Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00059670
Status:
COMPLETED
Last Update Posted:
2010-01-13
First Post:
2003-05-01
Brief Title:
Comparison of Two Therapies for Upper Esophageal Sphincter UES Dysphagia
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Study Overview
Official Title:
Comparison of Two Therapies for UES Dysphagia
Status:
COMPLETED
Status Verified Date:
2010-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 100 of nutrition and hydration by mouth
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 ie 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 ie 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
1 Determine in a descriptive manner whether patients with residue in the pyriform sinuses who aspirate the residue after the swallow respond better ie 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: