A Randomized Controlled Study to Explore Effect of Myofascial Release on Dysphagia in Patients With Traumatic Brain Injury
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 Traumatic Brain injured Survivors. The main question it aims to answer is:
• Can Myofascial Release Therapy improve swallowing function in Traumatic Brain injured 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 Traumatic Brain injured Survivors. The main question it aims to answer is:
• Can Myofascial Release Therapy improve swallowing function in Traumatic Brain injured 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
- 否
入选标准
- •age ≥ 18 years, meeting the diagnosis of severe Traumatic Brain Injury.
- •presence of no contraindication for enteral nutrition;
- •with stable vital signs and no severe liver or kidney dysfunction, metabolic disorders, cardiovascular diseases, or multiple complications;
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
The experimental group
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)
The experimental group
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)
The control group
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)
- Swallowing Quality of Life questionnaire(day 1 and day 21)
- Functional Oral Intake Scale(day 1 and day 21)
研究者
Zeng Changhao
PI
People's Hospital of Zhengzhou University