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临床试验/NCT04364854
NCT04364854已完成2 期

Speech Entrainment for Aphasia Recovery

Medical University of South Carolina6 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年8月21日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
80
试验地点
6
主要终点
Average Verbs Per Minute (VPM) Change From Baseline

研究概览

简要总结

After a stroke, many people experience a language impairment called aphasia. One of the most debilitating types of aphasia is non-fluent aphasia. Non-fluent aphasia is defined by significantly reduced speech production, with the speaker producing only a few words or even less. Speech entrainment therapy (SET) is a treatment that has been shown to increase fluency in people with non-fluent aphasia. The study looks to define the best dose of SET that leads to sustained improvements in spontaneous speech production.

Participants who are eligible will undergo baseline language testing, an MRI, and will be randomized into one of 4 treatment groups: SET for 3 weeks, SET for 4.5 weeks, SET for 6 weeks, and no treatment (control group).

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
21 Years 至 81 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Average Verbs Per Minute (VPM) Change From Baseline

时间窗: 3 months after treatment (or no treatment)

VPM will be assessed through procedural storytelling and narrative storytelling tasks - with four items in each category. The procedural storytelling items are: 1) how to make a peanut butter and jelly sandwich, 2) how to make scrambled eggs, 3) how to brew coffee, and 4) how to wash dishes. The narrative items will be: 1) Cinderella story, 2) Little Red Riding Hood, 3) The Three Little Pigs, and 4) Goldilocks. VPM is averaged between the procedural storytelling and narrative storytelling tasks.

次要结局

  • Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39) Change From Baseline(3 months after treatment (or no treatment))
  • Narrative Verbs Per Minute (VPM)(3 months after treatment (or no treatment))
  • Procedural Verbs Per Minute (VPM) Change From Baseline(3 months after treatment (or no treatment))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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