Effect of transcranial direct current stimulation combined with pelvic muscle training in women: Randomized, controlled, double-blind, and clinical trial.

BACKGROUND: Pelvic floor muscle training (PFMT) is widely used for pelvic floor muscle (PFM) weakness in women; however, it has no prolonged effects. OBJECTIVE: To evaluate the effect of Transcranial Direct Current Stimulation (tDCS) associated with PFMT on PFM contraction, sexual function and quality of life (QoL) in healthy women. STUDY DESIGN: 32 nulliparous women, aged 22.7 ± 0.42 years, were randomized into two groups: G1 (active tDCS combined with PFMT) and G2 (sham tDCS combined with PFMT). The treatment was performed three times a week for 4 weeks, totaling 12 sessions. PFM function was assessed using the PERFECT scheme (P = power, E = endurance, R = repetitions, F = rapid contractions, ECT = each timed contraction) and the perineometer (cmH2O). Sexual function was assessed by The Female Sexual Function Index, and QoL by the SF-36 questionnaire. These assessments were performed before and after the 12nd treatment session and after 30-day follow-up. RESULTS: There was a significant increase (p = 0.037) in the power of G2 compared to G1; repetitions and fast contraction increased in the G1 group, and the resistance increased in both groups, however, without statistical difference between the groups. ECT increased in the G1 group (p = 0.0). CONCLUSION: Active tDCS combined with PFMT did not potentiate the effect of the PFMT to increase the PFM function, QoL, and sexual function in healthy women. However, adjunctive tDCS to PFMT improved the time of contractions, maintaining it during follow-up.

Immediate effect of transcranial direct current stimulation combined with functional electrical stimulation on activity of the tibialis anterior muscle and balance of individuals with hemiparesis stemming from a stroke.

[Purpose] The aim of the present study was to evaluate the immediate effects of transcranial direct current stimulation (tDCS) and functional electrical stimulation (FES) on activity of the tibialis anterior muscle (TA) and static balance of individuals with hemiparesis stemming from stroke. [Subjects and Methods] A randomized, double-blind, crossover, clinical trial conducted with 30 individuals with chronic post-stroke hemiparesis. Median frequency of electrical activity of the TA were determined using electromyography in five contractions concentrics and Static balance (body sway velocity and frequency), both before and immediately after the intervention. The participants were submitted to four 20-minute intervention protocols with 48-hour interval: anodal tDCS + sham FES; sham tDCS + active FES; anodal tDCS + active FES and sham tDCS + sham FES. Anodal tDCS was administered over C3 or C4, the cathode was positioned in the supraorbital region on the contralateral side and FES was administered to the affected TA. [Results] No significant differences among the protocols were found regarding electrical activity of the TA and static balance. [Conclusion] The results demonstrate that tDCS alone or in combination with FES had no immediate effect on electrical activity of the TA and static balance of the 30 individuals analyzed.

Psychometric properties of the stroke specific quality of life scale for the assessment of participation in stroke survivors using the rasch model: a preliminary study.

[Purpose] The aim of the present study was to analyze the psychometric properties of the Stroke Specific Quality of Life (SS-QOL) scale for the assessment of social participation following a stroke. [Methods] A preliminary analysis was performed of the SS-QOL items that address the participation category. For this, the scoring patterns of the answers of individuals and internal consistence were determined using the Rasch model. Reliability was assessed by intraclass correlation coefficients (ICC). [Results] The reliability coefficients analyzed by the Rasch model were 0.91 for the items and 0.87 for the patients. The separation index was 3.19 for the items and 2.58 for the patients. The findings indicate that the items separated the patients into three levels of participation: low, medium, and high. Among the 26 items addressing participation, three did not fit the model. All items showed adequate reliability (ICC ≥ 0.60). [Conclusion] The Rasch analysis detected three items with erratic behavior; however, the erratic patterns of these items may be explained by individual peculiarities among the patients. These items should be monitored to determine if the problems found in the present study persist. If so, the items should also be revised or possibly even eliminated.

Evaluation of post-stroke functionality based on the International Classification of Functioning, Disability, and Health: a proposal for use of assessment tools.

This study aimed to identify the International Classification of Functioning, Disability, and Health categories addressed by the assessment tools commonly used in post-stroke rehabilitation and characterize patients based on its evaluation model. [Subjects and Methods] An exploratory, descriptive, cross-sectional study was conducted involving 35 individuals with chronic post-stroke hemiparesis. Handgrip strength was assessed to evaluate body functions and structures. The 10-meter gait speed test and Timed Up and Go test were administered to evaluate activity. The Stroke Specific Quality of Life scale was used to evaluate participation. Moreover, a systematic review of the literature was performed to identify studies that have associated these assessment tools with the International Classification of Functioning, Disability, and Health categories. [Results] The tools employed in this study for evaluating function addressed 63 International Classification of Functioning, Disability, and Health categories: 24 related to body functions and structures; 36 related to activity and participation; and 3 related to environmental factors. [Conclusion] The assessment tools employed in this study addressed 63 International Classification of Functioning, Disability, and Health categories and allowed a more complete evaluation of stroke survivors with hemiparesis. Use of this classification can therefore be more easily incorporated into clinical practice.

The effect of transcranial direct current stimulation associated with video game training on the postural balance of older women in the community: A blind, randomized, clinical trial.

BACKGROUND: Falls are frequent in older adults and can cause trauma, injury, and death. Fall prevention with virtual reality presents good results in improving postural control. Transcranial Direct Current Stimulation (tDCS) has been used with the same aim; however, the combination of the two techniques has still been little studied. PURPOSE: To assess whether tDCS can enhance the effect of video game training (VGT) on improving the postural balance of healthy older women. METHOD: A blinded, randomized, controlled clinical trial was conducted with 57 older women who were randomized to three balance training groups: Control Group (VGT), Anodal Group (VGT combined with anodic tDCS-atDCS), and Sham Group (VGT combined with sham tDCS-stDCS). Balance training was performed twice a week for four weeks, totalizing eight 20-min sessions using VGT associated with tDCS. Postural balance was assessed pre-and post-training and 30 days after the end of the eight sessions using the Mini-Balance Evaluation Systems Test. RESULTS: Compared to pre-intervention the Mini BEST test increased similarly in the three groups in post-intervention (control: pre 23.7 ± 2.8 to post 27.0 ± 2.2; anodal: pre 24.4 ± 1 to post 27.7 ± 0.8 and sham: pre 24.2 ± 1.9 to post 26.5 ± 1.6; p < 0.001) and follow-up (control: pre 23.7 ± 2.8 to follow-up 26.8 ± 2.3; anodal: pre 24.4 ± 1 to follow-up 27.3 ± 1.4 and sham: pre 24.2 ± 1.9 to follow-up 26.8 ± 1.5; p < 0.001). CONCLUSION: There was an improvement in the postural balance of the three training groups that were independent of tDCS. DISCUSSION: Some studies have shown the positive tDCS effects associated with other tasks to improve balance. However, these results convey the effects of only anodic-tDCS compared to sham-tDCS. Possibly, the effect of VGT surpassed the tDCS effects, promoting a ceiling effect from the combination of these two therapies. However, studies with other therapies combined with tDCS for older adults deserve to be investigated, as well as in frail older people.

Predictors of the Social Participation of Adults with Down Syndrome: An Analysis Based on the Biopsychosocial Model of the International Classification of Functioning, Disability, and Health.

OBJECTIVE: The aim of the study is to identify the predictors of social participation in Down syndrome adults from the biopsychosocial model of the International Classification of Functioning, Disability, and Health. METHODS: An exploratory, analytical, cross-sectional study was conducted with Down syndrome adults. The social participation was assessed using the Life Habits Assessment. The independent variables were determined using the International Classification of Functioning, Disability, and Health biopsychosocial model: body functions were assessed by body mass index, cognition function (Mini-Mental State Examination), and lower limbs muscle strength (Sit-to-Stand Test). Activities were assessed by the 8-Foot Up and Go Test. Environmental factors were assessed by the measure of the quality of the environment, and personal factors were assessed by age, sex, and education level. RESULTS: The total Life Habits Assessment score indicates that individuals show moderate restriction in social participation, with major restriction in the education, employment, and responsibilities domains. The 8-Foot Up and Go Test was the best social participation predictor variable, followed by Mini-Mental State Examination, and the Sit-to-Stand Test. Contextual factors were not predictors of participation. CONCLUSIONS: It was concluded that individuals with Down syndrome present the most restrictions to social participation in activities that involve social roles. The predictors influencing social participation are functional mobility, cognition, and lower limb muscle strength.

Does Transcranial Direct Current Stimulation reduce central and peripheral muscle fatigue in recreational runners? A triple-blind, sham-controlled, randomized, crossover clinical study.

BACKGROUND: Runners seek health benefits and performance improvement. However, fatigue might be considered a limiting factor. Transcranial Direct Current Stimulation (tDCS) has been investigated to improve performance and reduce fatigue in athletes. While some studies showing that tDCS may improve a variety of physical measures, other studies failed to show any benefit. OBJECTIVE: To evaluate the acute effects of tDCS on central and peripheral fatigue compared to a sham intervention in recreational runners. METHODS: This is a triple-blind, controlled, crossover study of 30 recreational runners who were randomized to receive one of the two interventions, anodal or sham tDCS, after the fatigue protocol. The interventions were applied to the quadriceps muscle hotspot for 20 min. Peak torque, motor-evoked potential, and perceived exertion rate were assessed before and after the interventions, and blood lactate level was assessed before, during, and after the interventions. A generalized estimated equation was used to analyze the peak torque, motor-evoked potential, and blood lactate data, and the Wilcoxon test was used for perceived exertion rate data. RESULTS: Our findings showed no difference between anodal tDCS and sham tDCS on peak torque, motor-evoked potential, blood lactate, and perceived exertion rate. CONCLUSION: The tDCS protocol was not effective in improving performance and reducing fatigue compared to a sham control intervention. BRAZILIAN CLINICAL TRIALS REGISTRY: RBR-8zpnxz.

Analysis of the Applicability of an Ankle-Foot Orthosis during Gait in Poststroke Patients.

[Purpose] The aim of this study was to develop and assess the applicability of an experimental ankle-foot orthosis during gait in patients with hemiparesis. [Subjects and Methods] This was a noncontrolled cross-sectional study. Ten adult patients with hemiparesis but who were capable of independent gait were included in the study. Gait assessment was performed using two platforms (EMG System do Brasil), an electromyograph (EMG System do Brasil), and a video camera. The experimental orthosis consisted of a single piece that fit over the foot and 1/3 of the distal tibia and had a steel spring. [Results] There was greater activation of the rectus femoris and vastus lateralis muscles in the stance and mid-stance phases with the use of the experimental ankle-foot orthosis in comparison with the use of a polypropylene ankle-foot orthosis and no orthosis. Regarding spatial and temporal gait parameters, the individuals achieved an increase in stride length with the use of the experimental ankle-foot orthosis in comparison with the use of a polypropylene ankle-foot orthosis. [Conclusion] The results of the present study demonstrate that individuals with hemiparesis achieved an improvement in the stance and mid-stance phases of gait with the use of the experimental ankle-foot orthosis.

Validation and reproducibility of the Glittre activities of the daily living test for evaluation of functional capacity after a stroke.

METHODS: Thirty patients with hemiparesis stemming from a stroke and 20 healthy peers were evaluated. Reproducibility was determined using the intraclass correlation coefficient (ICC), standard measurement error (SME), minimum detectable change (MDC), and Bland-Altman analysis. For construct validity, the Glittre ADL test was correlated with the Six-Minute Walk Test (6MWT), Timed Up and Go Test (TUG), and Functional Independence Measure (FIM), and analyzed based on convergent validity and the comparison of known groups (stroke survivors and healthy peers). RESULTS: Intra- and inter-observer reliability were excellent (ICC3,1 = 0.98; 0.96, respectively). Intra-observer SME ranged from 0.27 to 0.31 minutes and inter-observer SME was 0.45 minutes. Intra-observer MDC ranged from 1.44 to 1.54 minutes and inter-observer MDC was 1.86 minutes. Strong statistically significant correlations were found between time on the Glittre ADL test and time on the 6MWT (rh = -0.91; p < .001) and TUG test (rh = 0.82; p < .001), whereas a moderate correlation was found with the FIM (rh = -0.47; p < .008). CONCLUSIONS: The Glittre ADL test is valid for assessing functional capacity in stroke patients. It demonstrated good convergent and construct validity and excellent intra- and inter-observer reproducibility.

Additive effect of transcranial direct current stimulation (tDCS) in combination with multicomponent training on elderly physical function capacity: a randomized, triple blind, controlled trial.

PURPOSE: To evaluate the additive effect of Transcranial Direct Current Stimulation (tDCS) associated with multi-component training (MT) on the functional capacity (FC) of older adults and to assess whether these effects remain after the end of training. The secondary objectives were to evaluate the locomotion capacity, balance, functional independence, and quality of life and correlate them with functional capacity. METHODOLOGY: Twenty-eight older adults were randomized into two groups: experimental (MT associated with active tDCS - a-tDCS) and control (MT associated with sham tDCS - s-tDCS). The FC was measured by the Glittre-ADL test, locomotion capacity by the 6-minute walk test, balance by the BESTest, functional independence by the FIM, and quality of life by the WHQOL. The assessments were performed pre-, post-intervention, and 30-day follow-up. RESULTS: There was a significant decrease in the time to the Glittre-ADL test when comparing the a-tDCS and s-tDCS groups after the interventions (139.77 ± 21.62, 205.10 ± 43.02, p < .001) and at the 30-day follow-up (142.74 ± 17.12, 219.55 ± 54.05, p < .001), respectively. There was a moderate correlation between FC and locomotion capacity and balance. CONCLUSIONS: The addition of tDCS potentiated the results of MT to impact FC, maintaining the positive results longer. Locomotion and balance influenced the improvement of functional capacity.

Effect of osteopathic visceral manipulation for individuals with functional constipation and chronic nonspecific low back pain: Randomized controlled trial.

OBJECTIVE: To investigate the effect of osteopathic visceral manipulation (OVM) on disability and pain intensity in individuals with functional constipation and chronic nonspecific low back pain. METHODS: This study is a randomized controlled trial with a blinded assessor. Seventy-six volunteers with functional constipation and chronic nonspecific low back pain were randomized to two groups: OVM and sham OVM. The primary clinical outcome was pain intensity measured using a numeric rating scale (NRS) and disability measured using the Oswestry Disability Index (ODI). The secondary outcomes were electromyographic signals measured during the flexion-extension cycle, the finger-to-floor distance during complete flexion of the trunk and the Fear-Avoidance Beliefs Questionnaire (FABQ). All outcomes were determined after six weeks of treatment as well as three months after randomization. RESULTS: The OVM group reported a reduction in pain intensity after six weeks of treatment and at the three-month evaluation (p < .0002) and the sham group reported a reduction in pain intensity after three-month evaluation (p < .007). For the ODI was also found in the OVM group six weeks after the end of treatment (treatment effect = -6.59, 95% CI: -12.01 to -1.17, p = .01) and at the three-month evaluation (treatment effect = -6.02, 95% CI: -11.55 to -0.49, p = .03). Significant differences were also found for paravertebral muscle activity during the dynamic phases (flexion and extension) six-week evaluations. CONCLUSIONS: The OVM group demonstrated a reduction in pain intensity and improvement in disability after six-weeks and three-month follow-up while the sham group reduction in pain three-month follow-up.

Translation and cross-cultural adaptation of the Brazilian version of the PM-Scale: A specific measure of participation after stroke.

BACKGROUND: The PM-Scale was developed specifically to assess participation in individuals after stroke based on the concepts contained in the International Classification of Functioning, Disability and Health. However, this measure is only available in English and French. OBJECTIVE: To translate and cross-culturally adapt the PM-Scale to Brazilian Portuguese, followed by the validation and testing of reliability of the translated version. METHODS: The translation process followed standard guidelines. Preliminary test-retest reliability was determined using the intraclass correlation coefficient (ICC2,1). The Rasch model was employed to analyse the validity, unidimensionality, invariance, and internal consistency of the Brazilian version of the PM-Scale. RESULTS: The final translated version of the PM-Scale presented appropriate semantic, idiomatic, cultural, and conceptual equivalence. The preliminary analysis revealed excellent intra-observer and inter-observer reliability (ICC2,1 = 0.91; 95%CI: 0.83, 0.95 and ICC2,1 = 0.81; 95%CI: 0.64, 0.89, respectively). The analysis of the Rasch model revealed only one erratic item. An excellent overall fit was found for items (mean ± SD = 0.01 ± 1.02) and adequate fit was found for persons (mean ± SD = 1.16 ± 0.88). Internal consistency was considered adequate (person separation index = 1.77, reliability = 0.76). No significant invariance was found with regards to the personal characteristics of the sample (p > 0.05). CONCLUSION: The Brazilian version of the PM-Scale is a valid, unidimensional, linear, reliable scale for measuring participation in stroke survivors and can be administered in less than five minutes.

Linking of concepts measured by SATIS-Stroke and the PM-Scale to the international classification of functioning, disability and health.

BACKGROUND: Rules have been developed to simplify the understanding of researchers/clinicians and standardize the linking process between concepts contained in the items on assessment measures and the International Classification of Functioning, Disability, and Health (ICF). OBJECTIVE: Link the concepts of the SATISPART Stroke (SATIS-Stroke) and Participation Measurement Scale (PM-Scale) to ICF codes. METHODS: Linking was performed by two evaluators with experience in the ICF taxonomy who applied the ten standard linking rules specifically developed and updated for this purpose. The level of agreement between the evaluators was determined using the Kappa coefficient with 95% confidence intervals. RESULTS: The SATIS-Stroke and PM-Scale address the nine domains of the ICF "Activities and Participation" component. Adequate agreement was found between the researchers during the linking process, mainly between the 1º and 3º evaluators. Identified 41 ICF codes were found among the SATIS-Stroke items and 24 ICF codes were found among the items of the PM-Scale. CONCLUSION: SATIS-Stroke addresses more issues regarding the domains of Learning and Applying Knowledge, Mobility, Self-Care, Domestic Life, and Major Life Areas, whereas the PM-Scale addresses more issues regarding the General Tasks and Demands, Communication, and Community, Social and Civic Life. Both instruments equally address issues related to Interpersonal Interactions and Relationships.

Effects of Transcranial Direct Current Stimulation on Muscle Fatigue in Recreational Runners: Randomized, Sham-Controlled, Triple-Blind, Crossover Study-Protocol Study.

OBJECTIVES: The aim of this study is to evaluate the effects of transcranial direct current stimulation (tDCS) on central and peripheral fatigue in recreational runners. DESIGN: This is a clinical randomized, sham-controlled, triple-blind, crossover study. Twenty adult runners will be randomized on the first day of the intervention to receive active or sham tDCS before fatigue protocol. After 1 wk, the participants will receive the opposite therapy to the one that they received on the first day. The tDCS, 2 mA, will be applied for 20 mins over the motor cortex. The fatigue protocol will be performed after tDCS, in which the participant should perform concentric knee flexion/extension contractions until reaching three contractions at only 50% of maximum voluntary contraction. Central fatigue will be evaluated with the motor evoked potential of the quadriceps muscle; peripheral fatigue with the peak torque (N.m) using an isokinetic dynamometer; the electrical activity of the quadriceps muscle using surface electromyography (Hz); blood lactate level (mmol/L); and the subjective perception of effort (Borg scale). All evaluations will be repeated before and after the interventions. CONCLUSION: This study will evaluate the effect of tDCS on fatigue in runners, possibly determining an application protocol for this population.

Transcutaneous auricular vagus nerve stimulation effects on inflammatory markers and clinical evolution of patients with COVID-19: a pilot randomized clinical trial.

OBJECTIVE: To evaluate the effects of transcutaneous auricular vagus nerve stimulation (taVNS) on inflammatory markers and clinical outcomes in patients with COVID-19. METHODS: A randomized blinded pilot study was carried out with 21 individuals hospitalized with COVID-19 who received 14 sessions of active (a-taVNS) or sham taVNS (s-taVNS). The level of interleukin-6 (IL-6), interleukin-10 (IL-10), cortisol, and C-reactive protein (CRP) in plasma and clinical evolution pre- and post-intervention were evaluated. The memory and attention levels were evaluated 14 days after the end of the treatment. RESULTS: After treatment, significant intragroup differences were found in the CRP (p = 0.01), IL-6 (p = 0.01), and cortisol (p = 0.01) levels; however, in the comparison between the groups, only the CRP level was statistically lower for the a-taVNS (p = 0.04). The impression of improvement in memory and attention was greater in the a-taVNS than in the s-taVNS (p = 0.01, p = 0.04, respectively). There was no difference between the other clinical outcomes. CONCLUSIONS: taVNS is a viable and safe intervention in the acute care of patients with COVID-19, which can modulate their inflammatory profile and improve cognitive symptoms. However, improvements in overall clinical outcomes were not detected. Larger sample sizes and longer follow-ups are needed to confirm the anti-inflammatory and clinical effects of taVNS in patients with COVID-19. TRIALS REGISTRY: The Brazilian Registry of Clinical Trials (RBR-399t4g5).

Transcutaneous Auricular Vagus Nerve Stimulation Improves Inflammation but Does Not Interfere with Cardiac Modulation and Clinical Symptoms of Individuals with COVID-19: A Randomized Clinical Trial.

Transcranial auricular vagus nerve stimulation (taVNS) has shown effectiveness in reducing inflammation and depression. Thus, this study evaluated its effect on inflammation, cardiac autonomic modulation, and clinical symptoms in individuals affected by COVID-19. Methods: There were 52 randomized participants hospitalized with COVID-19 diagnosis who were to receive active (a-taVNS) or sham taVNS (s-taVNS) for 90 min twice a day for seven consecutive days. Interleukin 6 (IL-6), 10 (IL-10), cortisol, C-reactive protein (CRP), heart rate variability (HRV), and clinical symptoms were assessed before and after seven days of treatment. There were also seven- and fourteen-day follow-ups for clinical symptoms, including anxiety and depression levels, as well as a six-month follow-up for memory and attention levels. Results: There was significant reduction in CRP −23.9%, (95% CI −46.3 to −1.4) and IL-6 −37.7%, (95% CI −57.6 to −17.7) for the a-taVNS group. There were no changes in IL-10, cortisol levels, or in HRV results (p > 0.05) in both groups. There were no changes regarding clinical symptoms, except for a significant decrease in depression level (−2.85, 95% CI −5.44 to −0.27) in the a-taVNS group. Conclusion: taVNS showed effects on CRP, IL-6, and depression levels; however, it did not affect other clinical symptoms.

Clinimetric properties of the SATIS-Stroke questionnaire in the Brazilian population: A satisfaction assessment measure addressing activities and participation after a stroke.

BACKGROUND: SATIS-Stroke questionnaire has been translated and adapted for use in the Brazilian population, however, it is necessary to test the measurement properties in Brazilian population. OBJECTIVE: To test the reliability, agreement, concurrent validity, and diagnostic accuracy of the SATIS-Stroke. METHODS: Chronic stroke survivors were included. The calculations were made using scores in logits (Rasch Model). Reliability was tested using the intraclass correlation coefficient (ICC2,1), standard error of measurement (SEM), minimal detectable change (MDC), and Bland-Altman plots. Concurrent validity was analyzed using Spearman's correlation coefficient. For such, the correlation between SATIS-Stroke and Stroke Specific Quality of Life (SS-QOL) questionnaires was determined. Diagnostic accuracy was estimated based on the area under the receiver operating characteristic (ROC) curve with a 95% confidence interval and considering the sensitivity and specificity of SATIS-Stroke in differentiating different types of activity and participation. RESULTS: Eighty stroke survivors were analyzed. Mean age was 57.98±13.85 years and 45.2% had severe impairment. Excellent reliability was found (intra-observer ICC2,1 = 0.90; 95% CI: 0.84, 0.93; inter-observer ICC2,1 = 0.89; 95% CI: 0.83, 0.93). The Bland-Altman plot demonstrated satisfactory agreement. In the analysis of concurrent validity, a strong, positive, significant correlation was found between SATIS-Stroke and SS-QOL (rs = 0.74; p <0.001 with an r2=0.44; p=0.001). Diagnostic accuracy was satisfactory, with 80.8% sensitivity and 85.2% specificity. CONCLUSION: The Brazilian version of the SATIS-Stroke questionnaire exhibited adequate reliability, concurrent validity, and diagnostic accuracy. Therefore, this is a valid, reproducible measure for the assessment of satisfaction with regard to activities and participation following a stroke.

To Combine or Not to Combine Physical Therapy With tDCS for Stroke With Shoulder Pain? Analysis From a Combination Randomized Clinical Trial for Rehabilitation of Painful Shoulder in Stroke.

Purpose: Transcranial Direct Current Stimulation (tDCS) is an intervention that seems to be an ideal tool to enhance the effects of rehabilitation therapies given it facilitates generation of plasticity in the stimulated brain area. In stroke this strategy has been highly utilized; however, the results have been mixed. In this trial we have evaluated the analgesic and functional effects of Transcranial Direct Current Stimulation (tDCS) combined with physiotherapy in stroke survivors with shoulder pain. Methods: Twenty-six stroke surviving adults with shoulder pain received 10 sessions of passive mobilization and performed upper limb exercises using a cycle ergometer, combined with active or sham tDCS. The intensity of pain in the hemiplegic shoulder was measured using the Visual Analog Scale (VAS); secondary outcomes were the level of motor impairment, handgrip strength, range of motion, motor function of the upper limbs, and quality of life (QOL) assessed before and after 10 sessions and 1 month after the end of the treatment. Results: A clinically important pain reduction (3 points) was found in both groups and was maintained at follow-up; there was no significant difference between groups (p = 0.3). Similarly, the shoulder range of motion improved, motor function and quality of life improved showed no significant differences between groups. One result that needs to be underscored is that both groups had a significant effect size toward improvement in all of these outcomes. Conclusions: We discuss in this study that tDCS is not a useful combination strategy when the physical therapy has a large effect by itself and we also review other negative trials of combined therapy under this framework of ceiling effect of the main physical therapy. Trial registry: Trial registration: Brazilian Registry of Clinical Trials, RBR-8F5MNY (http://www.ensaiosclinicos.gov.br/rg/RBR-8f5mny/). Registered on June 2, 2017. Beginning of the recruitment of the volunteers: august, 2017.

Protocol for a controlled, randomized, blind, clinical trial to assess the effects of anodal transcranial direct current stimulation dorsolateral prefrontal cortex associated with balance training using games in the postural balance of older people.

Aims: This study aims to evaluate the additional effect of anodal transcranial direct current stimulation (a-tDCS) applied on dorsolateral pré-frontal cortex on training postural balance with the use of video games in the aged. Methods: This is a blinded, randomized, controlled clinical trial protocol, with older people of both genders. Participants will be randomized into three training groups: Group 1 (videogame balance training), group 2 (videogame balance training associated with anodal tDCS), group 3 (videogame balance training associated with sham tDCS). The training will be carried out twice a week for four weeks, totaling eight sessions, and will be performed with the Nintendo Wii videogame console, using games that stimulate the postural balance associated with tDCS, with anode applied over the left dorsolateral prefrontal cortex and cathode on the contralateral supraorbital region at 2 mA for 20 minutes. The postural balance will be assessed using the Mini Test of the Balance Assessment System and posturography. Evaluations will be carried out before and after eight training sessions and 30 days after the end of treatment. Discussion: Some studies show favorable results from the use of video games in improving postural balance in older people; however, their effect does not remain long-term. TDCS associated with other therapies can potentiate and prolong the effects of these therapies owing to its ability to stimulate neurotrophins important for neurogenesis, facilitating tasks that require attention, and helping to consolidate learning and memory. The effect of the two associated techniques on balance has not yet been tested in this population. Registration: Brazilian Registry of Clinical Trials ID U1111-1213-4266; registered on 15 October 2018.

Effect of transcranial direct current stimulation and multicomponent training on functional capacity in older adults: protocol for a randomized, controlled, double-blind clinical trial.

INTRODUCTION: When physical activity contains training of at least three components such as balance, coordination and strength, among others, it is called multicomponent training. This type of training is recommended for improving the functional capacity in elderly individuals but has no lasting effects. The association of transcranial direct current stimulation (tDCS) with other types of therapy has been shown to facilitate the enhancement and prolongation of therapy outcomes. AIM: The objective of this study is to evaluate the effect of multicomponent training associated with active or sham tDCS on the performance of functional capacity in the elderly before treatment, after treatment and 30 days after the end of treatment. The secondary objective will be to correlate the performance of the primary outcome (functional capacity assessed by the Glittre Daily Life Activity Test) with walking capacity (by 6-min walk test), balance (with the mini-Balance Evaluation Systems Test), functional independence (by the Functional Independence Measure) and quality of life (with the World Health Organization Quality of Life Instrument). METHODS: Twenty-eight elderly people from the community will participate in the study, and will be randomized into two groups: 1) multicomponent training associated with active tDCS; and 2) multicomponent training associated with sham tDCS. The multicomponent training sessions will be held twice a week for 12 weeks, totaling 24 sessions. The tDCS will be administered over the dominant dorsolateral prefrontal cortex at the same time as multicomponent training, with an intensity of 2 mA, for 20 min. The evaluations will be made pretraining, after 24 training sessions and 30 days after the end of the training. DISCUSSION: We hypothesize that tDCS, when associated with multicomponent training, can potentiate and prolong the effects of this training on the functional capacity of the elderly. If this hypothesis is confirmed, this protocol may contribute to a longer-lasting physical rehabilitation of the elderly, encouraging them to maintain their independent daily activities for longer. TRIAL REGISTRATION: The study was registered in the Brazilian Clinical Trial Registry (RBR-2crd42) and received approval from the Human Research Ethics Committee of University Nove de Julho, São Paulo, Brazil (process number 3.077.953).