View clinical trials related to Stroke.
Filter by:For several years now, it has been demonstrated that the upper limb plays an important role in the function of an efficient and balanced gait pattern in healthy adults. After a stroke, the reduced muscle strength has a clear influence on the gait pattern, but also on the active movement possibilities of the upper limb. However, the role of the upper limb during gait is not sufficiently explored in the literature. The gold standard for motion analysis is a 3D analysis performed with infrared cameras capturing reflective markers during gait. Unfortunately, it is not possible for all people after a stroke to undergo this examination. On the one hand, patients must already have a certain degree of independence with regard to gait. On the other hand, not all centers have access to this expensive accommodation. There are some validated observation scales for people after stroke to describe the gait based on a 2D video image. This method is much more accessible and can be applied by any therapist. However, to date there has been little attention paid to the upper limb in these observation scales. Therefore, analogous to the observation scales for gait, an observation scale for the upper limb during gait was set up. The use of this scale can add value to the rehabilitation of people after a stroke. - The treatment team will receive information about the patient's complete movement pattern. - The arm will be more prominent when setting rehabilitation goals related to gait. This can lead to a positive effect on the gait pattern itself, but also to more attention being paid to the arm, which has a more difficult recovery than the leg after a stroke. The aim of the current study will be - to determine the inter and intra tester reliability of this visual observation scale - to investigate if the results of the visual observation scale correlate to a 3D assessment performed in a subgroup of participants
The purpose of this study is to explore whether an external focus or internal focus of attention leads to improved motor performance and learning with increased use of the affected side during sit to stand in individuals post stroke. Focus of attention refers to what a person is thinking about during a task, with an internal focus being thinking about what one's body is doing and an external focus being thinking about a target or outcome in the environment. A second purpose is to determine whether improved symmetry in sit to stand carries over to gait symmetry in individuals post stroke.
Background: Stroke is the third major cause of death and disability worldwide. It was shown that combining early reperfusion therapy (thrombolysis and/or thrombectomy) with stroke unit care and immediate rehabilitation have beneficial effects on the patient recovery and outcomes. Cerebrolysin that was proven to have s neuroprotective and neurotrophic effects in vitro and in vivo, administered in combination with endovascular therapy (EVT) could have a positive impact on the prognosis and outcome of these patients. Objectives: To evaluate the impact of early administration of neuroprotective drug (Cerebrolysin) in patient undergoing EVT on the outcome of patients diagnosed with acute ischemic stroke. Methods: 100 patients will be recruited to the proposed study according to the inclusion criteria: Inclusion criteria: Acute ischemic stroke patients NIHSS>8 Qualification for mechanical thrombectomy, without previous thrombolysis. The patients will be randomized into 2 subgroups: G1(standard dose of Cerebrolysin 30ml), - G2 (No Cerebrolysin). The patients will be randomized into 2 subgroups: G1(standard dose of Cerebrolysin 30ml), - G2 (No Cerebrolysin). Cerebrolysin will be administered immediately after randomization or at the latest during the EVT procedure and will be continued for 10 days. After the EVT all patients, depending on their clinical condition, will be hospitalized in ICU (intensive care unit) or Neurology Department, where standard treatment and monitoring will be implemented, as well as standard rehabilitation. Outcome assessments will include: the NIH Stroke Scale, modified Rankin Score, pre MRS, IQ code, Geriatric Depression Scales, MoCA. Additionally, the infarct volume of the control CT will be measured. The follow up should be performed on day 7( or discharge), 1 month, 3 months, 6 months. The duration of the study is planned forr: 12 -24 months
Study Design and Subject Recruitment: This was a cross-sectional study in a single centre outpatient setting at the Foot Care and Limb Design Centre, Tan Tock Seng Hospital. As this was a proof-of-concept clinical trial for the introduction of 3D printed AFOs as a patient service, only 5 subjects were recruited based on consecutive sampling. Interventions: Thermoformed AFOs moulded over the subject's lower limb plaster model served as the control intervention. The plaster models were rectified by an orthotist with over 20 years of experience and the AFO design was determined according to the subject's clinical presentation and needs. The AFOs were manufactured from 4 - 5mm thick homopolymer polypropylene. 3D printed AFOs served as the treatment intervention. It was fabricated through 3D scanning with an Artec Eva 3D scanner (Artec 3D, Luxembourg, Luxembourg) and an adjustable Perspex glass foot plate, CAD modelling with the OrtenShape software (Proteor, Saint-Apollinaire, France), and printed using fused deposition modelling with the Fortus 450mc (Stratasys, Minnesota, United States). The 3D printed AFO is printed of Polyamide Nylon-12 material in the same thickness as the thermoformed AFO. There were no blinding procedures as both interventions were distinctly different and it is not possible to blind subjects with daily use of the AFOs. Trial Schedule: A thermoformed and a 3D printed AFO were fitted to each subject in a single session. The QUEST survey was administered post-fitting. Subjects brought home both AFOs and were instructed to wear them during ambulation, alternating between the AFOs daily. Subjects returned for follow-up at 3 weeks and 6 weeks post-fitting for necessary adjustments and the administration of the QUEST surveys was repeated for each AFO.
A Feasibility Study to evaluate the initial safety and performance of the RapidPulseTM Aspiration System in the treatment of patients with Acute Ischemic Stroke (AIS) due to Large Vessel Occlusion (LVO).
Edaravone dexborneol, comprised of 2 active ingredients, edaravone and (+)-borneol, has been developed as a novel neuroprotective agent with synergistic effects of antioxidant and anti-inflammatory in animal models. The TASTE trial (Treatment of Acute Ischemic Stroke with Edaravone Dexborneol) administered edaravone dexborneol or edaravone alone to stroke patients within 48 hours after stroke onset, finding that 90-d functional outcome was better in edaravone dexborneol group. However, the TASTE trial excluded patients undergoing reperfusion therapy (i.e., intravenous thrombolysis and mechanical thrombectomy). Therefore, the investigators aim to evaluate the efficacy of edaravone dexborneol in addition to mechanical thrombectomy in the treatment of acute ischemic stoke.
English Synopsis I. Title of Study: A trial of BUN/Cr-based hydration therapy to reduce stroke-in-evolution and improve short-term functional outcomes for dehydrated patients with acute ischemic stroke-version 2. II. Indication: We use blood urea nitrogen (BUN)/blood creatinine (Cr) ratio≧15 as a dehydration biomarker. This clinical trial aims to determine if more aggressive intravenous fluid supplement instead of present treatment would yield a better outcome in patients with acute ischemic stroke and a BUN/Cr ratio≧15. III. Phase of Development: Phase III, randomized double-blind control trial. IV. Study Rationale: We have recently reported a novel finding that the blood urea nitrogen (BUN)/creatinine (Cr) ratio, a marker of hydration status, was an independent predictor of early neurological deterioration among patients who had suffered acute ischemic stroke. Pilot study was then designed to determine if providing hydration therapy, specifically intravenous saline infusion, to patients with a blood urea nitrogen/creatinine ratio (BUN/Cr) ≥15 improves outcomes after acute ischemic stroke. The results showed that patients with a presenting BUN/Cr ≥ 15 who received saline hydration therapy experienced a better functional outcome compared with similar patients who received standard therapy. V. Study Objectives: Primary objective: To compare the effectiveness of BUN/Cr-based hydration therapy with standard treatment in early neurological improvement (ENI) rate at 72 hours for dehydrated subjects with acute ischemic stroke Secondary objectives: To compare the benefit of BUN/Cr-based hydration therapy with standard treatment after three months using measure of modified Rankin scale (mRS) VI. Study Design: Duration of Treatment: 12 hours Number of Planned Patients: 288 subjects Investigational Product: normal saline Endpoints: 1. Primary endpoint: To compare the ENI rate between group at 72 hours. ENI is defined as the improvement of the NIHSS score by 2 or more points or a score of 1 or 0 at 72 hours after the onset of stroke. 2. Secondary endpoints: To compare the rate of favorable functional outcome at 3 months. Scores <=1 on the mRS are considered to indicate a favorable outcome. Criteria for Evaluation Inclusion criteria: 1. Acute ischemic stroke diagnosed by the clinical presentations and brain imaging is confirmed by a stroke care specialist. 2. has a measurable neurologic deficit according to the National Institutes of Health Stroke Scale (NIHSS) 3. the time between the onset of neurological symptoms and starting therapy are less than 24 hours 4. admission BUN/Cr≧15 Exclusion criteria: 1. no informed consent obtained 2. initial NIHSS >10 3. prepared for or received fibrinolytic therapy 4. prepared for or received surgical intervention with 14 days 5. congestive heart failure according to past history or Framingham criteria 6. history of liver cirrhosis or severe liver dysfunction (ALT or AST > x 3 upper normal limit) 7. admission blood Cr >2 mg/dl 8. initial blood pressure SBP<90 mmHg 9. fever with core temperature >=38°C 10. indication of diuretics for fluid overload 11. any conditions needed more aggressive hydration or blood transfusion 12. cancer under treatment 13. life expectancy or any reasons for follow-up < 3 months Statistical Methods: The primary objective is efficacy using the binary endpoint of ENI. Descriptive statistics on continuous measurements will include means, medians, standard deviations, and ranges, while categorical data will be summarized using frequency counts and percentages. For the primary endpoint of ENI rate, the proportion of subjects with ENI response will be summarized by treatment group. The proportions of ENI will be compared between BUN/Cr-based hydration therapy (Arm A) and Standard therapy (Arm B) using two proportion Z test. The secondary objectives of this study are to evaluate the benefit of BUN/Cr-based hydration therapy after three months using measure of modified Rankin scale. For the secondary endpoint comparisons between groups, independent t-test will be considered. Duration of the Study: 3 years (or From 01/09/2020 to 31/08/2023) End of Study : When total 288 participants are enrolled or meet the criteria of early termination.
Background: Although placement of an intra-cerebral catheter remains the gold standard method for measuring intracranial pressure (ICP), there are several limitations to the method. Objectives: The main objective of this study was to compare the correlation and the agreement of the wave morphology between the ICP (standard ICP monitoring) and a new nICP monitor in patients admitted with stroke. Our secondary objective was to estimate the accuracy of four non-invasive methods to assess intracranial hypertension. Methods: We prospectively collected data of adults admitted to an intensive care unit (ICU) with subarachnoid hemorrhage (SAH), intracerebral hemorrhage (ICH) or ischemic stroke (IS) in whom invasive ICP monitoring placed. Measures had been simultaneously collected from the following non-invasive indices: optic nerve sheath diameter (ONSD), pulsatility index (PI) using transcranial Doppler (TCD), a 5-point visual scale designed for Computed Tomography (CT) and two parameters (time-to-peak [TTP] and P2/P1 ratio) of a non-invasive ICP wave morphology monitor (Brain4care[B4c]). Intracranial hypertension was defined as an invasively measured ICP > 20 mmHg for at least five minutes.
Stroke is a disorder in which the areas of the brain that control the sensory and motor nerves are damaged due to poor blood supply to the brain. As a result of which oxygen and nutrients supply to the brain tissues is interrupted. This is either caused by infarction or a bleed in the blood arteries supplying the brain. A stroke occurs when the cerebral blood supply is disrupted, resulting in a localized neurological deficiency. At least 80% of strokes are ischemic, meaning they are caused by a blockage in blood flow, while 15-20% are caused by bleeding into the brain, known as intracerebral hemorrhage. The occurrence of the sudden neurological deficit caused by bleeding in the brain or ischemic damage gives rise to the disturbances in motion, senses, perception, language, and other such functions on the opposite side to the affected side of the brain. A randomized controlled trial was carried out on 36 chronic stroke patients. By using the sealed envelope method, the sample was divided into two groups, an experimental group and a control group. For a period of four weeks, the control group only received traditional balancing exercises including standing with feet together, standing with one foot directly in front of the other, standing eye open to eye closed, standing multidirectional functional reach and March in place and walk sideways. While the experimental group received ankle strategy exercises in addition to balance exercises which included raising and lowering heels and forefeet, heel to toe walking, stepping up and down and left right and diagonal inclination of the body during standing. Interventions were given three days weekly for four consecutive weeks. Pre and post-intervention assessment were done by using data collection tools which includes ABC Scale of balance confidence, TUG scale and 10meter walk test.
Central poststroke pain (CPSP) refers to the symptom of pain arising after a stroke. Patients with CPSP often complain of various painful or unpleasant sensation. Feelings of pain may interfere with sleep and hugely affect the patients' quality of life. Non-invasive brain stimulation, such as transcranial direct current stimulation (tDCS), is an emerging nonpharmacological treatment and has been shown to have promising pain reduction effects for patients with CPSP. Mirror therapy (MT), on the other hand, is a contemporary approach that has often been used to facilitate upper extremity motor recovery in patients with stroke. MT has been shown to be effective in ameliorating sensory deficits and reducing shoulder pain. To date, no study has determined whether combining MT with tDCS could reduce pain in patients with CPSP. The goal of this study is to determine the effect of combining MT and tDCS on pain, sensation, motor function, and quality of life in people with CPSP. Forty-five patients with CPSP will be randomly allocated to one of the 3 groups: combining MT with tDCS (MT+tDCS) group, MT with sham tDCS (MT+s-tDCS) group, and sham MT with tDCS (s-MT+tDCS) group. The participants in all groups will receive intervention 30 minutes/day, 3 days/ week, for 3 weeks. The participants in the MT+tDCS group will receive tDCS applied simultaneously with MT for 20 minutes. For the following 10 minutes, the tDCS will be turned off while the electrodes will be kept on the scalp, and the participants will continue with MT. For the MT+s-tDCS group, same tDCS procedures will be applied to the participants except that the stimulator will be turned off within 30 seconds. As for the s-MT+tDCS group, the participants will receive the same tDCS procedure as the MT+tDCS group while a sham MT condition will be applied. Clinical and neurophysiological assessments will be conducted before the treatment (pretest), after 3 weeks of treatment (post-test), and 1 month after the treatment (follow-up test). The assessments will be performed by research assistants who will be blinded to the group allocation of the participants. Mix-model Group × Time repeated measures ANOVAs will be used to determine the intervention effects of the 3 groups.