Completed

Facilitation of Oral Bolus Propulsion Using Electropalatography in Patients With Dysphagia

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Electropalatography

Device
Who is being recruted

Digestive System Diseases+3

+ Esophageal Diseases

+ Gastrointestinal Diseases

See all eligibility criteria
How is the trial designed

Interventional
Study Start: July 1998
See protocol details

Summary

Principal SponsorNational Institutes of Health Clinical Center (CC)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 1998

Actual date on which the first participant was enrolled.

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.

NCT00001718
Principal SponsorNational Institutes of Health Clinical Center (CC)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

10 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesOtorhinolaryngologic DiseasesPharyngeal DiseasesDeglutition Disorders

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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Warren G. Magnuson Clinical Center (CC)

Bethesda, United StatesOpen Warren G. Magnuson Clinical Center (CC) in Google Maps
CompletedOne Study Center