External Pharyngeal Exerciser for Dysphagia
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- 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
Exclusion criteria
- 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
30 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Anisa Associate Professor of Medicine; Associate Professor of Medicine
Data sourced from clinicaltrials.gov
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