NCT00903669

Brief 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. The investigators hypothesized that this measurement would provide objective data regarding the efficacy of rehabilitation for these challenging patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

May 14, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 18, 2009

Completed
Last Updated

May 18, 2009

Status Verified

May 1, 2009

Enrollment Period

8 months

First QC Date

May 14, 2009

Last Update Submit

May 14, 2009

Conditions

Peripheral Facial Paralysis

Keywords

Facial paralysisMuscle tonusRehabilitationMyofunctionalStomatognathic system

Study Arms (1)

Peripheral Facial Paralysis (PFP)

Patients who are diagnosed with peripheral facial paralysis.

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with PFP treated in the Hospital of Unicamp

You may qualify if:

  • age range between 20 and 70 years
  • incomplete PFP (Degree IV)
  • integral facial nerve (FN)

You may not qualify if:

  • systemic disease
  • potentially aggravating the PFP (neurological, degenerative, endocrinological)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade estadual de Campinas

Campinas, São Paulo, 13081-970, Brazil

Location

MeSH Terms

Conditions

Facial Paralysis

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jorge R Paschoal

    Universidade Estadual de Campinas, Unicamp

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 14, 2009

First Posted

May 18, 2009

Study Start

January 1, 2005

Primary Completion

September 1, 2005

Study Completion

February 1, 2006

Last Updated

May 18, 2009

Record last verified: 2009-05

Locations

BR(1)