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Stroke clinical trials

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NCT ID: NCT04264195 Completed - Clinical trials for Weakness of Extremities as Sequela of Stroke

Peer Group Regulated mCIMT Program for Adult Stroke Patients: Effects on Functional Activities

PEPS-MIT
Start date: October 27, 2018
Phase: N/A
Study type: Interventional

Each year more than 17 million people in the world are experiencing a stroke. Stroke is a major cause of mortality and one of the prevalent causes of serious disablement. Stroke sufferers often will have restricted participation in various domains e.g. not being able to fulfill the job requirements. That is why they are losing social contacts and are at risk for social deprivation. They also show limitations in common daily activities, which implies that they often need help or must use assistive devices because of muscle weakness, spasticity and impaired control over one of the hands, which are very common after stroke. Functional hand recovery will be only minimal at 6 months after stroke in most of the patients. Therefore, patients mainly rely on their unaffected hand to perform daily activities and refrain from using the impaired hand. However, it is known that also after a stroke new connection could be made in the brain when training tasks strenuously. This mechanism is applied in our program by constraint induced movement therapy (CIMT). In CIMT using the unaffected hand is hindered by a mitten, so that patients are forced to perform tasks predominantly with the paretic hand. The original CIMT protocol includes three main elements: - Constraining of the non-paretic hand to force the use of paretic hand. - Repetitive task-oriented training of the paretic hand. - Adherence-enhancing behavioral methods, to promote the use of this technique in the daily environment. Although CIMT trials are showing variations in the kind of tasks, the duration of practice per day and the intensity, they all published significant effects of CIMT compared to traditional therapy. Currently CIMT is worldwide considered the most effective rehabilitation treatment for improving the functioning of the paretic hand in stroke, but this treatment is not applied in Bangladesh. To overcome this,the investigators have made a protocol for CIMT application with the purpose to study the effects in stroke patients in the Bangladesh situation. Method Beside the CIMT program the investigators also developed a method for getting maximal social interaction in groups of stroke patients. That may help them to exercise on their own with support of their peers. The investigators call that a 'peer group regulated training' and stroke patients got that training in addition to the usual individually focused rehabilitation. This extra training includes the following elements: - Stroke patients perform repetitive tasks in a group together (groups 6-8 persons, max 15). - One of them is assigned as a 'leader', who announces the next task while the therapist is there mainly for helping and correcting patients. - Tasks are fine-tuned to the Bangladesh' situation regarding gender-specific clothing, manipulation of objects and tasks that needs cognitive solutions. - Within the training there are socializing tasks like singing, sharing of experiences, complimenting and encouraging each other. - Patients were asked to perform the tasks by themselves at home as well, and to report about that. This method was applied in two separate groups. The group that is indicated as the control group mainly performed the exercise tasks bilaterally, as in as usual therapy sessions. The experimental group performed the tasks with forced use of the paretic hand, wearing a mitten at the non-paretic hand. The investigators will be compared the performances of the two study groups at the start of the group therapy, at the finish one month later, and at 3, 6, 9 and 12 months afterwards. The hypothesis is that the applied adherence-enhancing behavioral method will have dominant effects, and that the methods: 'bilaterally' versus 'forced use of paretic arm/hand' (CIMT) will show equal improvements in the short and longer term.

NCT ID: NCT04261478 Recruiting - Stroke, Acute Clinical Trials

Endovascular Acute Stroke Intervention - Tandem OCclusion Trial

EASI-TOC
Start date: August 31, 2020
Phase: N/A
Study type: Interventional

Patients with tandem occlusion or tandem lesion (TL), that is, stroke with an acute intracranial anterior circulation occlusion and an ipsilateral cervical ICA (c-ICA) high-grade stenosis or occlusion, constitute about 15-20% of patients undergoing endovascular thrombectomy (EVT). However, the optimal treatment of acute stroke patients with TL remains uncertain, as relatively few patients with TL were included in the major randomized controlled trials of EVT and management of the c-ICA was generally not specified by protocol nor analyzed post-hoc. Recent large multi-centre retrospective cases series suggest that acutely stented patients may have more favorable outcomes than patients treated with angioplasty alone or those with no acute ICA intervention, but high quality randomized trial data are lacking. EASI-TOC, a phase 3, academic multi-centre, controlled trial (PROBE design) with embedded pilot phase, will seek to determine if in patients undergoing acute intracranial thrombectomy for anterior circulation stroke with concurrent ipsilateral symptomatic high-grade (≥70%) atherosclerotic stenosis or occlusion of the extracranial ICA, endovascular ICA revascularization with stenting is superior to intracranial thrombectomy alone with regards to functional outcome at 90 days. Patients will be randomized to Acute stenting or No acute stenting (1:1 allocation).

NCT ID: NCT04261257 Active, not recruiting - Stroke Clinical Trials

Cardiac Thrombus in Early Cardiac CT Scan in Etiological Workup of Ischemic Stroke: Prospective Study

CCT STROKE
Start date: March 11, 2020
Phase: N/A
Study type: Interventional

Stroke can be linked to atherosclerosis of the large vessels, occlusion of the small intracerebral vessels (gaps), cardioembolic pathology or other rarer etiologies. The cardioembolic etiology of stroke in elderly patients may be difficult to prove. Paroxysmal atrial fibrillation (AF) is a common cause of cerebral infarction (25%). Detecting AF is not easy. A 24-hour long-term holter and an implantable cardiac monitor (Reveal®) may be required. This etiology is all the more important as it requires anticoagulation treatment reducing the risk of recurrence in the short and long term. The left atrium thrombus is an indisputable marker of atrial fibrillation but it is rarely seen. Other cardiac etiologies such as a thrombus in the left ventricle, a large plaque or a thrombus of the aortic arch are possible. Finally, the permeable oval foramen and the aneurysm of the intra-auricular septum constitute a cause apart in young subjects (<60 years). Typically, the search for thrombus of the left atrium goes through a trans-thoracic cardiac ultrasound and a transesophageal cardiac ultrasound. These examinations, often negative, are performed several days after the onset of the cerebral infarction. The transesophageal cardiac ultrasound, considered as the "gold standard" examination to look for an intracardiac thrombus and an embologenic plaque in the aortic arch, is poorly tolerated. It is rarely performed in patients over 75 years of age. In addition, the length of stay for these patients may increase due to the wait for these exams. Several studies have validated the non-inferiority of the cardiac scanner compared to the transesophageal cardiac ultrasound for the detection of intracardiac thrombus (left atrium or left ventricle). In the study by Hur et al. performed in 55 consecutive patients with a probable cardioembolic infarction, 14 thrombi of the left atrium were detected and confirmed by the cardiac scanner, but the patients were young, with a median age of 61 years. In the Berlin prospective HEBRAS study, 475 patients underwent cardiovascular MRI. The results are being analyzed but the cardiac scanner is more sensitive for the detection of thrombus in the left atrium. A prospective study confirmed that the cardiac scanner is more precise in differentiating the left atrial thrombus from circulatory stasis in patients with stroke In this study, there is no information on the time between the stroke and the completion of the cardiac scanner. Almost all patients with stroke benefit from an angio-scan of the CT scan of supra-aortic trunks as part of the urgent assessment on Day 1 or Day 2. The investigators propose to perform at the same time a cardiac scanner in order to allow a rapid morphological cardiological assessment, at the level of the left atrium, the left ventricle and the arch of the aorta.

NCT ID: NCT04260815 Completed - Stroke Clinical Trials

The Effect of Non-invasive Brian Stimulation on Language Production in Healthy Older Adults

Start date: October 2, 2018
Phase: N/A
Study type: Interventional

The use of non-invasive brain stimulation techniques like transcranial direct-current stimulation (tDCS) for rehabilitation of language is a growing field that needs further studies to determine how best it can be used to enhance treatment outcomes. It has been shown that tDCS can improve language performance in healthy and brain-injured individuals such as increased naming accuracy. However, at present, it is not known what effect tDCS has on higher-level language skills like discourse production (i.e. story telling, giving instructions) in healthy, older speakers. Therefore, the aim of this study is to investigate in healthy older adults, the effect of tDCS on discourse production as well as the ideal tDCS electrode placement for improving language at the discourse level. It is hypothesised that tDCS will result in greater language changes and improvements during discourse production compared to no stimulation.

NCT ID: NCT04260347 Completed - Ischaemic Stroke Clinical Trials

SITS-IVT in Patients >80 Years Study

SITS_ELDERLY
Start date: May 14, 2020
Phase:
Study type: Observational

A non-interventional post-approval study on Safe Implementation of Treatment in Stroke - International Stroke Thrombolysis Register (SITS-ISTR) existing data of intravenous recombinant tissue plasminogen Activator (rt-PA) (0.9 mg/kg) in acute ischaemic stroke patients over 80 years, treated according to the Summary of Product Characteristics (SmPC) in European countries.

NCT ID: NCT04260061 Withdrawn - Chronic Stroke Clinical Trials

Differential Effectiveness of Robotic Assisted Therapy on Upper Extremity Function in Patients With Chronic Stroke

Start date: August 19, 2019
Phase: N/A
Study type: Interventional

The objectives of this study are to: determine the effects of exoskeleton vs. end effector training systems on upper extremity motor and physiological function, daily functions, quality of life and self-efficacy in patients with chronic stroke.

NCT ID: NCT04259424 Completed - Stroke Clinical Trials

Exercise-primed Upper Extremity Motor Practice in Chronic Stroke

PUMP-Ex
Start date: March 22, 2021
Phase: N/A
Study type: Interventional

The purpose of this project is to establish initial feasibility and tolerability of a combined aerobic exercise (AEx) and upper extremity motor practice intervention on upper extremity (UE) function in chronic stroke survivors. This novel intervention pairs AEx with a virtual reality-based upper extremity rehabilitation game, Duck Duck Punch (DDP). AEx has been shown to improve overall brain function and promote a healthy brain environment; thus it may serve as an effective 'primer' and enhance the effects of DDP. Movement-based priming for rehabilitation involves performing movement or exercise before, or simultaneous to, an intervention with the goal of improving the effectiveness of the intervention. AEx combined with UE rehabilitation can improve UE function and self-reported health status in chronic stroke survivors. However, gaps remain regarding the clinical applicability of an AEx priming session and the mechanisms contributing to changes in UE functions in response to AEx-primed UE rehabilitation. Therefore, the aim of this project is to: 1) demonstrate the feasibility of pairing AEx + DDP in stroke survivors; 2) quantify the magnitude of the effect of the AEx + DDP intervention on UE function; 3) examine relationship of biomarkers of the nervous system and response to AEx + DDP.

NCT ID: NCT04259307 Completed - Stroke Clinical Trials

Effect of Intensive Nutritional Support in Subacute Stroke Patient

Start date: January 29, 2020
Phase: N/A
Study type: Interventional

Proper nutritional support during early rehabilitation may be beneficial for functional improvements in gaining functional independence and preventing complications in stroke patients. However, there was no consensus of proper amount of nutritional support in stroke patients. In this study, the investigators aimed to clarigy the effects of the intensive nutritional support during comprehensive rehabilitation during subacute phase to improve function in patients with first-ever strokes.

NCT ID: NCT04257149 Recruiting - Stroke, Acute Clinical Trials

Mobile Microwave-based Diagnosis and Monitoring of Stroke

MODS
Start date: February 1, 2018
Phase: N/A
Study type: Interventional

This is a prospective, open, multicentre trial that will enrol patients with clinical signs of stroke in the acute phase admitted for CT scan. The study assesses the diagnostic capability and safety of Strokefinder MD100.

NCT ID: NCT04256720 Recruiting - Healthy Clinical Trials

The Multi-Ethnic Lifestyle Study

MELS
Start date: December 10, 2018
Phase:
Study type: Observational [Patient Registry]

The study design is cross-sectional using a self-completion questionnaire in an English speaking multi-ethic population within Leicester and Leicestershire. The study will adopt a convenient and purposive sampling recruitment strategy across a variety of settings within Leicestershire to facilitate recruitment of a wide range of participants.