Study: C-Collar and Dysphagia
Effects of Cervical Bracing on Elderly Patients With Dysphagia
3 other identifiers
observational
23
1 country
1
Brief Summary
The purpose of this study is to characterize oral-pharyngeal swallow function with the guidance of videofluoroscopy under two conditions, with and without cervical bracing, in patients determined to have dysphagia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2013
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 17, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 17, 2017
CompletedFirst Submitted
Initial submission to the registry
October 25, 2017
CompletedFirst Posted
Study publicly available on registry
November 21, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 5, 2018
CompletedOctober 2, 2019
October 1, 2019
3.7 years
October 25, 2017
October 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To identify aspiration between study conditions (with and without a collar).
Measures of dysphagia aspiration (Y/N) and will be obtained in subjects both with and without a collar during the swallow evaluation.
Comparing aspiration presence between two study conditions (with and without a cervical collar). Data will be reported at the end of study completion, an average of 1 year.
Study Arms (2)
Collar On
Individuals who have been referred for videoflouroscopic swallow study (VFSS) as per standard of care, with a stable cervical injury, will have trials of liquids and solids with the Cervical Brace (Collar) on.
Collar Off
Individuals who have been referred for videoflouroscopic swallow study (VFSS) as per standard of care, with a stable cervical injury, will have trials of liquids and solids with the Cervical Brace (Collar) off.
Interventions
Eligibility Criteria
Inpatients with dysphagia in a cervical brace.
You may qualify if:
- Inpatients receiving treatment for a spine injury
- Treating physician's approval that cervical cervical spinal column injury is stable
- Approval for collar removal by treating physician during VFSS
- Adults 60 and over.
- All races.
- Males and females.
- Glasgow coma scale of 13 or greater.
You may not qualify if:
- History of oral-pharyngeal dysphagia.
- Neurologic disorders associated with dysphagia including dementia, Parkinson's disease, multiple sclerosis, stroke, and ALS.
- Pharyngeal/laryngeal surgery or head/neck radiation treatment.
- Glasgow coma scale of less than 13 at time of evaluation.
- Patient's with a tracheotomy.
- Barium intolerance.
- Patients who lack the capacity to consent on their own behalf
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Wisconsin - Madison
Madison, Wisconsin, 53792, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jodi Hernandez, MS
University of Wisconsin, Madison
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2017
First Posted
November 21, 2017
Study Start
September 17, 2013
Primary Completion
May 17, 2017
Study Completion
April 5, 2018
Last Updated
October 2, 2019
Record last verified: 2019-10