Myofunctional Therapy in Facial Palsy

Facial Paralysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00989209
• Other study ID #: CAPPesq 890/04
• Status: Completed
• Phase: N/A
• First received: October 2, 2009
• Last updated: October 2, 2009
• Start date: January 2005
• Est. completion date: December 2006

Study information

• Verified date: October 2009
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of HealthBrazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2006
• Est. primary completion date: December 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years to 62 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bell Palsy
• Facial Paralysis
• Facies
• Paralysis

Intervention

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.

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.

Locations

Country	Name	City	State
Brazil	University of Sao Paulo General Hospital	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical score		2 months	Yes
Secondary	Facial Disability Index (self-report instrument)		2 months	Yes