title: Stroke Treatment Associated with Rehabilitation Therapy and Transcranial DC Stimulation (START-tDCS): a study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Traditional treatment for motor impairment after stroke includes medication and physical rehabilitation. The transcranial direct current stimulation associated with a standard physical therapy program may be an effective therapeutic alternative for these patients.
  
  
  METHODS
  This study is a sham-controlled, double-blind, randomized clinical trial aiming to evaluate the efficacy of transcranial direct current stimulation in activities of daily living and motor function post subacute stroke. In total there will be 40 patients enrolled, diagnosed with subacute, ischemic, unilateral, non-recurring stroke. Participants will be randomized to two groups, one with active stimulation and the other with a placebo current. Patients and investigators will be blinded. Everyone will receive systematic physical therapy, based on constraint-induced movement therapy. The intervention will be applied for 10 consecutive days. Patients will undergo three functional assessments: at baseline, week 2, and week 4. Neuropsychological tests will be performed at baseline and week 4. Adverse effects will be computed at each session. On completion of the baseline measures, randomization will be conducted using random permuted blocks. The randomization will be concealed until group allocation.
  
  
  CONCLUSIONS
  This study will investigate the combined effects of transcranial direct current stimulation and physical therapy on functional improvement after stroke. We tested whether the combination of these treatments is more effective than physical therapy alone when administered in the early stages after stroke.
  
  
  BACKGROUND
  NCT02156635---May 30, 2014. Randomization is ongoing (40 participants randomized as of the end of December 2015).
authors.affiliation: Cognitive Neuroscience and Behavior Program, Federal University of Paraíba, João Pessoa, Brazil. suellenandrade@gmail.com.
authors.forename: Suellen M
authors.initials: SM
authors.lastname: Andrade
authors.affiliation: Perception, Neurosciences and Behavior Laboratory, Federal University of Paraíba, João Pessoa, Brazil. natanael_labv@yahoo.com.br.
authors.forename: Natanael A
authors.initials: NA
authors.lastname: Santos
authors.affiliation: Department of Psychology, Federal University of Paraíba, João Pessoa, Brazil. bfcalvo@usal.es.
authors.forename: Bernardino
authors.initials: B
authors.lastname: Fernández-Calvo
authors.affiliation: Cognitive Neuroscience Laboratory and Developmental Disorders Program, Mackenzie Presbyterian University, São Paulo, Brazil. psboggio@gmail.com.
authors.forename: Paulo S
authors.initials: PS
authors.lastname: Boggio
authors.affiliation: Center for Research in Human Movement Sciences, Federal University of Paraíba, João Pessoa, Brazil. elianeao@gmail.com.
authors.forename: Eliane A
authors.initials: EA
authors.lastname: Oliveira
authors.affiliation: Study Group of Human Movement, Federal University of Paraíba, João Pessoa, Brazil. jamacy@gmail.com.
authors.forename: José J
authors.initials: JJ
authors.lastname: Ferreira
authors.affiliation: Center for Research in Human Movement Sciences, Federal University of Paraíba, João Pessoa, Brazil. amandasobreira_@hotmail.com.
authors.forename: Amanda
authors.initials: A
authors.lastname: Sobreira
authors.affiliation: Center for Research in Human Movement Sciences, Federal University of Paraíba, João Pessoa, Brazil. felipe_slip78@hotmail.com.
authors.forename: Felipe
authors.initials: F
authors.lastname: Morgan
authors.affiliation: Study Group of Human Movement, Federal University of Paraíba, João Pessoa, Brazil. germannamb@gmail.com.
authors.forename: Germana
authors.initials: G
authors.lastname: Medeiros
authors.affiliation: Center for Research in Human Movement Sciences, Federal University of Paraíba, João Pessoa, Brazil. gyovannasc@yahoo.com.br.
authors.forename: Gyovanna S
authors.initials: GS
authors.lastname: Cavalcanti
authors.affiliation: Center for Research in Human Movement Sciences, Federal University of Paraíba, João Pessoa, Brazil. ingridgadelha_@hotmail.com.
authors.forename: Ingrid D
authors.initials: ID
authors.lastname: Gadelha
authors.affiliation: Study Group of Human Movement, Federal University of Paraíba, João Pessoa, Brazil. jaderacus@gmail.com.
authors.forename: Jader
authors.initials: J
authors.lastname: Duarte
authors.affiliation: Center for Research in Human Movement Sciences, Federal University of Paraíba, João Pessoa, Brazil. joerciamarrocos_@hotmail.com.
authors.forename: Joercia
authors.initials: J
authors.lastname: Marrocos
authors.affiliation: Center for Research in Human Movement Sciences, Federal University of Paraíba, João Pessoa, Brazil. michelebr@live.com.
authors.forename: Michele A
authors.initials: MA
authors.lastname: Silva
authors.affiliation: Study Group of Human Movement, Federal University of Paraíba, João Pessoa, Brazil. tathy_mary@hotmail.com.
authors.forename: Thatiana
authors.initials: T
authors.lastname: Rufino
authors.affiliation: Neuromuscular Adaptations Laboratory, Federal University of São Carlos, São Carlos, Brazil. sanmy_rocha_@hotmail.com.
authors.forename: Sanmy R
authors.initials: SR
authors.lastname: Nóbrega
mesh_terms: D000203:Activities of Daily Living; D002985:Clinical Protocols; D003627:Data Interpretation, Statistical; D004311:Double-Blind Method; D006801:Humans; D017063:Outcome Assessment, Health Care; D026741:Physical Therapy Modalities; D018401:Sample Size; D020521:Stroke / Q000628:therapy*; D000071939:Stroke Rehabilitation; D065908:Transcranial Direct Current Stimulation
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