Protocol study for a randomised, controlled, double-blind, clinical trial involving virtual reality and anodal transcranial direct current stimulation for the improvement of upper limb motor function in children with Down syndrome.

Autor:	Lopes JBP; Doctoral and Master Programs in Rehabilitation Sciences, Movement Analysis Lab, University Nove de Julho, Sao Paulo, Brazil., Grecco LAC; Center of Pediatric Neurosurgery-CENEPE-Rehabilitation, and Post Doctoral student, Sao Paulo, Brazil.; NANI-Educação e Saúde na Infãncia e Adolescência, Unifesp, Sao Paulo, Brazil., Moura RCF; Doctoral and Master Programs in Rehabilitation Sciences, Movement Analysis Lab, University Nove de Julho, Sao Paulo, Brazil., Lazzari RD; Doctoral and Master Programs in Rehabilitation Sciences, Movement Analysis Lab, University Nove de Julho, Sao Paulo, Brazil., Duarte NAC; Doctoral and Master Programs in Rehabilitation Sciences, Movement Analysis Lab, University Nove de Julho, Sao Paulo, Brazil., Miziara I; Doctoral Postgraduate Program in Electrical Engineering, Nucleus of Assistive Technologies (NTA) and Biomedical Engineering Laboratory (Biolab), Federal University of Uberlândia, Uberlândia, Brazil., Melo GEL; Doctoral and Master Programs in Rehabilitation Sciences, Movement Analysis Lab, University Nove de Julho, Sao Paulo, Brazil., Dumont AJL; Doctoral and Master Programs in Rehabilitation Sciences, Movement Analysis Lab, University Nove de Julho, Sao Paulo, Brazil., Galli M; Department of Electronic Information and Bioengineering, Politecnico di Milano,Italy and IRCCS San Raffaele Pisana, Rome, Italy., Santos Oliveira C; Doctoral and Master Programs in Rehabilitation Sciences, Movement Analysis Lab, University Nove de Julho, Sao Paulo, Brazil.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2017 Aug 11; Vol. 7 (8), pp. e016260. Date of Electronic Publication: 2017 Aug 11.
DOI:	10.1136/bmjopen-2017-016260
Abstrakt:	Introduction: Down syndrome results in neuromotor impairment that affects selective motor control, compromising the acquisition of motor skills and functional independence. The aim of the proposed study is to evaluate and compare the effects of multiple-monopolar anodal transcranial direct current stimulation and sham stimulation over the primary motor cortex during upper limb motor training involving virtual reality on motor control, muscle activity, cerebral activity and functional independence. Methods and Analysis: A randomised, controlled, double-blind, clinical trial is proposed. The calculation of the sample size will be defined based on the results of a pilot study involving the same methods. The participants will be randomly allocated to two groups. Evaluations will be conducted before and after the intervention as well as 1 month after the end of the intervention process. At each evaluation, three-dimensional analysis of upper limb movement muscle activity will be measured using electromyography, cerebral activity will be measured using an electroencephalogram system and intellectual capacity will be assessed using the Wechsler Intelligence Scale for Children. Virtual reality training will be performed three times a week (one 20 min session per day) for a total of 10 sessions. During the protocol, transcranial stimulation will be administered concomitantly to upper limb motor training. The results will be analysed statistically, with a p value≤0.05 considered indicative of statistical significance. Ethical Aspects and Publicity: The present study received approval from the Institutional Review Board of Universidade Nove de Julho (Sao Paulo,Brazil) under process number 1.540.113 and is registered with the Brazilian Registry of Clinical Trials (N° RBR3PHPXB). The participating institutions have presented a declaration of participation. The volunteers will be permitted to drop out of the study at any time with no negative repercussions. The results will be published and will contribute evidence regarding the use of this type of intervention on children. Competing Interests: Competing interests: None declared. (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)
Databáze:	MEDLINE
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