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Facilitation of Oral Bolus Propulsion Using Electropalatography in Patients With Dysphagia

This study has been completed.

Sponsored by: National Institutes of Health Clinical Center (CC)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00001718
  Purpose

Electropalatography (EPG), a noninvasive device that provides specific visual output on tongue-palate contact, has well-established usefulness as a biofeedback tool in speech therapy. While EPG has also been shown to be capable of revealing the details of linguopalatal interactions during swallowing, its applicability in swallowing therapy has not been evaluated to date. This study will determine if EPG can facilitate bolus propulsion in patients presenting with swallowing problems of the oral phase. Seven patients with oral dysphagia will be selected to serve as subjects based on specific inclusion and exclusion criteria, and each will be custom-fitted with a pseudo-palate. Each patient will undergo four 45-minute sessions of biofeedback training with emphasis on developing systematic front-to-back anchoring of the tongue against the palate during propulsion of liquid and semisolid boluses. Ultrasound imaging will be used to determine swallow durations and identify oral deficits of swallowing before the EPG biofeedback training, and to identify any changes that may result from the training. Quantitative measurements will also be made of the swallow-related EPG contact timing and pattern before and after training and compared for each individual subject as a function of training and bolus volume. Appropriate statistical analyses will be conducted.


Condition Intervention
Deglutition Disorders
Dysphagia
Device: Electropalatography

MedlinePlus related topics:   Swallowing Disorders   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Other
Official Title:   Facilitation of Oral Bolus Propulsion Using Electropalatography in Patients With Dysphagia

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment:   10
Study Start Date:   July 1998
Estimated Study Completion Date:   June 2000

Detailed Description:

Electropalatography (EPG), a noninvasive device that provides specific visual output on tongue-palate contact, has well-established usefulness as a biofeedback tool in speech therapy. While EPG has also been shown to be capable of revealing the details of linguopalatal interactions during swallowing, its applicability in swallowing therapy has not been evaluated to date. This study will determine if EPG can facilitate bolus propulsion in patients presenting with swallowing problems of the oral phase. Ten patients with oral dysphagia will be selected to serve as subjects based on specific inclusion and exclusion criteria, and each will be custom-fitted with a pseudo-palate. Each patient will undergo four 45-minute sessions of biofeedback training with emphasis on developing systematic front-to-back anchoring of the tongue against the palate during propulsion of liquid and semisolid boluses. Ultrasound imaging will be used to determine swallow durations and identify oral deficits of swallowing before the EPG biofeedback training, and to identify any changes that may result from the training. Quantitative measurements will also be made of the swallow-related EPG contact timing and pattern before and after training and compared for each individual subject as a function of training and bolus volume. Appropriate statistical analyses will be conducted.

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Patients who have undergone comprehensive swallowing evaluations (i.e., ultrasound and/or videofluoroscopic swallow studies, oral sensorimotor examination, and swallowing questionnaire) in the Speech Pathology Section and have been found to have dysphagia with prominent oral signs.

All subjects must be alert and oriented to time and place, able to ingest food by mouth, and have intact or aided hearing and vision.

No patients that exhibit oral apraxia, dementia, aphasia, behavioral problems, and endentousness.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001718

Locations
United States, Maryland
Warren G. Magnuson Clinical Center (CC)    
      Bethesda, Maryland, United States, 20892

Sponsors and Collaborators
  More Information

Publications:

Study ID Numbers:   980135, 98-CC-0135
First Received:   November 3, 1999
Last Updated:   March 3, 2008
ClinicalTrials.gov Identifier:   NCT00001718
Health Authority:   United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Biofeedback  
Swallowing  
Swallowing Therapy  
Tongue/Palate
Ultrasound
Dysphagia

Study placed in the following topic categories:
Deglutition Disorders
Otorhinolaryngologic Diseases
Digestive System Diseases
Esophageal disorder
Gastrointestinal Diseases
Esophageal Diseases
Pharyngeal Diseases

ClinicalTrials.gov processed this record on September 05, 2008




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