Acute Ischemic Stroke Clinical Trial
Official title:
Stroke Center, Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital
Verified date | August 2022 |
Source | National Taiwan University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of the study will to test the hypothesis that combining early out-of-bed mobilization within 72 hours of stroke onset with treated by intravenous recombinant tissue-type plasminogen activator (IV-rtPA) or endovascular thrombectomy (ET) would result in a greater benefit than standard early rehabilitation within 72 hours of stroke onset with treated by IV-rtPA or ET.
Status | Completed |
Enrollment | 122 |
Est. completion date | June 10, 2022 |
Est. primary completion date | October 10, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 85 Years |
Eligibility | Inclusion Criteria: 1. for experimental group: first ischemic stroke episode to receive either medical therapy (including intravenous thrombolysis using recombinant tissue-type plasminogen activator within 3 hours of onset) or endovascular therapy within 8 hours of onset (including intravenous thrombolysis following thrombectomy); for control group: first ischemic stroke episode to receive general medical therapy; 2. completely activities of daily living independent before stroke; 3. age above 20 years old; 4. stroke with unilateral hemiparesis lesions confirmed using magnetic resonance imaging or computed tomography; 5. no other peripheral or central nervous system dysfunction; 6. no active inflammation or pathologic changes in the joints; 7. no other active medical problems; and 8. able to react to verbal commands, with systolic blood pressure between 120 and 160 mm Hg when resting, oxygen saturation >92% (with or without supplementation), and a heart rate below 130 beats per minute when resting with temperature <38.5 ? Exclusion Criteria: 1. unstable vital sign; 2. medical conditions unrelated to the cerebrovascular accident but which have affected walking performance; 3. any other cognitive, emotional, or behavioral impairments resulting in insufficient comprehension, understanding, or collaboration; 4. unable receive the informed consent form 5. acute deterioration within 24 hours or symptomatic intracerebral hemorrhage defined by a parenchymal hemorrhage type 2 within 36 hours with an increase of 4 points or more in National Institute of Health Stroke Scale; 6. acute hydrocephalus within 24 hours of onset |
Country | Name | City | State |
---|---|---|---|
Taiwan | National Taiwan University Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
National Taiwan University Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Safety/Adverse event outcome | Number of participants with serious adverse event | up to 4 weeks after stroke | |
Other | the length of stay in the stroke center | the length of stay in the stroke center | within admission | |
Primary | The total score-change of the Functional Independence Measure (FIM) assessment for daily living function | The total FIM with total score ranges from 13 to 126, which was used to assess each patient's capacities in terms of activities of daily living, comprises 18 seven-level items and assesses dependence in self-care, sphincter management, transfer, locomotion, communication, social interaction, and cognition. The functional independence of patient's capacities in terms of activity of daily living. Higher values represent a better outcome and all subscales are summed as a total score. | at baseline, at 2 weeks after stroke, at 4 weeks after stroke, and at follow-up 3 months after stroke | |
Secondary | The total score-change of the Postural Assessment Scale for Stroke Patients (PASS) assessment for postural stability | The Postural Assessment Scale for Stroke Patients (PASS): The PASS contains 12 four-level items of varying difficulty for assessing a patient's ability to maintain or change a given lying, sitting, or standing posture. Its total score ranges from 0 to 36.Higher values represent a better outcome and all subscales are summed as a total score. | at baseline, at 2 weeks after stroke, at 4 weeks after stroke, and at follow-up 3 months after stroke | |
Secondary | Achievement of the walking motor milestones | the achievement of the three motor milestones (yes or no/ days) | within 2 weeks after stroke |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06113848 -
Adjunctive Use of Intra-Arterial TNK and Albumin Following Thrombectomy
|
Phase 3 | |
Completed |
NCT04069546 -
The Efficacy of Remote Ischemic Conditioning on Stroke-induced Immunodeficiency
|
N/A | |
Active, not recruiting |
NCT05700097 -
Dengzhanxixin Injection for Acute Ischemic Stroke Receiving Reperfusion Therapy
|
Phase 2 | |
Recruiting |
NCT06058130 -
Combination of Antiplatelet and Anticoagulation for AIS Patients Witn Concomitant NVAF and Extracranial/Intracranial Artery Stenosis
|
N/A | |
Recruiting |
NCT04415164 -
Evaluation of Xueshuantong in Patients With AcutE IschemiC STroke
|
Phase 4 | |
Recruiting |
NCT05363397 -
Safety and Tolerability of Adjunctive TBO-309 in Reperfusion for Stroke
|
Phase 2 | |
Completed |
NCT05429658 -
Single Arm Trial to Evaluate the Safety and Effectiveness of the Route 92 Medical Reperfusion System
|
N/A | |
Recruiting |
NCT05390580 -
Neuromodulation Using Vagus Nerve Stimulation Following Ischemic Stroke as Therapeutic Adjunct
|
N/A | |
Enrolling by invitation |
NCT05515393 -
A Study of XY03-EA Tablets in the Treatment of Acute Ischemic Stroke
|
Phase 2 | |
Active, not recruiting |
NCT05070260 -
ACTISAVE: ACuTe Ischemic Stroke Study Evaluating Glenzocimab Used as Add-on Therapy Versus placEbo
|
Phase 2/Phase 3 | |
Terminated |
NCT05547412 -
Validation of Velocity Curvature Index as a Diagnostic Biomarker Tool for Assessment of Large Vessel Stroke
|
||
Completed |
NCT03366818 -
New Stent Retriever, VERSI System for AIS
|
N/A | |
Not yet recruiting |
NCT05293080 -
Early Treatment of Atrial Fibrillation for Stroke Prevention Trial in Acute STROKE
|
Phase 3 | |
Not yet recruiting |
NCT06040476 -
Human Umbilical Cord Blood Infusion in Patients With Acute Ischemic Stroke (AIS)
|
Phase 2 | |
Completed |
NCT02223273 -
Brazilian Intervention to Increase Evidence Usage in Practice - Stroke (BRIDGE-Stroke)
|
N/A | |
Completed |
NCT02586233 -
Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of DS-1040b in Subjects With Acute Ischemic Stroke
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT01594190 -
Physical Activity Immediately After Acute Cerebral Ischemia
|
N/A | |
Terminated |
NCT01694381 -
Research Into the Effect of a Clot-dissolving Agent and Its Inhibitor
|
Early Phase 1 | |
Completed |
NCT01120301 -
Efficacy and Safety Trial of Transcranial Laser Therapy Within 24 Hours From Stroke Onset (NEST-3)
|
Phase 3 | |
Completed |
NCT00963989 -
Imaging Guided Patient Selection for Interventional Revascularization Therapy
|
N/A |