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NCT ID: NCT03563209 Recruiting - Clinical trials for Post-stroke Elbow Spasticity

Assesment of Post-stroke Elbow Flexor Spasticity in Different Forearm Positions

Start date: March 15, 2018
Study type: Observational

Determination of which muscle is more spastic before injection of the botulinum toxin, and the application of the targeted treatment to that muscle results in more improvement in spasticity. It is known that the muscles that flex elbow in healthy individuals change according to forearm position. While the biceps brachii flexes the forearm in supination, the brachioradialis flexes the forearm in the neutral position. The brachialis muscle acts as a primary flexor muscle when the forearm is in pronation. In this study, hypothesis is that the severity of spasticity differs depending on the forearm position.

NCT ID: NCT03561285 Recruiting - Clinical trials for Stroke in Young Adults

Antiphospholipid Antibodies & Osteopontin as Risk Factors for Cerebrovascular Stroke in Young Adults

Start date: July 1, 2018
Study type: Observational

The burden of stroke is increasing in many low- and middle income countries.(1) Around 10% of all thrombotic cerebrovascular events (CVE) occur in young population defined as younger than 50 years old (2) In the majority of these patients, the cause of the ischaemic stroke remains undetermined.(3) Arterial thrombosis is a major clinical manifestation of the antiphospholipid syndrome (APS), an autoimmune condition characterised by thrombotic events and/or pregnancy morbidity with persistently positive antiphospholipid antibodies (aPL) (4). Considering all patients with cerebral ischaemia, the prevalence of aPL seems rather high in young adults, who might constitute a subgroup at high risk for recurrence.(5) Through the support of the Antiphospholipid Syndrome Alliance for Clinical Trials and International Networking (APS ACTION), a systematic review aiming to estimate the frequency of clinically significant aPL profiles in the general population (no age limit) was completed. (6) The pathogenesis of ischemic stroke is complex, and several studies documented hypercoagulable states as a significant mechanism underlying stroke. (8). The latter include protein C, protein S, or antithrombin III deficiencies, activated protein C resistance and anti-phospholipid antibodies (aPLA), including anticardiolipin (aCL) antibodies or lupus anticoagulant (LAC), which influence stroke susceptibility owing to their capacity to disturb normal hemostatic mechanisms (9). While aPLA are clinically associated with a state of hypercoagulation and prothrombotic disorders, the exact mechanism underlying their prothrombotic effects remains unknown (10). aPLA are detected either functionally, owing to their ability to prolong coagulation time in a phospholipid-dependent coagulation test (LAC), or by measuring specific [anticardiolipin (aCL) and antiphosphatidylserine (aPS)] antibodies by specific immunoassays, using anionic phospholipids as antigens (11). The contribution of LAC to the overall risk of both venous and arterial thrombosis, including ischemic stroke, is now well recognized (12). While the contribution of aPLA (including LAC and aCL antibodies) to thrombosis is well established, their role as independent risk factors in the pathogenesis of ischemic stroke yielded apparently conflicting results. (13). These conflicting results could be explained by differences in ethnic origin , inherent variation in aPLA levels and in the failure in some studies to account for the contribution of covariates (14). Osteopontin (OPN) was first identified as a protein involved in bone remodelling, but later also shown to have important immunological roles. (15).

NCT ID: NCT03555643 Recruiting - Stroke Clinical Trials

Evaluation of the HARM for the Detection of a Cerebral Ischemia in TIA/TNA Patients

Start date: November 1, 2017
Study type: Observational

The research project investigates the incidence of the hyperintense acute reperfusion marker (HARM) in patients with transient ischemic attack (TIA) or transient neurological attack (TNA). Initially, HARM was described after acute ischemic stroke and is caused by a blood-brain barrier disorder after recanalization of an acute vessel occlusion and consecutive reperfusion. These result in a contrast agent extravasation into the subarachnoid space, which can be easily detected on fluid attenuated inversion recovery (FLAIR) images. TIA is defined as a transient focal neurological deficit with a probably cerebrovascular cause. In contrast, TNA is defined as a transient non-focal neurological deficit with multiple causes, including cerebrovascular. The clinical diagnosis of TIA is often flawed and the delineation of TIA and TNA can be difficult. MRI is the most important diagnostic method for the detection or exclusion of cerebral ischemia in patients with TIA/TNA in daily clinical practice. However, on diffusion-weighted imaging (DWI) approximately two-thirds of TIA cases and only one-fifth of TNA cases demonstrate acute cerebral ischemia. Supplementary perfusion-weighted imaging (PWI) scans can only slightly increase this percentage. The well-known HARM could prove to be complementary to DWI and PWI and close or at least reduce the existing gap. In the case of TNA in particular, this could be of clinical relevance in order to avoid mistreatment or even dismissal without further clarification after supposedly inconspicuous imaging. Therefore, the aim of this study is to record the incidence of HARM in a statistically significant number of cases of patients with TIA and TNA and to investigate relationships with symptom duration and anatomical localization. In addition, the dynamics of contrast enhancement in the subarachnoid space in TIA and TNA cases with HARM will be analyzed in detail.

NCT ID: NCT03554642 Recruiting - Ischemic Stroke Clinical Trials

Walkbot Robotic Training for Improvement in Gait

Start date: September 2016
Phase: Phase 3
Study type: Interventional

This clinical study will involve up to 30 ischemic stroke inpatients during their stay at Burke Rehabilitation Hospital. Participants will be randomized to receive 30 additional minutes of therapy every day, for a total of 2 weeks (14 days). One group will receive 30 minutes of standard physical therapy focused on pre-gait or gait training activities, while the experimental group will receive 30 minutes of Walkbot with Augmented Reality. Both groups will receive the same time in therapy aimed at gait training.

NCT ID: NCT03552354 Recruiting - Stroke, Ischemic Clinical Trials

Argatroban Combined With Antiplatelet Versus Antiplatelet for Acute Ischemic Stroke

Start date: October 25, 2017
Phase: Phase 4
Study type: Interventional

Intravenous thrombolysis is considered as the first choice for ischemic stroke. In the recent years, endovascular therapy is demonstrated to be effective to treat ischemic with big vessel occlusion. However, only a minority of patients can get intravenous thrombolysis or endovascular therapy due to the restricted time window and strict indications. Dual antiplatelet has been demonstrated to be effective in the patients with high risk of TIA or minor ischemic stroke (NIHSS<4). But there is still stroke progression although dual antiplatelet. The ischemic stroke patients with NIHSS > 3 has been recommended to give aspirin in most guidelines. Of those patients, mild to moderate stroke patients (3<NIHSS<10) will result in the poor outcomes if the progression occurs. In addition, large artery atherosclerosis (LAA) stroke is prone to progress. So, we argue that the mild to moderate stroke with LAA should be give more intensive antiplatelet. In the present study, argatroban combined with antiplatelet therapy (3-5 days) is used to treat the proposed patients to investigate the safety and effectiveness.

NCT ID: NCT03551093 Recruiting - Ischemic Stroke Clinical Trials

THE IMPACT- 24M TRIAL (IMPlant Augmenting Cerebral Blood Flow in Mild Strokes Trial 24 Hours From Stroke Onset)

ImpACT- 24M
Start date: May 14, 2018
Phase: Phase 3
Study type: Interventional

Study Population: Subjects with Mild Acute Ischemic Stroke in the anterior circulation within 24 hours from onset. Study objectives: 1. Identify the personal stimulation level for each patient based on physiological biomarkers 2. Identify improvement in stroke symptoms during ISS treatment at the personal stimulation level

NCT ID: NCT03546959 Recruiting - Stroke Clinical Trials

Dynamic Lycra Orthosis as an Adjunct to Botulinum Toxin-A Injection for Post-stroke Spasticity

Start date: June 6, 2018
Phase: N/A
Study type: Interventional

Upper extremity splints are one of the nonpharmacologic treatments used to treat hypertonicity after stroke. The purpose of splinting is to support, to position, to immobilize, to prevent contracture and deformities, to reduce spasticity and to enhance function. Dynamic lycra splints have been found to improve spasticity, posture, and fluency of upper extremity movements in computerized analysis systems due to the effects of neutral warmth, circumferential pressure and by creating a low intensity prolonged stretch on hypertonic muscles , all of which contribute to increased sensory awareness of the involved limb. These splints are frequently used in the field of neurological rehabilitation, but there is not enough scientific evidence about their efficacy. It was demonstrated that lycra sleeves have positive effects on upper extremity function of children with cerebral palsy. Lycra sleeves for upper extremity function after stroke is a relatively new field of research. The aim of this study is to investigate effects of dynamic lycra orthosis as an adjunct to botulinum toxin-a injection of the upper limb in adults following stroke.

NCT ID: NCT03545477 Recruiting - Parkinson Disease Clinical Trials

Assessment of the Rehabilitative Effects of Curved-walking Training in Stroke, Parkinson and Orthopaedic Populations

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

The recovery of walking ability is crucial to promote independence in daily living and is one of the major goal of neuromotor rehabilitation. Currently, standard rehabilitative programs are usually based on straight-walking training (SWT) and the assessment of their effects is performed through functional scales based on straight-walking trajectories, e.g. Timed Up and Go (TUG), 10 meters walking test (10mWT). Curved-walking training (CWT) may be interesting to provide an ecological and challenging context during rehabilitation. Indeed, CWT is based on demanding neural processes that drive an asymmetrical contribution at lower limb level, challenging balance ability and complex adaptation such as body weight shifting in response to centrifugal force and production of different step lengths. Up to now, literature has investigated CWT in healthy adults in terms of muscular activation, kinematics and kinetics of the movement. Results showed that CWT needs a different biomechanical strategy with respect to SWT. Nevertheless CWT has not been investigated in pathological adults. The present study aims at assessing the effectiveness of a rehabilitative physical therapy based on CWT with respect to traditional SWT for the recovery of locomotor abilities in neurological and orthopaedic patients. The hypothesis is that a training based on curved-walking is ecologically meaningful and may be superior with respect to standard training in improving balance, walking abilities, and independence in activity of daily live of patients. A secondary aim of the project is to propose an innovative functional scale based on the timed up and go on curved trajectory (CTUG), and to determine its reliability and responsiveness, establishing the minimum Detectable Change (MDC) and the Minimal Clinically Important Difference (MCID). A single-blind randomized controlled study is being carried out on three different populations: - Post-acute stroke patients - Idiopathic Parkinson Disease - Femoral fracture A healthy group is also being recruited to provide reference values of CTUG. For each of the three populations, subjects are randomized into two groups. The experimental one performs a novel rehabilitative program composed by a 30-minute training on curved trajectory ("S" trajectory composed by two semicircle with a radius of 1.2 m) in addition to usual care. The control group performs an equal dose of traditional treatment on straight trajectories. Both groups undergo 20 90-minutes sessions of training (three times a week for seven weeks). Participants are evaluated at baseline (T0), after training (T1), and at a three-months follow-up visit (T2). The primary outcome measure is the 10mWT (minimal clinically important difference of 0.16 m/s identified by Tilson and colleagues). On the basis of this measure, a sample size of 70 subjects for each population was computed.

NCT ID: NCT03543917 Recruiting - Clinical trials for Cerebrovascular Accident

Post-Stroke Improvement of Motor Function

Start date: August 8, 2017
Phase: Phase 1
Study type: Interventional

Open-label clinical study where all new patients presenting with cerebrovascular accidents and consenting to treatment are given intravenously a new combination of medications. Patients are evaluated neurologically with NIHSS scores before treatment administration and at 1 month after the first treatment. Further evaluations at 6 months after treatment by NIHSS and Barthel scores are ongoing

NCT ID: NCT03543319 Recruiting - Ischemic Stroke Clinical Trials

Norwegian Microemboli in Acute Stroke Study

Start date: June 2018
Study type: Observational

BACKGROUND: The cause of ischemic stroke remains undetermined in 30-40% of the cases, but circulating blood clots (thromboemboli) are a postulated common denominator in approx. 75% of patients. Transcranial Doppler monitoring (TCDM) is a non-invasive method of detecting circulating microemboli (CME) in the human cerebral circulation. The method is not used systematically in unselected groups of patients with repeated long-term registrations. New ultrasound equipment is ambulatory, less unpleasant for the patient and allows extended monitoring sessions. This may vastly simplify the implementation of TCDM as a clinically useful diagnostic tool. AIMS: Determine the usefulness of TCDM in acute stroke diagnostics by assessing prevalence and frequency of CME in unselected patients with ischemic stroke, the influence of antithrombotic drugs on CME and the relationship between MES and recurrent stroke or transient ischemic attack (TIA). HYPOTHESES: Prevalence and frequency of CME are higher during the first 24 hours than at later follow-up. Stroke etiology can be assessed by the presence or absence of CME. Presence of CME is associated with increased risk of recurrent TIA of stroke within 3 months and 1 year. Cessation of CME after the start of antithrombotic treatment is associated with reduced risk of recurrent TIA or stroke.