Impact of External Pharyngeal Exerciser on Dysphagia in Patients With Pharyngeal Weakness
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Determine efficacy: effect of EPE on swallowing via effects on pyriform sinus and vallecular residue height and width
研究概览
简要总结
Pharyngeal muscle weakness and dysphagia is common in individuals post-stroke or with Parkinson's disease and in individuals with head/neck cancer who have undergone surgery and/or radiation therapy. Therapeutic options for these patients are limited. This pilot study is intended to assess the feasibility, safety, and efficacy of the External Pharyngeal Exerciser (EPE) on patients with pharyngeal dysphagia receiving swallow therapy. Feasibility will be assessed by patient acceptance and practice records. Safety will be compared between groups to test whether there is an increased risk of the EPE versus standard therapy.
详细描述
Pharyngeal dysphagia is incredibly common in individuals who suffer from neurological disorders such as stroke or Parkinson's disease and in individuals with head/neck cancer who have undergone surgery and/or radiation therapy. The pharyngeal muscles in these patients are weak. Other than standard patient-driven swallow therapy, the therapeutic options for these patients are limited. Response to standard patient-drive therapy is variable and dependent on a variety of factors including the muscles most affected by the underlying disorder and patient motivation. This pilot study is intended to assess the feasibility, safety, and efficacy of the External Pharyngeal Exerciser (EPE) on patients with pharyngeal dysphagia receiving swallow therapy. Feasibility will be assessed by patient acceptance and practice records. Safety will be compared between groups to test whether there is an increased risk of the EPE versus standard therapy.
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
- •Pharyngeal dysphagia diagnosed with validated questionnaire and modified barium swallow. Participants must be at least 18 years of age or older.
- •Pharyngeal dysphagia secondary to central neurological disorder such as Parkinson's disease or stroke
- •Pharyngeal dysphagia head/neck cancer secondary to surgery/radiation
- •Pharyngeal dysphagia secondary to elderly age > 65
排除标准
- •Carotid artery bruit or carotid vascular disorders
- •Muscle diseases like muscular dystrophies, myopathies
- •Neuro-muscular junction disorders myasthenia gravis, Eaton-Lambert disorders
- •Current esophageal symptoms like heartburn, dysphagia, chest pain or regurgitation
- •Autonomic dysfunction
- •Pregnancy or lactation
- •Advanced uncontrolled medical disorders (COPD, congestive heart failure, cirrhosis, cancer, chronic renal failure, etc)
- •Medically unstable
结局指标
主要结局
Determine efficacy: effect of EPE on swallowing via effects on pyriform sinus and vallecular residue height and width
时间窗: 1 year
To objectively define pharyngeal response to External Pharyngeal Exerciser with Modified Barium swallow before and after therapy: To determine if application of pharyngeal exerciser changes swallowing as evidenced by reduction in height and width of pyriform sinus and vallecular residue using fluoroscopy study.
Determine efficacy: effect of EPE on swallowing via effects on routinely measured markers of deglutition (penetration-aspiration scale, larynx and hyoid anterior/superior excursion; UES diameter, and pharyngeal transit time)
时间窗: 1 year
To objectively define pharyngeal response to External Pharyngeal Exerciser with Modified Barium swallow before and after therapy: To determine if application of pharyngeal exerciser changes deglutition as noticed by 1) change in aspiration and penetration measured by Rosenbek's penetration-aspiration scale; 2) change in anterior and superior excursion of larynx and hyoid; 3) change in AP and Lateral diameter of UES; 4) change in pharyngeal transit time.
Determine efficacy as assessed by validated pharyngeal dysphagia questionnaire EAT-10
时间窗: 1 year
Subjective evaluation of participant response to an External Pharyngeal Exerciser with a validated pharyngeal dysphagia questionnaire (EAT-10) administered as standard of care before and after therapy (scores 1-10, with higher scores mean worse outcome).
Determine the number of adverse events associated with EPE
时间窗: 1 year
The aim is to determine whether there are any risks associated with the use of the EPE. There are no known risks to placing external pressure to the larynx. However, there is the possibility that the participant may experience discomfort such as rash or may not be able to tolerate the minimal pressure associated with the exerciser. The participant will be evaluated every two weeks by the study physician and reports of adverse events will be recorded. If the participant experiences difficulty in tolerating the minimal pressure, the study will be stopped.
次要结局
- Physiologic change in swallow performance identified on routine Modified barium swallow(1 year)
研究者
Anisa Shaker
Associate Professor of Medicine
University of Southern California