title: Static balance and function in children with cerebral palsy submitted to neuromuscular block and neuromuscular electrical stimulation: study protocol for prospective, randomized, controlled trial.
abstract: BACKGROUND
  The use of botulinum toxin A (BT-A) for the treatment of lower limb spasticity is common in children with cerebral palsy (CP). Following the administration of BT-A, physical therapy plays a fundamental role in potentiating the functionality of the child. The balance deficit found in children with CP is mainly caused by muscle imbalance (spastic agonist and weak antagonist). Neuromuscular electrical stimulation (NMES) is a promising therapeutic modality for muscle strengthening in this population. The aim of the present study is to describe a protocol for a study aimed at analyzing the effects of NMES on dorsiflexors combined with physical therapy on static and functional balance in children with CP submitted to BT- A.
  
  
  METHODS
  Protocol for a prospective, randomized, controlled trial with a blinded evaluator. Eligible participants will be children with cerebral palsy (Levels I, II and III of the Gross Motor Function Classification System) between five and 12 years of age, with independent gait with or without a gait-assistance device. All participants will receive BT-A in the lower limbs (triceps surae). The children will then be randomly allocated for either treatment with motor physical therapy combined with NMES on the tibialis anterior or motor physical therapy alone. The participants will be evaluated on three occasions: 1) one week prior to the administration of BT-A; 2) one week after the administration of BT-A; and 3) four months after the administration of BT-A (end of intervention). Spasticity will be assessed by the Modified Ashworth Scale and Modified Tardieu Scale. Static balance will be assessed using the Medicapteurs Fusyo pressure platform and functional balance will be assessed using the Berg Balance Scale.
  
  
  CONCLUSIONS
  The aim of this protocol study is to describe the methodology of a randomized, controlled, clinical trial comparing the effect of motor physical therapy combined with NMES on the tibialis anterior muscle or motor physical therapy alone on static and functional balance in children with CP submitted to BT-A in the lower limbs. This study describes the background, hypotheses, methodology of the procedures and measurement of the results.
  
  
  BACKGROUND
  RBR5qzs8h.
authors.affiliation: Post Graduate Program in Reabilitation Sciences, Nove de Julho University, UNINOVE, Sao Paulo, Brazil.
authors.forename: Soráia
authors.initials: S
authors.lastname: Kazon
authors.forename: Luanda A C
authors.initials: LA
authors.lastname: Grecco
authors.forename: Hugo
authors.initials: H
authors.lastname: Pasini
authors.forename: João C F
authors.initials: JC
authors.lastname: Corrêa
authors.forename: Thaluanna C L
authors.initials: TC
authors.lastname: Christovão
authors.forename: Paulo de Tarsocamillo
authors.initials: Pde T
authors.lastname: de Carvalho
authors.forename: Lilian Chrystiane
authors.initials: LC
authors.lastname: Giannasi
authors.forename: Paulo R G
authors.initials: PR
authors.lastname: Lucareli
authors.forename: Luis Vicente Franco
authors.initials: LV
authors.lastname: de Oliveira
authors.forename: Afonso Shiguemi Inoue
authors.initials: AS
authors.lastname: Salgado
authors.forename: Luciana M M
authors.initials: LM
authors.lastname: Sampaio
authors.forename: Claudia S
authors.initials: CS
authors.lastname: Oliveira
mesh_terms: D000842:Ankle; D019274:Botulinum Toxins, Type A / Q000627:therapeutic use*; D002547:Cerebral Palsy / Q000503:physiopathology / Q000628:therapy*; D002648:Child; D002675:Child, Preschool; D002985:Clinical Protocols; D003131:Combined Modality Therapy; D004599:Electric Stimulation Therapy; D005081:Exercise Therapy; D006801:Humans; D018482:Muscle, Skeletal / Q000502:physiology; D009465:Neuromuscular Agents / Q000627:therapeutic use*; D004856:Postural Balance; D011446:Prospective Studies; D016037:Single-Blind Method; D016896:Treatment Outcome
chemical_list: D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A