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Investigators propose a research design protocol to evaluate the efficacy of acupuncture in improving function recovery after acute intracranial hemorrhage.
Stroke is a major cause of death and disability. According to the Ministry of Health and Welfare in Taiwan, stroke accounted for 6.8% of all deaths and was the 4th leading cause of death in Taiwan in 2020. Stroke can be divided into acute, subacute, and chronic stages, and the initial severity of stroke affects recovery from sequelae. Therefore, how to effectively improve the sequelae and accelerate the recovery of patients through early interventions is an important issue. This study aimed to investigate the effect of early acupuncture treatment in the acute stage of hemorrhagic stroke. Subjects will be divided into two main groups by random assignment. The intervention group will be treated with traditional acupuncture, while the control group will be treated with pseudo-acupuncture(superficial acupuncture). The treatment frequency was 3 times a week for at least one week. Consciousness, neurological status and disability status were assessed before treatment, at the end of the first week, the second week and the third week, and biomarker were examined before and after treatment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group(acupuncture group) | Experimental | After blind random allocation, investigators applied acupuncture on patient with acute intracranial hemorrhage. |
|
| Control group(sham acupuncture group (superficial acupuncture)) | Placebo Comparator | After blind random allocation, investigators applied superficial acupuncture on patient with acute intracranial hemorrhage. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Procedure | Applied acupuncture on specific acupoints in patient with acute intracranial hemorrhage. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Barthel Index | The Barthel Index is a scale used to measure performance in activities of daily living (ADL). The total score can range from 0 (complete dependence) to 100 (complete independence), providing a quantitative measure of an individual's functional independence. | 3 weeks and follow-up for one year |
| Muscle Power | Muscle power is often assessed using a grading system. The most common is the Medical Research Council (MRC) Scale, which grades muscle strength on a scale from 0 to 5 and the lower scores mean the worse outcome. | 3 weeks and follow-up for one year |
| The Modified Rankin Scale | The Modified Rankin Score (mRS) is a scale with scores ranging from 0 to 6, the higher scores mean the worse outcome. | 3 weeks and follow-up for one year |
| National Institute of Health Stroke Scale | The total NIHSS score can range from 0 to 42, where a score of 0 means no stroke symptoms, and a higher score indicates a more severe stroke. | 3 weeks and follow-up for one year |
| Glasgow Coma Scale(GCS) | The Glasgow Coma Scale(GCS) is a clinical scale used to reliably measure a person's level of consciousness. The total score can range from 3 to 15, and the lower scores mean the worse outcome. | 3 weeks and follow-up for one year |
| Karnofsky Performance Scale | The Karnofsky Performance Score (KPS) ranking runs from 100 to 0, where 100 is "perfect" health and 0 is death. | 3 weeks and follow-up for one year |
| Measure | Description | Time Frame |
|---|---|---|
| Pulse analysis system (PPAS-96)(Sphygmography) | Pulse analysis system (PPAS-96) can realize the digitization of pulse wave graphics, establish a pulse wave database (scale unit: Hertz, Hz). | 3 weeks and follow-up for one year |
| Completed blood count (CBC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yan Ru Ko | Contact | 886972792003 | b9403213@cgmh.org.tw |
| Name | Affiliation | Role |
|---|---|---|
| Yan Ru Ko | Chang Gung Memorial Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang-Gung Memorial Hospital | Recruiting | Keelung | Taiwan |
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| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| Sham Acupuncture(Superficial Acupuncture) | Procedure | Applied superficial acupuncture on specific acupoints in patient with acute intracranial hemorrhage. |
|
Measuring the amounts of red blood cells (RBC, million/μL), white blood cells (WBC, 1000/μL), platelets (Plt, 1000/μL), along with the hemoglobin (Hb, g/dL) and hematocrit (Hct, %) values via automated hematology analyzer. |
| 3 weeks and follow-up for one year |
| White blood cells differential count | Calculating the percentage of each type of white blood cell (WBC): Segment(%), Band(%), Lymphocyte(%), Monocyte(%), Eosinophil(%), Basophil(%) | 3 weeks and follow-up for one year |
| C reactive protein (CRP) | Measuring the level of C reactive protein in blood. (CRP, mg/L) | 3 weeks and follow-up for one year |
| Albumin | Measuring the level of albumin in blood. (Alb, g/dL) | 3 weeks and follow-up for one year |
| Blood urea nitrogen (BUN) | Measuring the level of blood urea nitrogen. (BUN, mg/dL) | 3 weeks and follow-up for one year |
| Creatinine | Measuring the level of creatinine in blood. (Crea, mg/dL) | 3 weeks and follow-up for one year |
| Sodium | Measuring the level of sodium in blood. (Na, milliequivalent (mEq)/L) | 3 weeks and follow-up for one year |
| Potassium | Measuring the level of potassium in blood. (K, milliequivalent (mEq)/L) | 3 weeks and follow-up for one year |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |