Myofunctional Therapy in Facial Palsy

October 2, 2009 updated by: University of Sao Paulo General Hospital

Improvement of Facial Symmetry With Myofunctional Therapy Combined to Botulinum Toxin Injections in Long Standing Facial Paralysis

Objective: Quantify the benefits of myofunctional therapy associated to botulinum toxin injection in patients with long standing facial unilateral palsy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Twenty-five patients with long standing facial palsy were studied; all had been previously treated for facial reanimation. Patients were randomly divided in two groups; Group A did the myofunctional therapy sessions with the speech therapist before the botulinum toxin injection, while the participants of Group B did the myofunctional therapy after it.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

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

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil, 05403-000
        • University of Sao Paulo General Hospital

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

16 years to 62 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • facial paralysis with more than 2 years elapsed since the onset of symptoms
  • surgically treated for reanimation at least 12 months before
  • static and/or dynamic facial asymmetry causing aesthetic concern

Exclusion Criteria:

  • spastic paralysis
  • serious systemic or neuromuscular diseases
  • cognition impairment
  • pregnant women

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A: myofunctional prior to botulinum
All the facial paralysis patients received treatment with botulinum toxin type A to the non-paralyzed side, according to the Institution Protocol. To the participants of Group A, botulinum toxin was applied after myofunctional therapy.
Drug: Botulinum Toxin Type A
All the patients received a one-time treatment with botulinum toxin type A to the non-paralyzed side, according to the Institution Protocol,the total dose used per patient ranged from 15-69U, mean 37.9±5.4U.
Other Names:
  • BOTOX (Allergan)
Procedure: myofunctional therapy
All the patients were submitted to individual myofunctional therapy with the speech therapist, once a week, by four weeks.The myofunctional therapy began with isometric maneuvers for muscular elongation on the non paralyzed side, and on the paralyzed side when microsurgical reconstruction was present. It also included isotonic maneuvers to increase muscle tonus and isokinetic maneuvers to increase force on the paralyzed side.
Active Comparator: B: myofunctional after botulinum
All the facial paralysis patients received treatment with botulinum toxin type A to the non-paralyzed side, according to the Institution Protocol. To the participants of Group B, botulinum toxin was applied before myofunctional therapy.
Drug: Botulinum Toxin Type A
All the patients received a one-time treatment with botulinum toxin type A to the non-paralyzed side, according to the Institution Protocol,the total dose used per patient ranged from 15-69U, mean 37.9±5.4U.
Other Names:
  • BOTOX (Allergan)
Procedure: myofunctional therapy
All the patients were submitted to individual myofunctional therapy with the speech therapist, once a week, by four weeks.The myofunctional therapy began with isometric maneuvers for muscular elongation on the non paralyzed side, and on the paralyzed side when microsurgical reconstruction was present. It also included isotonic maneuvers to increase muscle tonus and isokinetic maneuvers to increase force on the paralyzed side.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical score
Time Frame: 2 months
2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Facial Disability Index (self-report instrument)
Time Frame: 2 months
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Investigators

  • Study Director: Alessandra G Salles, University of Sao Paulo General Hospital
  • Study Chair: Marcus C Ferreira, University of Sao Paulo General Hospital
  • Principal Investigator: Paula N Toledo, University of Sao Paulo General Hospital
  • Study Director: Claudia F Andrade, University of Sao Paulo General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

December 1, 2005

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

October 2, 2009

First Submitted That Met QC Criteria

October 2, 2009

First Posted (Estimate)

October 5, 2009

Study Record Updates

Last Update Posted (Estimate)

October 5, 2009

Last Update Submitted That Met QC Criteria

October 2, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAPPesq 890/04

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.

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