Stroke Clinical Trials

The Barrett Upper Extremity Robot (BURT) is an FDA-approved upper extremity robot that assists patients with both passive and active range of motion while providing adjustable resistance (Barrett_Medical. Robotic Assist Rehabilitation Made Easy. https://medical.barrett.com/). Activities are directed by therapists and encourage patient involvement through video game activities providing active proprioceptive, vibrational, visual and auditory feedback. Engaging and colorful games are beneficial in holding patients' interest, and gravity assistance may also allow for increased repetition in the face of patient fatigue. In this prospective study, the investigators will determine if a standardized BURT Upper Extremity (UE) program can be consistently implemented within an acute inpatient rehabilitation facility (IRF). In addition, the investigators will see if patients who receive BURT have improved UE mobility and function as a result. The investigators will also study the perceived enjoyment and value of the intervention by patients, and perceived value by therapists. Because BURT therapy is able to provide more repetitions of upper extremity movement in a shorter length of time than conventional therapy, the investigators hypothesize that patients who participate in neuro re-education activities using BURT will achieve greater improvements in strength, upper extremity function, fine motor coordination, activities of daily living and mobility during their time in an IRF than patients receiving conventional therapy. In this study, eligible patients admitted to Sunnyview Rehabilitation Hospital (SRH) for rehabilitation following stroke will be randomized to receive conventional or BURT therapy. Meaningful clinical benchmarks for upper extremity function, tone, fine motor coordination, activities of daily living and mobility will be assessed using the Upper Extremity Motor Assessment Scale (UE-MAS)(Zelter, 2010), manual muscle testing (MMT), Modified Ashworth Scale (MAS) (Figueiredo, 2011) and the 9-hole peg test (9HPT)(Figueiredo, 2011). The investigators also hypothesize that patients in the BURT cohort will report greater value/usefulness and interest/enjoyment. Read Less

Aphasia is a language disorder caused by stroke and other acquired brain injuries that affects over two million people in the United States and which interferes with life participation and quality of life. Anomia (i.e., word- finding difficulty) is a primary frustration for people with aphasia. Picture-based naming treatments for anomia are widely used in aphasia rehabilitation, but current treatment approaches do not address the long-term retention of naming abilities and do not focus on using these naming abilities in daily life. The current research aims to evaluate novel anomia treatment approaches to improve long-term retention and generalization to everyday life. This study is one of two that are part of a larger grant. This record is for sub-study 1, which will adaptively balance effort and accuracy using speeded naming deadlines. Read Less

To compare the effect of constraint induced movement therapy (CIMT) vs. treadmill training only on walking function in individuals post-stroke, a 6 week, single-blind, randomized training study will be conducted with three assessments of gait to determine the training effect. Subjects will be randomized to either the CIMT or treadmill training only groups at the initial test. Following the initial test, individuals from the 2 groups will undergo intensive locomotor training. Training will be performed 3 times per week for 6 weeks with the training time for each visit set to 45 minutes as tolerated. Data collection will proceed until 36 subjects from 2 groups have been trained. Read Less

Stroke is a neurological injury that adversely impacts psychosocial functioning and quality of life. This may occur due to direct insult to the brain circuits integral to adaptive psychosocial functioning, and/or indirectly via significant disruption to routine motor, sensory and cognitive performance. Yet, few evidence-based interventions exist for addressing the broad disruption to emotional and interpersonal functioning specific to stroke, highlighting a clear unmet need. The investigators propose that 1) identifying the most significant disruptions and 2) developing a cognitive-behavioral intervention to promote psychosocial functioning post-stroke is particularly important for overall quality of life, but additionally for adherence to physical rehabilitation and related interventions intended to promote holistic recovery. Read Less

People who had a stroke at least 6 months prior and who still have difficulty with walking will each be randomly assigned to receive either moderate or vigorous intensity walking exercise. Both protocols will be performed individually with a physical therapist for 45 minutes, 3x/week for 12 weeks. Measures including walking function will be assessed at baseline (PRE), after 4, 8 and 12 weeks of training (12WK) and at 3-month follow up (3moPOST), by raters who are unaware of the participant randomization. Read Less

The optimal site of neuromodulation for post-stroke aphasia has yet to be established. This study will investigate whether multiple sessions of cerebellar transcranial direct current stimulation (tDCS) boosts language therapy in helping people recover from aphasia as well as predict who is likely to respond to cerebellar tDCS. Read Less

The goal of this clinical trial is to test a gait (walking) training program in non-ambulatory (unable to walk) chronic stroke survivors. The main question it aims to answer is: • Will gait training improve the cardiovascular system in non-ambulatory chronic stroke survivors better than a sitting leg cycling exercise? Participants will walk on a treadmill with a partial body-weight support system and the gait training device. Researchers will compare with a leg-cycling exercise to see if there are significant differences in resting heart rate, systolic blood pressure (SBP), and A1c levels in the blood. Read Less

Intracranial atherosclerosis (ICAS) accounts for 10 to 40%, depending on ethnicity, of the 700,000 ischemic strokes in the United States every year. The annual rate of recurrent stroke in patients with optimally treated ICAS remains more than twice the average of other stroke etiologies (12.5% vs. 5). A robust literature has established that vessel wall magnetic resonance imaging (vwMRI) of extracranial carotid vessel wall enhancement (VWE) can predict stroke, independent of stenosis. VWE has been reported in symptomatic ICAS, but the role of local and systemic inflammation is unknown. Inflammatory biomarkers are elevated in symptomatic extracranial atherosclerosis, but the association with vwMRI findings in ICAS has not yet been explored. VWE is typically demonstrated by the uptake of gadolinium MRI contrast into the aneurysm wall or atherosclerotic plaque. A novel MRI contrast agent, ferumoxytol, allows multi-contrast weighting on T1w and T2w images and provides important insight into the role of local vessel wall inflammation by accumulating in macrophages on delayed T2* sequences. To identify effective prevention and treatment strategies for cerebrovascular disease, we need to critically evaluate vwMRI techniques, determine VWE prevalence, and explore the link between VWE and inflammation. Read Less

The goal of this phase I/II clinical trial is to determine the behavioral and neural effects of 5-daily transcranial direct current stimulation on post-stroke fatigue. The three aims are: Aim 1: Investigate the behavioral effect of 5 daily sessions of anodal tDCS over the ipsilesional M1 on PSF. Aim 2: Investigate the neurophysiological effect of 5 daily sessions of anodal tDCS over the ipsilesional M1. Aim 3: Determine the relationship between changes in M1 excitability, brain connectivity and changes in PSF. Participants will receive either a real or sham stimulation for 5 consecutive days and fatigue will be assessed before, immediately after and 1-month after the intervention. Fatigue will be assessed using clinical, behavioral, and neurophysiological outcomes. Read Less

This study will conduct a preliminary evaluation of and obtain user data on a novel game-based visual interface for stroke gait training. Study participants will complete one session comprising exposure to gait biofeedback systems in an order determined by randomization. Participants will be exposed to 2 types of biofeedback interfaces: newly developed game-based interface (projector screen display) traditional, non-game interface Read Less

In the United States, more than 795,000 people have a stroke every year. Motor impairment after a stroke is common and can be debilitating. To date, there remain few treatments available to help improve motor recovery after a stroke, making this an important area of research. Novel use of neuromodulation such as Invasive Vagus Nerve Stimulation (VNS) has been shown to improve motor recovery in stroke patients. Vagus nerve stimulation (VNS), in which the nerve is stimulated with electrical pulses, has demonstrated success for a variety of conditions, including inflammation, depression, cognitive dysfunction, chronic fatigue, headaches/migraines, pain, insomnia, and cardiovascular issues. Very recently, non-invasive options have been developed and might be a promising alternative. The research in this area is still very limited and much more research is needed to investigate non-invasive/trancutaneous auricular vagus nerve stimulation (taVNS) related biomechanisms and to further support its efficacy in acute patients. The purpose of this study is to build upon the current research to investigate changes in electrical brain activity (using electrophysiology) related to improvements in both motor and cognitive recovery following the use of taVNS in acute stroke patients. Read Less

The purpose of this clinical trial is to investigate the efficacy of a hybrid-based rehabilitation program for the upper extremity(UE) combining the interventions- Functional Electrical Stimulation (FES) and Robotic rehabilitation in individuals with chronic stroke. The main question it aims to answer is if the Hybrid multi-muscle FES+Robot upper extremity rehabilitation is more effective in improving the upper extremity motor impairments and function as compared to robotic upper extremity training alone. Read Less