Evaluation of masticatory function in adult patients with cerebral palsy

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-2m9mgq
• Date of registration: 25/01/2012
• Primary sponsor: Faculdade de Odontologia \ UNESP - Brazil
• Public title: Evaluation of masticatory function in adult patients with cerebral palsy
• Scientific title: Clinical and electromyographic evaluation of masticatory dynamics in adult patients with cerebral palsy
• Date of first enrolment: 01/07/2011
• Target sample size: 33
• Recruitment status: recruiting
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-2m9mgq/
• Study design: Analytical observational cross-sectional study.

Countries of recruitment

Brazil

Contacts

• Name: Mônica Gomes
• Affiliation: Faculdade de Odontologia \ UNESP

• Name: Mônica Gomes
• Affiliation: Faculdade de Odontologia \ UNESP

Key inclusion & exclusion criteria

Inclusion criteria: Origin of the volunteers: Patients from ‘Associação Pró-Saúde para Pacientes com Necessidades Especiais’ - ASPE and Training Program in Dentistry for Persons with Disabilities from Dentistry School of São José dos Campos / UNESP.
Type of cerebral palsy: diparetic, quadriparesis or hemiparesis.
Age: from 18 to 50 years old.
Characteristics of participants: no cognitive deficits, collaborative behavior and without treatment of botulinum toxin at least six months before the study begins.
Concordance of the participants and the legal representative to join the study.

Exclusion criteria: Origin of the volunteers: originating from other institutions than DentistrySchoolof São José dos Campos / UNESP .
Type of cerebral palsy: Any paralysis different than quadriparesis, hemiparesis or diparetic.
Age: not adults.
Characteristics of participants: presentingcognitive deficits, not collaborative behaviorand / or under botulinum toxin treatmtentat least six months before the survey.
Lack of agreement of the participant in this study.


Age minimum: 18Y
Age maximum: 50Y
Gender: -

Health Condition(s) or Problem(s) studied

Cerebbral palsy.
C10.228.140.140.254

Intervention(s)

33 adults with cerebral palsy. Anamnesis and clinical examination will be conducted, as well as the determination of oral motor function through quantification by means of scores. The score achieved by each patient according to her/his performance in accomplishing oral movements will classify her/his impairment of oral motor function in mild, moderate and severe.
Surface electromyography, bite force and maximum mandibular opening will be recorded for electromyographic (EMG) evaluation. The EMG data will be bilaterally obtained from masseter, anterior temporalis and suprahyoid muscles at rest, isometry and openness. The values of electromyographic signals achieved by each patient will allow her/his classification in mild, moderate and severe. Finally, the compatibility between the clinical and electromyographic classifications of will be statistically assessed.

Primary Outcome(s)

It is expected a statistical agreement (p<0,05) between the classification obtained by the clinical examination ( mild, moderate and severe)and electromyography evaluation (mild, if higher than 50 microvolts; moderate, if higher than 20 but lower than 50 microvolts; and severe, if lower than 20 microvolts)of masticatory dynamics of the patients.

Secondary Outcome(s)

It is expected lower electromyographic values (in microvolts) for masticatory muscles of patients with cerebral palsy in relation to those found in the literature for individuals without cerebral palsy, of the same age, with no motor and cognitive impairment (50 e 100 microvolts).

Secondary ID(s)

054/2011-PH/CEP-

Source(s) of Monetary Support

Faculdade de Odontologia \ UNESP - Brazil

Secondary Sponsor(s)

Faculdade de Odontologia \ UNESP - Brazil