Speech Entrainment for Aphasia Recovery (SpARc) phase II trial design

Background: and purpose: Speech entrainment therapy (SET) is a computerized therapeutic approach that involves mimicking an audiovisual speech model to improve speech production. In a pilot study using SET for treatment of post-stroke non-fluent aphasia, significant gains were achieved in verbs per...

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Autores principales:	Christy Cassarly, Anna Doyle, Trinh Ly, Janet Horn, Mary Aitchison, Jordan Elm, Julius Fridriksson, Leonardo Bonilha
Formato:	article
Lenguaje:	EN
Publicado:	Elsevier 2021
Materias:	Aphasia Non-fluent speech Speech production Randomized controlled trial Study design Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/9f91169750d2433a9d72ea83abad8023
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spelling	oai:doaj.org-article:9f91169750d2433a9d72ea83abad80232021-11-20T05:08:10ZSpeech Entrainment for Aphasia Recovery (SpARc) phase II trial design2451-865410.1016/j.conctc.2021.100876https://doaj.org/article/9f91169750d2433a9d72ea83abad80232021-12-01T00:00:00Zhttp://www.sciencedirect.com/science/article/pii/S2451865421001769https://doaj.org/toc/2451-8654Background: and purpose: Speech entrainment therapy (SET) is a computerized therapeutic approach that involves mimicking an audiovisual speech model to improve speech production. In a pilot study using SET for treatment of post-stroke non-fluent aphasia, significant gains were achieved in verbs per minute (VPM) during discourse using untrained items 1 and 6 weeks after treatment, suggesting that SET may yield meaningful improvements in fluent spontaneous speech for individuals with non-fluent aphasia. Methods: The Speech Entrainment for Aphasia Recovery (SpARc) trial is a prospective, randomized, assessor-blinded, multicenter phase II clinical trial studying persons with chronic post-stroke non-fluent aphasia. Participants will be randomized to 3 weeks, 4.5 weeks, or 6 weeks of SET delivered via telehealth or a no SET control condition for 6 weeks. 80 adults (ages 21–81) with history of left hemisphere ischemic or hemorrhagic stroke with residual chronic (>6 months post stroke) non-fluent aphasia diagnosed by the Western Aphasia Battery-Revised (WAB-R) will be randomized (1:1:1:1) over 4 years. The trial will be conducted at the clinical research facilities at three sites: the Medical University of South Carolina, the University of South Carolina, and the University of Utah. Conclusions: This paper details the trial design of the SpARc trial, which aims to determine the dose of SET that will generate the highest effect size on speech fluency, VPM, sustained at 3 months post-treatment compared to a no SET control arm, for individuals with chronic post-stroke non-fluent aphasia to permit a future definitive trial to test the clinical utility of SET.Christy CassarlyAnna DoyleTrinh LyJanet HornMary AitchisonJordan ElmJulius FridrikssonLeonardo BonilhaElsevierarticleAphasiaNon-fluent speechSpeech productionRandomized controlled trialStudy designMedicine (General)R5-920ENContemporary Clinical Trials Communications, Vol 24, Iss , Pp 100876- (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Aphasia Non-fluent speech Speech production Randomized controlled trial Study design Medicine (General) R5-920
spellingShingle	Aphasia Non-fluent speech Speech production Randomized controlled trial Study design Medicine (General) R5-920 Christy Cassarly Anna Doyle Trinh Ly Janet Horn Mary Aitchison Jordan Elm Julius Fridriksson Leonardo Bonilha Speech Entrainment for Aphasia Recovery (SpARc) phase II trial design
description	Background: and purpose: Speech entrainment therapy (SET) is a computerized therapeutic approach that involves mimicking an audiovisual speech model to improve speech production. In a pilot study using SET for treatment of post-stroke non-fluent aphasia, significant gains were achieved in verbs per minute (VPM) during discourse using untrained items 1 and 6 weeks after treatment, suggesting that SET may yield meaningful improvements in fluent spontaneous speech for individuals with non-fluent aphasia. Methods: The Speech Entrainment for Aphasia Recovery (SpARc) trial is a prospective, randomized, assessor-blinded, multicenter phase II clinical trial studying persons with chronic post-stroke non-fluent aphasia. Participants will be randomized to 3 weeks, 4.5 weeks, or 6 weeks of SET delivered via telehealth or a no SET control condition for 6 weeks. 80 adults (ages 21–81) with history of left hemisphere ischemic or hemorrhagic stroke with residual chronic (>6 months post stroke) non-fluent aphasia diagnosed by the Western Aphasia Battery-Revised (WAB-R) will be randomized (1:1:1:1) over 4 years. The trial will be conducted at the clinical research facilities at three sites: the Medical University of South Carolina, the University of South Carolina, and the University of Utah. Conclusions: This paper details the trial design of the SpARc trial, which aims to determine the dose of SET that will generate the highest effect size on speech fluency, VPM, sustained at 3 months post-treatment compared to a no SET control arm, for individuals with chronic post-stroke non-fluent aphasia to permit a future definitive trial to test the clinical utility of SET.
format	article
author	Christy Cassarly Anna Doyle Trinh Ly Janet Horn Mary Aitchison Jordan Elm Julius Fridriksson Leonardo Bonilha
author_facet	Christy Cassarly Anna Doyle Trinh Ly Janet Horn Mary Aitchison Jordan Elm Julius Fridriksson Leonardo Bonilha
author_sort	Christy Cassarly
title	Speech Entrainment for Aphasia Recovery (SpARc) phase II trial design
title_short	Speech Entrainment for Aphasia Recovery (SpARc) phase II trial design
title_full	Speech Entrainment for Aphasia Recovery (SpARc) phase II trial design
title_fullStr	Speech Entrainment for Aphasia Recovery (SpARc) phase II trial design
title_full_unstemmed	Speech Entrainment for Aphasia Recovery (SpARc) phase II trial design
title_sort	speech entrainment for aphasia recovery (sparc) phase ii trial design
publisher	Elsevier
publishDate	2021
url	https://doaj.org/article/9f91169750d2433a9d72ea83abad8023
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Speech Entrainment for Aphasia Recovery (SpARc) phase II trial design

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