Peripheral Facial ParalysisPFNCT00903669
Anthropometric Angular Measurement to Determine Muscle Tonus in Patients With Peripheral Facial Paralysis
An observational study of Peripheral Facial Paralysis, run by University of Campinas, Brazil at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Peripheral Facial Paralysis
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2005to Feb 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with PFP treated in the Hospital of Unicamp
Who may be able to join
- age range between 20 and 70 years
- incomplete PFP (Degree IV)
- integral facial nerve (FN)
Who cannot join
- systemic disease
- potentially aggravating the PFP (neurological, degenerative, endocrinological)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Peripheral Facial Paralysis
- Keywords
- Facial paralysis, Muscle tonus, Rehabilitation, Myofunctional, Stomatognathic system
- Medical subject headings
- Facial Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Peripheral Facial Paralysis (PFP) | Patients who are diagnosed with peripheral facial paralysis. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2009 (estimated)
- Study startJan 2005
- Primary completionSep 2005
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Facial ParalysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Investigators
- Jorge R Paschoal, Principal investigator, Universidade Estadual de Campinas, Unicamp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00903669
- Sponsor's protocol ID
- ATessitore
- Acronym
- PF
- Status last verified
- May 2009
- First submitted
- 14 May 2009
- Last updated
- 18 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anthropometric Angular Measurement to Determine Muscle Tonus in Patients With Peripheral Facial Paralysis
- ClinicalTrials.gov ID
- NCT00903669
- Acronym / sponsor ID
- PF / ATessitore
- Conditions
- Peripheral Facial Paralysis
- Keywords
- Facial paralysis, Muscle tonus, Rehabilitation, Myofunctional, Stomatognathic system
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Sep 2005 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 18 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peripheral Facial Paralysis (PFP) | – | –Patients who are diagnosed with peripheral facial paralysis. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with PFP treated in the Hospital of Unicamp
Key inclusion criteria (3 listed)
- age range between 20 and 70 years
- incomplete PFP (Degree IV)
- integral facial nerve (FN)
Key exclusion criteria (2 listed)
- systemic disease
- potentially aggravating the PFP (neurological, degenerative, endocrinological)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorge R Paschoal principal investigator
Universidade Estadual de Campinas, Unicamp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Facial Paralysis, run by University of Campinas, Brazil at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2009.