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Published in: Trials 1/2016

Open Access 01-12-2016 | Study protocol

Transcranial direct current stimulation combined with upper limb functional training in children with spastic, hemiparetic cerebral palsy: study protocol for a randomized controlled trial

Authors: Renata Calhes Franco Moura, Cibele Almeida Santos, Luanda André Collange Grecco, Roberta Delasta Lazzari, Arislander Jonathan Lopes Dumont, Natalia Carvalho de Almeida Duarte, Luiz Alfredo Braun, Jamile Benite Palma Lopes, Ligia Abram dos Santos, Eliane Lopes Souza Rodrigues, Giorgio Albertini, Veronica Cimolin, Manuela Galli, Claudia Santos Oliveira

Published in: Trials | Issue 1/2016

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Abstract

Background

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.

Methods

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).

Discussion

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.

Trial registration

ReBEC RBR-6V4Y3K. Registered on 11 February 2015.
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Metadata
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
Authors
Renata Calhes Franco Moura
Cibele Almeida Santos
Luanda André Collange Grecco
Roberta Delasta Lazzari
Arislander Jonathan Lopes Dumont
Natalia Carvalho de Almeida Duarte
Luiz Alfredo Braun
Jamile Benite Palma Lopes
Ligia Abram dos Santos
Eliane Lopes Souza Rodrigues
Giorgio Albertini
Veronica Cimolin
Manuela Galli
Claudia Santos Oliveira
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-016-1534-7

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