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Real-Time Internet Evaluation of Swallowing
This study is currently recruiting participants.
Verified by University of Arkansas, January 2009
First Received: December 20, 2007   Last Updated: January 8, 2009   History of Changes
Sponsors and Collaborators: University of Arkansas
University of Illinois
University of Wisconsin, Madison
Information provided by: University of Arkansas
ClinicalTrials.gov Identifier: NCT00580138
  Purpose

The purpose of this study is to determine whether real-time internet evaluations of swallowing, or x-ray swallow studies viewed over closed internet circuit, are a reliable method of evaluating swallowing function.


Condition
Stroke and/or Head and Neck Cancer.

Study Type: Observational
Study Design: Case-Only, Prospective
Official Title: Real-Time Internet Evaluation of Oropharyngeal Dysphagia

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • Reliability ratings among clinicians using traditional and real-time internet evaluation of swallowing. [ Time Frame: Continuous, ongoing ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 100
Study Start Date: May 2005
Estimated Study Completion Date: February 2009
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Stroke or Head & Neck Cancer
Any subject who has suffered a stroke or has some form of head & neck cancer (non-laryngectomee) may be enrolled.

Detailed Description:

The objective of this proposal is to establish the validity of an Internet based protocol for real-time, remote, telefluoroscopic evaluation of oropharyngeal swallowing function. The investigators will achieve this goal by testing the hypothesis that oropharyngeal swallowing function evaluated by an experienced speech-language pathologist (SLP) using a remote, interactive, real-time, dynamic Internet telefluoroscopic procedure, which was developed in the PI's laboratory, has an acceptable level of agreement with the evaluations performed by an experienced SLP who is present in the fluoroscopy suite and using the traditional videofluoroscopic methodology. In other words, the primary aim of this investigation is to determine whether the telemedicine approach to evaluation of swallowing function is reliable relative to the traditional method by which a clinician is in direct contact with a patient for a pre-examination interview, clinical examination, and videofluoroscopic evaluation of swallowing function. Confirmation of the reliability of the telefluoroscopic evaluation of oropharyngeal dysphagia (hereafter referred to as dysphagia) can result in equity of access for underserved groups for whom SLPs with expertise in evaluating swallowing function are locally unavailable. Ultimately, the success of this project could translate specialty services into routine clinical practice across the United States and globally.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Individuals who have suffered a stroke and/or head and neck cancer and are referred for evaluation of swallowing function.

Criteria

Inclusion Criteria:

  • Stroke, Head & neck cancer, referred for swallowing evaluation.

Exclusion Criteria:

  • No stroke or no head and neck cancer, or not referred for swallowing evaluation.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00580138

Contacts
Contact: Adrienne Perlman, Ph.D. (217)244-0893 aperlman@uiuc.edu

Locations
United States, Illinois
University of Illinois Recruiting
Urbana-Champaign, Illinois, United States, 61802
Contact: Adrienne Perlman, Ph.D.     217-244-0893     aperlman@uiuc.edu    
United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53205
Contact: JoAnne Robbins, Ph.D.     608-280-7000     jrobbin@wisc.facstaff.edu    
Sponsors and Collaborators
University of Arkansas
University of Illinois
University of Wisconsin, Madison
Investigators
Principal Investigator: Adrienne Perlman University of Illinois, Urbana Champaign
Principal Investigator: Gary H McCullough, Ph.D. UAMS Medical Center
  More Information

No publications provided

Responsible Party: University of Illinois, Urbana-Champaign ( Adrienne Perlman )
Study ID Numbers: 1 R01 DC005603, 1 R01 DC005603
Study First Received: December 20, 2007
Last Updated: January 8, 2009
ClinicalTrials.gov Identifier: NCT00580138     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by University of Arkansas:
Deglutition Disorders
Evaluation
Real-time internet

Study placed in the following topic categories:
Deglutition Disorders
Otorhinolaryngologic Diseases
Digestive System Diseases
Cerebral Infarction
Esophageal Disorder
Gastrointestinal Diseases
Head and Neck Neoplasms
Stroke
Esophageal Diseases
Pharyngeal Diseases

Additional relevant MeSH terms:
Deglutition Disorders
Neoplasms
Otorhinolaryngologic Diseases
Digestive System Diseases
Neoplasms by Site
Gastrointestinal Diseases
Head and Neck Neoplasms
Esophageal Diseases
Pharyngeal Diseases

ClinicalTrials.gov processed this record on July 02, 2009