Telerehab for Aphasia (TERRA)

失语症远程康复 (TERRA)

• 批准号: 10094379
• 负责人: JULIUS FRIDRIKSSON
• 金额: $ 84.73万
• 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/10094379
• 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; 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 现在通常认为，慢性中风中的失语症治疗对于改善语言有效 处理，也许在较小程度上是生活质量。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。尽管这种状况的原因有几个，但 两个因素尤其重要：补偿治疗服务不足，无法获得 当地运输往返治疗。解决这两个问题的一种方法是提供失语症 以较低的成本并消除了运输需求。通过远程医疗（临床医生）提供失语症治疗 在整个互联网上进行治疗）将通过消除对物理的需求来提供廉价的治疗 提供服务的设施，并减少需要运输和从治疗的运输需求 临床（家庭健康）或患者（门诊诊所）。项目1的目的是进行II期，非 - Telerehab进行失语症治疗的自卑试验（Aphoodia Remote Therapy; ART） 由语言病理学家管理。所有参与者（n = 100）将随机分配以接收任何一个 Telerehab（ART）或临界疗法（I-CT）使用我们目前在项目1中使用的相同类型的疗法。 结果度量将集中在语音生产上，并结合正确的命名和正确的单词 话语期间每分钟产生。主要终点是6个月后的结果度量的变化 与基线相比。将设置不效率的边距，以便如果艺术的提高不到50％ 除了I-CT之后的改进，它将被认为是治疗递送的次数。除了比较 艺术和I-CT的结果差异，我们还将探索影响Teleheb效率的因素 为此，我们使用一个通常用于研究的理论框架 接受远程医疗和个人与会者。此外，我们将测试参与者的认知 - 语言状态并收集传记信息以研究参与者可能会遇到困难 在未来的第三阶段试验中，Telerehab，可能是较差的候选人。如果我们的审判发现艺术不属于I- CT，它将提供强大的动力，以进行III期试验，以进行治疗方式 显着改变并改善了目前估计超过2的人群的失语治疗的机会 北美的百万个人。 除了进行及时的艺术临床试验外，这里提出的工作还将继续扩展我们 在项目1的当前阶段正在填充的有关失语症治疗结果的数据库。根据 将保持项目1中当前和拟议工作之间的协同作用。此外，项目1 将继续为3和4的项目提供数据，以研究与失语治疗结果有关的大脑健康 分别是语言的神经心理模型。