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临床试验/NCT06674356
NCT06674356招募中不适用

The Effects of Chin Tuck Against Resistance Exercise on Swallowing Function, Depression, and Quality of Life in Acute Stroke Patients With Dysphagia

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2024年12月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
74
试验地点
1
主要终点
swallowing function

研究概览

简要总结

The aim of this study is to investigate the effects of chin tuck against resistance exercise on swallowing function, depression, and quality of life in acute stroke patients with dysphagia.

详细描述

The study is an experimental research design, with participants randomly assigned to either the experimental group or the control group. The experimental group will undergo chin tuck against resistance exercises, while the control group will receive traditional swallowing rehabilitation training. The subjects of this study are patients from the neurology and rehabilitation wards of a medical center in northern Taiwan. The research tools include a personal basic information questionnaire, the standardized swallowing assessment, the Functional Oral Intake Scale, the Patient Health Questionnaire-9, and the Taiwan version of the Swallowing Quality of Life Questionnaire. Data collection for both groups will be conducted using a pre-test and post-test method.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients diagnosed with hemorrhagic or ischemic stroke, including those with initial diagnoses or recurrent strokes.
  • •Patients who did not pass the swallowing screening based on the standard swallowing scale.
  • •Adults aged 18 years and older.
  • •Vital signs are stable: systolic blood pressure (hemorrhagic < 160 mmHg, ischemic < 220 mmHg), heart rate 40-130 beats per minute, and oxygen saturation > 92%.
  • •The patient's consciousness is clear, able to express themselves, can communicate in Mandarin or Taiwanese, and can follow commands to perform actions.
  • •The patient can be in a seated position.

排除标准

  • •Patients who have had a stroke for more than one month (inclusive).
  • •Patients with a history of depression or related mental health disorders.
  • •Patients with a history of neck pain, injury, or disease.
  • •Patients who have previously undergone tracheostomy or have a tracheostomy tube in place.

研究组 & 干预措施

Experimental Group

Experimental

Experimental Group:Participants in this group will receive traditional swallowing rehabilitation combined with chin tuck against resistance (CTAR) training to enhance suprahyoid muscle strength and improve swallowing function.

干预措施: chin tuck against resistance exercise (Behavioral)

Control Group

Placebo Comparator

Control Group:Participants in this group will receive only traditional swallowing rehabilitation without any additional CTAR training.

干预措施: chin tuck against resistance exercise (Behavioral)

结局指标

主要结局

swallowing function

时间窗: before intervention and up to 6 weeks

Use the Functional Oral Intake Scale(FOIS) 、calculating the residual volume of 60 ml of water, swallowing speed, and whether a nasogastric tube is in place to assess swallowing function. FOIS items range from 1 to 7,the higer the better swallowing function。The less residual water and fast swallowing speed(ml/sec), the better the swallowing function. The absence of a nasogastric tube also indicates improvement in swallowing.

次要结局

  • Depression(before intervention and up to 6 and 10 weeks)
  • Swallowing-Related Quality of Life(before intervention and up to 6 and 10 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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