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临床试验/NCT03787524
NCT03787524Unknown不适用

Prediction of Functional Health Status and Aspiration Using Multiple Dysphagia Scales Over 6 Months After Acute Stroke: Prospective, Observational, Parallel Group, Case-control Trial

Ulsan University Hospital1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2019年3月4日最近更新:
适应症

试验速览

阶段
不适用
入组人数
68
试验地点
1
主要终点
Change of Body mass index (Kg/m2)

研究概览

简要总结

In order to discover dysphagia scales, which shows meaningful predictability of aspiration and functional health status in patients with acute stroke, authors plan to find out more predictable indicators than existing penetration-aspiration scale (PAS) to validate their predictions and their internal and external validity over 6 months following stroke .

详细描述

To determine the dysphagia scale with significant predictions of aspiration and functional health status in patients with acute stroke, video-fluoroscopic swallowing study (VFSS) will be performed to the patients who will be referred for VFSS among stroke patients who would be diagnosed by Brain MRI / CT. When any type of dysphagia is found, participant will be assigned to the test group (DYS), and when no dysphagia is found, they will be assigned to the control group (NOD).

Numerous kinds of assessment will be conducted before and after VFSS, before discharge, and 3, 6, and 9 months after the stroke onset.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • brain MRI / CT-based stroke patients who were referred for VFSS

排除标准

  • In case of a history of dysphagia
  • Unstable patient in neurology
  • 2 or higher of NIHSS 1a (level of consciousness)
  • Patients with other neurological diseases
  • Patients with decompression skull resection
  • Refusal of participation

结局指标

主要结局

Change of Body mass index (Kg/m2)

时间窗: 1 day before and 1 day, 3 weeks after the VFSS, 3 month, 6 months and 9 months after the stroke onset

Body mass index (Kg/m2)

次要结局

  • Check the Penetration/aspiration on PAS(1 day after the VFSS, 3 month, 6 months and 9 months after the stroke onset)

研究者

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

Chang Ho Hwang

Associate Professor

Ulsan University Hospital

研究点 (1)

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