Effects of specific therapies on the masticatory system and on sleep variables in cerebral palsy patients.

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-994xfs
• Date of registration: 24/11/2011
• Primary sponsor: UNESP-Universidade EStadual Paulista Juluo de Mesquita Filho/ Faculdade de Odontologia de Sâo José dos Campos - Brazil
• Public title: Effects of specific therapies on the masticatory system and on sleep variables in cerebral palsy patients.
• Scientific title: Randomized, five arm clinical trial to evaluate the effects of neuromuscular electrical stimulation, lasertherapy and ledtherapy on the masticatory system and the impact on sleep variables in cerebral palsy patients.
• Date of first enrolment: 07/03/2011
• Target sample size: 50
• Recruitment status: recruiting
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-994xfs/
• Study design: Clinical trial, five arm, randomized controlled.

Countries of recruitment

Brazil

Contacts

• Name: Luis Franco de Oliveira
• Affiliation: UNINOVE -Universidade Nove de Julho- São Paulo - SP

• Name: Monica Gomes
• Affiliation: UNESP-Universidade EStadual Paulista Juluo de Mesquita Filho/ Faculdade de Odontologia de Sâo José dos Campos

Key inclusion & exclusion criteria

Inclusion criteria: Subjects from both gender, between 7-15 years old with cerebral palsy; present cognitive system partly preserved; sign the consent term.
Exclusion criteria: Have used botulim toxin before 6 month prior the study;have underwent ortodontic treatment prior the study.

Age minimum: 7Y
Age maximum: 15Y
Gender: -

Health Condition(s) or Problem(s) studied

Cerebral palsy.
C10.228.140.140.254
C10.886

Intervention(s)

Polysomnographic exam and electromiographic inicial data will be carry out in all sample. Then, it will be divided in 5 groups with 10 subjects each. Group 1 will be treated with neuromuscular electrical stimulation twice a week, during 8 consecutive weeks; Group 2 will be treated with laser terapy twice a week, during 8 consecutive weeks; Group 3 will be treated with led therapy twice a week, during 8 consecutive weeks; Group 4 will be treated with neuromuscular electrical stimulation and laser therapy twice a week, during 8 consecutive weeksand Group 5 will be treated with neuromuscular electrical stimulation and led therapy twice a week, during 8 consecutive weeks. At the end of each therapy, the polysomnographic and electromiographic data will be colected.

Primary Outcome(s)

To evaluate the effects of LED on the masticatory muscles activity and mandibular opening in cerebral palsy subjects, will be used surface electromiography, power transductor and goniometer.

To evaluate the effects of lower power laser on the masticatory muscles activity and mandibular opening in cerebral palsy subjects, will be used surface electromiography, power tranductor and goniometer.

To evaluate the effects of neuromuscular electrical stimulation on the masticatory muscles activity and mandibular opening in cerebral palsy subjects, will be used surface electromiography, power transductor and goniometer.

To evaluate the effects of neuromuscular electrical stimulation plus laserterapy on the masticatory muscles activity and mandibular opening in cerebral palsy subjects, will be used surface electromiography, power transductor and goniometer.

To evaluate the effects of neuromuscular electrical stimulation plus ledterapy on the masticatory muscles activity and mandibular opening in cerebral palsy subjects, will be used surface electromiography, power transductor and goniometer.

Secondary Outcome(s)

Polysomnograpy will be used to detect and diagnose the sleep breathing disorders, mostly obstructive sleep apnea.

Polysomnograpy will be used to evaluate the oxyhemogloblin dessaturation.

Polysomnograpy will be used to evaluate the sleep architerure status, detecting the balance and / or imbalance between superficial and deep sleep stages.

Secondary ID(s)

007/2011

02495/09-0

Source(s) of Monetary Support

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior-CAPES - Brazil

Secondary Sponsor(s)

UNINOVE -Universidade Nove de Julho- São Paulo - SP - Brazil