Real-Time Internet Evaluation of Swallowing

Stroke and/or Head and Neck Cancer. Clinical Trial

Official title:

Real-Time Internet Evaluation of Oropharyngeal Dysphagia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00580138
• Other study ID #: 1R01DC005603
• Secondary ID: 1R01DC005603
• Status: Completed
• Phase: N/A
• First received: December 20, 2007
• Last updated: October 21, 2014
• Start date: May 2005
• Est. completion date: March 2009

Study information

• Verified date: October 2014
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Stroke and/or Head and Neck Cancer.

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin
United States	University of Illinois	Urbana-Champaign	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
University of Arkansas	University of Illinois at Chicago, University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reliability Ratings Among Clinicians Using Real-time Internet Evaluation of Swallowing.	Percentages were calculated for agreement between ratings made by on site clinician and clinician off site with telemedicine.	2 years	No