jRCT1032250587
Recruiting
Not Applicable
Development of a New Swallowing Maneuver and Assessment of Its Effects Using High-Resolution Manometry
Not provided0 sites120 target enrollmentStarted: TBD
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 120
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Single Arm Study
Eligibility Criteria
- Ages
- 20age old over to No limit (—)
- Sex
- All
Inclusion Criteria
- •Healthy subjects with normal swallowing function
- •Individuals aged 20 years or older with normal swallowing function who have provided informed consent after receiving an explanation of this study using the explanatory document.
- •Patients with dysphagia
- •Patients with dysphagia aged 20 years or older who meet the following criteria:
- •Stable general condition.
- •Are inpatients or outpatients in the Department of Rehabilitation at Nippon Medical School Hospital, OR patients visiting the Department of Swallowing and Dysphagia Rehabilitation at Tokyo Medical and Dental University Hospital.
- •Have provided informed consent after receiving an explanation of this study using the explanatory document.
Exclusion Criteria
- •Healthy subjects with normal swallowing function (Exclusion Criteria) Individuals who meet any of the following criteria:
- •Individuals with a history of stroke, neuromuscular diseases (e.g., Parkinson disease, spinocerebellar degeneration, amyotrophic lateral sclerosis, Guillain-Barre syndrome, muscular dystrophy), organic pharyngolaryngeal diseases (diseases causing abnormalities in the throat due to inflammation, cancer, etc.), respiratory diseases, or upper gastrointestinal (esophagus or stomach) diseases.
- •2, Individuals with subjective symptoms suggestive of dysphagia, such as discomfort during swallowing.
- •Individuals otherwise judged inappropriate for participation in this study by the principal investigator or sub-investigator.
- •Patients with dysphagia (Exclusion Criteria) Patients who meet any of the following criteria:
- •Patients whose general condition is unstable.
- •Patients who have difficulty understanding instructions.
- •Patients judged to have severe dysphagia preventing oral intake (Clinical Severity Scale for Dysphagia: Grade 2 (Food aspiration) or below).
- •Patients otherwise judged inappropriate for participation in this study by the principal investigator or sub-investigator.
Investigators
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