title: Transcranial direct current stimulation combined with upper limb functional training in children with spastic, hemiparetic cerebral palsy: study protocol for a randomized controlled trial.
abstract: The aim of the proposed study is to perform a comparative analysis of functional training effects for the paretic upper limb with and without transcranial direct current stimulation over the primary motor cortex in children with spastic hemiparetic cerebral palsy.
  
  
  
  The sample will comprise 34 individuals with spastic hemiparetic cerebral palsy, 6 to 16 years old, classified at level I, II, or III of the Manual Ability Classification System. Participants will be randomly allocated to two groups: (1) functional training of the paretic upper limb combined with anodic transcranial stimulation; (2) functional training of the paretic upper limb combined with sham transcranial stimulation. Evaluation will involve three-dimensional movement analysis and electromyography using the SMART-D 140® system (BTS Engineering) and the FREEEMG® system (BTS Engineering), the Quality of Upper Extremity Skills Test, to assess functional mobility, the Portable Device and Ashworth Scale, to measure movement resistance and spasticity, and the Pediatric Evaluation of Disability Inventory, to evaluate performance. Functional reach training of the paretic upper limb will include a range of manual activities using educational toys associated with an induced constraint of the non-paretic limb during the training. Training will be performed in five weekly 20-minute sessions for two weeks. Transcranial stimulation over the primary motor cortex will be performed during the training sessions at an intensity of 1 mA. Findings will be analyzed statistically considering a 5 % significance level (P ≤ 0.05).
  
  
  
  This paper presents a detailed description of a prospective, randomized, controlled, double-blind, clinical trial designed to demonstrate the effects of combining transcranial direct current stimulation over the primary motor cortex and functional training of the paretic limb in children with cerebral palsy classified at level I, II, or III of the Manual Ability Classification System. The results will be published and evidence found may contribute to the use of transcranial stimulation for this population.
  
  
  
  ReBEC RBR-6V4Y3K . Registered on 11 February 2015.
authors.affiliation: Rehabilitation Sciences, Nove de Julho University (UNINOVE), São Paulo, SP, Brazil.
authors.forename: Renata Calhes Franco
authors.initials: RC
authors.lastname: Moura
authors.affiliation: Rehabilitation Sciences, Nove de Julho University (UNINOVE), São Paulo, SP, Brazil.
authors.forename: Cibele Almeida
authors.initials: CA
authors.lastname: Santos
authors.affiliation: Rehabilitation Sciences, Nove de Julho University (UNINOVE), São Paulo, SP, Brazil.
authors.forename: Luanda André Collange
authors.initials: LA
authors.lastname: Grecco
authors.affiliation: Rehabilitation Sciences, Nove de Julho University (UNINOVE), São Paulo, SP, Brazil.
authors.forename: Roberta Delasta
authors.initials: RD
authors.lastname: Lazzari
authors.affiliation: Rehabilitation Sciences, Nove de Julho University (UNINOVE), São Paulo, SP, Brazil.
authors.forename: Arislander Jonathan Lopes
authors.initials: AJ
authors.lastname: Dumont
authors.affiliation: Rehabilitation Sciences, Nove de Julho University (UNINOVE), São Paulo, SP, Brazil.
authors.forename: Natalia Carvalho de Almeida
authors.initials: NC
authors.lastname: Duarte
authors.affiliation: Rehabilitation Sciences, Nove de Julho University (UNINOVE), São Paulo, SP, Brazil.
authors.forename: Luiz Alfredo
authors.initials: LA
authors.lastname: Braun
authors.affiliation: Rehabilitation Sciences, Nove de Julho University (UNINOVE), São Paulo, SP, Brazil.
authors.forename: Jamile Benite Palma
authors.initials: JB
authors.lastname: Lopes
authors.affiliation: Hospital Servidor Publico, São Paulo, SP, Brazil.
authors.forename: Ligia Abram Dos
authors.initials: LA
authors.lastname: Santos
authors.affiliation: Mandaqui Hospital Complex, São Paulo, SP, Brazil.
authors.forename: Eliane Lopes Souza
authors.initials: EL
authors.lastname: Rodrigues
authors.affiliation: Motion Analysis Laboratory, IRCCS San Raffaele Pisana, Pisana, Rome, Italy.
authors.forename: Giorgio
authors.initials: G
authors.lastname: Albertini
authors.affiliation: Department of Electronic Information and Bioengineering, Politecnico di Milano, Milan, Italy.
authors.forename: Veronica
authors.initials: V
authors.lastname: Cimolin
authors.affiliation: Motion Analysis Laboratory, IRCCS San Raffaele Pisana, Pisana, Rome, Italy.|Department of Electronic Information and Bioengineering, Politecnico di Milano, Milan, Italy.
authors.forename: Manuela
authors.initials: M
authors.lastname: Galli
authors.affiliation: Rehabilitation Sciences, Nove de Julho University (UNINOVE), São Paulo, SP, Brazil. csantos@uninove.br.|Rua Itapicuru, 380 apto 111, Perdizes bairro, CEP 05006-000, São Paulo, SP, Brazil. csantos@uninove.br.
authors.forename: Claudia Santos
authors.initials: CS
authors.lastname: Oliveira
mesh_terms: D000293:Adolescent; D000367:Age Factors; D001696:Biomechanical Phenomena; D001938:Brazil; D002547:Cerebral Palsy / Q000175:diagnosis / Q000503:physiopathology / Q000534:rehabilitation*; D002648:Child; D002657:Child Development; D002985:Clinical Protocols; D004185:Disability Evaluation; D004311:Double-Blind Method; D004576:Electromyography; D005260:Female; D006801:Humans; D008297:Male; D009043:Motor Activity; D009044:Motor Cortex / Q000503:physiopathology*; D010291:Paresis / Q000175:diagnosis / Q000503:physiopathology / Q000534:rehabilitation*; D026741:Physical Therapy Modalities; D010988:Play and Playthings; D011446:Prospective Studies; D012107:Research Design; D012720:Severity of Illness Index; D013997:Time Factors; D065908:Transcranial Direct Current Stimulation / Q000009:adverse effects; D016896:Treatment Outcome; D034941:Upper Extremity / Q000294:innervation*
keywords: Cerebral palsy; Electrical stimulation; Physical therapy