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Completed

NCT Number: NCT00989209

Myofunctional Therapy in Facial Palsy

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

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Key information

Conditions

Facial Paralysis Mouth Diseases Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases

Age range

16 year–62 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Sao Paulo General Hospital

São Paulo, 05403-000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botulinum Toxin Type A

Drug

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 names: BOTOX (Allergan)

Myofunctional Therapy

Procedure

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 outcomes

  1. Clinical score

    Time frame: 2 months

Secondary outcomes

  1. Facial Disability Index (self-report instrument)

    Time frame: 2 months

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2005
Study completion
2006
First posted
Oct 5, 2009
Registry last updated
Oct 5, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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