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临床试验/NCT06256848
NCT06256848Unknown不适用

A Randomized Controlled Study to Explore Effect of Myofascial Release on Dysphagia in Stroke Survivors

Zeng Changhao1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年2月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
1
主要终点
Penetration-Aspiration Scale

研究概览

简要总结

The goal of this clinical trial is to explore Clinical Effect of Myofascial Release Therapy in Dysphagic Stroke Survivors. The main question it aims to answer is:

• Can Myofascial Release Therapy improve swallowing function in Stroke Survivors? Patients will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Myofascial Release Therapy. The study lasts 21 days for each patient. Researchers will compare the Functional Oral Intake Scale, Penetration-Aspiration Scale, Swallowing Quality of Life to see if the Myofascial Release Therapy can help improve the situation.

详细描述

Myofascial release, also known as fascial release or fascial manipulation, is a physical therapy used to treat muscle and fascial tissue tension or pain. It involves applying appropriate pressure and stretching to release tight fascia and soft tissues, improving blood circulation, alleviating pain, and promoting rehabilitation.

The goal of this clinical trial is to explore Clinical Effect of Myofascial Release Therapy in Dysphagic Stroke Survivors. The main question it aims to answer is:

• Can Myofascial Release Therapy improve swallowing function in Stroke Survivors? Patients will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Myofascial Release Therapy. The study lasts 21 days for each patient. Researchers will compare the Functional Oral Intake Scale, Penetration-Aspiration Scale, Swallowing Quality of Life to see if the Myofascial Release Therapy can help improve the situation.

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
Double (Investigator, 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 stroke;
  • any degree of dysphagia at admission;
  • steady vital signs, without severe cognitive impairment or sensory aphasia, able to cooperate with the assessment.
  • transferred out within three weeks of hospitalization in the neurology department.

排除标准

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

研究组 & 干预措施

rehabilitation treatment+ Myofascial Release group

Experimental

Study lasts 21 days for each patient. All patients are given rehabilitation treatment.The experimental group was given the Myofascial Release Therapy, five days a week, once a day, for 30-60 minutes each time.

干预措施: Myofascial Release Therapy (Behavioral)

rehabilitation treatment+ Myofascial Release group

Experimental

Study lasts 21 days for each patient. All patients are given rehabilitation treatment.The experimental group was given the Myofascial Release Therapy, five days a week, once a day, for 30-60 minutes each time.

干预措施: Rehabilitation treatment (Behavioral)

rehabilitation treatment group

Active Comparator

Study lasts 21 days for each patient. All patients are given rehabilitation treatment, five days a week, once a day, for 30-60 minutes each time.

干预措施: Rehabilitation treatment (Behavioral)

结局指标

主要结局

Penetration-Aspiration Scale

时间窗: day 1 and day 21

Penetration-Aspiration Scale was used to assess dysphagia under Videofluoroscopic Swallowing Study, primarily evaluating the extent to which fluid food entered the airway and caused penetration or aspiration during the swallowing process. The scores ranged 1 point to 8 points. As the level increased, the severity of dysphagia also increased.

次要结局

  • Patient health questionnaire-9(day 1 and day 21)
  • Functional Oral Intake Scale(day 1 and day 21)
  • Swallowing Quality of Life questionnaire(day 1 and day 21)

研究者

发起方
Zeng Changhao
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Zeng Changhao

Research Director

People's Hospital of Zhengzhou University

研究点 (1)

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