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NCT ID: NCT03759691 Active, not recruiting - Stroke Clinical Trials

Predictors for Prehospital Delay in Stroke Treatment

Start date: January 28, 2018
Phase:
Study type: Observational

Stroke is the second-leading cause of death worldwide and a leading cause of long-term disability. Annually 12,000 people in Denmark suffers a stroke; half of them will have long-term disabilities that may affect the activities of daily living. In addition to substantial individual suffering, stroke is also associated with considerable costs to society. Acute reperfusion therapies started within 4.5 to 6 hours (in some up to 24 hours) from symptom onset for acute ischaemic stroke (AIS) have revolutionized the acute stroke treatment and considerably improved the overall prognosis and mortality. However, only 15-25% of Danish patients are eligible to acute treatment. Numerous attempts to reduce both prehospital and in-hospital delay in stroke have been made, but much time is still lost in the prehospital phase. Many stroke patients do not recognize their own symptoms as signs of a stroke or do not understand the importance of calling Emergecy Medical Services (EMS) immediately. Others cannot call for help unless they have a bystander, because of cognitive impairment or aphasia. Some patients have a wait-and-see attitude, contact their GP or out-of-hours GP, which also can increase the delay. Educational stroke campaigns can increase knowledge, improve help-seeking behaviour and increase the number of patients eligible for reperfusion therapies. The foundation TrygFonden is planning a national stroke campaign in 2019. Aims: 1. To explore the knowledge of stroke in stroke patients and bystanders. 2. To explore the process from onset of symptoms until admission to hospital and the reasons for prehospital delay. 3. To explore the association between stroke knowledge, help-seeking behaviour and receiving revascularization therapy. 4. To evaluate the immediate effect of the national campaign six months after initiation. Material and methods: Study 1: Structured interviews of stroke patients (and bystanders) admitted to the Department of Neurology at Aarhus University Hospital and Regional Hospital West Jutland (Holstebro). The investigators will use the patient's medical record (EPJ) and the Danish Stroke Register (DSR) and map the patient's route from onset of symptoms to admission to stroke centre, including contact to general practitioner (GP), out-of-hours GP or Emergency Medical Services (EMS). For patients who have been in contact with their GP, the GP will receive an electronic questionnaire to explore the time- and event pathway from first contact until admitting the patient to hospital. The investigators will interview 500 patients and approximately 300 bystanders over a period of 3 months. Study 2: The investigators will evaluate the effect of the national stroke campaign by conducting a similar study in 2020 when the campaign has been running for six months. Perspectives: This study will provide new information about stroke patients and bystanders, their knowledge of stroke and their help-seeking behaviour. If more knowledge about the factors that cause prehospital delay in stroke treatment are obtained, the investigators will know which areas to focus on in the future to improve the outcome for stroke patients. Part of this project will examine the effect of TrygFondens national stroke campaign, which is expected to have impact on general knowledge and help-seeking behaviour. If more people know the core symptoms of stroke, hopefully more people will also know how to react to these symptoms by calling EMS. This will eventually increase reperfusion therapy rates, considerably improve stroke morbidity and mortality and reduce both individual suffering and the societal costs.

NCT ID: NCT03726047 Active, not recruiting - Stroke Clinical Trials

Exercise and Motor Learning After Stroke

Start date: June 12, 2018
Phase: N/A
Study type: Interventional

Subjects with chronic stroke (> 6 months post-stroke) will learn a new walking pattern through distorted visual feedback. Retention of the pattern will be tested without visual feedback immediately after learning and 24 hours later. Subjects will be randomly assigned to the control group or the exercise group. The control group will simply complete the learning task. The exercise group will complete 5 minutes of exercise immediately following the first retention test to test for the effects of exercise on retention 24 hours later.

NCT ID: NCT03708835 Active, not recruiting - Stroke Clinical Trials

The Effect of Transitional Care Model-Based Interventions for Stroke Patients and Their Caregivers

TEMpEST
Start date: March 1, 2018
Phase: N/A
Study type: Interventional

Stroke affects both the patient's and the caregiver's whole life by creating permanent damages. Patients and their families need further information and support in the transition from hospital to home. For stroke patients and their families after discharge, transition models can be used to provide continuously and rapidly the service by establishing a communication network between the institutions. In this study, the feasibility and impact of a transitional care model from hospital to home for stroke patients and caregivers will be tested. The purpose of the project is to assess the effect of Transitional Care Model (TCM)-based interventions for stroke patients and their caregivers on caregivers' competence, in increasing their readiness to care and electronic health literacy, in reducing their burnout, and on patient results. Types of interventions that are applied to stroke patients and caregivers based on Transitional Care Model are hospital interview, home visit, telephone interview and web-based training. As stated in TCM, the intervention was planned to be performed three months after discharge. Multiple interventions including at least three face-to-face interviews at the hospital, distance education via Web and telephone communication for three months, and one home visit within seven days after discharge will be performed in order to increase health literacy levels and caregiving competence of the caregivers and to reduce burnout. In pre-tests and post-tests to be applied to the caregivers, the effectiveness of the support programs provided will be assessed quantitatively by the electronic health literacy, caregiving competence, and burnout scales. The satisfaction with the intervention will be evaluated qualitatively. Rate of return to the hospital, risk of pressure sore, and time of access to home health services will be assessed in stroke patients. As a result of web-based distance education, home visit, telephone communication service and informing at the hospital, caregivers of stroke patients will begin to receive information about what patients experience during their treatment and about all what patients need after treatment. The website to be prepared for caregivers of stroke patients will be put into service also for the control group upon completion of the data collection of the intervention group and the website will also continue to be used after the project is completed.

NCT ID: NCT03698357 Active, not recruiting - Stroke Clinical Trials

Video Balance-based Exercise in Persons With Stroke

Start date: September 4, 2017
Phase: N/A
Study type: Interventional

This study is to compare the effects of Interactive video balance-based exercise (IVBE) intervention and conventional rehabilitation on the balance and functional performance in stroke survivors. Fifteen participants will receive Interactive video balance-based exercise, while the other half will receive conventional rehabilitation.

NCT ID: NCT03697525 Active, not recruiting - Acute Stroke Clinical Trials

Repeated Muscle Vibration in Acute Stroke

Start date: January 1, 2016
Phase: N/A
Study type: Interventional

prospective randomized double-blind sham-controlled study aimed to investigate the effects of Repeated Muscle Vibration (rMV) on motor recovery in acute stroke patients, treated within 72 hours from symptoms onset

NCT ID: NCT03689491 Active, not recruiting - Stroke Clinical Trials

The Combining rTMS With Visual Feedback Training for Patients With Stroke

rTMS
Start date: February 13, 2015
Phase: N/A
Study type: Interventional

After stroke, patients often experience motor deficits that interrupt normal lower extremity movement and gait function. Recent developments in neuroimaging have focus on the reasons why some patients recover well while some do poorly. However, there is still no consensus on the exact mechanisms involved in regaining the functions after rehabilitation. Application of repetitive transcranial magnetic stimulation (rTMS) to facilitate neural plasticity during stroke treatment has recently gained considerable attention. The possible mechanism through which rTMS acts is based on the interhemispheric competition (IHC) model, which explains that patients with stroke experience alterations in cortical excitability and exhibit abnormally high interhemispheric inhibition from the unaffected hemisphere to the affected hemisphere. The visual feedback training can improve postural control and enhance motor performance. Several rTMS studies have evaluated the lower extremity dysfunction following stroke, but few studies have explored the efficacy of applying rTMS on the lower extremities. We expect the study can help us to further exploration of the change of clinical function and cortical excitability following rTMS and visual feedback training in subjects with stroke. In addition, the results of this project will be provided for further rehabilitation programs in people with stroke.

NCT ID: NCT03666806 Active, not recruiting - Clinical trials for Preventing Stroke in Sickle Cell Anaemia

Preventing Stroke Triggers in Children With Sickle Cell Anaemia in Mulago Hospital, Kampala (PREST ): a Randomized Control Trial

PREST
Start date: August 22, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

Sickle cell anaemia (SCA) is a common hereditary haemoglobin disorder in Africa. World wide it is estimated that about 300,000 newborns are born every year. Of which 75% of them live in Sub-saharan Africa (SSA). In Uganda, about 15,000 babies are born with sickle cell disease per year. In Uganda, the stroke prevalence was found to be 6.2% in children admitted to the National referral hospital in Kampala. Notable between 21 to 30% of these children presented with co-morbidities such as anaemia, bacteraemia and painfull crisis. Stroke in SCA is mediated by several mechanism such as cellular adhesions, inflammatory markers, hemolysis associated oxidative stress and hemostatic activation. Stroke in SCA is primarily a large vessel stroke and the mechanisim state above lead to a narrowing of the lumen of the cerebral arteries Arterial ischaemic stroke which occurs frequently in children with SCA has been associated with bacterial infections. Recent studies have shown that minor infections such as flu like infections can play a critical role in the trigger of stroke in children. Our hypothesis is that viral flu infections is a key trigger for the risk of stroke in children with SCA. Our objective is to prevent the occurrence of flu illnesses in children with SCA thereby reducing the risk for stroke in our population of children with SCA. Methods: A randomized controlled double blinded study Study site: The study will be conducted at the Sickle Cell Clinic (SCC), Mulago Hospital. Inclusion criteria: will be ;age between 2 years and 12 years;All children whose parents will have consented and those above 7years will have to assent. Exclusion criteria: all children with previous strokes; children who have acute illness and are not clinically stable; any child with previous documented adverse event following immunization (AEFI). Sample Size: Using Open EPI calculator for cohort studies we calculated a total sample size of 136 participant to achieve our objective. Using a 95% confidence interval, power of 80% and an unexposed outcome of 25% (4) using a ratio of 1:1. Each arm will have 68 participants. With anticipated 10% loss to follow up a total sample size of 150 with each arm having 75 participants. Study utility: Globally, stroke triggers have been recently identified independent of the existing risk factors such as high cerebral velocity speeds on TCDs. Flues like illnesses have been reported to be stroke triggers in children with arterial ischaemic strokes worldwide.This study may influence the role of influenza vaccination in the prevention of stroke triggers in children with sickle cell anaemia. It will also add to the existing modalities which have helped to reduce the incidence of stroke amongst this high risk group of children with

NCT ID: NCT03638089 Active, not recruiting - Stroke Clinical Trials

Fall Recovery Training for Individuals With Chronic Stroke

Start date: September 11, 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to quantify how fall-recovery training improves the fall-recovery response of individuals with chronic stroke. Up to 20 participants with chronic stroke will be recruited from the community. Over six laboratory visits, participants will undergo sessions of fall-recovery training. Each session is comprised of simulated trips and slips as participants stand on a computer-controlled treadmill. Trip-recovery training consists of treadmill-delivered disturbances that induce a forward fall. Slip-recovery training consists of a treadmill-delivered disturbances that induce a backward fall. Separate progressions focus on initial steps with the left and right limbs. The training intensity, as determined by the disturbance magnitude, is progressive and dependent on participant performance. Step length and maximum trunk angle will be calculated. The hypothesis is that, with practice, participants will recover from larger perturbations, and they will increase step length and reduce trunk rotation during fall recoveries.

NCT ID: NCT03610828 Active, not recruiting - Stroke Clinical Trials

Meta-analysis of Vegetarian Diets and Incident Cardiovascular Outcomes

Start date: October 1, 2017
Phase:
Study type: Observational

Vegetarian and vegan diets have been shown to reduce cardiometabolic risk factors for chronic diseases, such as cardiovascular disease and diabetes, and have been associated with decreased risk of these chronic diseases. The role of vegetarian and/or vegan dietary patterns and incident cardiovascular outcomes still remains unclear. To address these uncertainties, the investigators propose to conduct a systematic review and meta-analysis of the totality of evidence from prospective cohort studies to distinguish the association of vegetarian and/or vegan dietary patterns on the prevention and management of cardiovascular diseases. This proposed knowledge synthesis was commissioned by the Diabetes and Nutrition Study Group (DNSG) of the European Association for the Study of Diabetes (EASD) and will be used to inform clinical practice and dietary guidelines, help improve health outcomes, and guide future research design.

NCT ID: NCT03596502 Active, not recruiting - Atrial Fibrillation Clinical Trials

Direct Oral Anticoagulants in Patients With Atrial Fibrillation (DOACs vs Warfarin)

Start date: February 1, 2018
Phase:
Study type: Observational

The purpose of this study is to assess safety and effectiveness of direct oral anticoagulants (DOACs) and warfarin for stroke prevention in patients with non-valvular atrial fibrillation (AF). The comparison of DOACs versus oral vitamin K antagonists, in particular warfarin, is of interest. The investigators will carry out separate population-based, matched cohort studies, using health administrative databases in seven Canadian provinces. New users of oral anticoagulants (DOACs or warfarin) for stroke prevention in non-valvular AF will be eligible to enter the cohorts. Follow-up will continue until a hospitalization or emergency department visit for a stroke. The results from the separate sites will be combined by meta-analysis to provide an overall assessment of the safety and effectiveness of the different anticoagulation regimens in stroke prevention in AF. We hypothesize that DOACs and warfarin will have similar safety and effectiveness profiles.