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临床试验/NCT04889170
NCT04889170已完成不适用

Prevalence of Subclinical and Clinical Dysphagia in Parkinson's Disease and Evaluation of the NRZ Dysphagia Pathway

Neurological Rehabilitation Hospital Rosenhügel1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2020年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
180
试验地点
1
主要终点
Prevalence of dysphagia

研究概览

简要总结

Background:

In idiopathic Parkinson's disease, 50% of patients develop in the course of the disease a dysphagia and aspiration pneumonia is the leading cause of death in all parkinsonian syndromes . Dysphagia can negatively impact on the course of Parkinson's disease due to complications such as aspiration pneumonia, malnutrition, inadequate drug action, it causes a deterioration in quality of life and leads to an increase in health care costs of more than 10% Therefore, it is very important to detect subclinical dysphagia in time in Parkinson's disease and to initiate a targeted swallowing therapy. In the Neurological Rehabilitation Center Rosenhügel, patients with Parkinson's disease participate in the Parkinson rehabilitation pathway during their rehabilitation program. A part of the Parkinson rehabilitation pathway is the dysphagia pathway. It includes a clinical swallowing examination, an instrumental assessment of swallowing, performed by a fiberoptic endoscopic evaluation of swallowing (FEES) and a dysphagia training. Because of the serious clinical consequences of dysphagia, the investigators decided to further evaluate the prevalence of subclinical and clinical dysphagia in Parkinson's disease and to assess the efficacy of the NRZ dysphagia pathway. Our goal is to detect and classify all Parkinson's disease patients with dysphagia and to prevent the complications of dysphagia by an early therapeutic intervention.

Objectives Primary objective: Evaluation of prevalence of dysphagia in Parkinson's disease Secondary objective: Evaluation of the impact of the NRZ dysphagia pathway on the severity of dysphagia through vocal training or dysphagia training Methods A prospective cohort study will be conducted for 24 months. All patients with the diagnosis of a Parkinson's disease, who are treated as inpatients in the Neurological Rehabilitation Center Rosenhügel from 5/2020 till 5/2022 and have signed an informed consent form will be enrolled in the study. The patients will be examined for dysphagia by a clinical swallowing examination, by a FEES and by measuring the swallowing related quality of life before and after dysphagia training.

Intervention A dysphagia training, which consists of a biofeedback therapy and a swallow training or a voice training. The intervention lasts 3 weeks, by extended stay it lasts 5 or 7 weeks.

详细描述

Background:

In idiopathic Parkinson's disease, 50% of patients develop in the course of the disease a dysphagia and aspiration pneumonia is the leading cause of death in all parkinsonian syndromes. Dysphagia in idiopathic Parkinson's disease is subjectively perceived and communicated only in the late stages. Dysphagia can negatively impact on the course of Parkinson's disease due to complications such as aspiration pneumonia, malnutrition, inadequate drug action, it causes a deterioration in quality of life and leads to an increase in health care costs of more than 10% . Therefore, it is very important to detect subclinical dysphagia in time in Parkinson's disease and to initiate a targeted swallowing therapy. Simple screening methods are insufficient for the diagnosis of subclinical swallowing disorders. In the Neurological Rehabilitation Center Rosenhügel, patients with Parkinson's disease participate in the Parkinson rehabilitation pathway during their rehabilitation program. A part of the Parkinson rehabilitation pathway is the dysphagia pathway. It includes a clinical swallowing examination, an instrumental assessment of swallowing, performed by a fiberoptic endoscopic evaluation of swallowing (FEES) and a dysphagia training. Because of the serious clinical consequences of dysphagia, the investigators decided to further evaluate the prevalence of subclinical and clinical dysphagia in Parkinson's disease and to assess the efficacy of the NRZ dysphagia pathway. Our goal is to detect and classify all Parkinson's disease patients with dysphagia and to prevent the complications of dysphagia by an early therapeutic intervention.

Objectives Primary objective: Evaluation of prevalence of dysphagia in Parkinson's disease Secondary objective: Evaluation of the impact of the NRZ dysphagia pathway on the severity of dysphagia through vocal training or dysphagia training Methods A prospective cohort study will be conducted for 24 months. All patients with the diagnosis of a Parkinson's disease, who are treated as inpatients in the Neurological Rehabilitation Center Rosenhügel from 5/2020 till 5/2022 and have signed an informed consent form will be enrolled in the study. The patients will be examined for dysphagia by a clinical swallowing examination, by a FEES and by measuring the swallowing related quality of life before and after dysphagia training.

Intervention A dysphagia training, which consists of a biofeedback therapy and a swallow training or a voice training. The intervention lasts 3 weeks, by extended stay it lasts 5 or 7 weeks.

Results The primary endpoint is the prevalence of clinical and subclinical dysphagia in patients with Parkinsons'disease. Secondary endpoints are the change in the food texture modification categorie as well as the changes in the liquid texture modification categorie, in the Rosenbek Penetration-Aspiration Scale, in the drooling scale an in the swallowing-related quality of life.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of a Parkinson's disease
  • Inpatient in the Neurological Rehabilitation Center Rosenhügel from 12/2020 till 12/2022
  • Informed consent form signed

排除标准

  • General contraindications of fiberoptic endoscopic evaluation of swallowing.
  • Not feasible fiberoptic endoscopic evaluation of swallowing due to anatomical changes.
  • Not feasible fiberoptic endoscopic evaluation of swallowing due to hypersensitivity .
  • Not feasible fiberoptic endoscopic evaluation of swallowing due to incompliance.
  • Pregnancy.

结局指标

主要结局

Prevalence of dysphagia

时间窗: 24 Months

Primary objectives (Hypothesis): Evaluation of prevalence of dysphagia in Parkinson's disease. We assume that 30 percent of the patients will have a clinical dysphagia and 70 percent will have no clinical dysphagia.

次要结局

  • Evaluation of the impact of the NRZ dysphagia pathway on the severity of dysphagia as measured by the Rosenbek Penetration-Aspiration Scale(24 Months)
  • Evaluation of the impact of the NRZ dysphagia pathway on the severity of dysphagia as measured by the liquid texture modification categorie(24 Months)
  • Evaluation of the impact of the NRZ dysphagia pathway on the severity of dysphagia as measured by the Drooling Severity and Frequency Scale(24 Months)
  • Evaluation of the impact of the NRZ dysphagia pathway on the severity of dysphagia as measured by the food texture modification categorie(24 Months)

研究者

发起方
Neurological Rehabilitation Hospital Rosenhügel
申办方类型
Other
责任方
Sponsor

研究点 (1)

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