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用于增强中风步态的自适应髋部外骨骼

2026年6月5日 更新者:Georgia Institute of Technology

适用于步态障碍的中风幸存者的动力髋部外骨骼

这项工作将重点关注机器人外骨骼的新算法,并在人体测试中测试这些算法。 以前患有中风的人将穿着机器人外骨骼在专门的跑步机上行走。 该研究将比较先进算法与不使用该设备的性能,以确定临床益处。

研究概览

地位

完全的

条件

详细说明

这项工作的重点是提出一种新颖的人工智能(AI)系统,该系统可以自适应动力外骨骼中的控制策略,以帮助部署系统,从而根据患者的个体步态进行个性化设置。 研究人员假设,通过使用自适应控制策略系统,步行速度将会提高。 中风后的个体面临广泛的行动能力挑战,包括步态不对称、SSWS 大幅下降和稳定性降低,因此大大损害了社区的整体行动独立性。 研究人员预计,所提出的新型控制器能够针对这种可变和不对称的步态模式进行个性化,对于提高中风后患者的社区独立性和活动性将具有显着的好处。 12 名中风后患者将安装髋部外骨骼,并在 Motek CAREN 系统上以不同的速度和倾斜度行走,同时研究人员测量自我选择的行走速度。 自适应系统将直接与最佳平均控制策略(非自适应)以及“护理标准”基线进行比较。 该基线将是在不使用外骨骼加上任何临床规定的被动矫形器的情况下行走。 研究人员期望自适应系统能够学习最适合患者步态模式的控制策略,从而在步行速度方面产生优势。

研究类型

介入性

注册 (实际的)

12

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Georgia
      • Atlanta、Georgia、美国、30332
        • Exoskeleton and Prosthetic Intelligent Controls Lab

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 85年 (成人、年长者)

接受健康志愿者

不

描述

纳入标准:

  • 既往有中风病史并经医生批准可以安全地进行实验活动。
  • 中风必须发生在参与研究之前至少 6 个月。
  • 年龄在18-85岁之间。
  • 简易精神状态检查 (MMSE) 分数大于 17。
  • 能够在无人支撑的情况下坐至少 30 秒。
  • 能够遵循三步命令。
  • 必须能够在没有支撑的情况下行走(可以根据需要使用导轨),行走速度至少为 0.4 m/s(限制社区行走速度)。
  • 必须能够步行至少 6 分钟。
  • 必须愿意并且能够参加 1-4 小时的实验,并根据需要定期休息。
  • 必须能够在没有外部支撑(允许扶手支撑)的情况下转移(坐到站和站到坐)。
  • 必须能够在小斜坡(3 度)和几步(6 步)上行走。

排除标准:

  • 腿部感觉丧失、脊髓完全损伤、过去 6 个月内有脑震荡病史、任何严重心血管疾病史、严重关节炎或会限制全面参与研究的骨科问题。
  • 诊断其他神经系统疾病,如帕金森病、肌萎缩侧索硬化症 (ALS)、多发性硬化症 (MS)、痴呆、未完全解决的头部外伤史(根据参与者报告)、下肢截肢、不愈合溃疡下肢、肾透析或终末期肝病、法定失明或严重视力障碍。
  • 使用起搏器或在头部区域植入金属或降低癫痫阈值的药物。
  • 最后,如果您正在参加另一项临床研究和/或您的身体状况仅限于完成不同的任务,首席研究员 (PI) 认为这可能会影响研究结果或混淆结果,您将被排除在外研究。

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:基础科学
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Hip Exoskeleton for Stroke Gait Assistance
This study will be conducted on a sample population of stroke subjects (single arm). Subjects will be tested with the hip exoskeleton and baseline.
The intervention is an experimental robotic hip exoskeleton in a powered state providing assistance to the user that has been previously developed by the team. It is used to improve walking gait performance.
The intervention will serve as a baseline where participants will be asked to perform the tasks without wearing a hip exoskeleton.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Temporal Convolutional Network (TCN) Model Performance (Joint Moment Accuracy)
大体时间:5 Days
This outcome represents the error with which the deep learning model embedded into our hip exoskeleton's microprocessor predicts hip joint moments in stroke patients. Specifically, the coefficient of determination (R²) is computed between the predicted hip joint moments and the ground truth measurements. Ground truth measurements are obtained from a laboratory-grade force plate system and inverse dynamics calculations. For these measures, higher R² values (closer to 1.0) indicate better correlation between predicted and actual hip joint moments. This metric provides a comprehensive assessment of the exoskeleton's ability to accurately estimate hip joint moments in stroke patients during tasks, with improved outcomes representing better assistive capabilities for the user.
5 Days
Metabolic Cost for Level Ground Walking
大体时间:5 days
Metabolic energy expenditure will be quantified using an indirect calorimetry system (Parvo Medics, UT) that measures oxygen consumption (VO₂) and carbon dioxide production (VCO₂) during experimental tasks. Measurements will be collected from each participant during a 5-minute baseline standing period followed by level ground walking trials under three conditions: without the exoskeleton, with the exoskeleton in a powered state, and with the exoskeleton in an unpowered state. Metabolic cost will be calculated from respiratory gas exchange data using standard equations for energy expenditure.
5 days
Biological Joint Work - Level Walking
大体时间:5 days
Mechanical work performed by the lower limb joints during level walking will be quantified through biomechanical analysis of motion capture data. Joint moments and angular velocities will be derived through inverse dynamics and kinematics, respectively. Joint power, calculated as the product of joint moment and angular velocity, will be integrated with respect to time using trapezoidal integration to determine mechanical work. Positive work will be calculated by integrating positive joint powers, providing comprehensive quantification of joint energy generation at each joint during level walking.
5 days
Biological Joint Work - Incline Walking
大体时间:5 days
Mechanical work performed by the lower limb joints will be quantified during incline walking through biomechanical analysis of motion capture data. Joint moments and angular velocities will be derived through inverse dynamics and kinematics, respectively. Joint power, calculated as the product of joint moment and angular velocity, will be integrated with respect to time using trapezoidal integration to determine mechanical work. Positive work will be calculated by integrating positive joint powers, providing comprehensive quantification of joint energy generation at each joint during the incline walking.
5 days
Biological Joint Work - Stair Ascent
大体时间:5 days
Mechanical work performed by the lower limb joints will be quantified during stair ascent through biomechanical analysis of motion capture data. Joint moments and angular velocities will be derived through inverse dynamics and kinematics, respectively. Joint power, calculated as the product of joint moment and angular velocity, will be integrated with respect to time using trapezoidal integration to determine mechanical work. Positive work will be calculated by integrating positive joint powers, providing comprehensive quantification of joint energy generation at each joint during the stair ascent task.
5 days
Biological Joint Work - Sit to Stand
大体时间:5 days
Mechanical work performed by the lower limb joints will be quantified during sit to stand through biomechanical analysis of motion capture data. Joint moments and angular velocities will be derived through inverse dynamics and kinematics, respectively. Joint power, calculated as the product of joint moment and angular velocity, will be integrated with respect to time using trapezoidal integration to determine mechanical work. Positive work will be calculated by integrating positive joint powers, providing comprehensive quantification of joint energy generation at each joint during the sit to stand task.
5 days
Biological Joint Work - go and Grab
大体时间:5 days
Mechanical work performed by the lower limb joints will be quantified during a go and grab task through biomechanical analysis of motion capture data. In the go and grab task, participants take several steps, lean forward, and pick up a weighted object from a low surface just above ground level. Joint moments and angular velocities will be derived through inverse dynamics and kinematics, respectively. Joint power, calculated as the product of joint moment and angular velocity, will be integrated with respect to time using trapezoidal integration to determine mechanical work. Positive work will be calculated by integrating positive joint powers, providing comprehensive quantification of joint energy generation at each joint during the go and grab task.
5 days

次要结果测量

结果测量
措施说明
大体时间
10 Meter Walk Test (Self-selected)
大体时间:5 days
This will be measured as the participant walks a distance of 10 meters across a gait mat at their self-selected (or comfortable) walking speed. This measure will be recorded in seconds with lower values indicating faster speed and higher values indicating slower speeds. Self-selected walking speed is highly correlated with functional ability and dependence.
5 days
The Timed up and go (TUG)
大体时间:5 days
This will be measured as the time it takes a participant to rise from a chair, walk three meters at a self-selected pace, turn, walk back to the chair and sit down. The total time taken will be measured in seconds with longer times indicating poorer physical performance. This test assesses functional mobility and dynamic balance.
5 days
6 Minute Walk Test
大体时间:5 days
This is a measurement of endurance and functional ability that assesses the participants ability to walk a distance over a time period of 6 minutes. It is measured in distance with greater distances indicating improved levels of endurance and functional ability.
5 days
Modified Stroke Impact Scale
大体时间:5 days
The Modified Stroke Impact Scale (SIS) is a self-report questionnaire that evaluates disability and health-related quality of life after stroke. Each item is rated in a 5-point Likert scale in terms of the difficulty the patient has experienced in completing each item. Scores are transformed to a 0-100 scale, with 0 indicating the poorest perceived health status and 100 indicating the best, across domains of disability and health-related quality of life. Higher scores are indicative of improved quality of life.
5 days
Modified Activities-specific Balance Confidence
大体时间:5 days
The modified activities specific balance confidence is a self-report measure of balance confidence in performing various activities without losing balance or experiencing a sense of unsteadiness. Confidence is rated for various activities on a scale from 0% to 100% for each activity, with 0% indicative of no confidence and 100% indicative of complete confidence. Scores reflect balance confidence with higher scores indicative of improved balance confidence.
5 days
Fast Self-selected Walking Speed
大体时间:5 days
This will be measured as the participant walks on a treadmill at their fastest and safest walking speed. This measure will be recorded in meters/seconds with higher values indicating faster speed and lower values indicating slower speeds.
5 days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Aaron Young, Ph.D.、Georgia Institute of Technology

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年5月21日

初级完成 (实际的)

2025年8月29日

研究完成 (实际的)

2025年8月29日

研究注册日期

首次提交

2022年9月8日

首先提交符合 QC 标准的

2022年9月8日

首次发布 (实际的)

2022年9月13日

研究记录更新

最后更新发布 (实际的)

2026年7月1日

上次提交的符合 QC 标准的更新

2026年6月5日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • H18182
  • R03HD097740 (美国 NIH 拨款/合同)
  • DP2HD111709 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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