Telerehabilitation for Aphasia (TERRA)

Официальное название

Center for the Study of Aphasia Recovery (C-STAR): Telerehabilitation for Aphasia (TERRA)

Обзор

Speech-language therapy is generally found to be helpful in the rehabilitation of aphasia. However, not all patients with aphasia have access to adequate treatment to maximize their recovery. The goal of this project is to compare the efficacy of telerehabilitation or Aphasia Remote Therapy (ART) to the more traditional In-Clinic Therapy (I-CT).

Подробное описание

Stroke is the leading cause of adult disability in the United States. One of the most debilitating impairments resulting from stroke is aphasia, a language disorder caused by damage to the left hemisphere of the brain. While evidence shows that aphasia therapy improves speech production and communicative quality of life 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 probably necessary to maximize recovery. There are a few important reasons underlying this discrepancy. For example, considerable emphasis is placed on acute and subacute stroke recovery with less therapy focus on the chronic period, when recovery is usually slower. Also, access to rehabilitation services can be limited by the availability of providers (e.g., in rural regions) or by difficulties with transportation logistics related to disabilities and the physical sequelae of stroke. One way to increase access to aphasia therapy is to rely on telerehabilitation (a.k.a., aphasia remote therapy; ART). So far, telerehabilitation in stroke has primarily focused on physical therapy, with only a handful of smaller studies involving aphasia therapy. The purpose of this study is to compare aphasia therapy administered via ART to aphasia therapy administered in person (In-Clinic Therapy; I-CT). We will conduct the first phase II, non-inferiority trial of telerehabilitation for aphasia therapy that is exclusively administered by a speech-language pathologist. Participants with chronic aphasia will be randomized to either a telerehabilitation or aphasia remote therapy (ART) group or an in-clinic therapy (I-CT) group relying on the same therapy approach currently used in our ongoing POLAR study. The outcome measure will focus on speech production and combines correct naming on the Philadelphia Naming Test and correct words produced per minute (CWPM) 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. Neuroimaging will be used to evaluate how aphasia is shaped by the stroke lesion in combination with residual brain integrity.

Вмешательства

• Поведенческое Semantically-focused therapy tasks
  1\) Semantic feature analysis (SFA; Boyle \& Coelho, 1995; Boyle, 2004). For each pictured stimulus the participant is prompted to name the picture. Then, s/he is encouraged to produce semantically related words that represent features similar to the target word. 2) Semantic barrier task. This approach includes features of the Promoting Aphasics' Communication Effectiveness (PACE; Davis \& Wilcox,1985). The goal of the task is for one participant (e.g., person with aphasia) to describe each card
• Поведенческое Phonologically-focused therapy tasks
  1\) Phonological components analysis task (PCA; Leonard et al., 2008). The participant first attempts to name a given picture and then to identify the phonological features of the target words. 2) Phonological production task focuses on the identification of phonological features of targeted, imageable nouns and verbs. It requires the participant to sort picture stimuli based on the number of syllables and then to identify a hierarchy of phonological features. Once each targeted feature is ident

Первичные конечные точки

• Speech Production Outcome Score (SPOTS) [Срок оценки: Compare baseline score to 6 month follow-up (after treatment) score.]

Вторичные конечные точки (2)

• Improvement in overall aphasia severity [Срок оценки: Compare baseline score to 6 month follow-up (after treatment) score.]
• Improvement in quality of life [Срок оценки: Compare baseline score to 6 month follow-up (after treatment) score.]

Критерии участия

Критерии включения

• Participants must have sustained a left hemisphere ischemic or hemorrhagic stroke at least 12 months prior to enrollment.
• Participants must primarily speak English for at least the past 20 years.
• Participants must be capable of giving informed consent or indicating another to provide informed consent.
• Participants must be between 21-80 years of age.
• Participants must be magnetic resonance imaging (MRI) compatible (e.g., no metal implants, not claustrophobic) on a 3-Tesla (3T) scanner.

Критерии исключения

• Participants must not have previous neurological disease affecting the brain (e.g. history of traumatic brain injury).
• Participants must not have severely limited speech production (severe unintelligibility) and/or auditory comprehension that interferes with adequate participation in the therapy provided (i.e., WAB-R Spontaneous Speech rating scale score of 0-1 or WAB-R Comprehension score of 0-1).
• Participants must not have a history of stroke to the right hemisphere of the brain.
• Participants must not have a bilateral, cerebellar or brainstem stroke.
• Participants must not have anything that makes them be 3T MRI incompatible
• Insufficient intelligible speech to provide accurate responses with discourse/naming.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of South Carolina Aphasia Lab — Columbia

Публикации

• Bak TH, Hodges JR. Kissing and dancing-a test to distinguish the lexical and conceptual contributions to noun/verb and action/object dissociation. Preliminary results in patients with frontotemporal dementia. Journal of Neurolinguistics. 2003; 16(2): 169-181.
• Breitenstein C, Grewe T, Floel A, Ziegler W, Springer L, Martus P, Huber W, Willmes K, Ringelstein EB, Haeusler KG, Abel S, Glindemann R, Domahs F, Regenbrecht F, Schlenck KJ, Thomas M, Obrig H, de Langen E, Rocker R, Wigbers F, Ruhmkorf C, Hempen I, List J, Baumgaertner A; FCET2EC study group. Intensive speech and language therapy in patients with chronic aphasia after stroke: a randomised, open- PMID 28256356
• Brady MC, Kelly H, Godwin J, Enderby P, Campbell P. Speech and language therapy for aphasia following stroke. Cochrane Database Syst Rev. 2016 Jun 1;2016(6):CD000425. doi: 10.1002/14651858.CD000425.pub4. PMID 27245310
• Brady MC, Kelly H, Godwin J, Enderby P. Speech and language therapy for aphasia following stroke. Cochrane Database Syst Rev. 2012 May 16;(5):CD000425. doi: 10.1002/14651858.CD000425.pub3. PMID 22592672
• Boyle M. Semantic feature analysis treatment for anomia in two fluent aphasia syndromes. Am J Speech Lang Pathol. 2004 Aug;13(3):236-49. doi: 10.1044/1058-0360(2004/025). PMID 15339233
• Boyle M, Coelho CA. Application of semantic feature analysis as a treatment for aphasic dysnomia. American Journal of Speech-Language Pathology. 1995; 4(4): 913-919.
• Cho-Reyes S, Thompson CK. Verb and sentence production and comprehension in aphasia: Northwestern Assessment of Verbs and Sentences (NAVS). Aphasiology. 2012;26(10):1250-1277. doi: 10.1080/02687038.2012.693584. PMID 26379358
• Conners C, Connelly V, Campbell S, MacLean M, Barnes J. Conners' Continuous Performance Test. Multi-Health Systems, Inc. 2000.

Идентификаторы

NCT: NCT04682223 · Pro00105675 · P50DC014664

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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