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VIRTUAL REALITY AND ANODAL TRANSCRANIAL DIRECT CURRENT STIMULATION FOR THE IMPROVEMENT OF UPPER LIMB MOTOR FUNCTION IN CHILDREN WITH DOWN'S SYNDROME: A RANDOMIZED, CONTROLLED, DOUBLE-BLIND, CLINICAL TRIAL
ABSTRACTObjective: The aim of the study is to evaluate and compare the effects of 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 in children with Down syndrome. Methods and Analysis: A randomized, 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 1) prior to the intervention, 2) after the last intervention session, and 3) one month after the end of the intervention process. At each evaluation, three-dimensional analysis of upper limb movement will be performed with the SMART-D 140® system (BTS, Milan, Italy) following the SMARTup: The experimental setup protocol, muscle activity will be measured using electromyography (FREEEMG®, BTS Engineering), cerebral activity will be measured using an electroencephalogram system (BrainNet BNT36), and intellectual capacity will be assessed using the Wechsler Intelligence Scale for Children (WISC III). Virtual reality training will be held three times per week for a total of ten 20-minute sessions. Transcranial stimulation will be administered simultaneously to the training. The results will be analyzed statistically, with a p-value d 0.05 considered indicative of statistical significance.
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