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...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2021-12-01
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| Series: | Contemporary Clinical Trials Communications |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2451865421001769 |
| _version_ | 1818403912345976832 |
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| 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 |
| collection | DOAJ |
| 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. |
| first_indexed | 2024-12-14T08:31:48Z |
| format | Article |
| id | doaj.art-9f91169750d2433a9d72ea83abad8023 |
| institution | Directory Open Access Journal |
| issn | 2451-8654 |
| language | English |
| last_indexed | 2024-12-14T08:31:48Z |
| publishDate | 2021-12-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Contemporary Clinical Trials Communications |
| spelling | doaj.art-9f91169750d2433a9d72ea83abad80232022-12-21T23:09:31ZengElsevierContemporary Clinical Trials Communications2451-86542021-12-0124100876Speech Entrainment for Aphasia Recovery (SpARc) phase II trial designChristy Cassarly0Anna Doyle1Trinh Ly2Janet Horn3Mary Aitchison4Jordan Elm5Julius Fridriksson6Leonardo Bonilha7Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA; Corresponding author. Department of Public Health Sciences, Medical University of South Carolina, 135 Cannon Street, Suite 303, MSC 835, Charleston, SC, 29425, USA.Department of Neurology, Medical University of South Carolina, Charleston, SC, USANational Institute on Deafness and Other Communication Disorders, Bethesda, MD, USADepartment of Health Sciences and Research, Medical University of South Carolina, Charleston, SC, USADepartment of Communications Sciences and Disorders, University of South Carolina, Columbia, SC, USADepartment of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USADepartment of Communications Sciences and Disorders, University of South Carolina, Columbia, SC, USADepartment of Neurology, Medical University of South Carolina, Charleston, SC, USABackground: 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.http://www.sciencedirect.com/science/article/pii/S2451865421001769AphasiaNon-fluent speechSpeech productionRandomized controlled trialStudy design |
| spellingShingle | 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 Contemporary Clinical Trials Communications Aphasia Non-fluent speech Speech production Randomized controlled trial Study design |
| title | 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_short | Speech Entrainment for Aphasia Recovery (SpARc) phase II trial design |
| title_sort | speech entrainment for aphasia recovery sparc phase ii trial design |
| topic | Aphasia Non-fluent speech Speech production Randomized controlled trial Study design |
| url | http://www.sciencedirect.com/science/article/pii/S2451865421001769 |
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