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临床试验/NCT02048826
NCT02048826已完成不适用

Study of Influence of Timing on Motor Learning

University of California, Irvine2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2013年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
31
试验地点
2
主要终点
Motor and Strength Outcome Measure Using Box and Block Test Measured in Units of Blocks Placed

研究概览

简要总结

The purpose of this study is to determine the effectiveness of training hand movement using FINGER robot after stroke. FINGER is a robot that measures finger movements and allows users to play computer games using those movements.

详细描述

Robotic devices can be used to retrain movement after stroke. However, it is unclear how best to assist in movement. Providing physical assistance may improve the flow of proprioceptive information to the nervous system, which may help a person relearn to move a limb. On the other hand, assisting movement with a robot may cause a person to "slack", not trying as hard during therapy. This study will test the effect of different levels of assistance on recovery of finger function during robot-assisted therapy after stroke.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 to 80 years of age
  • Have history of stroke affecting the arm, at least 6 months prior to enrollment
  • have arm and/or hand weakness as measured on a standard clinical scale
  • do not have active major psychological problems, or problems affecting the stroke-affected arm or hand besides the stroke
  • do not have active major brain disease other than the stroke
  • have absence of pain in the stroke-affected arm and hand

排除标准

  • severe stiffness of the arm or hand as measured on a standard clinical scale
  • severe problems speaking or understanding speech as measured on a standard clinical scale
  • severe reduced level of consciousness
  • severe loss ability to sense movement of your limbs as measured on a standard clinical scale
  • currently pregnant
  • difficulty in understanding or complying with the instructions given by the researcher
  • inability to perform the experimental task that will be studied
  • increased pain with movement of the stroke-affected arm or hand
  • Exclusion criteria that will prevent subjects from participating in the MRI:
  • Subjects having any implanted metal such as metallic splinters, metallic surgical clips, prosthetic heart valves, pacemakers, neuro-stimulation devices, orthodontic work that contains ferromagnetic materials,
  • Subjects whose occupation or activities may cause accidental lodging of ferromagnetic materials, or that may have imbedded metal fragments from military activities, unless cleared by a screening head CT scan
  • Subjects with tattoo(s) presenting metallic or ferromagnetic color ingredients or with facial make-up
  • Subjects who have claustrophobia
  • Subjects who are currently pregnant or breastfeeding.

结局指标

主要结局

Motor and Strength Outcome Measure Using Box and Block Test Measured in Units of Blocks Placed

时间窗: From baseline to 1-month post therapy

The primary endpoint was the change in Box and Blocks score, which measures how many blocks a subject can pick up and place in a box in 60 seconds, from baseline to 1-month post-therapy. The higher the scores, the better arm and hand function indicated.

次要结局

  • Motor and Strength Measure Using Action Research Arm Test Measured as a Score(From baseline to 1-month post therapy)
  • Motor, Strength and Sensory Using Fugl-Meyer Test Measured as a Score(From baseline to 1-month post therapy)

研究者

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

David Reinkensmeyer

Professor of Anatomy and Neurobiology

University of California, Irvine

研究点 (2)

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