Telerehab for Aphasia (TERRA)

失语症远程康复 (TERRA)

• 批准号: 10617709
• 负责人: JULIUS FRIDRIKSSON
• 金额: $ 90.71万
• 依托单位: UNIVERSITY OF SOUTH CAROLINA AT COLUMBIA
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-04-01 至 2026-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10617709
• 关键词: Acute; Adopted; Affect; Ambulatory Care Facilities; Aphasia; Attitude; Biography; Caring; Case Study; Chronic; Clinic; Clinical Trials; Cognitive; Communication; Data; Databases; Effectiveness; Enzyme-Linked Immunosorbent Assay; Future; Goals; Health; Home; Improve Access; Individual; Inferior; Internet; Language; Language Therapy; Linguistics; Logistics; Medical; Meta-Analysis; Modality; Modeling; Motivation; Names; Neuropsychology; North America; Outcome; Outcome Measure; Participant; Pathologist; Patients; Personal Computers; Persons; Phase; Philadelphia; Physical therapy; Policies; Population; Probability; Production; Provider; Quality of life; Randomized; Recovery; Rehabilitation therapy; Research; Semantics; Services; Severities; Source; Speech; Speech Therapy; Stroke; Technology; Telemedicine; Testing; Third-Party Payer; Transportation; Underserved Population; United States; Work; aphasia recovery; brain health; chronic stroke; comparative efficacy; computerized; cost; disability; executive function; improved; language processing; personalized predictions; phase III trial; phonology; pre-clinical; predicting response; primary endpoint; rehabilitation service; remote therapy; rural area; stroke recovery; stroke-induced aphasia; stroke-like outcome; synergism; technology validation; telerehabilitation; therapy outcome

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.

摘要：项目 1 现在人们普遍认为慢性中风的失语症治疗对于改善语言是有效的 处理，也许在较小程度上，生活质量。然而，大多数患有慢性失语症的人 美国获得治疗的机会非常有限。尽管造成这种状况的原因是多方面的， 有两个因素特别重要：治疗服务报销不足和缺乏获得治疗服务的机会 往返治疗的当地交通。解决这两个问题的一种方法是提供失语症治疗 以较低的成本并消除运输的需要。通过远程医疗提供失语症治疗（临床医生 通过互联网进行的治疗）将通过消除物理治疗的需要来提供更便宜的治疗 提供服务的设施，并减少往返治疗的交通需求 临床医生（家庭健康）或患者（门诊诊所）。项目 1 的目的是进行第二阶段、非 远程康复用于失语症治疗（失语症远程治疗；ART）的劣势试验，该试验将独家 由言语病理学家进行管理。所有参与者 (N=100) 将被随机分配接受 远程康复 (ART) 或临床治疗 (I-CT) 使用与我们目前在项目 1 中使用的相同疗法。 结果衡量标准将侧重于言语表达，并结合正确的命名和正确的词语 谈话期间每分钟产生一次。主要终点是 6 个月时结果测量的变化 与基线相比。如果 ART 带来的改善低于 50%，则将设定非劣效性界限 与 I-CT 后的改善相比，它的治疗效果将被认为较差。除了比较 为了了解 ART 和 I-CT 结果的差异，我们还将探讨影响远程康复效果的因素 用于失语症治疗。为此，我们使用通常用于研究的理论框架 对远程医疗的接受程度和个人态度。此外，我们将测试参与者的认知能力 语言状况并收集传记信息以研究哪些参与者可能有困难 远程康复，可能是未来第三阶段试验中较差的候选者。如果我们的试验发现 ART 不劣于 I- CT，它将为继续进行治疗方式的 III 期试验提供强大的动力，该试验可以 显着改变和改善目前估计超过 2 的人群获得失语症治疗的机会 北美有 100 万人。 除了对 ART 进行非常及时的临床试验外，这里提出的工作还将继续扩大我们的研究范围。 项目 1 当前阶段正在填充失语症治疗结果数据库。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 4 提供数据，以研究与失语症治疗结果相关的大脑健康 和语言的神经心理学模型。