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

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, 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

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.

Keywords: Cerebral palsy; Electrical stimulation; Physical therapy.

Figures

Fig. 1
Fig. 1
Flowchart of the study following Consolidated Standards of Reporting Trials (CONSORT) guidelines. tDCS, transcranial direct current stimulation
Fig. 2
Fig. 2
Placement of markers for three-dimensional analysis (SMARTup protocol). Schematic diagram of frontal and rear views of marker set used for 3D kinematic analysis adapted by Menegoni, 2009 [34]
Fig. 3
Fig. 3
Sequential phases. Schematic representation of the distance profile between finger and target, during pointing movement. Using a threshold on the distance profile, the adjusting phase was defined Menegoni, 2009 [34]
Fig. 4
Fig. 4
Educational toys

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