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| Tracking Information | |||||||||
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| First Received Date ICMJE | December 20, 2007 | ||||||||
| Last Updated Date | October 13, 2009 | ||||||||
| Start Date ICMJE | May 2005 | ||||||||
| Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Reliability ratings among clinicians using traditional and real-time internet evaluation of swallowing. [ Time Frame: Continuous, ongoing ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00580138 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Real-Time Internet Evaluation of Swallowing | ||||||||
| Official Title ICMJE | Real-Time Internet Evaluation of Oropharyngeal Dysphagia | ||||||||
| Brief Summary | 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. |
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| 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. |
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| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Case-Only, Prospective | ||||||||
| Condition ICMJE | Stroke and/or Head and Neck Cancer. | ||||||||
| Intervention ICMJE | |||||||||
| Study Arms / Comparison Groups | Any subject who has suffered a stroke or has some form of head & neck cancer (non-laryngectomee) may be enrolled. | ||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 60 | ||||||||
| Completion Date | March 2009 | ||||||||
| Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 21 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00580138 | ||||||||
| Responsible Party | Adrienne Perlman, University of Illinois, Urbana-Champaign | ||||||||
| Study ID Numbers ICMJE | 1 R01 DC005603, 1 R01 DC005603 | ||||||||
| Study Sponsor ICMJE | University of Arkansas | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | University of Arkansas | ||||||||
| Verification Date | October 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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