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临床试验/NCT01968096
NCT01968096Unknown不适用

The Reversal of Neuromuscular Adaptation in Human With Spinal Cord Injury II

Chang Gung University2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2013年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
52
试验地点
2
主要终点
Clinical muscle tone tests & Peripheral nerve Stimulation machine

研究概览

简要总结

Following injury to the spinal cord, the spinal circuit undergoes a series of adaptations. In parallel with the spinal circuit adaptation, the muscular properties also adapt. In human and animal studies, histochemical and physiological evidences showed that the paralyzed muscle transferred from slow, fatigue-resistant to fast, fatigable after injury.

Reversal of neuromuscular property for persons with SCI needs to be resolved. Studies using high load electrical stimulations showed a reverse change of muscular properties, such as hypertrophy and reversal of fiber type transformations but failed to show a reversal of spinal circuitry function. Previous studies found that fast continuous passive motion (CPM) altered the H reflex excitability in human. Animal studies found that passive cycling and passive stretching delayed atrophy and influenced the transition of type I and IIa MHC. Theses findings lead to a hypothesis that mechanical stimulation might be able to reverse both spinal circuitry and muscular properties after SCI but it has not been confirmed in human study.

The purpose of this project is to investigate the effect of mechanical stimulation by fast CPM on the reversing adaptation of human paralyzed muscle after SCI.

研究设计

研究类型
Interventional
分配方式
Non 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

  • Clinical diagnosis of spinal cord injury < 2 years
  • Stage 2 subjects: Incomplete spinal cord injury subject
  • Inclusion Criteria:
  • Clinical diagnosis of incomplete spinal cord injury
  • ASIA classification:B, C, or D
  • Stage 3 subjects: Spinal cord injury subjects with high muscle tone
  • Inclusion Criteria:
  • Clinical diagnosis of spinal cord injury.
  • ASIA classification: A, B, C, or D

排除标准

  • 未提供

结局指标

主要结局

Clinical muscle tone tests & Peripheral nerve Stimulation machine

时间窗: Participants will be followed for the duration of invention, an expected average of 24 weeks.

Clinical muscle tone test include Modified Ashworth Scale, Pendulum test ,and withdraw reflex,etc.. Normalization of muscle tone, and influence of muscle property will be evaluated. Peripheral nerve Stimulation machine stimulate Soleus and Tibialis anterior. Restoration of post activation will be evaluated.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ya-Ju Chang

Associate Professor

Chang Gung University

研究点 (2)

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