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Sour Taste and Cold Temperature in Dysphagia

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ClinicalTrials.gov Identifier: NCT00780364
Recruitment Status : Terminated
First Posted : October 27, 2008
Last Update Posted : June 1, 2015
Sponsor:
Information provided by (Responsible Party):
Paula Cristina Cola, UPECLIN HC FM Botucatu Unesp

Tracking Information
First Submitted Date October 24, 2008
First Posted Date October 27, 2008
Last Update Posted Date June 1, 2015
Study Start Date March 2008
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 29, 2015)
Sour Taste and Cold Temperature in Dysphagia [ Time Frame: 24 months ]
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00780364 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Outcome Measures Not Provided
Original Other Outcome Measures Not Provided
 
Descriptive Information
Brief Title Sour Taste and Cold Temperature in Dysphagia
Official Title Sour Taste and Cold Temperature Effects on Pharyngeal Transit Time After Ischemic Stroke:Anatomic and Functional Bases.
Brief Summary The objective is to establish the effect of sour taste and cold temperature on the pharyngeal swallowing transit time after ischemic hemisphere stroke.
Detailed Description Over the past decade there were many studies over normal and pathological swallowing that discuss the influence of taste and temperature. Nevertheless there were many questions on the issue that remains to be solved, including the hemispheric lateralization of lesions dysphagic patients remains also to be fully understood.Swallowing disorder is defined as oropharyngeal dysphagia in presence of alterations in any phase of the complex swallowing dynamics. It could be congenital or acquired, affecting nutritional aspects, hydration, lung function and the individual's social integration [1]. Stroke, has a high incidence among neurological diseases, and cause disturbs on swallowing dynamics presenting signs of dysphagia in at least 50% of cases.A study that analyzed swallowing dynamics by videofluoroscopy in individuals with history of one or more stroke episodes with oropharyngeal dysphagia shows shorter pharyngeal and oropharyngeal transit times with cold stimulus than without them. Other study of heterogeneous neurological diseases such as cerebral palsy, brain trauma, stroke, and Alzheimer's disease, concluded that sour taste improved swallowing, minimizing laryngotracheal penetration and aspiration in individuals with neurological damaged. Chen et al. in an analysis of 42 healthy individuals with several taste bolus found that awareness and arousal could also influence the swallowing function.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population patients in hospital
Condition Stroke
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: October 24, 2008)
30
Original Estimated Enrollment Same as current
Actual Study Completion Date February 2011
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Clinical diagnosis of stroke

Exclusion Criteria:

  • instability clinic
Sex/Gender
Sexes Eligible for Study: All
Ages 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Brazil
Removed Location Countries  
 
Administrative Information
NCT Number NCT00780364
Other Study ID Numbers upeclin/HC/FMB-Unesp-18
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Paula Cristina Cola, UPECLIN HC FM Botucatu Unesp
Study Sponsor UPECLIN HC FM Botucatu Unesp
Collaborators Not Provided
Investigators
Principal Investigator: Paula C Cola, master Sao Paulo State University
PRS Account UPECLIN HC FM Botucatu Unesp
Verification Date June 2012