- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00903669
Anthropometric Angular Measurement to Determine Muscle Tonus in Patients With Peripheral Facial Paralysis (PF)
May 14, 2009 updated by: University of Campinas, Brazil
The current study sought to determine the reliability of the rehabilitation protocol using the labial commissure angle (LCA) as an indicator of both muscle tonus and therapeutic success.
The investigators hypothesized that this measurement would provide objective data regarding the efficacy of rehabilitation for these challenging patients.
Study Overview
Status
Completed
Conditions
Detailed Description
CONTEXT AND OBJECTIVE: In cases of peripheral facial paralysis (PFP), diminished facial movements and their resultant cosmetic sequelae may have significant emotional repercussions, in addition to producing pronounced functional deficits.
Abnormal muscle proprioception and deviation of the nasal-labial filter may also interfere with articulation of the labiodental and bilabial phonemes, thus diminishing speech intelligibility.
In relation to stomatognathic functions, weakened labial occlusion decreases intraoral pressure, thereby hindering liquid retention in the buccal cavity and giving rise to vestibular stasis on the paralyzed side.
The aim of this study was to evaluate the reliability of the labial commissure angle (LCA) as an anthropometric marker for objectively assessing changes in facial muscle tonus.
Study Type
Observational
Enrollment (Actual)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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São Paulo
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Campinas, São Paulo, Brazil, 13081-970
- Universidade Estadual de Campinas
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients diagnosed with PFP treated in the Hospital of Unicamp
Description
Inclusion Criteria:
- age range between 20 and 70 years
- incomplete PFP (Degree IV)
- integral facial nerve (FN)
Exclusion Criteria:
- systemic disease
- potentially aggravating the PFP (neurological, degenerative, endocrinological)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Peripheral Facial Paralysis (PFP)
Patients who are diagnosed with peripheral facial paralysis.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jorge R Paschoal, Universidade Estadual de Campinas, Unicamp
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2005
Primary Completion (Actual)
September 1, 2005
Study Completion (Actual)
February 1, 2006
Study Registration Dates
First Submitted
May 14, 2009
First Submitted That Met QC Criteria
May 14, 2009
First Posted (Estimate)
May 18, 2009
Study Record Updates
Last Update Posted (Estimate)
May 18, 2009
Last Update Submitted That Met QC Criteria
May 14, 2009
Last Verified
May 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ATessitore
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.