Acupuncture Therapy on Dysphagia in Parkinson's Disease: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Penetration-Aspiration Scale-liquid
研究概览
简要总结
From June 2019 to May 2021, we conducted a randomized controlled study, including dysphagic patients with Parkinson's diseases who were admitted to the department of rehabilitation medicine in 3 hospitals in China. The participants were divided randomly into the experimental group and the control group, with 56 in each one. Both two groups were given routine treatment and swallowing rehabilitation training. Moreover, the experimental group was given acupuncture therapy.
详细描述
From June 2019 to May 2021, we conducted a randomized controlled study, including dysphagic patients with Parkinson's diseases who were admitted to the department of rehabilitation medicine in 3 hospitals in China. The participants were divided randomly into the experimental group and the control group, with 56 in each one. Both two groups were given routine treatment and swallowing rehabilitation training. Moreover, the experimental group was given acupuncture therapy. 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
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
All researchers were required to maintain isolation from participants beyond necessary contact and strictly keep confidentiality of research content. We used blind labels to identify participants' intervention or treatment allocation. These labels remained confidential during the research process and were accessible only to researchers and specific staff. In addition, all data collection and assessment were conducted by professionals who were not involved in the intervention and were not aware of the study design to ensure objectivity and independence. All medical staff responsible for the intervention received detailed training before the start of the study to ensure their understanding and proper implementation.
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 developed by the Neurology Branch of the Chinese Medical Association in
- •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.
结局指标
主要结局
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.
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.
次要结局
- Swallowing time-The oral transit time-liquid(day 1 and day 42)
- Nutritional status-Hemoglobin(day 1 and day 42)
- Swallowing time-The oral transit time-paste(day 1 and day 42)
- Swallowing time-pharyngeal transit time-paste(day 1 and day 42)
- Swallowing time-pharyngeal transit time -liquid(day 1 and day 42)
- Nutritional status-Serum Albumin(day 1 and day 42)
- Swallowing time-swallowing reaction time-liquid(day 1 and day 42)
- Swallowing time-laryngeal closure duration-paste(day 1 and day 42)
- Nutritional status-Prealbumin(day 1 and day 42)
- Swallowing time-laryngeal closure duration-liquid(day 1 and day 42)
- Swallowing time-swallowing reaction time-paste(day 1 and day 42)
- Nutritional status-body mass index(day 1 and day 42)
- Standardized Swallowing Assessment(day 1 and day 42)
研究者
Zeng Changhao
Research Director
People's Hospital of Zhengzhou University