PMID- 33019888 OWN - NLM STAT- MEDLINE DCOM- 20211025 LR - 20211025 IS - 1747-4949 (Electronic) IS - 1747-4930 (Print) IS - 1747-4930 (Linking) VI - 16 IP - 5 DP - 2021 Jul TI - A randomized control trial of intensive aphasia therapy after acute stroke: The Very Early Rehabilitation for SpEech (VERSE) study. PG - 556-572 LID - 10.1177/1747493020961926 [doi] 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 At 12 weeks after stroke, the primary outcome was assessed in 217 participants (88%); 14 had died, 9 had withdrawn, and 6 were too unwell for assessment.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. FAU - Godecke, Erin AU - Godecke E AUID- ORCID: 0000-0002-7210-1295 AD - School of Medical and Health Sciences, Edith Cowan University, Joondalup, Australia. AD - Speech Pathology Department, Sir Charles Gairdner Hospital, Perth, Australia. FAU - Armstrong, Elizabeth AU - Armstrong E AUID- ORCID: 0000-0003-4469-1117 AD - School of Medical and Health Sciences, Edith Cowan University, Joondalup, Australia. FAU - Rai, Tapan AU - Rai T AD - School of Mathematical and Physical Sciences, University of Technology NSW, Broadway, Australia. FAU - Ciccone, Natalie AU - Ciccone N AUID- ORCID: 0000-0002-1822-7217 AD - School of Medical and Health Sciences, Edith Cowan University, Joondalup, Australia. FAU - Rose, Miranda L AU - Rose ML AUID- ORCID: 0000-0002-8892-0965 AD - School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Australia. FAU - Middleton, Sandy AU - Middleton S AUID- ORCID: 0000-0002-7201-4394 AD - St Vincent's Health Australia, Sydney and Australian Catholic University, Darlinghurst, Australia. FAU - Whitworth, Anne AU - Whitworth A AD - Faculty of Health Sciences, Curtin University, Bentley, Australia. FAU - Holland, Audrey AU - Holland A AD - Speech Language Pathology, University of Arizona, Tucson, AZ, USA. FAU - Ellery, Fiona AU - Ellery F AD - Florey Institute of Neuroscience and Mental Health, The University of Melbourne, Melbourne, Australia. FAU - Hankey, Graeme J AU - Hankey GJ AD - Medical School, The University of Western Australia, Perth, Australia. FAU - Cadilhac, Dominique A AU - Cadilhac DA AUID- ORCID: 0000-0001-8162-682X AD - Stroke and Ageing Research, School of Clinical Science at Monash Health, Monash University, Clayton, Australia. FAU - Bernhardt, Julie AU - Bernhardt J AUID- ORCID: 0000-0002-2787-8484 AD - Florey Institute of Neuroscience and Mental Health, The University of Melbourne, Melbourne, Australia. CN - VERSE Collaborative Group LA - eng PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20201006 PL - United States TA - Int J Stroke JT - International journal of stroke : official journal of the International Stroke Society JID - 101274068 SB - IM MH - *Aphasia/etiology MH - Humans MH - Prospective Studies MH - Speech MH - Speech Therapy MH - *Stroke/complications MH - *Stroke Rehabilitation MH - Treatment Outcome PMC - PMC8267088 OTO - NOTNLM OT - Aphasia OT - communication OT - early OT - rehabilitation OT - stroke OT - therapy fidelity EDAT- 2020/10/07 06:00 MHDA- 2021/10/26 06:00 PMCR- 2021/07/09 CRDT- 2020/10/06 05:23 PHST- 2020/10/07 06:00 [pubmed] PHST- 2021/10/26 06:00 [medline] PHST- 2020/10/06 05:23 [entrez] PHST- 2021/07/09 00:00 [pmc-release] AID - 10.1177_1747493020961926 [pii] AID - 10.1177/1747493020961926 [doi] PST - ppublish SO - Int J Stroke. 2021 Jul;16(5):556-572. doi: 10.1177/1747493020961926. Epub 2020 Oct 6.