Myofunctional Therapy in Facial Palsy

Not Applicable

Completed

• Conditions: Facial Paralysis
• Interventions: Drug: Botulinum Toxin Type A; Procedure: myofunctional therapy

• Registration Number: NCT00989209
• Lead Sponsor: University of Sao Paulo General Hospital

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.

Study Timeline

• Study Start: 2005-01
• Primary Completion: 2005-12
• Study Completion: 2006-12
• Status Verified: 2009-10
• Study First Submitted: 2009-10-02
• Study First Submitted QC: 2009-10-02
• Last Update Submitted: 2009-10-02
• Study First Posted: 2009-10-05
• Last Update Posted: 2009-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A: myofunctional prior to botulinum	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 A, botulinum toxin was applied after myofunctional therapy.
B: myofunctional after botulinum	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.
A: myofunctional prior to botulinum	Botulinum Toxin Type A	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.
B: myofunctional after botulinum	Botulinum Toxin Type A	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.

Primary Outcome Measures

Name	Time	Method
Clinical score	2 months

Secondary Outcome Measures

Name	Time	Method
Facial Disability Index (self-report instrument)	2 months

Trial Locations

Locations (1)

University of Sao Paulo General Hospital; 🇧🇷 Sao Paulo, SP, Brazil