Active clinical trials for "Stroke"

On the basis of previous studies, standardized randomized controlled clinical trials were conducted to observe the efficacy and safety of acupuncture in the treatment of mild cognitive impairment after stroke using the international rating scale, and the clinical experience was transformed into evidence. According to the clinical outcomes reported by patients, the differences between Chinese and western scales in evaluating mild cognitive impairment after stroke were compared. On the basis of "disease differentiation, syndrome differentiation and meridian differentiation", the syndrome differentiation and treatment system of mild cognitive impairment after stroke was preliminarily constructed, and the TCM syndrome prediction model was improved.

The goal of this study is to determine the efficacy of electromechanical exoskeleton-assisted gait training on rehabilitation functional outcomes in patients with stroke undergoing therapy in an in-patient rehabilitation facility.

The purpose of this study is to determine whether a single treatment with administration of 400 Units NT 201 (botulinum toxin) is superior to placebo (no medicine) for the treatment of lower limb spasticity caused by stroke or traumatic brain injury (Main Period). Participants will be assigned to the treatment groups by chance and neither the participants nor the research staff who interact with them will know the allocation. The following 4 to 5 treatment cycles will investigate the safety and tolerability of treatment with NT 201 (botulinum toxin) when administered in doses between 400 and 800 Units (Open Label Extension Period). All participants will receive the treatment and the dose will depend on whether only lower limb spasticity or combined upper and lower limb spasticity are treated.

People with stroke should exercise to maintain function and reduce the risk of another stroke. Different types of exercise target different components of fitness, such as aerobic, strength, and balance. Post-stroke exercise guidelines exist for each type of exercise separately (eg, brisk walking as aerobic exercise, resistance training for strength, and Tai Chi for balance). Meeting these recommendations means spending a lot of time exercising, and people with stroke say that lack of time and fatigue are barriers to exercise. It is possible to target several components of fitness with one type of exercise. 'Reactive balance training' (RBT) is a type of exercise that improves control of reactions that are needed to prevent a fall after losing balance, and is the only type of exercise with potential to prevent falls in daily life post-stroke. Because RBT involves repeated whole-body movements it may have similar aerobic benefit as other exercises using whole-body movements (eg, brisk walking). Also, leg muscles need to generate a lot of force to make rapid steps in RBT; repeatedly generating this force may help to improve strength. The purpose of this study is to determine if RBT improves two important components of fitness among people with chronic stroke: aerobic capacity and strength. The investigators expect that the improvements in aerobic capacity and strength after RBT will not be any worse than after an exercise program that specifically targets aerobic fitness and strength. A secondary purpose of this study is to determine the effects of RBT compared to aerobic and strength training on balance control and balance confidence. The investigators expect that RBT will lead to greater improvements in balance control and balance confidence than an aerobic and strength training program.

Randomised, double blind, Phase 2 Trial to evaluate the efficacy of oral Capsaicin in patients with post-stroke dysphagia in the (sub-)acute setting.

Aspirin was reported to induce hemolysis in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency on some occasions, while still widely uesd for stroke prevention. The SAST trial is designed to evaluate the safety and efficacy of aspirin in patients this enzyme disorder.The primary purpose of the trial is to evaluate the hemolytic effects of a 3-month regimen of aspirin 100mg/d versus a 3-month regimen of clopidogrel 75mg/d.

The long-term goal of this research is to improve activity performance and reduce motor impairment in individuals with stroke. Contemporary stroke rehabilitation focuses on remediation of post-stroke impairments with a false assumption that reduction in impairments will automatically lead to improvements in activity performance. Specifically, stroke rehabilitation is focused primarily on the use of task-specific training (TST), which recent research has found to yield negligible improvement in upper extremity motor function often consistent with or less than control conditions. These protocols are time intensive and often do not lead to transfer of training effects to improvement in activity performance. This is a common issue that has been evidenced in longitudinal studies of individuals with stroke; over half of stroke survivors continue to be dependent on others for the most basic of life activities after rehabilitation. Decreases in activity performance further contribute to lower life satisfaction, quality of life, and participation in daily life. The goal of this proposed project is to evaluate the efficacy of a clinically-feasible metacognitive strategy training (MCST) intervention, the Cognitive Orientation to daily Occupational Performance (CO-OP) approach, to improve activity performance and reduce stroke impairment for individuals with sub-acute stroke. Recent evidence highlights two primary issues in stroke rehabilitation. 1) Interventions are needed that directly target activity performance. Gains in upper extremity function, even using the most contemporary approaches, are not translating to meaningful gains in activity performance. 2) Interventions need to be clinically feasible for future implementation. In recent stroke rehabilitation clinical trials, participants received an average of over 30 hours of therapy in only one treatment modality. Individuals in stroke rehabilitation receive a median of only 6 outpatient visits across all health care specialties combined (OT, PT, SLP, physiatrist). Metacognitive strategy training (MCST), specifically the Cognitive Orientation to daily Occupational Performance (CO-OP) approach, is a potential solution to address both of these gaps. CO-OP is a performance-based, problem-solving approach that enables participants to improve task performance through cognitive strategy use. In the exploratory clinical trial for individuals with sub-acute stroke (n=26), the study compared ten, 45-minute sessions of MCST (CO-OP) with dose-matched outpatient usual care outpatient occupational therapy (OT). The MCST (CO-OP) group demonstrated a large effect over usual care on objective measures of trained functional activities (d=1.6) and untrained functional activities (d = 1.1). The MCST group also demonstrated a moderate effect over usual care outpatient OT on improving motor function (r = 0.3). The goal of this proposed project is to determine the efficacy of MCST to improve activity performance and to reduce motor impairments in individuals with subacute stroke. A single-blind, parallel, randomized clinical trial will be conducted with individuals with sub-acute stroke. Participants will be randomized to a 10-session MCST (CO-OP) treatment group or to a dose matched usual care outpatient OT control group. Data will be collected pre-intervention, post-intervention, and at 3-months post-intervention assessment. Our central research hypothesis is that MCST will produce a significant improvement on objective and subjective measures of activity performance (trained and untrained goals) and reduce motor impairment in comparison to a usual care OT group. Objective 1: Evaluate the efficacy of MCST to improve subjective and objective activity performance in individuals with subacute stroke. Primary Endpoint: MCST will have a greater positive effect compared to usual care OT on subjective and objective activity performance of trained goals. Primary Endpoint: MCST will have a greater positive effect compared to usual care OT on subjective and objective activity performance of untrained activity goals to demonstrate transfer of the treatment effect. Secondary Endpoint: MCST will have a greater positive effect compared to usual care OT on subjective stroke recovery (participation and role functioning) Objective 2: Evaluate the efficacy of MCST to improve motor function in individuals with subacute stroke. Primary Endpoint: MCST group will have a greater positive effect compared to usual care OT on reducing motor impairment. Secondary Endpoint: MCST will have a greater positive effect compared to usual care OT on subjective stroke recovery (physical functioning)

The study presented is part of the departmental project entitled: BEHAVIORS AND WELLNESS: A MULTIDISCIPLINARY APPROACH TO PROMOTE THE QUALITY OF LIFE IN VULNERABILITY CONDITIONS - winner of the MIUR grant "Departments of Excellence", provided by Law 232 of 2016. The departmental project has the general aim of understanding the interaction between behaviours, motivational and psycho-biological aspects in a situation of neurodegenerative disease and/or mental distress, from which derive six different types of patients that constitute the six lines of research into which the departmental project is divided. The project, as all lines of research, is organized into two essential phases: Phase I: the creation of basic models based on the in-depth knowledge of the molecular, structural and functional mechanisms (both physiological and cognitive) as well as on the psychological components (e.g. the ability to cope with the disease and the implementation of strategies functionals to the well-being) which are better indicative of an improvement in the health conditions of the six different patient populations studied; Phase II: clinical-applicative integration in which studies will be carried out on the motivations and consequent behaviours in everyday life contexts. Therefore, will be highlighted actions to take place in the healthcare, educational and organizational fields, aimed to promote the implementation of the practices most clearly associated with improving the health conditions highlighted by basic research. The peculiarity of the studies, that make the departmental project, consists in the effort to encourage translational research, multidisciplinarity and the integration of knowledge, stimulating an innovative dialogue between the different scientific disciplinary sectors present in the department. The purpose is to make evidence-based the whole path related to behaviours and strategies that promote well-being, connecting biological, motivational or behavioural aspects each other, that make it possible to recover or not worsen the conditions of health. The idea is to encourage, where possible, the implementation, even outside or in continuity with the strictly hospital context, of practices aimed at promoting the well-being and quality of life in people in conditions of vulnerability. Each of the six research lines (1. Young patients with multiple sclerosis; 2. People with chronic brain stroke outcomes; 3. Parkinson's disease patients with symptoms of both physical and mental fatigue; 4. Preschooler population presents "regulatory disturbances"; 5. Migrants seeking international protection; 6. Population in old age and at risk of frailty) is integrated into the purposes and outcome of the departmental project, however, each providing a specific and appropriate study protocol, it is independently submitted to the approval of the Ethics Committee.

The purpose of this study is to use Transcranial Magnetic Stimulation (TMS) while subjects are making reaching movements in a robotic arm device in order to discover how different brain areas control movement before and after stroke and when these brain areas are most sensitive to TMS.

Hemodialysis is a therapeutic strategy used in subjects with chronic renal failure. Our working hypothesis is based on results published in experimental animal models of stroke where the investigators have demonstrated that peritoneal dialysis is an effective technique to reduce blood glutamate levels and reduce infarct volume. The objective of this clinical trial is to evaluate the viability, safety and efficacy of hemodialysis in patients with acute ischemic stroke, proposing that it may have a) a potential neuroprotective effect by reducing the excitotoxic levels of glutamate and proinflammatory cytokines in blood and b) fewer technical problems than peritoneal dialysis to apply in usual clinical practice.