title: A randomized controlled trial of very early rehabilitation in speech after stroke.
abstract: The efficacy of rehabilitation therapy for aphasia caused by stroke is uncertain.
  
  
  
  The Very Early Rehabilitation of Speech (VERSE) trial aims to determine if intensive prescribed aphasia therapy (VERSE) is more effective and cost saving than non-prescribed, intensive (usual care-plus) and non-intensive usual care (UC) therapy when started within 15 days of stroke onset and continued daily over four weeks. We hypothesize that aphasia therapy when started very early after stroke and delivered daily could enhance recovery of communication compared with UC.
  
  
  
  A total of 246 participants (82 per arm) will provide 80% power to detect a 4.4% improvement on aphasia quotient between VERSE and UC plus at a significance level of α = 0.05.
  
  
  
  Acute-care hospitals and accompanying rehabilitation services throughout Australia, 2014-2017.
  
  
  
  Three-arm, prospective, randomized, parallel group, open-label, blinded endpoint assessment (PROBE) trial.
  
  
  
  Acute stroke in previous 14 days and aphasia diagnosed by aphasia quotient (AQ) of the Western Aphasia Battery (WAB).
  
  
  
  Computer-generated blocked randomization procedure stratified by aphasia severity according to Western Aphasia Battery, to one of three arms.
  
  
  
  All participants receive UC-usual ward-based aphasia therapy. Arm 1: UC-no additional therapy; Arm 2: UC-plus usual ward-based therapy; Arm 3: VERSE therapy-a prescribed and structured aphasia therapy program. Arms 2 and 3 receive a total of 20 additional sessions (45-60 min, provided daily) of aphasia therapy. The additional intervention must be provided before day 50 post stroke.
  
  
  
  The aphasia quotient of Western Aphasia Battery at 12 weeks post stroke. Secondary outcomes include discourse measures, the Stroke and Aphasia Quality of Life Scale-39 and the Aphasia Depression Rating Scale at 12 and 26 weeks.
  
  
  
  Incremental cost-effectiveness ratios at 26 weeks will be reported.
  
  
  
  This trial is designed to test whether the intensive and prescribed VERSE intervention is effective in promoting maximum recovery and preventing costly health complications in a vulnerable population of survivors of stroke. It will also provide novel, prospective, aphasia specific cost-effectiveness data to guide future policy development for this population.
authors.affiliation: School of Medical and Health Sciences, Edith Cowan University, Western Australia, Australia e.godecke@ecu.edu.au.
authors.forename: Erin
authors.initials: E
authors.lastname: Godecke
authors.affiliation: School of Medical and Health Sciences, Edith Cowan University, Western Australia, Australia.
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Armstrong
authors.affiliation: University of Technology, Sydney, Australia.
authors.forename: Tapan
authors.initials: T
authors.lastname: Rai
authors.affiliation: St Vincent's Health Australia (Sydney) & Australian Catholic University, New South Wales, Australia.
authors.forename: Sandy
authors.initials: S
authors.lastname: Middleton
authors.affiliation: School of Medical and Health Sciences, Edith Cowan University, Western Australia, Australia.
authors.forename: Natalie
authors.initials: N
authors.lastname: Ciccone
authors.affiliation: Curtin University, Western Australia, Australia.
authors.forename: Anne
authors.initials: A
authors.lastname: Whitworth
authors.affiliation: La Trobe University Melbourne, Victoria, Australia.
authors.forename: Miranda
authors.initials: M
authors.lastname: Rose
authors.affiliation: University of Arizona Tucson, AZ, USA.
authors.forename: Audrey
authors.initials: A
authors.lastname: Holland
authors.affiliation: Stroke Division, Florey Insitiute of Neuroscience and Mental Health, University of Melbourne, Parkville, Australia.
authors.forename: Fiona
authors.initials: F
authors.lastname: Ellery
authors.affiliation: School of Medicine and Pharmacology, The University of Western Australia, Perth, Australia.
authors.forename: Graeme J
authors.initials: GJ
authors.lastname: Hankey
authors.affiliation: School of Clinical Sciences, Monash University, Victoria, Australia.
authors.forename: Dominique A
authors.initials: DA
authors.lastname: Cadilhac
authors.affiliation: Stroke Division, Florey Insitiute of Neuroscience and Mental Health, University of Melbourne, Parkville, Australia.
authors.forename: Julie
authors.initials: J
authors.lastname: Bernhardt
mesh_terms: D001037:Aphasia / Q000209:etiology* / Q000534:rehabilitation*; D001315:Australia; D003362:Cost-Benefit Analysis; D006801:Humans; D007807:Language Tests; D009520:New Zealand; D018579:Patient Selection; D016037:Single-Blind Method; D013060:Speech; D013070:Speech Therapy; D020521:Stroke / Q000150:complications*; D000071939:Stroke Rehabilitation; D016896:Treatment Outcome
keywords: Aphasia; aphasia therapy; controlled trial; intensity; randomized; rehabilitation; stroke