Effect of transcranial direct current stimulation combined with gait and mobility training on functionality in children with cerebral palsy: study protocol for a double-blind randomized controlled clinical trial

Abstract

Background: The project proposes three innovative intervention techniques (treadmill training, mobility training with virtual reality and transcranial direct current stimulation that can be safely administered to children with cerebral palsy. The combination of transcranial stimulation and physical therapy resources will provide the training of a specific task with multiple rhythmic repetitions of the phases of the gait cycle, providing rich sensory stimuli with a modified excitability threshold of the primary motor cortex to enhance local synaptic efficacy and potentiate motor learning. Methods/design: A prospective, double-blind, randomized, controlled, analytical, clinical trial will be carried out. Eligible participants will be children with cerebral palsy classified on levels I, II and III of the Gross Motor Function Classification System between four and ten years of age. The participants will be randomly allocated to four groups: 1) gait training on a treadmill with placebo transcranial stimulation; 2) gait training on a treadmill with active transcranial stimulation; 3) mobility training with virtual reality and placebo transcranial stimulation; 4) mobility training with virtual reality and active transcranial stimulation. Transcranial direct current stimulation will be applied with the anodal electrode positioned in the region of the dominant hemisphere over C3, corresponding to the primary motor cortex, and the cathode positioned in the supraorbital region contralateral to the anode. A 1 mA current will be applied for 20 minutes. Treadmill training and mobility training with virtual reality will be performed in 30-minute sessions five times a week for two weeks (total of 10 sessions). Evaluations will be performed on four occasions: one week prior to the intervention; one week following the intervention; one month after the end of the intervention;and 3 months after the end of the intervention. The evaluations will involve three-dimensional gait analysis, analysis of cortex excitability (motor threshold and motor evoked potential), Six-Minute Walk Test, Timed Up-and-Go Test, Pediatric Evaluation Disability Inventory, Gross Motor Function Measure, Berg Balance Scale, stabilometry, maximum respiratory pressure and an effort test.

Motor learning through virtual reality in cerebral palsy - a literature review

“…Yet, although these programs are successful in terms of adherence, it remains unclear if increases in motor functioning in virtual environments transfer positively to motor functioning in natural environments. 20 Three studies included in this review, Straker et al, 6 Golomb et al 15 and Grecco et al 17 claim that motor learning can be potentiated with VR, with transfer of motor abilities and real-life integration; they observed that VR can also be an important educational and therapeutic tool. Forms of physical therapy seek to promote motor learning through the administration of functional training and multiple sensory stimuli.…”

“…Luanda André Collange Grecco et al 2013 17 The combination of transcranial stimulation and physical therapy resources will provide the training for a specific task with multiple rhythmic repetitions of the phases of the gait cycle, providing rich sensory stimuli with a modified excitability threshold of the primary motor cortex, to enhance local synaptic efficacy and potentiate motor learning. The combination physical therapy resources will provide the training of a specific task with multiple repetitions of the phases of the gait cycle, promoting rich sensory proprioceptive and visual) stimuli with a modified threshold of excitability of the primary motor cortex (enhanced local synaptic efficacy), thereby potentiating motor learning.…”

“…by way of the on-screen avatar), auditory, and cognitive (e.g., through game scores and performance) feedback to the user. 13 Grecco et al 17 reported that feedback provided by the image generates positive reinforcement, thereby facilitating the practice and perfection of the exercises. Gordon et al 12 and Straker et al 6 reported that the training of these patients with VR devices may have a positive impact, because of the high level of visual and spacial integration.…”

“…Forms of physical therapy seek to promote motor learning through the administration of functional training and multiple sensory stimuli. 17 Although it is clear that VR systems rely on hardware and software, their use in all rehabilitation situations requires clinicians to make decisions about the appropriateness of the intervention for the patient, implementation of treatment parameters and progression through different levels of the game or task. 19 There is evidence to confirm that VR is a promising tool in the treatment of such children.…”

Applications of transcranial direct current stimulation in children and pediatrics

“…The impact of tDCS on symptoms of cerebral palsy and dystonia has been investigated by a few studies in children and adolescents. Most published studies report some clinical improvements without important adverse effects (Grecco et al, 2013(Grecco et al, , 2014aYoung et al, 2013Young et al, , 2014Duarte et al, 2014;Gillick et al, 2014Gillick et al, , 2015aCollange Grecco et al, 2015), with one exception that will be mentioned in the discussion section (Ekici, 2015). A null effect was also reported in one case ( Bhanpuri et al, 2015).…”