Facilitation of Oral Bolus Propulsion Using Electropalatography in Patients With Dysphagia
Primary Purpose
Deglutition Disorders, Dysphagia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electropalatography
Sponsored by
About this trial
This is an interventional trial for Deglutition Disorders focused on measuring Biofeedback, Swallowing, Swallowing Therapy, Tongue/Palate, Ultrasound, Dysphagia
Eligibility 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.
Sites / Locations
- Warren G. Magnuson Clinical Center (CC)
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00001718
First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Institutes of Health Clinical Center (CC)
1. Study Identification
Unique Protocol Identification Number
NCT00001718
Brief Title
Facilitation of Oral Bolus Propulsion Using Electropalatography in Patients With Dysphagia
Official Title
Facilitation of Oral Bolus Propulsion Using Electropalatography in Patients With Dysphagia
Study Type
Interventional
2. Study Status
Record Verification Date
July 1999
Overall Recruitment Status
Completed
Study Start Date
July 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2000 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institutes of Health Clinical Center (CC)
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deglutition Disorders, Dysphagia
Keywords
Biofeedback, Swallowing, Swallowing Therapy, Tongue/Palate, Ultrasound, Dysphagia
7. Study Design
Study Phase
Not Applicable
Enrollment
10 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Electropalatography
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Warren G. Magnuson Clinical Center (CC)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
8870350
Citation
Chi-Fishman G, Stone M. A new application for electropalatography: swallowing. Dysphagia. 1996 Fall;11(4):239-47. doi: 10.1007/BF00265208.
Results Reference
background
PubMed Identifier
9712125
Citation
Chi-Fishman G, Stone M, McCall GN. Lingual action in normal sequential swallowing. J Speech Lang Hear Res. 1998 Aug;41(4):771-85. doi: 10.1044/jslhr.4104.771.
Results Reference
background
PubMed Identifier
2701094
Citation
Logemann JA, Kahrilas PJ, Hurst P, Davis J, Krugler C. Effects of intraoral prosthetics on swallowing in patients with oral cancer. Dysphagia. 1989;4(2):118-20. doi: 10.1007/BF02407156.
Results Reference
background
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Facilitation of Oral Bolus Propulsion Using Electropalatography in Patients With Dysphagia
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