TY - JOUR
T1 - A randomized control trial of intensive aphasia therapy after acute stroke
T2 - The Very Early Rehabilitation for SpEech (VERSE) study
AU - Godecke, Erin
AU - Armstrong, Elizabeth
AU - Rai, Tapan
AU - Ciccone, Natalie
AU - Rose, Miranda L.
AU - Middleton, Sandy
AU - Whitworth, Anne
AU - Holland, Audrey
AU - Ellery, Fiona
AU - Hankey, Graeme J.
AU - Cadilhac, Dominique A.
AU - Bernhardt, Julie
AU - on behalf of the VERSE Collaborative Group
N1 - Funding Information:
The authors sincerely thank the VERSE Collaboration investigators for their commitment to this trial and the participants and their families who have helped us to add valuable information and help guide best practice for the management of early aphasia recovery. Thank you to our data management team for their hard work?Sanita Kratina (Trial Operations Manager), Edith Cowan University, Perth Australia; Crystal Ladzinski (Therapy Data monitor), Perth Australia; Oriana Borschmann (Assessment Data monitor), Melbourne Australia; Leonid Churilov and Li Chun Quang for REDCap? assistance and to Jan Chamberlain for her assistance with preparation of this article. The content of this publication is solely the responsibility of the authors and the funding bodies played no part in the trial or interpretation of the findings. Australian New Zealand Clinical Trials Registry number: ACTRN12613000776707. The authors sincerely thank the members of our DSMB (appendix 2) for their oversight of the trial.
Publisher Copyright:
© 2020 World Stroke Organization.
Copyright:
Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2021/7
Y1 - 2021/7
N2 - 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.
AB - 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.
KW - Aphasia
KW - communication
KW - early
KW - rehabilitation
KW - stroke
KW - therapy fidelity
UR - http://www.scopus.com/inward/record.url?scp=85092147443&partnerID=8YFLogxK
U2 - 10.1177/1747493020961926
DO - 10.1177/1747493020961926
M3 - Article
C2 - 33019888
AN - SCOPUS:85092147443
VL - 16
SP - 556
EP - 572
JO - International Journal of Stroke
JF - International Journal of Stroke
SN - 1747-4930
IS - 5
ER -