Telerehab for Aphasia (TERRA)

摘要：项目1 现在普遍认为，慢性中风的失语治疗对改善语言能力是有效的 处理，也许在较小程度上，是生活质量。然而，大多数慢性失语症患者在 美国获得治疗的机会非常有限。虽然造成这种状况的原因是多方面的， 有两个因素尤为重要：治疗服务的报销不足和无法获得 当地往返治疗的交通工具。解决这两个问题的一种方法是提供失语症治疗。 以更低的成本，消除了运输的需要。通过远程医疗提供失语症治疗(临床医生 通过互联网进行治疗)将通过消除对物理治疗的需要来提供更便宜的治疗 提供服务的设施，并通过减少往返治疗的需要 临床医生(家庭健康)或患者(门诊)。项目1的目的是进行第二阶段，非- 失语症治疗(失语症远程治疗；ART)的telerehab自卑试验，将独家 由一位语言病理学家进行治疗。所有参与者(N=100)将被随机分配到 Telerehab(ART)或临床治疗(I-CT)，使用我们目前在项目1中使用的相同类型的治疗。 结果衡量标准将重点放在言语产出上，并将正确的命名和正确的单词结合起来 在话语过程中每分钟产生一次。主要终点是6个月时结局测量的变化 与基线相比。非自卑边际将被设置为，如果ART导致的改善低于50% 相比I-CT后的改善，它将被认为是较差的治疗交付。除了比较 ART和I-CT治疗结果的差异，我们还将探讨影响Telerehab疗效的因素 用来治疗失语症。为此，我们使用了一个通常用于研究 对远程医疗的接受和个人态度。此外，我们将测试参与者的认知- 语言状态和收集传记信息以研究哪些参与者可能有困难 Telerehab，在未来的第三阶段试验中可能是糟糕的候选者。如果我们的审判发现抗逆转录病毒治疗不比我差- CT，它将提供强大的动力来继续进行一种治疗模式的III期试验，该治疗模式可以 极大地改变和改善了失语症治疗的可及性，目前估计失语症治疗的人口超过2 北美有一百万人。 除了对ART进行非常及时的临床试验外，这里提出的工作将继续扩大我们的 关于失语症治疗结果的数据库，正在项目1的当前阶段填充。因此， 将保持项目1中当前工作和拟议工作之间的协同作用。此外，项目1 将继续为项目3和项目4提供数据，以研究大脑健康与失语症治疗结果的关系 和语言的神经心理学模型。

Summary: Project 1 It is now commonly accepted that aphasia therapy in chronic stroke is effective for improving language processing, and perhaps to a lesser extent, quality of life. Nevertheless, most persons with chronic aphasia in the United States have very limited access to therapy. Although the reasons for this state of affairs are several, two factors are particularly important: insufficient reimbursement for therapy services and lack of access to local transportation to and from therapy. A way to tackle both of these problems is to provide aphasia therapy at a lower cost and eliminate the need for transportation. Providing aphasia therapy via telemedicine (clinician administered therapy across the internet) will provide cheaper therapy by eliminating the need for a physical facility to provide services and by reducing the need for transportation to and from therapy for either the clinician (home health) or the patient (outpatient clinic). The purpose of Project 1 is to conduct a phase II, non- inferiority trial of telerehab for aphasia therapy (aphasia remote therapy; ART), which will be exclusively administered by a speech-language pathologist. All participants (N=100) will be randomized to receive either telerehab (ART) or in-clinic therapy (I-CT) using the same kind of therapy we are currently using in Project 1. The outcome measure will focus on speech production and combines correct naming and correct words produced per minute during discourse. The primary endpoint is change in the outcome measure at 6 months compared to baseline. The non-inferiority margin will be set so that if ART leads to less than 50% improvement than the improvement following I-CT, it will be considered inferior for therapy delivery. In addition to comparing the difference in outcome for ART and I-CT, we will also explore factors that influence the efficacy of telerehab for aphasia therapy. For this purpose, we use a theoretical framework that is typically used to study the acceptance of and personal attitudes towards telemedicine. Moreover, we will test participants’ cognitive- linguistic status and collect biographical information to study which participants may have difficulty with telerehab and may be poor candidates in a future, phase III trial. If our trial finds that ART is non-inferior to I- CT, it will provide strong motivation to proceed with a phase III trial on a therapy modality that could significantly alter and improve access to aphasia therapy for a population that now is estimated to exceed 2 million individuals in North America. In addition to conducting a very timely clinical trial on ART, the work proposed here will continue to expand our database on aphasia therapy outcome that is being populated in the current phase of Project 1. Accordingly, the synergy between the current and the proposed work in Project 1 will be maintained. Moreover, Project 1 will continue to provide data for Projects 3 and 4 to study brain health in relation to aphasia therapy outcome and neuropsychological models of language, respectively.