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针对髌骨股骨疼痛跑者的步态再训练

2026年9月29日 更新者:wanghaonan、Beijing Sport University

针对患有髌骨股骨疼痛的女性跑步者的步态再训练干预:随机对照试验

Patellofemoral pain (PFP) is a common overuse injury in runners. Increased patellofemoral joint stress (PFJS) is an important biomechanical factor associated with PFP. Gait retraining, especially cadence modification, may reduce PFJS and improve symptoms, but evidence from randomized controlled trials remains limited. This study investigated whether wearable device-assisted gait retraining was more effective than education alone in reducing pain, improving function, and altering running biomechanics in female runners with PFP.

研究概览

研究类型

介入性

注册 (估计的)

44

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

      • Beijing、中国
        • Beijing Sport University

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 45年 (成人)

接受健康志愿者

不

有资格学习的性别

女性

描述

Inclusion Criteria:

  • Female, Age 18-45 years
  • Unilateral/bilateral anterior knee pain > 4 weeks
  • VAS pain ≥ 3/10 during running and ≥ 2 of the following: jumping, squatting, kneeling, stairs, prolonged sitting, or resisted knee extension
  • Running ≥ 15 km per week
  • Natural rearfoot striker

Exclusion Criteria:

  • Acute trauma, history of patellar dislocation, meniscal/chondral lesions
  • Prior knee surgery or injection in past 12 months
  • Rheumatologic, neurologic, or degenerative disease
  • Pregnancy

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:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Gait retraining group

Participants received a 6-week gait retraining program plus patient education.

The intervention is a wearable device-assisted gait retraining program (home) designed specifically for female runners with patellofemoral pain.

PFP education, load management strategies, symptom-based training modifications, and strengthening exercises

有源比较器:Control group

Participants received a 6-week patient education program

PFP education, load management strategies, symptom-based training modifications, and strengthening exercises

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
Visual Analogue Scale for Pain during running
大体时间:Baseline, Week 6, Week 18

The Visual Analogue Scale (VAS) is a validated, widely used instrument for assessing subjective pain intensity. It consists of a 10-centimeter horizontal line, with one end (0) representing "no pain" and the other end (10) representing "worst imaginable pain." It will be evaluated during running.

Baseline, Week 6, Week 18

次要结果测量

结果测量
措施说明
大体时间
Visual Analogue Scale for usual pain
大体时间:Baseline, Week 6, Week 18

The Visual Analogue Scale (VAS) is a validated, widely used instrument for assessing subjective pain intensity. It consists of a 10-centimeter horizontal line, with one end (0) representing "no pain" and the other end (10) representing "worst imaginable pain." It will be evaluated for usual pain.

Baseline, Week 6, Week 18
Anterior Knee Pain Scale
大体时间:Baseline, Week 6, Week 18

The Anterior Knee Pain Scale (AKPS), also referred to as the Kujala Score, is a patient-reported outcome measure designed to evaluate symptoms and functional limitations associated with anterior knee pain and patellofemoral disorders. It consists of 13 items covering domains such as pain during various activities (e.g., walking, running, jumping, climbing stairs, squatting), functional limitations, abnormal gait, muscle atrophy, and difficulty with prolonged sitting. Each item is scored on an ordinal scale, and the total score ranges from 0 to 100, with higher scores indicating better knee function and fewer symptoms.

Baseline, Week 6, Week 18
Knee Flexion Angle
大体时间:Baseline, Week 6

Peak knee flexion angle will be assessed during running trials using a 3-dimensional motion capture system. Reflective markers will be placed according to a standard lower-limb biomechanical model.

Baseline, Week 6
Ground Reaction Force
大体时间:Baseline, Week 6

Ground reaction force (GRF) will be measured during overground running using embedded force plates synchronized with motion capture.

Baseline, Week 6
Visual Analogue Scale for the worst pain
大体时间:Baseline, Week 6, Week 18

The Visual Analogue Scale (VAS) is a validated, widely used instrument for assessing subjective pain intensity. It consists of a 10-centimeter horizontal line, with one end (0) representing "no pain" and the other end (10) representing "worst imaginable pain." It will be evaluated for the worst pain.

Baseline, Week 6, Week 18

其他结果措施

结果测量
措施说明
大体时间
Step rates
大体时间:Baseline, Week 6

Step rates refer to the number of steps taken per unit of time, usually expressed as steps per minute (steps/min).

Baseline, Week 6
Weekly running distance
大体时间:Baseline, Week 6

Weekly running distance refers to the total distance covered by a participant through running over one week, usually expressed in kilometers (km) or meters (m). This outcome is used to assess running volume.

Baseline, Week 6

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:Haonan Wang、Beijing Sport University

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)

2026年5月15日

初级完成 (估计的)

2026年12月15日

研究完成 (估计的)

2026年12月15日

研究注册日期

首次提交

2026年4月16日

首先提交符合 QC 标准的

2026年4月25日

首次发布 (实际的)

2026年4月29日

研究记录更新

最后更新发布 (实际的)

2026年10月2日

上次提交的符合 QC 标准的更新

2026年9月29日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

What IPD will be shared:De-identified individual participant data that underlie the results reported in the publication, including baseline characteristics, outcome measures (pain scores, functional scores, running mechanics), and adverse events.

When will IPD be available:

Beginning 6 months after publication of the main trial results, for up to 5 years.

With whom:

Researchers who provide a methodologically sound proposal to achieve aims consistent with the original study.

For what types of analyses:

For individual participant data meta-analyses and reproducibility purposes.

How to access data:

Proposals should be directed to the corresponding author (wanghaonan@bsu.edu.cn). Data access will be provided via secure data transfer after approval of a data-sharing agreement.

IPD 共享时间框架

Beginning 6 months after publication of the main trial results, for up to 5 years.

IPD 共享访问标准

With whom: Researchers who provide a methodologically sound proposal to achieve aims consistent with the original study.

For what types of analyses:

For individual participant data meta-analyses and reproducibility purposes.

How to access data:

Proposals should be directed to the corresponding author (wanghaonan@bsu.edu.cn). Data access will be provided via secure data transfer after approval of a data-sharing agreement.

IPD 共享支持信息类型

  • 研究方案
  • 树液

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

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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