TEleRehabilitation foR Aphasia (TERRA) phase II trial design
Background and purpose: Despite comprehensive evidence that supports the utility of aphasia therapy in persons with chronic (≥6 months) stroke-induced aphasia, the amount of therapy provided to patients in the United States is typically far less than what is likely necessary to maximize recovery. Tw...
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| Format: | Article |
| Language: | English |
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Elsevier
2024-12-01
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| Series: | Contemporary Clinical Trials Communications |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2451865424001534 |
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| author | Christy Cassarly Alexandra Basilakos Lisa Johnson Janina Wilmskoetter Jordan Elm Argye E. Hillis Leonardo Bonilha Chris Rorden Gregory Hickok Dirk-Bart den Ouden Julius Fridriksson |
| author_facet | Christy Cassarly Alexandra Basilakos Lisa Johnson Janina Wilmskoetter Jordan Elm Argye E. Hillis Leonardo Bonilha Chris Rorden Gregory Hickok Dirk-Bart den Ouden Julius Fridriksson |
| author_sort | Christy Cassarly |
| collection | DOAJ |
| description | Background and purpose: Despite comprehensive evidence that supports the utility of aphasia therapy in persons with chronic (≥6 months) stroke-induced aphasia, the amount of therapy provided to patients in the United States is typically far less than what is likely necessary to maximize recovery. Two potential contributors to this discrepancy are limited access to rehabilitation services due to the availability of providers and logistical difficulties with transportation. One way to increase access to aphasia therapy is to rely on telerehabilitation. Methods: The TEleRehabilitation foR Aphasia (TERRA) trial is a prospective, randomized, rater-blinded, multicenter phase II non-inferiority trial to evaluate telerehabilitation for aphasia therapy in persons with chronic post-stroke aphasia. Participants are randomized (1:1) to receive either aphasia remote therapy or in-clinic therapy for 30 total days of treatment (15 days of a semantically focused approach and 15 days of a phonologically focused approach) for 45 min per day. A total of 100 adults (ages 21–80) with a history of left hemisphere ischemic or hemorrhagic stroke incurred at least 12 months prior to study enrollment will be randomized. The trial will be conducted at the clinical research facilities at two sites: the Medical University of South Carolina and the University of South Carolina. Conclusions: This paper details the design of the TERRA trial, which aims to test whether aphasia therapy delivered by a remote speech-language pathologist through videoconferencing (i.e., via telerehabilitation) is not clinically worse than in-clinic therapy for individuals with chronic post-stroke aphasia to provide an opportunity to move to a definitive phase III trial. |
| format | Article |
| id | doaj-art-52fc1ee7cb7a4392b6e6f75f38519979 |
| institution | Kabale University |
| issn | 2451-8654 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Contemporary Clinical Trials Communications |
| spelling | doaj-art-52fc1ee7cb7a4392b6e6f75f385199792024-12-18T08:49:59ZengElsevierContemporary Clinical Trials Communications2451-86542024-12-0142101406TEleRehabilitation foR Aphasia (TERRA) phase II trial designChristy Cassarly0Alexandra Basilakos1Lisa Johnson2Janina Wilmskoetter3Jordan Elm4Argye E. Hillis5Leonardo Bonilha6Chris Rorden7Gregory Hickok8Dirk-Bart den Ouden9Julius Fridriksson10Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA; Corresponding author.Department of Communications Sciences and Disorders, University of South Carolina, Columbia, SC, USADepartment of Communications Sciences and Disorders, University of South Carolina, Columbia, SC, USADepartment of Health Sciences and Research, Medical University of South Carolina, Charleston, SC, USADepartment of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USADepartment of Neurology, Johns Hopkins University, Baltimore, MD, USADepartment of Communications Sciences and Disorders, University of South Carolina, Columbia, SC, USADepartment of Communications Sciences and Disorders, University of South Carolina, Columbia, SC, USADepartment of Cognitive Sciences, University of California, Irvine, Irvine, CA, USA; Department of Language Science, University of California, Irvine, Irvine, CA, USADepartment of Communications Sciences and Disorders, University of South Carolina, Columbia, SC, USADepartment of Communications Sciences and Disorders, University of South Carolina, Columbia, SC, USABackground and purpose: Despite comprehensive evidence that supports the utility of aphasia therapy in persons with chronic (≥6 months) stroke-induced aphasia, the amount of therapy provided to patients in the United States is typically far less than what is likely necessary to maximize recovery. Two potential contributors to this discrepancy are limited access to rehabilitation services due to the availability of providers and logistical difficulties with transportation. One way to increase access to aphasia therapy is to rely on telerehabilitation. Methods: The TEleRehabilitation foR Aphasia (TERRA) trial is a prospective, randomized, rater-blinded, multicenter phase II non-inferiority trial to evaluate telerehabilitation for aphasia therapy in persons with chronic post-stroke aphasia. Participants are randomized (1:1) to receive either aphasia remote therapy or in-clinic therapy for 30 total days of treatment (15 days of a semantically focused approach and 15 days of a phonologically focused approach) for 45 min per day. A total of 100 adults (ages 21–80) with a history of left hemisphere ischemic or hemorrhagic stroke incurred at least 12 months prior to study enrollment will be randomized. The trial will be conducted at the clinical research facilities at two sites: the Medical University of South Carolina and the University of South Carolina. Conclusions: This paper details the design of the TERRA trial, which aims to test whether aphasia therapy delivered by a remote speech-language pathologist through videoconferencing (i.e., via telerehabilitation) is not clinically worse than in-clinic therapy for individuals with chronic post-stroke aphasia to provide an opportunity to move to a definitive phase III trial.http://www.sciencedirect.com/science/article/pii/S2451865424001534AphasiaNon-fluent speechSpeech productionRandomized controlled trialStudy design |
| spellingShingle | Christy Cassarly Alexandra Basilakos Lisa Johnson Janina Wilmskoetter Jordan Elm Argye E. Hillis Leonardo Bonilha Chris Rorden Gregory Hickok Dirk-Bart den Ouden Julius Fridriksson TEleRehabilitation foR Aphasia (TERRA) phase II trial design Contemporary Clinical Trials Communications Aphasia Non-fluent speech Speech production Randomized controlled trial Study design |
| title | TEleRehabilitation foR Aphasia (TERRA) phase II trial design |
| title_full | TEleRehabilitation foR Aphasia (TERRA) phase II trial design |
| title_fullStr | TEleRehabilitation foR Aphasia (TERRA) phase II trial design |
| title_full_unstemmed | TEleRehabilitation foR Aphasia (TERRA) phase II trial design |
| title_short | TEleRehabilitation foR Aphasia (TERRA) phase II trial design |
| title_sort | telerehabilitation for aphasia terra phase ii trial design |
| topic | Aphasia Non-fluent speech Speech production Randomized controlled trial Study design |
| url | http://www.sciencedirect.com/science/article/pii/S2451865424001534 |
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