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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00059670
First Posted: May 2, 2003
Last Update Posted: January 13, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  Purpose

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.


Condition Intervention
Deglutition Disorders Procedure: Shaker Exercise vs. Traditional Dysphagia Therapy Regime

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Comparison of Two Therapies for UES Dysphagia

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Estimated Enrollment: 204
Study Completion Date: December 2007
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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00059670


Locations
United States, Wisconsin
Medical College University of Wisconsin
Milwaukee, Wisconsin, United States
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00059670     History of Changes
Other Study ID Numbers: UESD (completed)
First Submitted: May 1, 2003
First Posted: May 2, 2003
Last Update Posted: January 13, 2010
Last Verified: January 2010

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
UES
Dysphagia

Additional relevant MeSH terms:
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases