Early robotic gait training after stroke (ERA Stroke): study protocol for a randomized clinical trial.

BACKGROUND: Walking impairment after stroke is associated with substantial limitations in functional independence, quality of life, and long-term survival. People in the subacute phase after stroke who are unable to walk are most likely to benefit the greatest from use of overground robotic gait training (RGT). This study will provide preliminary evidence regarding the clinical use and efficacy of RGT during the subacute phase of stroke recovery as well as observational findings associated with the safety, tolerability, feasibility, and cost of delivering RGT during inpatient stroke rehabilitation. METHODS: This prospectively registered randomized controlled trial will enroll 54 patients admitted to inpatient rehabilitation within six months of stroke. Admitted patients will be screened at admission to inpatient rehabilitation for eligibility. Consented patients will be randomized based on stroke severity to receive either RGT or usual care for 90 minutes per week of gait training intervention during inpatient rehabilitation length of stay. Patients will complete assessments on walking and health outcomes at admission and discharge from inpatient rehabilitation and at 1- and 3-month follow-up. Intent-to-treat and per protocol analysis will be performed to evaluate safety [rate of adverse events, visual analog scale, and treatment completion rate], walking function [gait speed via 10-Meter Walk Test, Functional Ambulation Category, gait endurance via 6-Minute Walk Test] and health outcomes [Modified Rankin Scale, Stroke Rehabilitation Assessment of Movement, Continuity Assessment Record and Evaluation Tool, 5 Times Sit-to-Stand Test, Berg Balance Scale, and Stroke Impact Scale-16], and cost-analysis. DISCUSSION: This study will provide foundational evidence regarding the clinical use and efficacy of a RGT program during the subacute phase of stroke recovery with specific findings associated with the safety, tolerability, feasibility, and cost-analysis of delivering RGT during inpatient stroke rehabilitation. TRIAL REGISTRATION: NCT06430632.

Variables associated with physical health-related quality of life in Parkinson's disease patients presenting for deep brain stimulation.

Deep brain stimulation (DBS) benefits Parkinson's disease (PD) patient's quality of life specially in domains as mobility, activities of daily living (ADL) and bodily discomfort (BD), but little is known about the variables associated with these HRQOL domains in patients presenting for DBS. The objective is to evaluate variables associated with of HRQOL in a Brazilian sample of PD patients presenting for DBS treatment, specifically in the domains related with motor symptoms. In a cross-sectional study of 59 PD patients evaluated at outpatient Unit for Movement Disorders, multiple linear regression analysis was performed to identify independent variables associated with mobility, ADL and BD domains of the 39-item Parkinson's disease questionnaire (PDQ-39). UPDRS III "on" scores, duration of the disease, age, presence of comorbidities and anxiety and depressive symptoms quantified by hospital anxiety and depression scale (HADS), were the independent variables. In our results, HADS scores were independently associated to mobility domain: ß coefficient 1.36 (95 % CI 0.55-2.15) and BD domain: ß coefficient 1.57 (95 % CI 0.67-2.48). UPDRS III "on" scores were independently associated to mobility domain: 0.42 (95 % CI 0.03-0.81). The model of each multiple linear regression analysis explains 25 % of the mobility domain variability (p < 0.01) and 24 % of the BD domain variability (p < 0.01). Psychiatric symptoms were at least as relevant to quality of life as motor symptoms in PD patients presenting for DBS treatment. The effect of treating these psychiatric symptoms on patients' HRQOL deserves further investigation.

Influence of bilateral transcranial direct-current stimulation on muscle strength and respiratory endurance: Randomized, placebo-controlled, double-blind trial protocol.

Transcranial direct current stimulation (tDCS) has become established as an effective therapeutic approach, employed to modulate cortical excitability in various conditions. Nonetheless, few studies have assessed the use of tDCS in improving respiratory performance both in healthy and in subjects with respiratory disfunction. This randomized double-blind placebo-controlled trial evaluated the outcomes of lung function, strength of inspiratory muscles, general strength after intervention with bilateral tDCS both in young and elderly female subjects. Eighty subjects were randomized into four groups divided by age (40 young and 40 elderly) and intervention vs. placebo. After a basal (day 1) evaluation all subjects performed two evaluation/intervention rounds with 48 to 72 h interval. Lung function evaluated with spirometry evaluation with Forced vital capacity (FVC), Forced Expiratory Volume in 1 S (FEV1), FEV1/FVC Ratio, Maximal Voluntary Ventilation (MVV); Dynamic Inspiratory muscle strength evaluated with Powerbreathe and general strength with dynamometer. This study intends to understand the behavior of respiratory muscle strength and endurance after intervention with bilateral cathodal tDCS over the primary motor cortex in healthy young and elderly subjects, as a bridge for larger studies both in healthy and rehabilitation setting.

Dosing overground robotic gait training after spinal cord injury: a randomized clinical trial protocol.

BACKGROUND: Robotic exoskeletons have changed rehabilitation care available to people after spinal cord injury (SCI). Yet, the current evidence base is insufficient to identify the optimal dose and neurophysiological mechanism of robotic exoskeleton gait training (RGT) as an effective rehabilitation approach. This study will (1) examine whether the frequency of RGT after motor incomplete SCI impacts function and health outcomes, (2) analyze the neuroplastic effects of RGT dose, and (3) evaluate the safety, tolerability, and feasibility of delivering RGT. METHODS: We will enroll 144 participants with motor incomplete SCI admitted to inpatient rehabilitation within 6 months of SCI. Participants will be randomized based on injury severity and level into one of 3 RGT frequency groups (high, moderate, low) or none/usual care only. Participants will complete 24 RGT sessions and be assessed at admission and discharge to inpatient rehabilitation, post-RGT intervention, 1-month post-RGT, and 9-month post-SCI. Outcomes include Walking Index for Spinal Cord Injury-II, health outcomes (gait speed, Spinal Cord Independence Measure, pain, fatigue, spasticity, general health, quality of life, physical activity), and motor evoked potential amplitudes obtained using transcranial magnetic stimulation. DISCUSSION: Successful completion of this study will provide an evidence-based intervention, specifically tailored to meet the unique needs of people with SCI, which supports walking recovery; maximizing health, function, and ultimately participation. The intervention will further support widespread clinical implementation of exoskeleton use during acute rehabilitation. TRIAL REGISTRATION: ClinicalTrials.gov NCT05218447. Registered on June 23, 2022.

Anodal transcranial direct current stimulation associated with aerobic exercise on the functional and physical capacity of patients with heart failure with reduced ejection fraction: ELETRIC study protocol.

BACKGROUND: The hallmark symptom of heart failure (HF) is severe exercise intolerance. Fortunately, accumulated evidence suggests that exercise programs improve physical performance, enhance autonomy in daily activities and quality of life, and reduce cardiovascular and other hospitalizations. Recently, experimental studies have explored the application of non-invasive brain stimulation techniques, especially transcranial direct current stimulation (tDCS), aiming to improve physical performance due to its ability to modulate brain functioning. The primary objective of the present study is to evaluate the effects of anodal tDCS associated with aerobic exercise on the functional capacity of patients with HF with reduced ejection fraction (HFrEF). Secondary objectives are to compare the effects of tDCS associated with aerobic exercise vs. sham-tDCS associated with aerobic exercise on cardiopulmonary exercise capacity; inflammatory cytokines; and quality of life. METHODS: This is a two-arm, prospectively registered, randomized trial with concealed allocation, double-blind, and intention-to-treat analysis. Forty-four patients with HFrEF will be recruited. The experimental group will undertake 25-30 min aerobic exercise training associated with tDCS, for 4 weeks. The control group will undergo the same aerobic exercise training, but with sham-tDCS. The primary outcome will be functional performance by the 6-min walk test. Secondary outcomes will include cardiopulmonary exercise capacity, inflammatory cytokines, and quality of life. Outcomes will be collected by a researcher blinded to group allocation at baseline (T0) and after 4 weeks of intervention (T1). DISCUSSION: Although previous studies have investigated the combined effect of tDCS on T3 area and physical performance and have suggested that tDCS could have reduced ratings of perceived exertion by affecting the activity of the insular cortex, and therefore increase exercise tolerance, this study is the first to evaluate the effects of the addition of anodal tDCS to aerobic exercise training for improving physical and functional performance, decreasing the perceived exertion, altering the quantification of inflammatory cytokines, and improving the subclinical values of the cardiopulmonary test in patients with HFrEF, which could result in an important advance in cardiac rehabilitation for patients with chronic HF. TRIAL REGISTRATION: Brazilian Registry of Clinical Trials (ReBEC) RBR-10w787j6. Registered on 25 April 2023. https://ensaiosclinicos.gov.br/pesquisador.

Transcranial direct current stimulation (tDCS) in addition to walking training on walking, mobility, and reduction of falls in Parkinson's disease: study protocol for a randomized clinical trial.

BACKGROUND: Transcranial direct current stimulation (tDCS) has the potential to modulate cortical excitability and enhance the effects of walking training in people with Parkinson's disease. This study will examine the efficacy of the addition of tDCS to a task-specific walking training to improve walking and mobility and to reduce falls in people with Parkinson's disease. METHODS: This is a two-arm, prospectively registered, randomized trial with concealed allocation, blinded assessors, participants and therapists, and intention-to-treat analysis. Twenty-four individuals with Parkinson's disease, categorized as slow or intermediate walkers (walking speeds ≤ 1.0 m/s), will be recruited. The experimental group will undertake a 30-min walking training associated with tDCS, for 4 weeks. The control group will undertake the same walking training, but with sham-tDCS. The primary outcome will be comfortable walking speed. Secondary outcomes will include walking step length, walking cadence, walking confidence, mobility, freezing of gait, fear of falling, and falls. Outcomes will be collected by a researcher blinded to group allocation at baseline (week 0), after intervention (week 4), and 1 month beyond intervention (week 8). DISCUSSION: tDCS associated with walking training may help improve walking of slow and intermediate walkers with Parkinson's disease. If walking is enhanced, the benefits may be accompanied by better mobility and reduced fear of falling, and individuals may experience greater free-living physical activity at home and in the community. TRIAL REGISTRATION: Brazilian Registry of Clinical Trials (ReBEC) RBR-6bvnx6 . Registered on September 23, 2019.