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

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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Key information

Conditions

Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

21 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical College University of Wisconsin

Milwaukee, Wisconsin, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Shaker Exercise vs. Traditional Dysphagia Therapy Regime

Procedure

Sponsors and collaborators

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Nih

Registry information

Official study title

Comparison of Two Therapies for UES Dysphagia

Important dates

Study completion: 2007
First posted: May 2, 2003
Registry last updated: Jan 13, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed