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

Primary Purpose

Deglutition Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Shaker Exercise vs. Traditional Dysphagia Therapy Regime
Sponsored by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Deglutition Disorders focused on measuring UES, Dysphagia

Eligibility Criteria

21 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical College University of Wisconsin

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 1, 2003
Last Updated
January 12, 2010
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT00059670
Brief Title
Comparison of Two Therapies for Upper Esophageal Sphincter (UES) Dysphagia
Official Title
Comparison of Two Therapies for UES Dysphagia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

5. Study Description

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: 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 Define the pathophysiology underlying the swallow dysfunction and those pathophysiologic elements which change as a result of each therapy program including changes in - anteroposterior and lateral diameter of maximum deglutitive UES opening maximum deglutitive laryngeal anterior and superior excursions

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deglutition Disorders
Keywords
UES, Dysphagia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Allocation
Randomized
Enrollment
204 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Shaker Exercise vs. Traditional Dysphagia Therapy Regime

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reza Shaker, M.D.
Organizational Affiliation
Professor and Chief, Division of Gastroenterology and Hepatology, Director, Digestive Disease Center, Medical College of Wisconsin
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jerilyn A. Logemann, Ph.D.
Organizational Affiliation
Professor Department of Communication Sciences and Disorders, Ralph and Jean Sundin Professor of Communication Sciences and Disorders, Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical College University of Wisconsin
City
Milwaukee
State/Province
Wisconsin
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11984518
Citation
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.
Results Reference
background
Links:
URL
http://www.mcw.edu
Description
Division of Gastroenterology and Hepatology

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

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