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临床试验/NCT06393218
NCT06393218Unknown不适用

The Impact of Diaphragm Training on Dysphagia in Bulbar Palsy After Ischemic Stroke: A Randomized Controlled Study

Copka Sonpashan0 个研究点目标入组 100 人开始时间: 2024年4月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
主要终点
Penetration-Aspiration Scale

研究概览

简要总结

This was a prospective multicenter study. the patients after stroke with were randomly divided into the observation group and the control group. All patients were given comprehensive rehabilitation therapy. During the treatment, enteral nutrition support was provided for the two groups by Intermittent Oro-esophageal tube feeding. The observation group will be given Diaphragm Training Nutritional status, dysphagia, quality of life and depression before and after treatment were compared.

详细描述

Dysphagia in patients after stroke continues to be a challenge. This was a prospective multicenter study. the patients after stroke with were randomly divided into the observation group and the control group. All patients were given comprehensive rehabilitation therapy. During the treatment, enteral nutrition support was provided for the two groups by Intermittent Oro-esophageal tube feeding. The observation group will be given Diaphragm Training Nutritional status, dysphagia, quality of life and depression before and after treatment were compared.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age ≥ 18 years;
  • meeting the diagnostic criteria of Bulbar Palsy After Ischemic Stroke;
  • any degree of dysphagia at admission;
  • steady vital signs, without severe cognitive impairment or sensory aphasia, able to cooperate with the assessment.
  • clear mind.

排除标准

  • complicated with other neurological diseases;
  • damaged mucosa or incomplete structure in nasopharynx;
  • tracheostomy tube plugged;
  • unfeasible to the support of parenteral nutrition;
  • simultaneously suffering from liver, kidney failure, tumors, or hematological diseases.

结局指标

主要结局

Penetration-Aspiration Scale

时间窗: Day 1 and day 15

The Penetration-Aspiration Scale was conducted under video fluoroscopic swallowing study. The scale is a standardized tool used to assess the safety of swallowing. The scale was developed to evaluate the entry of material into the airway (penetration) and the subsequent passage of material below the vocal folds (aspiration) during swallowing. The scale ranges from 1 to 8, with each level representing different degrees of penetration or aspiration.

次要结局

  • Functional Oral Intake Scale(Day 1 and day 15)
  • Dysphagia Handicap Index(Day 1 and day 15)

研究者

发起方
Copka Sonpashan
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Copka Sonpashan

Research Director

Chao Phya Abhaibhubejhr Hospital

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