Effects of osteopathic manipulative treatment associated with transcranial direct current stimulation in individuals with chronic low back pain: A double-blind, randomised placebo-controlled trial.

OBJECTIVE: To evaluate the effectiveness of osteopathic manipulative treatment (OMT) associated with transcranial direct current stimulation (tDCS) in reducing pain, disability, and improving quality of life in participants with non-specific chronic low back pain. DESIGN: A randomised double-blind clinical trial. SETTING: Clinical outpatient unit. SUBJECTS: 72 participants with non-specific chronic low back pain were randomised into three groups: active tDCS + OMT (n = 24), sham tDCS + sham OMT (n = 24), and sham tDCS + OMT (n = 24). INTERVENTIONS: Evaluations were performed before, after the intervention, and one month post-intervention. tDCS consisted of ten 20-minute sessions over two weeks (five sessions per week). OMT was administered once per week, with two sessions conducted before the first and sixth tDCS sessions. MAIN MEASURES: Pain, disability, and quality of life were assessed at baseline, after two weeks, and at one month of follow-up. RESULTS: The visual analogue scale showed a significant decrease in all groups (p < 0.001). However, tDCS + OMT and sham tDCS + OMT demonstrated a clinically significant reduction compared to the sham combination (effect size n² = 0.315). Roland-Morris scores decreased across all groups without specific group effects. EuroQoL 5-Dimension 3-Level improvement was observed only in the tDCS + OMT and sham tDCS + OMT groups (significant difference between T2 and T0, p = 0.002). CONCLUSION: The combination of OMT and tDCS did not provide clinically significant improvement over OMT alone in participants with non-specific chronic low back pain.

Acute effects of photobiomodulation therapy and magnetic field on functional mobility in stroke survivors: a randomized, sham-controlled, triple-blind, crossover, clinical trial.

Identify the optimal energy delivered with a single application of the combination of photobiomodulation therapy (PBMT) combining different light sources (low-level laser therapy-LLLT and light emitting diode therapy-LEDT) and static magnetic field (sMF) in order to determine the acute effects on functional mobility of stroke survivors. Was conducted a randomized, placebo-controlled, crossover, triple-blind, clinical trial (RCT). Twelve patients were recruited, however ten concluded the study, they were randomly treated with four PBMT/sMF energies (sham-0 J, 10 J, 30 J, and 50 J per site irradiated), with 1-week interval washout between treatments. PBMT/sMF were administered after the pre-intervention (baseline) evaluation and the total energy delivered per site at each treatment was determined based on the results of the randomization procedure. PBMT/sMF were administered in direct contact with the skin and applied with slight pressure to nine sites on the knee extensors, six sites on the knee flexors, and two sites on the plantar flexors' muscles in both lower limbs (bilaterally). The primary outcome measure was the 6-min walk test (6MWT) and the secondary outcome was the Timed Up and Go (TUG) test. Significant improvements were found in the 6MWT test using a total energy of 30 J per site compared with sham (0 J) (p < 0.05) and compared with the baseline evaluation (p < 0.01). And in the TUG test significant improvements were also found using a total energy per site of 30 J per site compared to sham (0 J) and baseline (p < 0.05). PBMT with different light sources (laser and LEDs) and wavelengths in combination with sMF with a total energy per site of 30 J has positive acute effects on functional mobility in stroke survivors.

Measures used for the evaluation of balance in individuals with Parkinson's disease: a systematic review.

[Purpose] The present literature review was conducted on the use of different measures for the evaluation of balance in patients with Parkinson's disease. [Materials and Methods] The PubMed, Bireme, SciELO, Lilacs, and PEDro electronic databases were searched for relevant studies. [Results] The searches initially led to the retrieval of 3,623 articles, 540 of which were potentially eligible after limiting the search to clinical trials published in the last five years. A total of 264 duplicates were removed, and 276 articles were excluded based on their titles and abstracts. The full texts of 84 articles were analyzed, and only those with a PEDro score higher than four points (n=25) were included in the review. [Conclusion] Different methods, such as scales, tests, and equipment, are used for the evaluation of balance in patients with Parkinson's disease. More than one measure has been employed in most studies, and there is no consensus on a single precise measure for the evaluation of balance in this population.

Effect of a single session of transcranial direct-current stimulation combined with virtual reality training on the balance of children with cerebral palsy: a randomized, controlled, double-blind trial.

[Purpose] The aim of the present study was to investigate the effects of a single session of transcranial direct current stimulation combined with virtual reality training on the balance of children with cerebral palsy. [Subjetcs and Methods] Children with cerebral palsy between four and 12 years of age were randomly allocated to two groups: an experimental group which performed a single session of mobility training with virtual reality combined with active transcranial direct current stimulation; and a control group which performed a single session of mobility training with virtual reality combined with placebo transcranial direct current stimulation. The children were evaluated before and after the training protocols. Static balance (sway area, displacement, velocity and frequency of oscillations of the center of pressure on the anteroposterior and mediolateral axes) was evaluated using a force plate under four conditions (30-second measurements for each condition): feet on the force plate with the eyes open, and with the eyes closed; feet on a foam mat with the eyes open, and with the eyes closed. [Results] An increase in sway velocity was the only significant difference found. [Conclusion] A single session of anodal transcranial direct current stimulation combined with mobility training elicited to lead to an increase in the body sway velocity of children with cerebral palsy.

Upper limb function evaluation scales for individuals with cerebral palsy: a systematic review.

[Purpose] The aim of the present study was to perform a systematic review of the literature on the scales and methods most often used for the evaluation of upper limb function in individuals with cerebral palsy. [Materials and Methods] Searches were conducted in the Medline, PEDro, Lilacs, Scielo, and PubMed databases. The following inclusion criteria were used for the selection of articles: randomized controlled study, evaluation of upper limb function in individuals with cerebral palsy, and publication between 2006 and 2014. The methodological quality of the articles was evaluated using the PEDro evidence scale. [Results] Five articles met the inclusion criteria and achieved 6 points or higher on the PEDro scale of methodological quality. [Conclusion] The studies analyzed used different evaluation scales, but no consensus has been reached thus far on which scale is the most appropriate. Thus, further studies are needed to establish an adequate method for the evaluation of upper limb function in individuals with cerebral palsy.

Effects of a single session of transcranial direct current stimulation on static balance in a patient with hemiparesis: a case study.

[Purpose] Cerebrovascular accident (stroke) is characterized by an abrupt onset of focal or global neurological signs and symptoms. Asymmetry of the limbs is common following a stroke due to hemiplegia or hemiparesis. [Subject and Methods] A male patient having suffered an ischemic stroke was initially evaluated using the Timed Up-and-Go Test and the Six-Minute Walk Test. Static balance was evaluated using a force plate (Kistler model 9286BA) for the stabilometry analysis of center of pressure (COP) sway. The data were interpreted using the SWAY software program (BTS Engineering) synchronized with the SMART-D 140(®) system. Anodal transcranial direct current stimulation (tDCS; 2 mA) was applied over the primary motor cortex for 20 minutes during gait training on a treadmill. [Results] Under the condition of eyes open, reductions were found in anteroposterior sway (6.18%), trace length (3.3%) and sway velocity (3.3%) immediately following tDCS. [Conclusion] A single session of anodal tDCS combined with treadmill training had a positive effect on the static balance of a subject with chronic hemiparesis stemming from a stroke.

Immediate Effect of Postural Insoles on Gait Performance of Children with Cerebral Palsy: Preliminary Randomized Controlled Double-blind Clinical Trial.

[Purpose] Improved gait efficiency is one of the goals of therapy for children with cerebral palsy (CP). Postural insoles can allow more efficient gait by improving biomechanical alignment. The aim of the present study was to assess the effect of postural insoles on gait performance of children with CP classified as levels I or II of the Gross Motor Function Classification System (GMFCS). [Subjects and Methods] the study was a randomized controlled double-blind clinical trial. After meeting the legal aspects and the eligibility criteria, 10 children between four and 12 years old were randomly divided into a two groups: a control group (n=5), and an experimental group (n=5). Children in the control group used a placebo insoles, and children in the experimental group used postural insoles. Evaluation consisted of three-dimensional gait analysis under three conditions: barefoot, shoes without insoles and shoes with postural insoles or shoes with placebo insoles. [Results] Regarding the immediate effects of insole use, significant improvements in gait velocity and cadence were observed in the experimental group in comparison to the control group. [Conclusion] The use of postural insoles led to improvements in gait velocity and cadence of the children with cerebral palsy classified as levels I or II of the GMFCS.

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.

Effects of Transcranial Direct Current Stimulation Combined with Treadmill Training on Kinematics and Spatiotemporal Gait Variables in Stroke Survivors: A Randomized, Triple-Blind, Sham-Controlled Study.

The present study assessed the effects of anodal transcranial direct current stimulation (tDCS) combined with treadmill training on spatiotemporal and kinematic variables in stroke survivors using gait speed as the primary outcome. A randomized, sham-controlled, triple-blind, study was conducted involving 28 patients with hemiparesis allocated to two groups. The experimental group was submitted to treadmill training combined with anodal tDCS over the primary motor cortex (M1) of the damaged hemisphere. The control group was submitted to treadmill training combined with sham tDCS. Stimulation was administered (2 mA, 20 min) five times a week for two weeks during treadmill training. No significant differences (p > 0.05) in spatiotemporal variables were found in the intra-group and inter-group analyses. However, the experimental group demonstrated improvements in kinematic variables of the knee and ankle (p < 0.05) and these results were maintained one month after the end of the intervention. The inter-group analysis revealed significant differences (p < 0.05) with regard to the pelvis, hip and knee. Anodal tDCS over M1 of the damaged hemisphere combined with treadmill training did not affect spatiotemporal variables, but promoted improvements in kinematic variables of the pelvis, hip, knee and ankle and results were maintained one month after treatment.

Evaluation of upper limb movements in children with Down's syndrome: A systematic review.

The aim of the present study was to perform a review of the literature on current quantitative clinical methods for the evaluation of upper limb movements in children and adolescents with Down syndrome, with a focus on describing the variables, protocols, motor function and motor control. METHODS: A survey of PubMed, Scielo, BVS Bireme and PEDro databases using the following key words: upper limb and EMG and Down syndrome; upper limb and kinematics and Down syndrome; upper limb and motion analysis and Down syndrome; movement and upper limb and Down syndrome; upper limb and Down syndrome; reach and Down syndrome. RESULTS: In all, 344 articles and five were selected to compose the present systematic review. No standardization was found among the studies analyzed with regard to data collection, data processing or procedures for the evaluation of the variables. CONCLUSION: A kinematic evaluation is effective for the discussion of the results, but methodological differences among the studies and inconsistent results exert a negative influence on clinical interpretations and the possibility of reproducibility. The standardization of an upper limb movement evaluation protocol using kinematic analysis is important, as it would provide the basis for comparable, reproducible results and facilitate the planning of treatment interventions.

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

OBJECTIVE: To evaluate the effects of gait training with virtual reality (VR) on walking distance and physical fitness in individuals with Parkinson's Disease (PD). METHODS: Thirty-seven individuals with PD participated in this prospective, randomized, controlled clinical trial. They were randomly allocated to a control group submitted to conventional training (n = 12), a treadmill group submitted to gait training on a treadmill (n = 13) and a VR group submitted to gait training using the XboxTM (n = 12). Clinical measures, gait variables and the Six-Minute Walk Test (6MWT) were evaluated: pre-intervention, after one intervention session, post-intervention and follow up (30 days after intervention). RESULTS: The VR and treadmill groups travelled longer distances on the 6MWT and had faster gait speed in comparison to the control group. The VR and treadmill groups demonstrated an increase in pre-6MWT HR. The VR group had more intense HR after the first session and throughout training, but these gains were not maintained at the follow-up. CONCLUSION: The present findings demonstrate that gait training with a VR program is as effective as treadmill training with regard to gains in walking distance and improvements in temporal gait variables in individuals with PD.

Effect of postural insoles on gait pattern in individuals with hemiparesis: A randomized controlled clinical trial.

INTRODUCTION: Recovering the ability to walk is an important goal of physical therapy for patients who have survived cerebrovascular accident (stroke). Orthotics can provide a reduction in plantar flexion of the ankle, leading to greater stability in the stance phase of the gait cycle. Postural insoles can be used to reorganize the tone of muscle chains, which exerts an influence on postural control through correction reflexes. The aim of the present study was to perform kinematic and spatiotemporal analyses of gait in stroke survivors with hemiparesis during postural insole usage. MATERIAL AND METHODS: Twenty stroke victims were randomly divided into two groups: 12 in the experimental group, who used insoles with corrective elements specifically designed for equinovarus foot, and eight in the control group, who used placebo insoles with no corrective elements. Both groups were also submitted to conventional physical therapy. The subjects were analyzed immediately following insole placement and after three months of insole usage. The SMART-D 140® system (BTS Engineering) with eight cameras sensitive to infrared light and the 32-channel SMART-D INTEGRATED WORKSTATION® were used for the three-dimensional gait evaluation. RESULTS: Significant improvements were found in kinematic range of movement in the ankle and knee as well as gains in ankle dorsiflexion and knee flexion in the experimental group in comparison to the control group after three months of using the insoles. CONCLUSION: Postural insoles offer significant benefits to stroke survivors regarding the kinematics of gait, as evidenced by gains in ankle dorsiflexion and knee flexion after three months of usage in combination with conventional physical therapy.

Stabilometric analysis of the effect of postural insoles on static balance in patients with hemiparesis: A randomized, controlled, clinical trial.

BACKGROUND: Stroke is one of the main causes of disability among adults. OBJECTIVE: The aim of the present study was to analyze the effect of postural insoles on static balance in individuals with stroke. METHODS: Twenty-four strokes survivors with hemiparesis were recruited from the rehabilitation clinics of the university and randomly allocated to two groups: experimental and control group. The subjects were analyzed for stabilometry, immediately following insole placement and after three months of insole usage, with eyes open and eyes closed. RESULTS: A significant difference was found immediately after postural insole placement regarding anteroposterior range of movement (p < 0.05). Moreover, significant reductions were found in the inter-group analysis after three months of insole usage. CONCLUSION: Based on the present findings, postural insoles combined with conventional physical therapy offer significant benefits regarding static postural control among stroke victims after three months of use, as demonstrated by computerized stabilometry.

Effect of Transcranial Direct Current Stimulation Combined With Virtual Reality Training on Balance in Children With Cerebral Palsy: A Randomized, Controlled, Double-Blind, Clinical Trial.

The authors' aim was to investigate the effects of continuous transcranial direct current stimulation (tDCS) combined with virtual reality training on static and functional balance in children with cerebral palsy (CP). Twenty children with CP (6 girls and 14 boys; M age = 7 years 6 months ± 2 years) were randomly allocated to two groups. The experimental group received active tDCS and the control group received sham stimulation during the 10 sessions of virtual reality mobility training protocols. The children were evaluated on 3 occasions (preintervention, postintervention, and 1-month follow-up). Static balance was evaluated using a force plate under 4 conditions: feet on force plate with (a) eyes open and (b) with eyes closed, and feet on foam mat with (c) eyes open and (d) with eyes closed. Functional balance was evaluated using the Pediatric Balance Scale and the Timed Up and Go Test. The analyses demonstrated statistically significant postintervention and follow-up effects favoring the experimental group over the control group with regard to the Pediatric Balance Scale, Timed Up and Go Test, and area of oscillation of the center of pressure when standing on the force plate with eyes open. The present findings suggest that tDCS can potentiate the effects of virtual reality training on static and functional balance among children with CP.

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 value≤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.

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.