Protocol study for a randomised, controlled, double-blind, clinical trial involving virtual reality and anodal transcranial direct current stimulation for the improvement of upper limb motor function in children with Down syndrome

Introduction Down syndrome results in neuromotor impairment that affects selective motor control, compromising the acquisition of motor skills and functional independence. The aim of the proposed study is to evaluate and compare the effects of multiple-monopolar 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. Methods and analysis A randomised, 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 before and after the intervention as well as 1 month after the end of the intervention process. At each evaluation, three-dimensional analysis of upper limb movement muscle activity will be measured using electromyography, cerebral activity will be measured using an electroencephalogram system and intellectual capacity will be assessed using the Wechsler Intelligence Scale for Children. Virtual reality training will be performed three times a week (one 20 min session per day) for a total of 10 sessions. During the protocol, transcranial stimulation will be administered concomitantly to upper limb motor training. The results will be analysed statistically, with a p valueâ\u89¤0.05 considered indicative of statistical significance. Ethical aspects and publicity The present study received approval from the Institutional Review Board of Universidade Nove de Julho (Sao Paulo,Brazil) under process number 1.540.113 and is registered with the Brazilian Registry of Clinical Trials (N° RBR3PHPXB). The participating institutions have presented a declaration of participation. The volunteers will be permitted to drop out of the study at any time with no negative repercussions. The results will be published and will contribute evidence regarding the use of this type of intervention on children

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

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

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

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

Photobiomodulation Therapy Combined with Static Magnetic Field (PBMT–SMF) on Spatiotemporal and Kinematics Gait Parameters in Post-Stroke: A Pilot Study

Background: Gait deficit is a major complaint in patients after stroke, restricting certain activities of daily living. Photobiomodulation therapy combined with a static magnetic field (PBMT-SMF) has been studied for several diseases, and the two therapies are beneficia. However, their combination has not yet been evaluated in stroke. Therefore, for PBMT–SMF to be used more often and become an adjunctive tool in the rehabilitation of stroke survivors at physical therapy rehabilitation centers and clinics, some important aspects need to be clarified. Purpose: This study aimed to test different doses of PBMT–SMF, to identify the ideal dose to cause immediate effects on the spatiotemporal and kinematic variables of gait in post-stroke patients. Methods: A randomized, triple-blinded, placebo-controlled crossover pilot study was performed. A total of 10 individuals with hemiparesis within 6 months to 5 years since the occurrence of stroke, aged 45–60 years, were included in the study. Participants were randomly assigned and treated with a single PBMT–SMF dose (sham, 10 J, 30 J, or 50 J) on a single application, with one dose per stage at 7-day intervals between stages. PBMT–SMF was applied with a cluster of 12 diodes (4 of 905 nm laser, 4 of 875 nm LEDs, and 4 of 640 nm LEDs, SMF of 35 mT) at 17 sites on both lower limbs after baseline evaluation: plantar flexors (2), knee extensors (9), and flexors (6). The primary outcome was self-selected walking speed, and the secondary outcomes were kinematic parameters. Gait analysis was performed using SMART-D 140(®) and SMART-D INTEGRATED WORKSTATION(®). The outcomes were measured at the end of each stage after the single application of each PBMT–SMF dose tested. Results: No significant differences (p > 0.05) in spatiotemporal variables were observed between the different doses, compared with the baseline evaluation. However, differences (p < 0.05) were observed in the kinematic variable of the hip in the paretic and non-paretic limbs, specifically in the minimum flexion/extension angulation during the support phase (HMST–MIN) in doses 10 J, 30 J, and 50 J. Conclusions: A single application of PBMT–SMF at doses of 10 J, 30 J, and 50 J per site of the lower limbs did not demonstrate positive effects on the spatiotemporal variables, but it promoted immediate effects in the kinematic variables of the hip (maximum and minimum flexion/extension angulation during the support phase) in the paretic and non-paretic limbs in post-stroke people

Effect of virtual reality training on walking distance and physical fitness in individuals with Parkinson's disease

To evaluate the effects of gait training with virtual reality (VR) on walking distance and physical fitness in individuals with Parkinson's Disease (PD)