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临床试验/NCT04818073
NCT04818073进行中(未招募)不适用

Determinants of the Effectiveness of Robot-assisted Hand Movement Training

University of California, Irvine2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年5月6日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
60
试验地点
2
主要终点
Box and Blocks Test

研究概览

简要总结

The investigators would like to investigate the effectiveness of somatosensory training for robot-assisted hand motor rehabilitation after stroke.

详细描述

From previous studies, the investigators learned that stroke survivors with impaired finger proprioception did not achieve as large a functional benefit from robotic finger training. For this study, the investigators would like to determine if and the extent of finger proprioception can be improved through targeted robotic proprioceptive training combined with robotic finger movement training. The investigators would also include imagining studies via Electroencephalogram (EEG) and other baseline predictors to provide insight to determine who responds best to proprioceptive training.

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
Single (Outcomes Assessor)

盲法说明

Randomized single-blinded

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

  • Age 18 to 85 years
  • Suffered from a single ischemic stroke (radiologically confirmed) at least 6-months prior to enrollment
  • An ability to score at least 3 blocks on the Box and Block Test

排除标准

  • A substantial decrease in alertness, language reception or attention
  • Pregnant or lactating
  • Advanced liver, kidney, cardiac or pulmonary disease
  • Plan to alter any current participation in other rehabilitation therapy in the time period of the study
  • A terminal medical diagnosis consistent with survival < 1 year
  • Coexistent major neurological disease
  • Coexistent major psychiatric disease
  • A history of significant alcohol or drug abuse in the prior 3 years
  • Current enrollment in another study related to stroke or stroke recovery
  • Any other medical contraindication to participation in this study evaluated by our team physician.

结局指标

主要结局

Box and Blocks Test

时间窗: From baseline to 1-month post intervention

We compare the change of Box and Block Test scores from baseline evaluation to 1-month post intervention. 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

  • Motor Activity Log(From baseline to 1-month post intervention)
  • Changes in finger proprioception measured using the Crisscross Assessment.(From baseline to 1-month post intervention)
  • Fugl-Meyer Motor Assessment of the Upper Extremity(From baseline to 1-month post intervention)

研究者

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

David Reinkensmeyer

Professor

University of California, Irvine

研究点 (2)

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