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临床试验/NCT01050231
NCT01050231已完成不适用

Robotics For Rehabilitation Therapy: Functional Versus Individual Joint Training

University of California, Irvine2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2006年10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
20
试验地点
2
主要终点
Box & Blocks Test

研究概览

简要总结

The purpose of this study is to develop an upper extremity robotic training system for use by people with stroke to practice arm and hand movement in the clinic.

详细描述

Each year in the U.S. over 400,000 people survive a stroke and approximately 80% of acute stroke survivors lose arm and hand movement skills. Movement impairments are typically treated with intensive, hands-on physical and occupational therapy for several weeks after the initial brain injury. Unfortunately, due to economic pressure on the U.S. health care system, stroke patients are receiving less therapy and going home sooner. Our goal for this study is to develop an upper extremity robotic training system for both acute and chronic stroke population to improve movement ability with intensive and repetitive movement in the clinic without continuous supervision from a therapist.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 73 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 and 73
  • Sustained single stroke at least three months previously
  • Minimal to moderate lost motor control of the arm after stroke

排除标准

  • Concurrent severe medical problems
  • Severe cognitive dysfunction
  • Severe neglect or apraxia
  • Severe visual deficits
  • Significant subluxation of the shoulder
  • Presence of severe elbow or wrist contracture
  • Any metal implants or surgical clips or mechanical devices
  • Metallic hardware on scalp region
  • prior diagnosis of seizure and epilepsy
  • severe migraine headache
  • currently pregnant or lactating
  • claustrophobic
  • currently taking medication that lower seizure threshold

结局指标

主要结局

Box & Blocks Test

时间窗: Baseline, Post first intervention at 5 weeks, post second intervention at 11 weeks, and 3-month after the completion of the second intervention.

We measured the Box and Blocks Test scores at baseline evaluation, after each intervention, and at the 3-month follow up evaluation. Participants are instructed to move as many blocks as possible, one at a time, from one compartment in a box to a second compartment over a divider for a period of 60 seconds; each block that is moved is counted, and multiple blocks moved at the same time are counted as a single block. The higher scores indicate a better outcome.

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

David Reinkensmeyer

Professor of Mechanical and Aerospace Engineering

University of California, Irvine

研究点 (2)

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