Myofunctional Therapy in Facial Palsy

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

Detailed Description
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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.

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

Conditions
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Facial Paralysis

Intervention / Treatment
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* Drug: Botulinum Toxin Type A
* Procedure: myofunctional therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 62 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A: myofunctional prior to botulinum<br>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<br>* 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.<br>* Other names: BOTOX (Allergan);Procedure: myofunctional therapy<br>* 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.<br>|
| Active Comparator: B: myofunctional after botulinum<br>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<br>* 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.<br>* Other names: BOTOX (Allergan);Procedure: myofunctional therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical score |  | 2 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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facial paralysis, asymmetry, myofunctional therapy, botulinum toxin, facial evaluation