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OpenTrials
Completed

NCT Number: NCT00001718

Facilitation of Oral Bolus Propulsion Using Electropalatography in Patients With Dysphagia

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Warren G. Magnuson Clinical Center (CC)

Bethesda, Maryland, 20892, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Electropalatography

Device

Sponsors and collaborators

Lead sponsor

National Institutes of Health Clinical Center (CC)

Nih

Registry information

Important dates

Study start
1998
Study completion
2000
First posted
Dec 10, 2002
Registry last updated
Mar 4, 2008

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.

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