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

Not Applicable

Completed

• Conditions: Deglutition Disorders

• Registration Number: NCT00059670
• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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 Timeline

• Study First Submitted: 2003-05-01
• Study First Submitted QC: 2003-05-01
• Study First Posted: 2003-05-02
• Study Completion: 2007-12
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-12
• Last Update Posted: 2010-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 204

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Medical College University of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States