JPRN-jRCTs032190191已完成2 期
Dose-Response of Repetitive Peripheral Magnetic Stimulation Therapy Combined with Intensive Occupational Therapy for Upper Limb Hemiparesis After Stroke: A Multi-Center Randomized Controlled Study
Abo Masahiro0 个研究点目标入组 9 人开始时间: 2020年1月20日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
研究概览
简要总结
Conclusion of Efficacy Efficacy of the drug has not been verified due to the lack of sufficient number of cases for statistical analysis. Safety No adverse events occurred in either group. However, the safety of the study could not be verified because there were not enough cases to perform a statistical analysis.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 80age old（—）
- 性别
- All
入选标准
- •Patients who meet all the inclusion criteria below.
- •1) Stroke patients with upper limb hemiparesis between the age of 18 and 80.
- •2) 3 months past after the stroke onset.
- •3) The Brunnstrom stage of the upper limb is 3 to 4.
- •4) The general condition is stable.
- •5) Patients without cognitive impairment who are able to understand the study plan.
- •6) Patients who give written informed consent of one's own free will.
- •7) Gender: Female or Male.
- •8) Patients who are able to adhere to the study protocol, including hospitalization and outpatient visits.
- •9) Patients who have received botulinum toxin therapy for their paretic upper limb at least 15 days before the admission.
排除标准
- •Exclusion Criteria
- •1) Patients with the self-contained medical implant (pacemaker, cochlear implant, or etc)
- •2) Patients with severe heart disease.
- •3) Patients with metal implants near the stimulation site of rPMS.
- •4) Patients with deep-vein thrombosis near the stimulation site of rPMS.
- •5) Patients with infection (such as acute cellulitis, etc) near the stimulation site of rPMS.
- •6) Pregnant women or suspected ones.
- •7) Patients considered not eligible for the study by the study researchers otherwise.
- •8) Patients who have unstable diseases or diseases that should be immediately treated (such as acute heart failure, acute kidney injury, severe diabetes, infection, etc).
- •9) Patients who have received the botulinum toxin therapy within 14 days of the admission.
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