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临床试验/NCT03300258
NCT03300258终止不适用

Robotic Pedaling Therapy for Targeted Neural Plasticity

University of Wisconsin, Madison2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2019年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
44
试验地点
2
主要终点
Change in Six Minute Walk Test (6MWT) Distance

研究概览

简要总结

The aim of this Pilot study is to determine whether robotically targeted lower-limb pedaling therapy can increase the extent of stroke recovery on behavioral measures and induce brain plasticity as measured by functional magnetic resonance imaging (fMRI). Forty (40) adult stroke patients and 80 healthy controls will be enrolled in this study. Of the 40 patients, half will be randomly assigned to the robotically-targeted training ("robotic") group and will receive training on the targeted training task. The other half of the patients will perform a duration-matched aerobic pedaling exercise ("control" group). All stroke patients will be scanned before and after their training program while performing or imagining simple motor tasks. Behavioral assessments of motor and cognitive capacities will be collected at each timepoint. Healthy control subjects enrolled for device testing (20) will receive up to 5 training sessions in a modified robotic paradigm and 1 fMRI scan, in order to investigate motor learning and brain activity in a novel motor control task. Additional healthy pilot subjects (up to 60) will test training protocols and assessments during preparatory design phases of the project.

研究设计

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

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change in Six Minute Walk Test (6MWT) Distance

时间窗: Baseline and at 5 weeks

A simple series of laps along a 30 m straight path in a level hallway.

次要结局

  • Change in Brain Activity in and Near Affected Areas, Through Functional MRI (fMRI)(Baseline and at 5 weeks)
  • Change in Self-Selected Walking Speed (SSWS)(Baseline and at 5 weeks)
  • Change in Fastest Comfortable Walking Speed (FCWS)(Baseline and at 5 weeks)
  • Change in Timed Up-and-Go Test (TUG)(Baseline and at 5 weeks)
  • Change in Center of Pressure (COP) Characteristics(Baseline and at 5 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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