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临床试验/jRCTs052210163
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)

研究者

发起方
未提供

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