NCT00780364

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

March 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 27, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

June 1, 2015

Status Verified

June 1, 2012

Enrollment Period

2.8 years

First QC Date

October 24, 2008

Last Update Submit

May 29, 2015

Conditions

Stroke

Keywords

stroke; sour taste; cold temperature; pharyngeal swallowing

Outcome Measures

Primary Outcomes (1)

  • Sour Taste and Cold Temperature in Dysphagia

    24 months

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients in hospital

You may qualify if:

  • Clinical diagnosis of stroke

You may not qualify if:

  • instability clinic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sao Paulo State University

Botucatu, São Paulo, 18618-970, Brazil

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Paula C Cola, master

    São Paulo State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

October 24, 2008

First Posted

October 27, 2008

Study Start

March 1, 2008

Primary Completion

December 1, 2010

Study Completion

February 1, 2011

Last Updated

June 1, 2015

Record last verified: 2012-06

Locations

BR(1)