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临床试验/NCT02346851
NCT02346851已完成不适用

The Effects of Accelerometer Triggered Functional Electrical Stimulation on Post-Stroke Hemiplegic Shoulder Subluxation

Yonsei University2 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2013年11月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
76
试验地点
2
主要终点
Difference of vertical distance

研究概览

简要总结

Post stroke hemiplegia patient have shoulder subluxation in affected side. The investigators use functional electrical stimulation in posterior deltoid and supraspinatus for prevention and treatment. But the investigators hypothesis self triggered myoelectric stimulation system has more effective for shoulder subluxation. The purpose of this study is to compare post-stroke shoulder subluxation treatment FES and triggered FES.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Within 3months after stroke
  • 1st stroke patients with hemiplegic shoulder subluxation which is measured above one finger breadth by physical examination
  • Shoulder abduction strength is above P- grade (MMT)
  • Male or female, ≥ 20 years of age
  • Written informed consent has beed obtained
  • Patients who understand purpose of this study and conform with intervention process

排除标准

  • Quadriplegia or double hemiplegia
  • History of injury, surgery, etc. of U/E and upper chest area
  • person who implanted metalic device(ex. pacemaker, vagus nerve stimulator)
  • patients who have lower motor neuron lesion
  • person who have difficulty using electrode due to skin problem such as skin ulcer or open wound
  • who have seizure or epilepsy history
  • Female who are pregnant

研究组 & 干预措施

control group

No Intervention

triggered FES

Experimental

干预措施: Functional Electrical Stimulation (FES) treatment (Procedure)

conventional FES

Active Comparator

干预措施: Functional Electrical Stimulation (FES) treatment (Procedure)

结局指标

主要结局

Difference of vertical distance

时间窗: 12 weeks

次要结局

  • Physical examination of affected side(12 weeks)
  • Difference of joint distance of shoulder A-P radiograph(12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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