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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00001718
Other study ID # 980135
Secondary ID 98-CC-0135
Status Completed
Phase N/A
First received November 3, 1999
Last updated March 3, 2008
Start date July 1998
Est. completion date June 2000

Study information

Verified date July 1999
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date June 2000
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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 Design

N/A


Related Conditions & MeSH terms


Intervention

Device:
Electropalatography


Locations

Country Name City State
United States Warren G. Magnuson Clinical Center (CC) Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Institutes of Health Clinical Center (CC)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Chi-Fishman G, Stone M, McCall GN. Lingual action in normal sequential swallowing. J Speech Lang Hear Res. 1998 Aug;41(4):771-85. — View Citation

Chi-Fishman G, Stone M. A new application for electropalatography: swallowing. Dysphagia. 1996 Fall;11(4):239-47. — View 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. — View Citation

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