Evaluation of the Efficacy of a Two-week Expiratory Muscle Training on Swallowing Function in Patients With Parkinsonian Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 6
- 主要终点
- dysphagia-score
研究概览
简要总结
This is an interventional therapy study designed to evaluate the efficacy of a two-week intervention, i.e. training with a specialized exhalation training device (called expiratory muscle strength training; EMST150 or EMST75; Aspire Products, Gainsville, FL) on swallowing function in patients with neurodegenerative Parkinsonian disorders. This study involves a routine endoscopic evaluation of swallowing (FEES) to diagnose dysphagia before and after the intervention. Between the two FEES, a two-week exhalation training program takes place, which the patients perform independently following instructions from a speech and lanuage pathologist. In addition demographic and disease-specific data and two questionnaires (Swallowing Disturbance Questionnaire for Parkinson's disease patients, SDQ-PD, and Swallowing specific Quality Of Life Questionnaire SWAL-QoL) are recorded.
详细描述
This is an interventional therapy study designed to evaluate the efficacy of a two-week intervention, i.e. training with a specialized exhalation training device (called expiratory muscle strength training; EMST150 or EMST75; Aspire Products, Gainsville, FL) on swallowing function in patients with neurodegenerative Parkinsonian disorders. This study involves a routine endoscopic evaluation of swallowing (FEES) to diagnose dysphagia before and after the intervention. Between the two FEES, a two-week exhalation training program takes place, which the patients perform independently following instructions from a speech and lanuage pathologist. In addition demographic and disease-specific data and two questionnaires (Swallowing Disturbance Questionnaire for Parkinson's disease patients, SDQ-PD, and Swallowing specific Quality Of Life Questionnaire SWAL-QoL) are recorded.
Main hypothesis: Two weeks of EMST will lead to a significant improvement of the endoscopic dysphagia score in patients with neurodegenerative Parkinsonian disorders with endoscopically proven oropharyngeal dysphagia. Patients with idiopathic Parkinson's syndrome as well as its differential diagnoses, multiple system atrophy (MSA) and diseases from the group of 4repeat tauopathies, will be examined.
Idiopathic Parkinson's disease (PD):
More than 80% of all patients with PD develop clinically relevant dysphagia during the course of the disease. This can lead to a significant reduction in quality of life, decreased medication efficacy, malnutrition, dehydration, and ultimately aspiration pneumonia in affected patients, which is the most common cause of death in advanced PD patients. The cause of PD-associated dysphagia is a multifactorial genesis with impairment of dopaminergic and non-dopaminergic pathways of the central swallowing network and additional peripheral neuromuscular influences.
Multiple System Atrophy (MSA):
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •≥ 18 years of age with.
- •diagnosis of idiopathic Parkinson's disease according to the updated diagnostic criteria (Postuma 2015) or (3) Diagnosis of a possible or probable Multiple System Atrophy according to the diagnostic criteria (Gilman 2008) or (4) Diagnosis of a possible or probable progressive supranuclear gaze palsy according to the diagnostic criteria (Höglinger 2017) (5) in Hoehn and Yahr stages I-V.
排除标准
- •Patients that do not sign the informed consent form
- •Patients who have contraindications for a fiberendoscopic swallowing examination
- •Patients who have contraindications to the two weeks of EMST training (e.g., severe pulmonary disease, severe dementia).
- •Patients who have competing causes of dysphagia (e.g., history of stroke, tumor in the neck).
结局指标
主要结局
dysphagia-score
时间窗: 14 days
improvement of dysphagia score observed on FEES after the intervention in all three groups. Three salient parameters of swallowing function are evaluated: 1. premature spillage 2. penetration-aspiration events 3. residue The scoring of these parameters is done separately using 3 ordinal 5-point scales (0- 4, from 0 = best to 4 = worst). Dysphagia severity, assessed by FEES, is classified according to a four-point scale (0-3) developed for patients with PD and atypical parkinsonism: 0 = no relevant dysphagia, 1. = mild dysphagia (premature spillage and/or residues without penetration/aspiration events), 2. = moderate dysphagia (penetration/aspiration events of one consistency), and 3. = severe dysphagia (penetration/aspiration events of two or more consistencies).
次要结局
- SDQ-PD score(14 days)
- SWAL-QoL score(14 days)