Telerehab for Aphasia (TERRA)

失语症远程康复 (TERRA)

• 批准号: 10390286
• 负责人: JULIUS FRIDRIKSSON
• 金额: $ 91.98万
• 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/10390286
• 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; Production; Provider; Quality of life; Randomized; Recovery; Rehabilitation therapy; Research; Semantics; Services; Severities; Source; Speech; Speech Therapy; Stroke; Supervision; Technology; Telemedicine; Testing; Third-Party Payer; Time; Transportation; 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 outcome; stroke recovery; stroke-induced aphasia; 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 目前普遍认为，失语症治疗慢性脑卒中是有效的改善语言 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， 美国人接受治疗的机会非常有限。尽管造成这种情况的原因有很多， 有两个因素特别重要：治疗服务的补偿不足， 往返治疗的当地交通工具。解决这两个问题的一种方法是提供失语症治疗 以较低的成本并且消除了对运输的需要。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）将通过消除对物理治疗的需要而提供更便宜的治疗。 提供服务的设施，并通过减少往返治疗的交通需要， 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 失语症远程康复治疗（失语症远程治疗; ART）的劣效性试验，该试验将专门 由一位语言病理学家进行。所有受试者（N=100）将随机接受 远程康复（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。 结果衡量将侧重于言语产生，并结合正确的命名和正确的单词 在演讲中每分钟产生。主要终点是6个月时结局指标的变化 与基线相比。将设定非劣效性界值，以便如果ART导致的改善小于50%， 与I-CT后的改善相比，认为其在治疗输送方面较差。除了比较 ART和I-CT结果的差异，我们还将探讨影响远程康复疗效的因素 进行失语症治疗为了这个目的，我们使用一个理论框架，通常用于研究 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- 语言状况，并收集传记信息，以研究参与者可能有困难 在未来的第三阶段试验中可能是糟糕的候选人。如果我们的试验发现ART不劣于I- CT，它将提供强大的动力，继续进行III期试验的治疗方式， 大大改变和改善了失语症治疗，目前估计超过2000人， 在北美有100万人 除了对ART进行非常及时的临床试验外，这里提出的工作将继续扩大我们的 失语症治疗结果的数据库，在项目1的当前阶段正在填充。因此，委员会认为， 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。