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Myofunctional Therapy in Facial Palsy

Primary Purpose

Facial Paralysis

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Botulinum Toxin Type A
myofunctional therapy
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Facial Paralysis focused on measuring facial paralysis, asymmetry, myofunctional therapy, botulinum toxin, facial evaluation

Eligibility Criteria

16 Years - 62 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Sao Paulo General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

A: myofunctional prior to botulinum

B: myofunctional after botulinum

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Clinical score

Secondary Outcome Measures

Facial Disability Index (self-report instrument)

Full Information

First Posted
October 2, 2009
Last Updated
October 2, 2009
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00989209
Brief Title
Myofunctional Therapy in Facial Palsy
Official Title
Improvement of Facial Symmetry With Myofunctional Therapy Combined to Botulinum Toxin Injections in Long Standing Facial Paralysis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Facial Paralysis
Keywords
facial paralysis, asymmetry, myofunctional therapy, botulinum toxin, facial evaluation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A: myofunctional prior to botulinum
Arm Type
Active Comparator
Arm Description
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.
Arm Title
B: myofunctional after botulinum
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Botulinum Toxin Type A
Other Intervention Name(s)
BOTOX (Allergan)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
myofunctional therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical score
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Facial Disability Index (self-report instrument)
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
62 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alessandra G Salles
Organizational Affiliation
University of Sao Paulo General Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Marcus C Ferreira
Organizational Affiliation
University of Sao Paulo General Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Paula N Toledo
Organizational Affiliation
University of Sao Paulo General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Claudia F Andrade
Organizational Affiliation
University of Sao Paulo General Hospital
Official's Role
Study Director
Facility Information:
Facility Name
University of Sao Paulo General Hospital
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403-000
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
19330369
Citation
Salles AG, Toledo PN, Ferreira MC. Botulinum toxin injection in long-standing facial paralysis patients: improvement of facial symmetry observed up to 6 months. Aesthetic Plast Surg. 2009 Jul;33(4):582-90. doi: 10.1007/s00266-009-9337-9. Epub 2009 Mar 28.
Results Reference
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Myofunctional Therapy in Facial Palsy

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