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Comparison of Two Therapies for Upper Esophageal Sphincter (UES) Dysphagia

This study has been completed.
Study NCT00059670.   Last updated on January 30, 2008.   Information provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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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.

Detailed Description

Secondary aims of this research are:

  1. Determine in a descriptive manner whether patients with residue in the pyriform sinuses who aspirate the residue after the swallow respond better, i.e., a higher percentage of them can return to 100% oral intake, than patients with residue in the valleculae who aspirate after the swallow or patients with residue in both locations who aspirate after the swallow and thus to define the spectrum of indications for the proposed exercise programs in the two groups of dysphagic patients (stroke and post-chemo radiation treatment for head and neck cancer) and whether postures enable each patient type to swallow more bolus types without aspiration at pre- and post
  2. Define the pathophysiology underlying the swallow dysfunction and those pathophysiologic elements which change as a result of each therapy program including changes in -

    1. anteroposterior and lateral diameter of maximum deglutitive UES opening
    2. maximum deglutitive laryngeal anterior and superior excursions
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 This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  204
Start Date 
Completion Date December 2007
Eligibility Criteria 

Inclusion Criteria (all required)

  • 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.

Exclusion Criteria

  • 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
  • Aspiration before or during the swallow (pre and intradeglutitive aspiration)
  • Not completely tube feeding dependent
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 
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    
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

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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