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实时运动捕获和截肢步态训练的视觉反馈

2026年11月7日 更新者:Hui-Ting Shih、National Yang Ming Chiao Tung University

实时2D运动捕获和视觉反馈步态训练系统对单方面经济截肢者的步行性能的影响

People with transfemoral amputation face challenges such as gait asymmetry, instability, and increased energy consumption due to loss of the knee joint. Because of the loss of proprioceptive feedback from their missing limbs, visual feedback is essential for gait correction. Additionally, current visual feedback systems lack portability, cost-effectiveness, and they fail to provide precise, intuitive feedback on spatiotemporal parameters, joint angles, and both frontal and sagittal plane information, limiting their effectiveness in correcting gait abnormalities.This study aims to investigate whether gait training using a real-time 2D motion capture and visual feedback gait training system (2DMV) can improve the gait biomechanics and psychosocial functions of people with unilateral transfemoral amputation (uTFA). The 2DMV system analyzes spatiotemporal parameters and joint kinematics during gait and displays the uTFA's image on a screen, providing visual feedback specifically targeting gait abnormalities. This allows individuals with uTFA to intuitively understand the feedback and make real-time gait adjustments. The biomechanical parameters include joint kinematics, gait symmetry, and walking performance.

研究概览

研究类型

介入性

注册 (估计的)

40

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。

学习联系方式

学习地点

      • Taipei、台湾、112
        • 招聘中
        • National Yang Ming Chiao Tung University
        • 接触:

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 65年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Age between 18 and 65 years
  • Individuals with unilateral transfemoral amputation or knee disarticulation
  • Wear a prosthesis for at least 3 hours per day
  • Have been using a prosthesis for more than 6 months
  • Medicare Functional Classification Level (K-level) of 2 or above
  • Able to walk independently for 5 meters without assistive devices
  • No pain caused by poor prosthetic fit
  • Montreal Cognitive Assessment Taiwan Version (MoCA-T) score ≥ 26

Exclusion Criteria:

  • Uncontrolled systemic diseases (e.g., diabetes mellitus, hypertension)
  • Cardiopulmonary or cardiovascular diseases (e.g., heart failure, severe asthma)
  • History of neurological conditions that affect movement (e.g., stroke, spinal cord injury, cerebellar injury)
  • Vestibular disorders
  • Severe osteoporosis
  • Other musculoskeletal injuries or open wounds
  • Epilepsy
  • Uncorrected visual impairments
  • Congenital limb deficiency

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:治疗
  • 分配:非随机化
  • 介入模型:并行分配
  • 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:Real-time 2D motion capture and visual feedback system gait training group (VF)

The VF group, the 2D motion capture and visual feedback training group, received an intervention consisting of 10 minutes of strength training followed by 30 minutes of visual feedback gait training using the 2DMV system.

The difference between the VF group and the PT group lies in the use of real-time visual feedback during gait training; the VF group receives real-time visual feedback, while the PT group undergoes gait training without visual feedback.

有源比较器:Conventional physical therapy group (PT)

The PT group, the conventional physical therapy group, received an intervention consisting of 10 minutes of strength training followed by 30 minutes of gait training without the use of the 2DMV system for visual feedback. During gait training, the therapist provided standard gait correction feedback typically used in conventional physical therapy.

Ten minutes of strength training followed by thirty minutes of gait training, during which the 2DMV system is not used to provide visual feedback. During the gait training, the therapist provides gait correction feedback typically used in conventional physical therapy.

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
Step width ratio
大体时间:The step width ratio will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.

Step width ratio is calculated by dividing step width by pelvis width (step width/pelvis width), and the normal range is between 0.4 to 1.1.

The step width ratio will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.
Step length ratio
大体时间:The step length ratio will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.

Step length ratio is calculated by dividing the step length of the amputated limb by the step length of the non-amputated limb (a value closer to 1 indicate more symmetry, the step length of amputated limb is calculated as the distance between the heel of the non-amputated limb when initial contact and the heel of the amputated limb when initial contact; the step length of non-amputated limb is calculated as the distance between the heel of the amputated limb when initial contact and the heel of the non-amputated limb when initial contact)

The step length ratio will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.
Stride time ratio
大体时间:The stride time ratio will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.

Stride time ratio is calculated by dividing the stride time of the amputated limb by the stride time of the non-amputated limb (a value closer to 1 indicates more symmetry, the stride time of the amputated limb is calculated as the time from initial contact of the amputated limb to next initial contact of the same limb; the stride time of the non-amputated limb is calculated as the time from initial contact of the non-amputated limb to next initial contact of the same limb).

The stride time ratio will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.
Stance time ratio
大体时间:The stance time ratio will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.

Stance time ratio is calculated by dividing the stance time of the amputated limb by the stance time of the non-amputated limb (a value closer to 1 indicates more symmetry, the stance time is calculated from initial contact to toe off of the same limb).

The stance time ratio will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.
Swing time ratio
大体时间:The swing time ratio will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.

Swing time ratio is calculated by dividing the swing time of the amputated limb by the swing time of the non-amputated limb (a value closer to 1 indicates more symmetry, the swing time is calculated from toe off to initial contact of the same limb).

The swing time ratio will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.
Hip extension angle
大体时间:The hip extension angle will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.

The hip extension angle is measured in the sagittal plane during terminal stance.

The hip extension angle will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.
Hip flexion angle
大体时间:The hip flexion angle will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.

The hip flexion angle is measured in the sagittal plane at the maximum angle of hip flexion during the swing phase.

The hip flexion angle will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.
Trunk extension and flexion angle
大体时间:The trunk extension and flexion angle will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.

The trunk extension and flexion angle is measured in the sagittal plane at the initial contact and terminal stance.

The trunk extension and flexion angle will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.
Hip adduction and abduction angle
大体时间:The hip adduction and abduction angle will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.

The hip adduction and abduction angle is measured in the coronal plane at the maximum angle of hip adduction or abduction angle during the swing phase.

The hip adduction and abduction angle will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.
Horizontal pelvis tilt angle
大体时间:The horizontal pelvis tilt angle will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.

The horizontal pelvis tilt angle is measured in the coronal plane at the maximum pelvis tilt angle during single-leg stance.

The horizontal pelvis tilt angle will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.
Trunk lateral flexion angle
大体时间:The trunk lateral flexion angle will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.

The trunk lateral flexion angle is measured in the coronal plane during midstance.

The trunk lateral flexion angle will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.

次要结果测量

结果测量
措施说明
大体时间
The Component Timed-Up-and-Go test, cTUG
大体时间:The Component Timed-Up-and-Go test will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.

The participant will first be instructed to sit on a chair with a backrest. When the assessor says 'go,' the participant will stand up, walk forward, circle around a cone, return to the chair, and sit down, all at a self-selected speed. The assessor will time the duration of the entire process. The timing of the Component Timed-Up-and-Go test will be divided into five components: standing up, walking forward, circling around the cone, walking back to the chair, and sitting down. Time will be measured in seconds.

The Component Timed-Up-and-Go test will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.
Gait speed
大体时间:The gait speed will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.

Gait speed will be measured by the assessor with a timer. The participant will be instructed to walk 5 meters at a self-selected speed. The first and last 1 meter will serve as the acceleration and deceleration phases, while the gait speed in middle 3 meters will be measured. Time will be measured in seconds.

The gait speed will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.
The Activities-specific Balance Confidence Scale, ABC scale
大体时间:The Activities-specific Balance Confidence Scale will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.

The Activities-specific Balance Confidence Scale is a self-reported questionnaire used to assess balance confidence. Scores range from 0% to 100%, with higher scores indicating greater confidence. The scale consists of 16 items in total.

The Activities-specific Balance Confidence Scale will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.
The National Aeronautics and Space Administration Task Load Index, NASA-TLX
大体时间:The National Aeronautics and Space Administration Task Load Index will be measured after the 12th intervention session.

The National Aeronautics and Space Administration Task Load Index is a self-repoted scale, totally has 6 items, including mental demand, physical demand, temporal demand, performance, effort, and frustration. The score will recorded as 0 to 100, with the higher score indicating higher work load.

The National Aeronautics and Space Administration Task Load Index will be measured after the 12th intervention session.

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。

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8月20日

初级完成 (估计的)

2027年7月10日

研究完成 (估计的)

2027年7月31日

研究注册日期

首次提交

2025年5月13日

首先提交符合 QC 标准的

2025年7月1日

首次发布 (实际的)

2025年7月3日

研究记录更新

最后更新发布 (实际的)

2026年11月12日

上次提交的符合 QC 标准的更新

2026年11月7日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • NYCU114067AE

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

不

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