jRCTs052210163已完成不适用
Functional Electronic Stimulated Rehabilitation Application for Treatment in patients with cerebrovascular disorders
未提供0 个研究点目标入组 16 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 主要终点
- Change in the amount of upper limb Fugl-Meyer Assessment(FMA)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 No limit(—)
- 性别
- All
入选标准
- •Within 1 month of cerebrovascular event (cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage)
- •With upper limb Brunnstrom stage(BRS)2-4
- •Who are 20 years of age or older at the time of obtaining informed consent
- •Whose consent to participate in this clinical study and the informed consent of the patient have has been obtained in writing
排除标准
- •Received treatments, such as botulinum therapy, repeated transcranial magnetic stimulation, transcranial direct current stimulation within 90 days of obtaining consent
- •With a history of surgery(including device therapy)or intravenous t-PA for cerebrovascular event (cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage)
- •3.Cognitive decline(Mini-Mental State Examination(MMSE)is 21 or less)
- •4.Severe skin symptoms on the affected upper limb
- •5.Have a history of epileptic seizures
- •6.With a history of substance abuse or addiction(including alcoholism)at the time of enrollment and within the past year, or patients with complications
- •7.Using an implantable cardiac stimulator such as a cardiac pacemaker or an implantable assisted heart
- •8.Using deep brain stimulation
- •9.With metal(excluding titanium products)implanted in the affected upper limb
- •10.Who are pregnant or may become pregnant
- •11.Who are judged by doctors to be inappropriate as research subjects
结局指标
主要结局
Change in the amount of upper limb Fugl-Meyer Assessment(FMA)
时间窗: week 2 or at the time of discontinuation
Change in the amount of upper limb Fugl-Meyer Assessment(FMA) with respect to pre-intervention value
次要结局
- Functional Independence Measure(FIM)(2nd and 4th weeks)
- upper limb BRS(2nd and 4th weeks)
- upper limb FMA(1st, 3rd, and 4th weeks)
- Barthel Index(BI)(2nd and 4th weeks)
- grip strength(1st, 2nd, 3rd, and 4th weeks)
- upper limb Manual Muscle Test(MMT)(1st, 2nd, 3rd, and 4th weeks)
