Comparison of Two Therapies for Upper Esophageal Sphincter (UES) Dysphagia
1 other identifier
interventional
204
1 country
1
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.
Trial Health
Trial Health Score
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participants targeted
Target at P75+ for not_applicable
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 1, 2003
CompletedFirst Posted
Study publicly available on registry
May 2, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedJanuary 13, 2010
January 1, 2010
May 1, 2003
January 12, 2010
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients with pharyngeal phase dysphagia due to stroke or chemoradiation for head and neck cancer (without surgical intervention)
- Incomplete UES opening and post-deglutitive aspiration
- Hypopharyngeal (pyriform sinus) residue or vallecular residue alone or in combination
- Dysphagia requiring tube feeding (at least 3 months non-oral condition)
- Able to comply with protocol mandates, willing to perform the exercise programs, and ability to attend study sessions.
You may not qualify if:
- Pharyngeal surgical procedures
- Other neuromuscular disorders such as
- Lack of cognition
- Metabolic myopathies
- History of alcoholic neuropathy
- Steroid myopathy
- Cervical spine injury, lesions, or large osteophytes
- Kerns-Sayers Syndrome
- Individuals unable to exercise independently
- Oculo-pharyngeal and other dystrophies
- Current use of anticholinergics:
- bensodiazopin, antihistamines
- Myasthenia gravis
- Elimination of aspiration with posture during VFG
- Absent pharyngeal swallow on VFG
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical College University of Wisconsin
Milwaukee, Wisconsin, United States
Related Publications (1)
Shaker R, Easterling C, Kern M, Nitschke T, Massey B, Daniels S, Grande B, Kazandjian M, Dikeman K. Rehabilitation of swallowing by exercise in tube-fed patients with pharyngeal dysphagia secondary to abnormal UES opening. Gastroenterology. 2002 May;122(5):1314-21. doi: 10.1053/gast.2002.32999.
PMID: 11984518BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Reza Shaker, M.D.
Professor and Chief, Division of Gastroenterology and Hepatology, Director, Digestive Disease Center, Medical College of Wisconsin
- PRINCIPAL INVESTIGATOR
Jerilyn A. Logemann, Ph.D.
Professor Department of Communication Sciences and Disorders, Ralph and Jean Sundin Professor of Communication Sciences and Disorders, Northwestern University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Sponsor Type
- NIH
Study Record Dates
First Submitted
May 1, 2003
First Posted
May 2, 2003
Study Completion
December 1, 2007
Last Updated
January 13, 2010
Record last verified: 2010-01