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临床试验/NCT01974635
NCT01974635
终止
不适用

Proprioception Testing in Persons With Sensorimotor Impairment

Oregon Health and Science University1 个研究点 分布在 1 个国家目标入组 2 人2013年10月

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Spinal Cord Injury
发起方
Oregon Health and Science University
入组人数
2
试验地点
1
主要终点
Joint Position Test - AMES Device
状态
终止
最后更新
6年前

概览

简要总结

In this study, an FDA-cleared device and type of treatment called "AMES," which stands for Assisted Movement with Enhanced Sensation, will be used to determine whether sensation in the upper limb of individuals with incomplete spinal cord injuries, acquired brain injury, or stroke improves along with movement through treatment. We hypothesize that measureable improvement in the sensation of the upper limb will precede improvement in functional movement.

详细描述

The AMES device performs tests of sensorimotor impairment as well as delivering therapy. In this study, we are testing 2 additional diagnostic tests (i.e., Joint Position Test and "Frisbee" Test), both of proprioception, in order to determine which of the two is the best test of proprioception. Our hypotheses are: (1) both sensation and movement recover with AMES treatment, (2) sensory recovery precedes that of movement, (3) robotic delivery of the Joint Position Test produces more reliable test results than does manual delivery of this test, and (4) the Frisbee Test results will parallel those of the Joint Position Test.

注册库
clinicaltrials.gov
开始日期
2013年10月
结束日期
2015年4月
最后更新
6年前
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

责任方
Principal Investigator
主要研究者

Paul J. Cordo

Site Sub-Investigator

Oregon Health and Science University

入排标准

入选标准

  • Traumatic incomplete SCI, stroke or acquired brain injured ABI subjects.
  • Able to tolerate sitting upright at for at least 1 hour.
  • Significant, but not complete, motor deficit in the hand and wrist, as determined by the Study Physician performing the screening.
  • Significant, but not complete somatosensory deficit in the hand and wrist as determined by the Study Physician performing the screening.
  • Cognitively and behaviorally capable of complying with the regimen.

排除标准

  • Fracture of the treated limb resulting in loss of range of motion.
  • Progressive neurodegenerative disorder.
  • DVT of the treated extremity.
  • Uncontrolled seizure disorder.
  • Uncontrolled high blood pressure/angina.
  • Osteo- or rheumatoid arthritis limiting range of motion
  • Contractures equal to or greater than 50% of the normal ROM.
  • Chronic ITB therapy.
  • Peripheral nerve injury of the treated extremity.
  • Pain in affected limb or exercise intolerance.

结局指标

主要结局

Joint Position Test - AMES Device

时间窗: Immediately after each treatment on the AMES Device

Testing proprioceptive sensation, the subject, with eyes closed, attempts to identify verbally the direction of motion (i.e., flexion or extension) as the AMES device randomly moves the subject's thumb and fingers, or the whole hand, into flexion and extension.

次要结局

  • Frisbee Test - Device(After each treatment on the AMES device.)

研究点 (1)

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