Cassarly Christy, Basilakos Alexandra, Johnson Lisa, Wilmskoetter Janina, Elm Jordan, Hillis Argye E, Bonilha Leonardo, Rorden Chris, Hickok Gregory, den Ouden Dirk-Bart, Fridriksson Julius
Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.
Department of Communications Sciences and Disorders, University of South Carolina, Columbia, SC, USA.
Contemp Clin Trials Commun. 2024 Nov 28;42:101406. doi: 10.1016/j.conctc.2024.101406. eCollection 2024 Dec.
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.
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.
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.
尽管有充分证据支持失语症治疗对慢性（≥6个月）中风后失语症患者的效用，但在美国，为患者提供的治疗量通常远低于最大程度促进康复所需的量。造成这种差异的两个潜在因素是，由于服务提供者数量有限以及交通方面的后勤困难，患者获得康复服务的机会受限。增加失语症治疗可及性的一种方法是依靠远程康复。
失语症远程康复（TERRA）试验是一项前瞻性、随机、评估者盲法、多中心II期非劣效性试验，旨在评估远程康复对慢性中风后失语症患者失语症治疗的效果。参与者被随机分组（1:1），接受失语症远程治疗或门诊治疗，总共治疗30天（语义聚焦方法治疗15天，语音聚焦方法治疗15天），每天治疗45分钟。共有100名年龄在21 - 80岁之间、在研究入组前至少12个月有左半球缺血性或出血性中风病史的成年人将被随机分组。该试验将在两个地点的临床研究机构进行：南卡罗来纳医科大学和南卡罗来纳大学。
本文详细介绍了TERRA试验的设计，该试验旨在测试远程言语病理学家通过视频会议提供的失语症治疗（即通过远程康复）对于慢性中风后失语症患者在临床效果上是否不劣于门诊治疗，从而为进入确定性的III期试验提供机会。
