Methods: Prospective, randomized, single-blinded trial conducted at 17 acute-care hospitals across Australia/New Zealand from 2014 to 2018. Participants with aphasia following acute stroke were randomized to receive usual care (direct usual care aphasia therapy), or one of two higher intensity regimens (20 sessions of either non-prescribed (usual care-plus or prescribed (VERSE) direct aphasia therapy). The primary outcome was improvement of communication on the Western Aphasia Battery-Revised Aphasia Quotient (AQ) at 12 weeks after stroke. Our pre-planned intention to treat analysis combined high intensity groups for the primary outcome. Findings: Among 13,654 acute stroke patients screened, 25% (3477) had aphasia, of whom 25% (866) were eligible and 246 randomized to usual care (n = 81; 33%), usual care-plus (n = 82; 33%) or VERSE (n = 83; 34%). At 12 weeks after stroke, the primary outcome was assessed in 217 participants (88%); 14 had died, 9 had withdrawn, and 6 were too unwell for assessment. Communication recovery was 50.3% (95% CI 45.7–54.8) in the high intensity group (n = 147) and 52.1% (95% CI 46.1–58.1) in the usual care group (n = 70; difference −1.8, 95% CI −8.7–5.0). There was no difference between groups in non-fatal or fatal adverse events (p = 0.72). Interpretation: Early, intensive aphasia therapy did not improve communication recovery within 12 weeks post stroke compared to usual care.

Funding

The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: Erin Godecke-NHMRC Funding: App1083010, APP1132468, App1153236, NIH (UK) HS&DR Program funding; Elizabeth Armstrong-NHMRC Funding: APP1132468; Tapan Rai reports no disclosures; Miranda L Rose-NHMRC Funding: App1083010, App1153236; Fiona Ellery FE reports personal fees from Florey Institute of Neurosciences and Mental Health, The University of Melbourne during the conduct of the study; Graham J Hankey has received honoraria from Bayer for lecturing at sponsored scientific symposia and consulting on advisory boards about stroke prevention in atrial fibrillation; Dominique A Cadilhac-NHMRC Funding App1063761, App1154273; Julie Bernhardt-NHMRC Funding JB-App1154904, App1058635. This study was funded by National Health and Medical Research Council (APP1044973), The Tavistock Trust for Aphasia (UK), Edith Cowan University, Australia.

History

Publication Date

01/07/2021

Journal

International Journal of Stroke

Volume

16

Issue

5

Pagination

556-572

Publisher

SAGE

ISSN

1747-4930

Rights Statement

The Author reserves all moral rights over the deposited text and must be credited if any re-use occurs. Documents deposited in OPAL are the Open Access versions of outputs published elsewhere. Changes resulting from the publishing process may therefore not be reflected in this document. The final published version may be obtained via the publisher’s DOI. Please note that additional copyright and access restrictions may apply to the published version.

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