title: 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.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  The protocol for this study is registered with the Brazilian Registry of Clinical Trials - ReBEC RBR-994XFS.
authors.affiliation: Department of Biosciences and Oral Diagnosis, School of Dentistry, São Paulo State University, São José dos Campos, SP, Brazil. odontogiannasi@uol.com.br
authors.forename: Lilian Chrystiane
authors.initials: LC
authors.lastname: Giannasi
authors.forename: Miriam Yumi
authors.initials: MY
authors.lastname: Matsui
authors.forename: Sandra Regina
authors.initials: SR
authors.lastname: de Freitas Batista
authors.forename: Camila Teixeira
authors.initials: CT
authors.lastname: Hardt
authors.forename: Carla Paes
authors.initials: CP
authors.lastname: Gomes
authors.forename: José Benedito Oliveira
authors.initials: JB
authors.lastname: Amorim
authors.forename: Isabella
authors.initials: I
authors.lastname: de Carvalho Aguiar
authors.forename: Luanda
authors.initials: L
authors.lastname: Collange
authors.forename: Israel
authors.initials: I
authors.lastname: Dos Reis Dos Santos
authors.forename: Ismael Souza
authors.initials: IS
authors.lastname: Dias
authors.forename: Cláudia Santos
authors.initials: CS
authors.lastname: de Oliveira
authors.forename: Luis Vicente Franco
authors.initials: LV
authors.lastname: de Oliveira
authors.forename: Mônica Fernandes
authors.initials: MF
authors.lastname: Gomes
mesh_terms: D000328:Adult; D001938:Brazil; D002547:Cerebral Palsy / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D004185:Disability Evaluation; D004599:Electric Stimulation Therapy; D004576:Electromyography; D005260:Female; D006801:Humans; D054023:Lasers, Semiconductor; D028022:Low-Level Light Therapy / Q000295:instrumentation; D008297:Male; D008409:Mastication; D008875:Middle Aged; D009469:Neuromuscular Junction / Q000503:physiopathology*; D010789:Phototherapy; D017286:Polysomnography; D020127:Recovery of Function; D012107:Research Design; D012890:Sleep; D013284:Stomatognathic System / Q000294:innervation*; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult