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临床试验/NCT01790880
NCT01790880已完成不适用

Enhancing Written Communication in Persons With Aphasia: A Clinical Trial

Shirley Ryan AbilityLab2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2013年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Writing Score on the Western Aphasia Battery-Revised (WAB-R) from pre-treatment to post-treatment

研究概览

简要总结

The purpose of this study is to evaluate whether a computerized speech-language treatment delivered by a virtual therapist (Oral Reading for Language in Aphasia (ORLA) + Writing) results in improved written communication skills of study participants with aphasia (i.e., difficulty with the comprehension and expression of spoken and written language).

详细描述

Stroke is the third leading cause of death and the most common cause of disability in the United States. According to the American Stroke Association, the prevalence of stroke in the U.S. is approximately 4.8 million with approximately 700,000 additional strokes occurring annually. Approximately 150,000 to 250,000 stroke survivors becoming severely and permanently disabled each year. A common neurological deficit among stroke survivors, and thus a substantial contributor to post-stroke disability, is aphasia. The loss of, or difficulty with language is extremely debilitating.

Adequate written communication skills may be one of the barriers that has prevented individuals with aphasia from returning to work. Writing skills are also important for participation in social roles, such as household management, civic activities, or recreational activities with friends. Individuals with aphasia struggle to compose written documents such as personal letters, memos and reports. Furthermore, society's increased reliance on written forms of communication including email correspondence, instant messaging, texting, Twitter, and social networking sites such as Facebook, exacerbate the challenge that individuals with aphasia have in connecting with others, reestablishing and redefining their social roles and accomplishing their life-participation goals.

Computer-directed treatment offers a practical alternative to one-on-one traditional treatment provided by a clinician and may be a cost-effective way of extending therapy beyond the hospital and clinic to meet the needs of the growing numbers of individuals with chronic aphasia and to help them reintegrate into the community and workforce. This project evaluates the efficacy of a theoretically-motivated writing program that has been integrated with novel computer-based virtual therapy systems and that can be provided intensively to individuals with chronic aphasia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • men or women with diagnosis of an aphasia subsequent to a left-hemisphere infarct(s) that is confirmed by CT scan or MRI
  • an Aphasia Quotient score on the Western Aphasia Battery of 50-
  • 6 months post injury
  • premorbidly right handed, determined by Edinburgh Handedness Inventory
  • completed at least an eighth grade education
  • premorbidly literate in English
  • visual acuity may be corrected but must be sufficient for reading visual stimuli on computer screen
  • auditory acuity may be aided but must be sufficient for hearing auditory stimuli in ORLA program

排除标准

  • any other neurological condition (other than cerebral vascular disease) that could potentially affect cognition or speech, such as Parkinson's Disease, Alzheimer's Dementia, traumatic brain injury.
  • any significant psychiatric history prior to the stroke, such as severe major depression or psychotic disorder requiring hospitalization; subjects with mood disorders who are currently stable on treatment will be considered.
  • active substance abuse.

结局指标

主要结局

Writing Score on the Western Aphasia Battery-Revised (WAB-R) from pre-treatment to post-treatment

时间窗: Change from baseline to 6 weeks

次要结局

  • Community Integration Questionnaire (CIQ)(Change from baseline to 6 weeks)
  • Western Aphasia Battery-Revised Aphasia Quotient (WAB-R AQ)(Change from baseline to 6 weeks)
  • Written Language Sample Analysis(Change from baseline to 6 weeks)
  • Communicative Effectiveness Index (CETI)(Change from baseline to 6 weeks)
  • ASHA Quality of Communication Life Scale (QCL)(Change from baseline to 6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Leora Cherney

Senior Research Scientist

Shirley Ryan AbilityLab

研究点 (2)

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