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| Sponsor: | University of Arkansas |
|---|---|
| Collaborators: |
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: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Real-Time Internet Evaluation of Oropharyngeal Dysphagia |
| Enrollment: | 30 |
| Study Start Date: | May 2005 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | March 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.
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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 |
Individuals who have suffered a stroke and/or head and neck cancer and are referred for evaluation of swallowing function.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Illinois | |
| University of Illinois | |
| Urbana-Champaign, Illinois, United States, 61802 | |
| United States, Wisconsin | |
| University of Wisconsin | |
| Madison, Wisconsin, United States, 53205 | |
| Principal Investigator: | Adrienne Perlman | University of Illinois, Urbana Champaign |
| Principal Investigator: | Gary H McCullough, Ph.D. | UAMS Medical Center |
More Information
| Responsible Party: | Adrienne Perlman, University of Illinois, Urbana-Champaign |
| ClinicalTrials.gov Identifier: | NCT00580138 History of Changes |
| Other Study ID Numbers: | 1 R01 DC005603, 1 R01 DC005603 |
| Study First Received: | December 20, 2007 |
| Results First Received: | May 6, 2010 |
| Last Updated: | May 6, 2010 |
| Health Authority: | United States: Institutional Review Board |
|
Deglutition Disorders Evaluation Real-time internet |
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Head and Neck Neoplasms Stroke Deglutition Disorders Neoplasms by Site Neoplasms Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Pharyngeal Diseases Otorhinolaryngologic Diseases |