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Myofunctional Therapy in Facial Palsy

This study has been completed.
Sponsor:
Information provided by:
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT00989209
First received: October 2, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

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


Condition Intervention
Facial Paralysis
 Drug: Botulinum Toxin Type A
Procedure: myofunctional therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Improvement of Facial Symmetry With Myofunctional Therapy Combined to Botulinum Toxin Injections in Long Standing Facial Paralysis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • Clinical score [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Facial Disability Index (self-report instrument) [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Enrollment: 25
Study Start Date: January 2005
Study Completion Date: December 2006
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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.

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.

  Eligibility

Ages Eligible for Study:   16 Years to 62 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00989209

Locations
Brazil
University of Sao Paulo General Hospital
Sao Paulo, SP, Brazil, 05403-000
Sponsors and Collaborators
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
  More Information

Publications:

Responsible Party: Paula Nunes Toledo, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT00989209     History of Changes
Other Study ID Numbers: CAPPesq 890/04
Study First Received: October 2, 2009
Last Updated: October 2, 2009
Health Authority: Brazil: Ministry of Health
Brazil: National Health Surveillance Agency

Keywords provided by University of Sao Paulo General Hospital:
facial paralysis
asymmetry
myofunctional therapy
botulinum toxin
facial evaluation

Additional relevant MeSH terms:
Facies
Facial Paralysis
Bell Palsy
Paralysis
Disease Attributes
Pathologic Processes
Mouth Diseases
Stomatognathic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Herpesviridae Infections
DNA Virus Infections
 Virus Diseases
Facial Nerve Diseases
Cranial Nerve Diseases
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013