Open Access Study protocol

Effects of neuromuscular electrical stimulation, laser therapy and LED therapy on the masticatory system and the impact on sleep variables in cerebral palsy patients: a randomized, five arms clinical trial

Lilian Chrystiane Giannasi12*, Miriam Yumi Matsui1, Sandra Regina de Freitas Batista1, Camila Teixeira Hardt1, Carla Paes Gomes1, José Benedito Oliveira Amorim1, Isabella de Carvalho Aguiar2, Luanda Collange2, Israel dos Reis dos Santos2, Ismael Souza Dias2, Cláudia Santos de Oliveira2, Luis Vicente Franco de Oliveira2 and Mônica Fernandes Gomes1

Author Affiliations

1 Department of Biosciences and Oral Diagnosis, School of Dentistry, São Paulo State University, São José dos Campos, SP, Brazil

2 Sleep Laboratory, Nove de Julho University, Sao Paulo, SP, Brazil

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BMC Musculoskeletal Disorders 2012, 13:71  doi:10.1186/1471-2474-13-71

Published: 15 May 2012

Abstract

Background

Few studies demonstrate effectiveness of therapies for oral rehabilitation of patients with cerebral palsy (CP), given the difficulties in chewing, swallowing and speech, besides the intellectual, sensory and social limitations. Due to upper airway obstruction, they are also vulnerable to sleep disorders. This study aims to assess the sleep variables, through polysomnography, and masticatory dynamics, using electromiography, before and after neuromuscular electrical stimulation, associated or not with low power laser (Gallium Arsenide- Aluminun, =780 nm) and LED (= 660 nm) irradiation in CP patients.

Methods/design

50 patients with CP, both gender, aged between 19 and 60 years will be enrolled in this study. The inclusion criteria are: voluntary participation, patient with hemiparesis, quadriparesis or diparetic CP, with ability to understand and respond to verbal commands. The exclusion criteria are: patients undergoing/underwent orthodontic, functional maxillary orthopedic or botulinum toxin treatment. Polysomnographic and surface electromyographic exams on masseter, temporalis and suprahyoid will be carry out in all sample. Questionnaire assessing oral characteristics will be applied. The sample will be divided into 5 treatment groups: Group 1: neuromuscular electrical stimulation; Group 2: laser therapy; Group 3: LED therapy; Group 4: neuromuscular electrical stimulation and laser therapy and Group 5: neuromuscular electrical stimulation and LED therapy. All patients will be treated during 8 consecutive weeks. After treatment, polysomnographic and electromiographic exams will be collected again.

Discussion

This paper describes a five arm clinical trial assessing the examination of sleep quality and masticatory function in patients with CP under non-invasive therapies.

Trial registration

The protocol for this study is registered with the Brazilian Registry of Clinical Trials - ReBEC RBR-994XFS

Descriptors

Cerebral Palsy. Stomatognathic System. Electromyography. Transcutaneous Electric Nerve Stimulation. Phototherapy. Sleep Disorders. Polysomnography.