RIvaroxaban for Stroke Patients With AntiPhospholipid Syndrome
Antiphospholipid SyndromeSystemic Lupus Erythematosus3 moreRivaroxaban Versus Warfarin for Stroke Patients With Antiphospholipid Syndrome, With or Without SLE (RISAPS): a Randomised, Controlled, Open label, Phase II/III, Non-inferiority Trial. 140 patients will be randomised with a ratio of 1:1 to receive either: Rivaroxaban 15mg twice daily orally for 24 months or Warfarin (standard of care in the RISAPS trial) to maintain a target INR of 3.5 (range 3.0-4.0) for 24 months. The primary outcome of the trial is the rate of change in brain white matter hyperintensity (WMH) volume between baseline and 24 months follow up, assessed on brain magnetic resonance imaging (MRI), a surrogate marker of ischaemic damage.
Rehabilitation Robotics, Cognitive Skills Training and Function
StrokeCerebrovascular AccidentThis study evaluates the effects of robot-assisted therapy for adults more than 6 months after stroke on upper limb functioning. Half of the participants will receive robot-assisted therapy for the arm affected by stroke, and the other half will receive robot-assisted therapy plus training in how to use the weaker arm during every day activities.
MultiStem® Administration for Stroke Treatment and Enhanced Recovery Study
Ischemic StrokeA Phase 3 study to examine the safety and effectiveness of the allogeneic, adult stem cell investigational product, MultiStem, in adults who have suffered an acute ischemic stroke in the previous 18-36 hours.
Lower Limb Flexor Synergy Training in Chronic Stroke
StrokeThis study evaluates whether a 4-week exercise training program focusing on lower limb flexors can improve lower limb motor function late after stroke. It is hypothesized that there would be significant improvements in gait and strength of the flexor muscles as a result of the training. It is also hypothesized that the training effects, if any, would be retained at 4 weeks after ending the training.
Lixiana Acute Stroke Evaluation Registry
Ischemic StrokeAtrial Fibrillation1 moreStudy Design: Lixiana Acute Stroke Evaluation Registry (LASER) is a randomized controlled trial with an associated registry. Patients with previously known or newly diagnosed atrial fibrillation (AF) and acute ischemic stroke within five days will be randomized 2:1 to early (≤ 5 days) or delayed (6-14 days) edoxaban initiation. Ischemic stroke will be defined as evidence of acute focal cerebral infarction confirmed on CT/MRI and/or focal hypoperfusion/vessel occlusion on multimodal CT, or by sudden focal and objective neurological deficits (i.e NIHSS ≥ 1) of presumed ischemic origin persisting > 24 hours. Study Aim and Objectives: The primary aim of LASER is to demonstrate the safety of edoxaban initiation within five days of cardioembolic stroke. Secondary aim is to determine predictors of hemorrhagic transformation (HT) after cardioembolic stroke. Investigators will systematically assess prospectively collected Computed Tomography (CT) scan images for evidence of HT and re-infarction.
CHinese Acute Tissue-Based Imaging Selection for Lysis In Stroke -Tenecteplase II
StrokeTo explore the efficacy and safety of tenecteplase for acute ischemic stroke patients (onset time 4.5-24h) of large vessel occlusion using early combined CT/MR imaging outcomes
Multi-task Gait Training Mode to Enhance Walking Function in Patients With Chronic Stroke
StrokeThe objective of this study is to investigate psychometric properties of dual-task walking assessments and compare effects of multi-task walking interventions on walking for patients with chronic stroke. Specifically, we will investigate psychometric properties (i.e. reliability, validity, and responsiveness) of dual-task walking assessments with the Stroop task for chronic stroke individuals (Aim 1). The second aim of this study is to compare the effects of multi-task walking training mode to traditional rehabilitation in patients with chronic stroke (Aim 2). The third aim of this study is to compare the immediate, retained, and transfer effect of multi-task overground walking training to multi-task treadmill walking training on walking function, cognitive performance, task coordination, and community ambulation in patients with chronic stroke (Aim 3).
Telerehabilitation for Post-stroke Patients
Stroke SequelaeIn the last few years, there has been an increasing shift towards outpatients setting in the care of patients with stroke. Unfortunately, this led to a high percentage of discharged patients who did not receive an adequate amount of rehabilitation, because of some non-clinical factors, such as resource availability, geographical location, age, and personal wealth. To date, there is growing evidence about the role of telerehabilitation as an effective method to deliver rehabilitative treatments to homebound subjects with no moving of therapists or patients. However, the most appropriate organizational models regarding Health Technology Assessment in telerehabilitation procedures still object of debate. On these bases, the aim of this project is to investigate the feasibility and effectiveness of multi-domains telerehabilitation procedures in stroke patients in order to supply the National Health Service with some useful information about the use of telerehabilitation in clinical practice of stroke rehabilitation.
Proximal Priority Versus Distal Priority Robotic Priming Effects in Patients With Chronic Stroke...
StrokeThis is a single-blind randomized comparative efficacy study involving 54-72 participants with chronic stroke. Participants will be randomized into proximal priority robotic group or distal priority robotic group and receive 18 intervention sessions (90 min/d, 3 d/wk for 6 weeks). The Fugl-Meyer Assessment Upper Extremity subscale, Medical Research Council Scale, Revised Nottingham Sensory Assessment, and Wolf Motor Function Test will be administered at baseline, after treatment, and at the 3-month follow-up. Two-way repeated-measures analysis of variance and the Chi-Square Automatic Interaction Detector Method will be used to examine the comparative efficacy and predictors of outcome, respectively, after intervention.
Efficacy of Cerebrolysin Treatment as an add-on Therapy to Mechanical Thrombectomy in Acute Ischemic...
StrokeIschemic3 moreThis study is designed to determine the efficacy and safety of Cerebrolysin treatment as an add- on therapy to mechanical thrombectomy (MT) in reducing global disability in subjects with acute ischemic stroke (AIS). The investigators have planned a single centre, prospective, open-label, single-arm study with 12 months follow-up of 50 patients with moderate to severe AIS, with a small established infarct core and with good collateral circulation who achieve significant reperfusion following MT and who receive additional Cerebrolysin within 8 hours of stroke onset compared to 50 historical controls treated with MT alone - matched for age, clinical severity, occlusion location, baseline perfusion lesion volume, onset to reperfusion time and use of iv thrombolytic therapy (rt-PA). The primary outcome measure will be overall proportion of subjects receiving Cerebrolysin comparing to control group experiencing a favorable functional outcome (by modified Rankin Scale [mRS] 0-2) at 7 day, 30 days, 90 days and 12 months following stroke onset. The secondary objectives are to determine the efficacy of Cerebrolysin as compared to control group in reducing risk of symptomatic secondary hemorrhagic transformation, improving neurological outcome (NIHSS 0-2 at day 7, day 30 and 90); reducing mortality rates (over the 90-day and 12 months study period); and improving: activities of daily living (by Barthel Index; BI), health-related quality of life (as measured by the EQ-5D-5L) assessed at day 30, 90 and at 12 months. The other measures of efficacy in Cerebrolysin group will include: assessment of final stroke volume and penumbral salvage (measured by CT/CTP at 30 days) and its change compared to baseline volume, changes over time in language function (by the 15-item Boston Naming Test), hemispatial neglect (by line bisection test), global cognitive function (by The Montreal Cognitive Assessment) and depression (by Hamilton Depression Rating Scale) between day 30 and day 90 assessments). The patients will receive 30 ml of Cerebrolysin within 8h of AIS stroke onset and continue treatment once daily until day 21 (first cycle) and they will receive a second cycle of treatment (30 ml/d for 21 days given in the Outpatient Department or Neurorehabilitation Clinic) from day 69 to 90 (± 3 days). All the patients (including those from the control group) receive the same standardized rehabilitation program (including speech therapy, occupational and physical therapy) during hospitalization at Stroke Unit and at Neurorehabilitation Clinic until day 90 according to local procedures. Historical data will be obtained by retrospective clinical chart reviews of patients hospitalized in the study center between Jan.2018 and Dec.2020 and fulfilling the same clinical and radiological inclusion criteria in whom 12-month follow-up (including mRS, NIHSS, BI, EQ-5D-5L) could be obtained.