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Transcranial direct current stimulation combined with upper limb functional training in children with spastic, hemiparetic cerebral palsy: study protocol for a randomized controlled trial
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 wil...
Autores principales: | , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BioMed Central
2016
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4987976/ https://www.ncbi.nlm.nih.gov/pubmed/27530758 http://dx.doi.org/10.1186/s13063-016-1534-7 |
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author | Moura, Renata Calhes Franco Santos, Cibele Almeida Grecco, Luanda André Collange Lazzari, Roberta Delasta Dumont, Arislander Jonathan Lopes Duarte, Natalia Carvalho de Almeida Braun, Luiz Alfredo Lopes, Jamile Benite Palma Santos, Ligia Abram dos Rodrigues, Eliane Lopes Souza Albertini, Giorgio Cimolin, Veronica Galli, Manuela Oliveira, Claudia Santos |
author_facet | Moura, Renata Calhes Franco Santos, Cibele Almeida Grecco, Luanda André Collange Lazzari, Roberta Delasta Dumont, Arislander Jonathan Lopes Duarte, Natalia Carvalho de Almeida Braun, Luiz Alfredo Lopes, Jamile Benite Palma Santos, Ligia Abram dos Rodrigues, Eliane Lopes Souza Albertini, Giorgio Cimolin, Veronica Galli, Manuela Oliveira, Claudia Santos |
author_sort | Moura, Renata Calhes Franco |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-4987976 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-49879762016-08-18 Transcranial direct current stimulation combined with upper limb functional training in children with spastic, hemiparetic cerebral palsy: study protocol for a randomized controlled trial Moura, Renata Calhes Franco Santos, Cibele Almeida Grecco, Luanda André Collange Lazzari, Roberta Delasta Dumont, Arislander Jonathan Lopes Duarte, Natalia Carvalho de Almeida Braun, Luiz Alfredo Lopes, Jamile Benite Palma Santos, Ligia Abram dos Rodrigues, Eliane Lopes Souza Albertini, Giorgio Cimolin, Veronica Galli, Manuela Oliveira, Claudia Santos Trials Study Protocol 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. BioMed Central 2016-08-17 /pmc/articles/PMC4987976/ /pubmed/27530758 http://dx.doi.org/10.1186/s13063-016-1534-7 Text en © The Author(s). 2016 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Study Protocol Moura, Renata Calhes Franco Santos, Cibele Almeida Grecco, Luanda André Collange Lazzari, Roberta Delasta Dumont, Arislander Jonathan Lopes Duarte, Natalia Carvalho de Almeida Braun, Luiz Alfredo Lopes, Jamile Benite Palma Santos, Ligia Abram dos Rodrigues, Eliane Lopes Souza Albertini, Giorgio Cimolin, Veronica Galli, Manuela Oliveira, Claudia Santos Transcranial direct current stimulation combined with upper limb functional training in children with spastic, hemiparetic cerebral palsy: study protocol for a randomized controlled trial |
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 |
title_full | Transcranial direct current stimulation combined with upper limb functional training in children with spastic, hemiparetic cerebral palsy: study protocol for a randomized controlled trial |
title_fullStr | Transcranial direct current stimulation combined with upper limb functional training in children with spastic, hemiparetic cerebral palsy: study protocol for a randomized controlled trial |
title_full_unstemmed | Transcranial direct current stimulation combined with upper limb functional training in children with spastic, hemiparetic cerebral palsy: study protocol for a randomized controlled trial |
title_short | Transcranial direct current stimulation combined with upper limb functional training in children with spastic, hemiparetic cerebral palsy: study protocol for a randomized controlled trial |
title_sort | transcranial direct current stimulation combined with upper limb functional training in children with spastic, hemiparetic cerebral palsy: study protocol for a randomized controlled trial |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4987976/ https://www.ncbi.nlm.nih.gov/pubmed/27530758 http://dx.doi.org/10.1186/s13063-016-1534-7 |
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