Clinical Research Directory

Natural History of Stroke: Cause and Development

The purpose of this study is to learn more about stroke and obtain information that may serve as the basis for future investigations. It will 1) establish a registry of patients with cerebrovascular disease (stroke); 2) characterize the natural history of acute stroke and transient ischemic attacks (TIA)-an interruption of blood flow to the brain that causes stroke symptoms for a short period of time); and 3) evaluate the data to generate ideas for future studies. Patients 18 years of age or older with suspected acute stroke or TIA may be eligible for this study. Subjects will be recruited from patients who present with stroke at the emergency department of Suburban Hospital in Bethesda, Maryland. The study will gather data collected from diagnostic and laboratory tests the patient undergoes as part of standard medical care, including findings of medical and neurological examinations and other tests. In addition, studies will be done for research purposes only to gather data about stroke and TIA. These may include the following: * Blood and urine tests not more than 2 tablespoons of blood will be drawn for various tests. * Electrocardiogram (EKG) (heart tracing)-electrodes placed on the chest wall detect the heartbeat and heart rhythm. * Computed tomography (CT) scan of the head-specialized X-rays are used to obtain images of the brain. * Magnetic resonance imaging (MRI) of the brain-a strong magnetic field and radio waves are used to produce images that provide information about the brain tissue and blood vessels. * Transcranial Doppler (TCD)-sound waves are used to image the arteries of the brain and neck. * Echocardiogram-sound waves are used to image the heart and evaluate heart function. Patients may be asked to return to Suburban Hospital for follow-up testing in 1, 3, and/or 12 months, when some of these tests may be repeated to assess changes over time

Cardiac Rehabilitation of Stroke Survivors (SRP-CROSS)

This study examines the effectiveness of the cardiac rehabilitation program for stroke patients. The study will examine if patients with stroke, who receive cardiac rehabilitation in addition to their standard of care treatments, demonstrate improved recovery of function. It will also examine if these patients have reduced hospital readmission, reduced rate of recurrent stroke, and mortality.

Cardiovascular Health Study (CHS)

To determine the extent to which known risk factors predict coronary heart disease and stroke in the elderly, to assess the precipitants of coronary heart disease and stroke in the elderly, and to identify the predictors of mortality and functional impairments in clinical coronary disease or stroke.

Cardio-Renal Registry

Cardiovascular disease is the leading cause of morbidity and mortality among patients with chronic kidney disease (CKD). Even after adjustment for known cardiovascular risk factors, including diabetes and hypertension, mortality risk progressively increases with worsening CKD. As glomerular filtration rate (GFR) declines the probability of developing coronary artery disease (CAD) increases linearly, and patients with GFR \<60 mL/min/1.73 m2 have 2-3-fold increased CV mortality risk, relative to patients without CKD. Management of CAD is complicated in CKD patients due to the likelihood of comorbid conditions and potential for side effects. Despite their high cardiovascular risk, ACS patients with renal dysfunction are less commonly treated with guideline-based medical therapy and are less frequently referred for coronary revascularisation. This observation, referred to as the "treatment risk paradox," has been well described and may be explained by physicians' concerns regarding possible nonrenal side effects as well as renal toxicities. Furthermore, patients with severe CKD have traditionally been under-represented in most large cardiovascular clinical trials. Therefore, recommendations for both medical and revascularisation of CAD have relied heavily on extrapolation of results from the non-CKD population. This data will add to that literature by assessing the characteristics and outcomes of patients with CAD and CKD. It will also identify and characterise predictors of outcomes, improve risk stratification and diagnostic evaluation.

Living With Stroke - Sustainable Utilization of Healthcare Services

The proposed study will generate a national mapping of healthcare utilization patterns in people post-stroke in the chronic phase living in the community; examine the associations between individual-level characteristics, health outcomes and healthcare utilization; and will describe patients' perspectives on their needs for health services and their experiences of using them. The study will use mixed-methods methodology (quantitative and qualitative) and will proceed in three parts. In part 1, data will be extracted retrospectively from electronic medical records of of Clalit Health Services, covering all patients with a stroke diagnosis. In part 2, a sub-sample of 240 patients will be asked to answer standardized questionnaires. In part 3, a sub-sample of 20 participants will participate in in-depth, semi-structured interviews.

Effects of tVNS and mCIMT in Chronic Stroke

Stroke is a leading cause of death and disability worldwide, resulting in significant physical and cognitive impairments. Arm weakness is most common after stroke and its treatment is recognized as an area of considerable need. The functional limitations and disabilities experienced by stroke survivors, particularly in the upper limb have a profound impact on their quality of life. Current treatment for arm weakness typically comprises intensive, task-specific and repetitive rehabilitative interventions. Transcutaneous auricular vagus nerve stimulation (tVNS) is a novel noninvasive treatment for stroke that directly stimulates the peripheral auricular branch of the vagus nerve. This study determines the effects of Vagus Nerve Stimulation and Modified Constraint Induced Movement Therapy on Motor Function, Cognition, and Quality of life in chronic stroke patients. This randomized clinical trial will be conducted at IIMCT Railway General Hospital and Al-firdous physiotherapy clinic over a duration of six months. The sample size will consist of 50 participants. Participants which meet the inclusion criteria will be taken through non-probability convenience sampling technique, which will further be randomized through online randomization tool. 25 Participants will be assigned to Group A receiving tVNS and mCIMT with routine physical therapy and 25 to Group B receiving mCIMT with routine physical therapy . Data will be collected using various assessment tools, including Fugl-Meyer Assessment-UE (FM-UE), and Nine-hole peg test (NHPT) to assess Motor function. Stroke Impact Scale (SIS) to assess QOL, Montreal cognitive assessment (MoCA) to assess cognition, and Modified Ashworth scale to assess spasticity. All participants will receive intervention 3 days a week on alternative days for 8 weeks. Pre-intervention assessments will be conducted for both groups. The effects of the interventions will be measured at pre-treatment, 4th week, and post-intervention. Data analysis will be performed by using SPSS 26 software. Key words: Modified Constraint Induced movement Therapy, Motor function, Rehabilitation, Stroke, Transcutaneous Vagus nerve stimulation, Upper extremity.

Use of Physical Therapy Outcome Measures to Predict Discharge Destination in People With Stroke From Acute Care Hospital

Physical therapy assessments assist in discharge planning along with demographic and social factors for patients with stroke in acute care. Understanding where a patient can be discharged to, based on the patient's functional status post stroke is important to be able to use resources effectively, decrease length of stay, and facilitate early initiation of rehabilitation services if needed. Standardized outcome measures can help quantify functional deficits and the scores on the standardized outcome measures can in turn guide the discharge planning process. The Activity Measure for Post Acute Care "6-Clicks" (AM-PAC "6-Clicks") has been used in the acute care setting to guide discharge planning. Based on its cutoff scores, it also can assist in predicting discharge destination. The Mobility Scale for Acute Stroke (MSAS) has been used to determine discharge to home versus not home in patients with stroke. Understanding the validity of the MSAS in comparison with the Postural Assessment Scale for Stroke (PASS) and the AM-PAC "6-Clicks" can be beneficial as the MSAS is a stroke specific outcome measure which is mainly used in acute care and is easy to administer. It can be administered in a short duration and consists of mobility and balance assessments which can help determine functional deficits.

Database for Stroke in Infants and Children: the International Pediatric Stroke Study

The International Pediatric Stroke Study (IPSS) was established in 2003 as a multi-center, multi-national clinical research registry. Over the years, it has grown to become a highly successful study vehicle for pediatric stroke research across over 100 institutions worldwide. Today, The IPSS continues to serve as the global clinical data and imaging core for multi-disciplinary pediatric experts who perform international collaborative research to better understand, prevent, and improve outcomes in pediatric stroke. The robust dataset and cohesive network enable high caliber and ground-breaking research in the field. Participating sites enroll neonates or children who have had an ischemic or hemorrhagic stroke, or may be at high risk of having a stroke. Participants have their medical and research records reviewed for information about their stroke and abstracted into a secure electronic database called REDCap, which is hosted at SickKids in Toronto Canada. The IPSS also provides an attractive imaging platform (through the Stroke Imaging Lab for Children, SILC, housed at SickKids) for sites to share clinically acquired brain images that will complement the clinical dataset. The clinical and imaging datasets will improve our understanding of the processes underlying plasticity and recovery in childhood stroke.

Nomad P-KAFO Study

The goal of this clinical trial is to evaluate the impact of using the Nomad powered KAFO in people who have had a musculoskeletal or neurological injury that has affected their ability to walk. The main questions it aims to answer are to quantify the effectiveness of the Nomad in improving mobility, balance, frequency of falls, and quality of life in individuals with lower-extremity impairments compared to their own brace, over three months of daily home and community use. Participants will: * Wear a sensor that records everyday activities and mobility. * Perform measures of mobility and different activities of participation using their own brace. * Perform measures of mobility and different activities of participation using the Nomad powered KAFO

Effects of Atalante Exoskeleton on Gait Recovery in Non- or Poorly Ambulatory Patients With Hemiparesis in the Acute/Subacute Phase (Month 1 to 4)

The present clinical investigation - EarlyExo, is an interventional, international, multicentric, prospective, single-blinded randomized controlled trial. This clinical investigation is designed to test the hypothesis that early and intense introduction of walking sessions assisted by the Atalante exoskeleton, in a sample of hemiparetic patients with still non or poor ambulatory capacities (FAC 0 or 1) between one- and four-months post stroke, would result in a better recovery of functional walking compared to a control group only receiving conventional therapy. Improved recovery will be measured through the proportion of patients reaching a FAC score of 4 or higher at the end of the intervention period. The tested hypothesis is that this proportion will be higher in the Exo group. The duration of the intervention period in both groups is 6 weeks. * For the Exo group: 3 sessions per week (i.e., 18 one-hour sessions) with the Atalante device and 2 sessions per week (i.e., 12 one-hour sessions) of conventional therapy. * For the Control group: 5 sessions per week of conventional therapy (i.e., 30 one-hour sessions). The study will include 66 patients (33 in each arm) and takes place in two French centers, two German centers and one Spanish center.

Videographic Feedback and Walk Rehabilitation in Post-Cerebrovascular Accident

Cerebrovascular Accident affects the majority of the elderly population and its frequency is constantly increasing. The resulting deficits are numerous and lead in particular to an alteration in the quality of walking and autonomy. Numerous rehabilitation techniques have been described. In practice, correction instructions are often given by the therapist while the motor activity is being performed. Walking is a complex activity, as is the processing of dual-task information in elderly stroke patients. It therefore appears interesting to separate the time of motor realization and that of correction instructions. Investigators therefore propose firstly to film the patient during the performance of a walking activity and then, secondly, to analyse the video with the patient, which thus represents a source of delayed feedback. The main objective of the study is to observe the effects of this practice on walking speed. Investigators are comparing two groups of patients: the control group receiving conventional rehabilitation and the experimental group receiving conventional rehabilitation plus sessions with the video tool. They expect to observe a greater improvement in walking speed in the experimental group.

COgnitive-somatoSensory-MOtor Training to Improve Arm and Hand Function After Stroke (iCOSMO)

The iCOSMO study investigates the feasibility and beneficial effects of an intervention combining sensation, motor and cognition to improve arm and hand function after chronic stroke.

Measuring the Concurrent Validity of the Upper Limb Use Ratio With Accelerometers in an Ecological Situation After Stroke.

The purpose of this stufy is to measure the concurrent validity of the upper limb use ratio with accelerometers in an ecological situation after stroke.

Nurses' Health Study (Cardiovascular Component)

To determine the relationships of hormonal, reproductive, dietary, and lifestyle factors, as well as biochemical and genetic factors, with the subsequent risk of coronary heart disease and other cardiovascular events in a cohort of female registered nurses. The current funding cycle involves comprehensive metabolomic profiling of coronary heart disease cases and controls and development of metabolomic risk scores for coronary heart disease.

Adherence to Long-term Exoskeleton Rehabilitation to Treat Lower Limb Weakness and / or Deficiencies in Adult Population

In 2019, approximately 2.4 billion people worldwide required rehabilitation for various health pathologies, a 63% increase since 1990. It has been suggested that current rehabilitation frameworks (inpatient, outpatient, and community-based) are insufficient to meet local population needs due to issues like long waiting times, lack of facilities, prioritization, funding, and accessibility.Patients with lower limb weaknesses, resulting from various conditions (for example stroke, traumatic brain injury, spinal cord injury and others) require long-term management and motivation for engagement, which are crucial for functional outcomes. This highlights the need for sustainable gait and balance rehabilitation. New technologies like exoskeletons have shown promising results in short-term inpatient programs, improving gait, balance, and quality of life, however, long-term follow-up data are still needed. The present clinical investigation is a national, prospective, open-label interventional trial, proposing a 12-month outpatient rehabilitation program with the Atalante X exoskeleton to treat lower limb weakness and/or impairments in 100 participants. The rehabilitation program consists of at least one exoskeleton rehabilitation session per week. At the end of the first-year experimental phase, participants can continue for an additional year in the voluntary phase. The program aims to explore the potential long-term effects of supervised robotic rehabilitation on motor, cognitive, bowel, bladder functions, quality of life, and well-being. Assessments are conducted at baseline, after 4 and 12 months of exoskeleton rehabilitation, and at 16 and 24 months for participants in the voluntary phase.

Neurorehabilitation Through Hippotherapy of a Brain Stroke

Cerebrovascular accident \[CVA\] (medical term for stroke) is a high burden worldwide disorder and the second leading cause of disability. As illustrated by the number of survivors that remain disabled after a CVA (2 out of 3 according to the US National Stroke Association), recovery is limited, and novel neurorehabilitation approaches are urgently needed. Hippotherapy is an emerging specialized rehabilitation approach, performed by accredited health professionals on a specially trained horse via its movement. A body of scientific evidence has gradually emerged in recent years, showing robust benefits of hippotherapy in various massive neurological disabling conditions including brain stroke. The aim of the study is to analyze the effect of a hippotherapy program of several cycles delivered during 22 weeks in total, on the functional and global evolution of post-stroke patients (with a score of Rankin ≥ 3 at inclusion) during the outpatient rehabilitation phase. A second purpose is to measure the impact of the intervention on the quality of life of their close caregivers. A prospective clinical trial on the effectiveness of hippotherapy versus conventional outpatient rehabilitation alone will be carried out. The 22-weeks program includes three cycles of hippotherapy as follows: an initial 2-weeks cycle, an intermediate 1-week cycle and a final 1-week cycle. One-hour daily sessions will be conducted during each cycle exclusive additional rehabilitation care. After each cycle, the patients will have a 9-weeks rest period where they will continue their conventional therapy. A battery of clinical tests will measure both functional and psychological outcome. The primary end point will be the functional independence of the patient. The secondary end points will consider the patient's sensorimotor and cognitive function, the severity of stroke and the quality of life, as well as the caregivers' burden and quality of life. Program evaluation is important in neurorehabilitation to ensure that patients are achieving meaningful outcomes from the care. A primary question is how do stroke patients clinically evolve after being discharged from the hospital and how stable is the achieved rehabilitation outcome. Hippotherapy optimizes brain plasticity and has a strong impact on the global rehabilitation process and functional outcome of these patients. A remaining question concerns the improvement of the caregivers' quality of life.

Promote Awareness of the Driving Abilities of Post-stroke Patients.

Patients with cerebrovascular accident (CVA) may present with a deficit of awareness of the disorders which results in a lack of correct self-estimation of their own abilities and difficulties in terms of both cognition and driving. It is therefore important to develop tools to help professionals take this deficit into account in their driving assessments and also to help patients better identify their real abilities. This research project thus proposes a protocol making it possible to promote decision-making whether or not to resume driving by multidisciplinary teams. The main objective is to determine to what extent video feedback promotes awareness of the ability to manage post-stroke patients, compared to a group of control patients receiving the usual recommendations.

iPSC Biobank of Biomarkers Diversity in Cardiovascular Disease

The Investigators will create a clinical database and a Biobank of stem cells derived from the blood of participants with cardiovascular disease. The Investigators will recruit participants from diverse racial and ethnic backgrounds with equal representation from both sexes. The Investigators expect to create stem cells and analyze the blood for protein biomarkers and genetic causes of cardiovascular disease. The stem cell biobank and clinical data will be a powerful tool for studying cardiovascular disease.

Novel Brain Neurotechnology for Optimizing Precision Mirror Therapy in Stroke

The primary aim of this project will be to determine the effects of the tRNS-augmented unilateral and bilateral MT, and their effects relative to the control interventions (sham tRNS with unilateral or bilateral MT) on restoring health outcomes including motor function, daily function, quality of life and self-efficacy, and motor control strategy as well as brain activities (electroencephalography, EEG) in stroke patients.