Brain activity and upper limb movement analysis in children with Down syndrome undergoing transcranial direct current stimulation combined with virtual reality training: study protocol for a randomized controlled trial.

BACKGROUND: Children with Down syndrome have poorer functional and sensory skills compared to children with typical development. Virtual reality (VR) training could help improve these skills. Moreover, transcranial direct current stimulation (tDCS) has achieved promising results in terms of enhancing the effects of physical and sensory therapy by modulating cortical excitability. METHODS/DESIGN: Two investigations are proposed: (1) an observational study with a convenience sample consisting of children with Down syndrome (group 1-cognitive age of 6 to 12 years according to the Wechsler Abbreviated Scale of Intelligence) and children with typical development 6 to 12 years of age (group 2). Both groups will undergo evaluations on a single day involving a three-dimensional analysis of upper limb movements, an analysis of muscle activity of the biceps and brachial triceps muscles and an analysis of visuospatial and cognitive-motor variables. (2) Analysis of clinical intervention: a pilot study and clinical trial will be conducted involving individuals with Down syndrome (cognitive age of 6 to 12 years according to the Wechsler Abbreviated Scale of Intelligence). The sample will be defined after conducting a pilot study with the same methodology as that to be used in the main study. The participants will be randomly allocated to two groups: An experimental group submitted to anodal tDCS combined with a VR game and a manual motor task and a control group submitted to sham tDCS combined with a VR game and a manual motor task. The training protocol will involve 10 sessions of active or sham tDCS during memory and motor task games. Three 20-min sessions will be held per week for a total of 10 sessions. Evaluations will be performed on three different occasions: pre-intervention, post-intervention (after 10 sessions) and follow-up (1 month after the intervention). Evaluations will consist of analyses of electroencephalographic signals, electromyographic signals of the biceps and triceps brachii, and the three-dimensional reconstruction of the reaching movement. The results will be analyzed statistically with the significance level set at 5% (p ≤ 0.05). DISCUSSION: The optimization of the results obtained with virtual reality training is believed to be related to the interactive experience with a wide range of activities and scenarios involving multiple sensory channels and the creation of exercises, the intensity of which can be adjusted to the needs of children. Therefore, the proposed study aims to complement the literature with further information on tDCS and VR training considering different variables to provide the scientific community with clinical data on this combination of interventions. TRIAL REGISTRATION: Brazilian Clinical Trials Registry (REBEC) protocol number RBR-43pk59 registered on 2019 March 27 https://ensaiosclinicos.gov.br/rg/RBR-43pk59 and Human Research Ethics Committee number 3.608.521 approved on 2019 September 30. Protocol version 2021 October 20. Any changes to the protocol will be reported to the committees and approved. Informed consent will be obtained from all participants by the clinical research coordinator and principal investigator.

An examination of the relationship between dynamic knee joint stiffness and gait pattern of children with cerebral palsy.

Dynamic joint stiffness represents the resistance that a joint opposes to an applied moment. Stiffness arises in conditions of joint laxity, instability and increased co-contraction and is commonly utilized as a means to stabilize the joint. The knee joint seems to be crucial for determining the walking pattern. The aim of this study was to investigate the association between the gait pattern, globally quantified by the Gait Profile Score (GPS), which indicates the 'quality' of a particular walking strategy, and knee dynamic joint stiffness (Kk) in children with diplegia. Kk is expressed by plotting the values of the knee flexion-extension moment versus the knee flexion-extension angle during weight acceptance. In this interval, the linear regression was fitted. The angular coefficient of the linear regression corresponded to the joint stiffness index. Sixty-one children with diplegia and 18 healthy individuals took part in this study. From their gait analysis data, the GPS (with its Gait Variable Scores-GVSs) and the Kk were calculated. Data showed that GPS (p = 2.73 × 10-21) and GVSs values for the patients with diplegia were higher in comparison to healthy controls. The Kk values for patients were not statistically different from those of controls. The correlation between Kk and GPS did not show the presence of any significant relationship (r = -0.04; p > 0.05). Thus, the functional limitation in diplegic children does not seems to be strictly related to Kk.

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.

Peripheral neurostimulation breaks the shuffling steps patterns in Parkinsonian gait: a double blind randomized longitudinal study with automated mechanical peripheral stimulation.

BACKGROUND: The shuffling steps pattern is a typical feature of gait in patients affected by Parkinson's disease (PD), which progressively reduces their quality of life, being related to the risk of falls in this population. Recently, Automated Mechanical Peripheral Stimulation (AMPS) was presented as an integrative rehabilitative treatment based on peripheral stimulation able to improve the gait spatiotemporal parameters in PD patients. AIM: The aim of this study was to evaluate the effects of AMPS on shuffling steps pattern by analyzing the kinematic and spatio-temporal gait parameters. DESIGN: Double blind randomized longitudinal study. SETTING: Outpatients. POPULATION: PD patients. METHODS: In this double blind randomized longitudinal study, 14 patients with PD were treated with effective-AMPS (AMPS group), while 14 PD patients were treated with placebo-AMPS (SHAM group); 32 healthy subjects were deemed the control group (CG). A dedicated medical device (Gondola™ Medical Technologies, Stabio, Switzerland) was used to deliver both stimulations. Each treatment session lasted about 15 minutes, including preparation (approx. 10 to 13 minutes) and stimulation (approx. 2 minutes). All PD patients were given six AMPS/SHAM treatments sessions, twice a week, delivered during the off-levodopa phase, having withdrawn from dopaminergic medication overnight. We evaluated spatio-temporal and kinematic variables of gait with quantitative 3D-gait analysis as follows: before and after the first intervention (acute phase), then after the sixth session (long term phase). RESULTS: We detected differences in all gait variables immediately after the first session of AMPS treatment and again after the sixth stimulation session. CONCLUSIONS: AMPS treatment changes the shuffling steps pattern that is typical of PD subjects, increasing the ROM of hip, knee and ankle joints during the gait cycle. CLINICAL REHABILITATION IMPACT: This data presents further evidence that a rehabilitative approach based on the AMPS treatment can induce improvements in the gait pattern of patients affected by PD.

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.

Long-term effects of automated mechanical peripheral stimulation on gait patterns of patients with Parkinson's disease.

New treatments based on peripheral stimulation of the sensory-motor system have been inspiring new rehabilitation approaches in Parkinson's disease (PD), especially to reduce gait impairment, levodopa washout effects, and the incidence of falls. The aim of this study was to evaluate the change in gait and the clinical status of PD patients after six sessions of a treatment based on automated mechanical peripheral stimulation (AMPS). Eighteen patients with PD and 15 age-matched healthy individuals (control group) participated in this study. A dedicated medical device delivered the AMPS. PD patients were treated with AMPS six times once every 4 days. All PD patients were treated in the off-levodopa phase and were evaluated with gait analysis before and after the first intervention (acute phase), after the sixth intervention, 48 h after the sixth intervention, and 10 days after the end of the treatment. To compare the differences among the AMPS interventions (pre, 6 AMPS, and 10 days) in terms of clinical scales, a t-test was used (α≤0.05). In addition, to compare the differences among the AMPS interventions (pre, post, 6 AMPS, 48 h and 10 days), the gait spatiotemporal parameters were analyzed using the Friedman test and the Bonferroni post-hoc test (α≤0.05). Also, for comparisons between the PD group and the control group, the gait spatiotemporal parameters were analyzed using the Mann-Whitney test and the Bonferroni post-hoc test (α≤0.05). The results of the study indicate that the AMPS treatment has a positive effect on bradykinesia because it improves walking velocity, has a positive effect on the step and stride length, and has a positive effect on walking stability, measured by the increase in stride length. These results are consistent with the improvements measured with clinical scales. These findings indicate that AMPS treatment seems to generate a more stable walking pattern in PD patients, reducing the well-known gait impairment that is typical of PD; regular repetition every 4 days of AMPS treatment appears to be able to improve gait parameters, to restore rhythmicity, and to reduce the risk of falls, with benefits maintained up to 10 days after the last treatment. The trial was registered online at ClinicalTrials.gov (number identifier: NCT0181528).

Osteopathic manipulative treatment in obese patients with chronic low back pain: a pilot study.

BACKGROUND: Obesity is frequently associated with various musculoskeletal disorders including chronic low back pain (cLBP). Osteopathy is a discipline emphasizing the conservative treatment of the disease in an olistic vision. We designed a randomized controlled study to investigate whether Osteopathic Manipulative Treatment (OMT) combined with specific exercises (SE) is more effective than SE alone in obese patients with cLBP. METHODS: nineteen obese females with cLBP, randomized into 2 groups: SE + OMT and SE were studied during the forward flexion of the spine using an optoelectronic system. A biomechanical model was developed in order to analyse kinematics and define angles of clinical interest. OUTCOME MEASURES: kinematic of the thoracic and lumbar spine and pelvis during forward flexion, pain according to a visual analogue scale (VAS), Roland Morris Disability Questionnaire and Oswestry Low Back Pain Disability Questionnaire. RESULTS: significant effects on kinematics were reported only for OMT + SE with an improvement in thoracic range of motion of nearly 20%. All scores of the clinical scales used improved significantly. The greatest improvements occurred in the OMT + SE group. CONCLUSIONS: combined rehabilitation treatment including Osteopathic Manipulative Treatment (OMT + SE) showed to be effective in improving biomechanical parameters of the thoracic spine in obese patients with cLBP. Such results are to be attributed to OMT, since they were not evident in the SE group. We also observed a reduction of disability and pain. The clinical results should be considered preliminary due to the small sample size.