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| Descriptive Information Fields | |||||||||
| Brief Title † | Comparison of Two Therapies for Upper Esophageal Sphincter (UES) Dysphagia | ||||||||
| Official Title † | Comparison of Two Therapies for UES Dysphagia | ||||||||
| Brief Summary | The aim of this research study is to determine the effectiveness of: 1) a traditional therapy regimen focusing on individual exercises for pharyngeal (throat) and laryngeal (voice box) musculature and 2) a new therapeutic exercise, the Shaker exercise. The primary objective of this 5-year project is to identify which of two therapy programs, the Shaker exercise versus traditional therapy, results in the largest number of stable, non-oral dysphagic patients who can swallow safely and return to full oral feeding after 6 weeks of intervention. The study is powered adequately so that this aim can be tested separately for head and neck cancer and stroke patients. Our primary outcome measure is return to oral feeding, i.e., 100% of nutrition and hydration by mouth. |
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| Detailed Description | Secondary aims of this research are:
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| Study Phase | |||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Efficacy Study | ||||||||
| Primary Outcome Measure † | |||||||||
| Secondary Outcome Measure † | |||||||||
| Condition † | Deglutition Disorders | ||||||||
| Intervention † | Procedure: Shaker Exercise vs. Traditional Dysphagia Therapy Regime | ||||||||
| MEDLINE PMIDs | 11984518 | ||||||||
| Links | Division of Gastroenterology and Hepatology ![]() |
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Completed | ||||||||
| Enrollment † | 204 | ||||||||
| Start Date † | |||||||||
| Completion Date | December 2007 | ||||||||
| Eligibility Criteria † | Inclusion Criteria (all required)
Exclusion Criteria
bensodiazopin, antihistamines
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| Gender | Both | ||||||||
| Ages | 21 Years to 90 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† | |||||||||
| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00059670 | ||||||||
| Organization ID | UESD | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | ||||||||
| Verification Date | January 2008 | ||||||||
| First Received Date † | May 1, 2003 | ||||||||
| Last Updated Date | January 30, 2008 | ||||||||