Effect of Acupuncture Therapy on Dysphagic Parkinson's Patients: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Penetration-Aspiration Scale-paste
研究概览
简要总结
We are currently conducting a randomized controlled study in China, specifically in three hospitals' rehabilitation medicine departments, focusing on dysphagic participants with Parkinson's disease. The aim of our study is to evaluate the effectiveness of acupuncture therapy as an additional intervention for these participants. Participants were randomly assigned to either the experimental group or the control group, with 56 individuals in each group. Both groups are receiving standard treatment and swallowing rehabilitation training, while the experimental group is also receiving acupuncture therapy. Our study aims to provide valuable insights into the potential benefits of acupuncture in improving swallowing difficulties in Parkinson's disease participants.
详细描述
We are currently conducting a randomized controlled study in China, specifically in three hospitals' rehabilitation medicine departments, focusing on dysphagic participants with Parkinson's disease. The aim of our study is to evaluate the effectiveness of acupuncture therapy as an additional intervention for these participants. Participants were randomly assigned to either the experimental group or the control group, with 56 individuals in each group. Both groups are receiving standard treatment and swallowing rehabilitation training, while the experimental group is also receiving acupuncture therapy. Our study aims to provide valuable insights into the potential benefits of acupuncture in improving swallowing difficulties in Parkinson's disease participants.
The study lasted 42 days (6 weeks) for each participant. Specifically, our main focus is on the study of Lianquan, Shanglianquan (depression between the hyoid bone and the lower border of the mandible), Yifeng, Fengchi, Wangu, Fengfu, Yamen, Neidaying (depression of 1 inch below the anterior margin of the mandible), Jinjin, Yuye, posterior pharyngeal wall (both sides of the uvula).
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 diagnostic criteria for Parkinson's disease.
- •Diagnosed with dysphagia confirmed by the video fluoroscopic swallowing study.
- •Water swallow test> Level
- •Stable vital signs, conscious, able to cooperate with assessment and treatment.
排除标准
- •Dysphagia possibly caused by other reasons, such as cerebrovascular disease, trauma, neuromuscular diseases, malignant diseases of the pharynx and larynx, and digestive tract diseases.
- •History of mental diseases or use of antipsychotics.
- •Complicated with cognitive impairment or consciousness dysfunction.
- •Simultaneously suffering from severe liver, kidney failure, tumors, or hematological diseases.
研究组 & 干预措施
routine treatment+swallowing rehabilitation training+acupuncture therapy
The experimental group was given routine treatment and swallowing rehabilitation training. Moreover, the experimental group was given acupuncture therapy.
干预措施: Acupuncture therapy (Procedure)
routine treatment+swallowing rehabilitation training+acupuncture therapy
The experimental group was given routine treatment and swallowing rehabilitation training. Moreover, the experimental group was given acupuncture therapy.
干预措施: Routine rehabilitation training (Behavioral)
routine treatment+swallowing rehabilitation training+acupuncture therapy
The experimental group was given routine treatment and swallowing rehabilitation training. Moreover, the experimental group was given acupuncture therapy.
干预措施: Swallowing rehabilitation training (Behavioral)
routine treatment+swallowing rehabilitation training
The control group was given routine treatment and swallowing rehabilitation training.
干预措施: Swallowing rehabilitation training (Behavioral)
routine treatment+swallowing rehabilitation training
The control group was given routine treatment and swallowing rehabilitation training.
干预措施: Routine rehabilitation training (Behavioral)
结局指标
主要结局
Penetration-Aspiration Scale-paste
时间窗: Day 1 and Day 42
The Penetration-Aspiration Scale (PAS) was conducted under video fluoroscopic swallowing study. PAS 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 PAS scale ranges from 1 to 8, with each level representing different degrees of penetration or aspiration. In this assessment, we used 180% barium sulfate suspension A higher level of PAS indicated a severer dysphagia.
Penetration-Aspiration Scale-liquid
时间窗: Day 1 and Day 42
The Penetration-Aspiration Scale (PAS) was conducted under video fluoroscopic swallowing study. PAS 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 PAS scale ranges from 1 to 8, with each level representing different degrees of penetration or aspiration. In this assessment, we used 60% barium sulfate suspension A higher level of PAS indicated a severer dysphagia.
次要结局
- Swallowing time(Day 1 and Day 42)
- Prealbumin(Day 1 and Day 42)
- Hemoglobin(Day 1 and Day 42)
- Swallowing Quality of Life(Day 1 and Day 42)
- Serum Albumin(Day 1 and Day 42)
- body mass index(Day 1 and Day 42)
研究者
Zeng Changhao
Research Director
People's Hospital of Zhengzhou University