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Myofunctional Therapy in Facial Palsy

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ClinicalTrials.gov Identifier: NCT00989209
Recruitment Status : Completed
First Posted : October 5, 2009
Last Update Posted : October 5, 2009
Sponsor:
Information provided by:
University of Sao Paulo General Hospital

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

Condition or disease Intervention/treatment Phase
Facial Paralysis Drug: Botulinum Toxin Type A Procedure: myofunctional therapy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Improvement of Facial Symmetry With Myofunctional Therapy Combined to Botulinum Toxin Injections in Long Standing Facial Paralysis
Study Start Date : January 2005
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2006

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Arms and Interventions
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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 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.


Outcome Measures
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Primary Outcome Measures :
  1. Clinical score [ Time Frame: 2 months ]

Secondary Outcome Measures :
  1. Facial Disability Index (self-report instrument) [ Time Frame: 2 months ]

Eligibility Criteria
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Ages Eligible for Study:   16 Years to 62 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted: October 5, 2009    Key Record Dates
Last Update Posted: October 5, 2009
Last Verified: October 2009

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

Additional relevant MeSH terms:
Paralysis
Facial Paralysis
Bell Palsy
Facies
Disease Attributes
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Mouth Diseases
Stomatognathic Diseases
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
 Facial Nerve Diseases
Cranial Nerve Diseases
Botulinum Toxins
Botulinum Toxins, Type A
onabotulinumtoxinA
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents