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临床试验/NCT02726204
NCT02726204已完成不适用

Evaluation of a Wearable Exoskeleton for Functional Arm Training (CAREX)

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2015年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
28
试验地点
1
主要终点
Passive range of motion measured by goniometry

研究概览

简要总结

The purpose of this study is to investigate how the cable-driven arm exoskeleton (CAREX) can assist task performance during 3D arm movement tasks under various experimental conditions in healthy individuals and patients with stroke. This study is designed to test motor learning with the robotic rehabilitative device CAREX under three conditions in healthy subjects and subjects with post-stroke hemiparesis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Investigator)

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

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Healthy Subjects

Active Comparator

Seven healthy patients will serve as controls based on preliminary data in healthy volunteers using CAREX with gravity elimination alone versus gravity elimination plus path assistance.

干预措施: Path Assistance and Gravity Elimination (Other)

Healthy Subjects

Active Comparator

Seven healthy patients will serve as controls based on preliminary data in healthy volunteers using CAREX with gravity elimination alone versus gravity elimination plus path assistance.

干预措施: Gravity Elimination Alone (Other)

Healthy Subjects

Active Comparator

Seven healthy patients will serve as controls based on preliminary data in healthy volunteers using CAREX with gravity elimination alone versus gravity elimination plus path assistance.

干预措施: Path Assistance Alone (Other)

Chronic Post Stroke Right Side Hemiparesis

Active Comparator

Radiologically verified unilateral stroke patients with at least 4 months previously.

干预措施: Gravity Elimination Alone (Other)

Chronic Post Stroke Right Side Hemiparesis

Active Comparator

Radiologically verified unilateral stroke patients with at least 4 months previously.

干预措施: Path Assistance Alone (Other)

Chronic Post Stroke Right Side Hemiparesis

Active Comparator

Radiologically verified unilateral stroke patients with at least 4 months previously.

干预措施: Path Assistance and Gravity Elimination (Other)

结局指标

主要结局

Passive range of motion measured by goniometry

时间窗: 1 Day

Active range of motion measured by goniometry

时间窗: 1 Day

Upper extremity motor impairment measured by performance on the 33 tasks of the Fugl-Meyer Scale (FMS)

时间窗: 1 Day

Spasticity measured by the Modified Ashworth Scale (MAS)

时间窗: 1 Day

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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