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

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.
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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.
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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.
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- Clinical score [ Time Frame: 2 months ]
- Facial Disability Index (self-report instrument) [ Time Frame: 2 months ]

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Ages Eligible for Study: | 16 Years to 62 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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