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临床试验/NCT06303895
NCT06303895Unknown不适用

How Acupuncture Therapy Improves Dysphagia in Parkinson's Patients: A Randomized Controlled Study

Muhammad0 个研究点目标入组 80 人开始时间: 2024年3月1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
主要终点
Penetration-Aspiration Scale-liquid

研究概览

简要总结

This study is 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

This study is 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
Treatment
盲法
Single (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

Experimental

The 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

Experimental

The 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+acupuncture therapy

Experimental

The 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

Active Comparator

The control was given routine treatment and swallowing rehabilitation training

干预措施: Swallowing rehabilitation training (Behavioral)

routine treatment+swallowing rehabilitation training

Active Comparator

The control 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-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

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.

次要结局

  • body mass index(Day 1 and Day 42)
  • Prealbumin(Day 1 and Day 42)
  • Serum Albumin(Day 1 and Day 42)
  • Swallowing time(Day 1 and Day 42)
  • Hemoglobin(Day 1 and Day 42)
  • Swallowing Quality of Life(Day 1 and Day 42)

研究者

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

Muhammad

Research Director

Ahmadu Bello University Teaching Hospital

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