A randomized controlled trial of very early rehabilitation in speech after stroke

Godecke, E; Armstrong, EA; Rai, T; Middleton, S; Ciccone, N; Whitworth, A; Rose, M; Holland, A; Ellery, F; Hankey, GJ; Cadilhac, DA; Bernhardt, J

A randomized controlled trial of very early rehabilitation in speech after stroke

Godecke, E Armstrong, EA Rai, T

Middleton, S Ciccone, N Whitworth, A Rose, M Holland, A Ellery, F Hankey, GJ Cadilhac, DA Bernhardt, J

Permalink

Publication Type:: Journal Article
Citation:: International Journal of Stroke, 2016, 11 (5), pp. 586 - 592
Issue Date:: 2016-01-01

Open Access

Copyright Clearance Process

Recently Added
In Progress
Open Access

This item is open access.

Adobe PDF

Download Submitted VersionAdobe PDF (183.02 kB)

View on publisher's site

View statistics

Full metadata record

Field	Value	Language
dc.contributor.author	Godecke, E	en_US
dc.contributor.author	Armstrong, EA	en_US
dc.contributor.author	Rai, T https://orcid.org/0000-0003-1610-8983	en_US
dc.contributor.author	Middleton, S	en_US
dc.contributor.author	Ciccone, N	en_US
dc.contributor.author	Whitworth, A	en_US
dc.contributor.author	Rose, M	en_US
dc.contributor.author	Holland, A	en_US
dc.contributor.author	Ellery, F	en_US
dc.contributor.author	Hankey, GJ	en_US
dc.contributor.author	Cadilhac, DA	en_US
dc.contributor.author	Bernhardt, J	en_US
dc.date.available	2020-05-25T19:02:28Z
dc.date.issued	2016-01-01	en_US
dc.identifier.citation	International Journal of Stroke, 2016, 11 (5), pp. 586 - 592	en_US
dc.identifier.issn	1747-4930	en_US
dc.identifier.uri	http://hdl.handle.net/10453/43750
dc.description.abstract	© 2016 World Stroke Organization. Rationale: The efficacy of rehabilitation therapy for aphasia caused by stroke is uncertain. Aims and hypothesis: 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. Sample size estimates: 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. Setting: Acute-care hospitals and accompanying rehabilitation services throughout Australia, 2014-2017. Design: Three-arm, prospective, randomized, parallel group, open-label, blinded endpoint assessment (PROBE) trial. Participants: Acute stroke in previous 14 days and aphasia diagnosed by aphasia quotient (AQ) of the Western Aphasia Battery (WAB). Randomization: Computer-generated blocked randomization procedure stratified by aphasia severity according to Western Aphasia Battery, to one of three arms. Intervention: 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. Study outcome measures: 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. Economic evaluation: Incremental cost-effectiveness ratios at 26 weeks will be reported. Discussion: 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.	en_US
dc.relation	http://purl.org/au-research/grants/nhmrc/APP1044973
dc.relation.ispartof	International Journal of Stroke	en_US
dc.relation.isbasedon	10.1177/1747493016641116	en_US
dc.subject.classification	Neurology & Neurosurgery	en_US
dc.subject.mesh	Humans	en_US
dc.subject.mesh	Aphasia	en_US
dc.subject.mesh	Treatment Outcome	en_US
dc.subject.mesh	Speech Therapy	en_US
dc.subject.mesh	Single-Blind Method	en_US
dc.subject.mesh	Speech	en_US
dc.subject.mesh	Language Tests	en_US
dc.subject.mesh	Patient Selection	en_US
dc.subject.mesh	Cost-Benefit Analysis	en_US
dc.subject.mesh	Australia	en_US
dc.subject.mesh	New Zealand	en_US
dc.subject.mesh	Stroke	en_US
dc.subject.mesh	Stroke Rehabilitation	en_US
dc.title	A randomized controlled trial of very early rehabilitation in speech after stroke	en_US
dc.type	Journal Article
utslib.citation.volume	5	en_US
utslib.citation.volume	11	en_US
utslib.for	1103 Clinical Sciences	en_US
utslib.for	1109 Neurosciences	en_US
pubs.embargo.period	Not known	en_US
pubs.organisational-group	/University of Technology Sydney
pubs.organisational-group	/University of Technology Sydney/DVC (Research)
pubs.organisational-group	/University of Technology Sydney/DVC (Research)/Graduate Research School
utslib.copyright.status	open_access
pubs.issue	5	en_US
pubs.publication-status	Published	en_US
pubs.volume	11	en_US

Abstract:

© 2016 World Stroke Organization. Rationale: The efficacy of rehabilitation therapy for aphasia caused by stroke is uncertain. Aims and hypothesis: 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. Sample size estimates: 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. Setting: Acute-care hospitals and accompanying rehabilitation services throughout Australia, 2014-2017. Design: Three-arm, prospective, randomized, parallel group, open-label, blinded endpoint assessment (PROBE) trial. Participants: Acute stroke in previous 14 days and aphasia diagnosed by aphasia quotient (AQ) of the Western Aphasia Battery (WAB). Randomization: Computer-generated blocked randomization procedure stratified by aphasia severity according to Western Aphasia Battery, to one of three arms. Intervention: 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. Study outcome measures: 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. Economic evaluation: Incremental cost-effectiveness ratios at 26 weeks will be reported. Discussion: 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.

Please use this identifier to cite or link to this item:

http://hdl.handle.net/10453/43750