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Impact of Footwear on Gait in Unilateral Transtibial Amputees

2026年8月17日 更新者：University of Salford

The Impact of Footwear on Gait in Unilateral Transtibial Amputees

The goal of this interventional study is to learn how different types of footwear affect gait, stability, comfort, and walking performance in adults with a unilateral transtibial amputation who use a lower limb prosthesis.

The main questions it aims to answer are:

  • Does footwear type affect gait characteristics such as gait speed, stride length, cadence, prosthetic foot clearance, and stance phase duration?
  • Does footwear type affect kinetic measures such as ground reaction forces and ankle power variables during walking?
  • Does footwear type affect in-shoe plantar pressure distribution?
  • Do participants perceive differences in comfort and stability between footwear conditions?

Participants will:

  • Attend a laboratory-based gait analysis session at the University of Salford.
  • Complete walking tasks while wearing four footwear conditions: their own preferred footwear, an Oxford shoe, a running/walking shoe, and a shoe with a forefoot rocker profile.
  • Perform straight-line walking, incline and decline walking, and S-shaped walking tasks.
  • Wear reflective markers and in-shoe pressure sensors during testing.
  • Complete visual analogue scale ratings of comfort and stability for each footwear condition.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

People with transtibial amputations often rely on footwear that is comfortable, practical, and compatible with their prosthetic device. Although footwear is known to influence walking mechanics in the general population, there is limited evidence regarding its effects on gait in people who use lower limb prostheses. This study aims to investigate the impact of different footwear types on gait performance, stability, and comfort in adults with unilateral transtibial amputations.

Fifteen participants aged 18 to 65 years who use an energy-storing-and-return (ESAR) prosthetic foot will be recruited. Participants must be able to walk independently without a walking aid.

Each participant will attend a laboratory-based testing session at the University of Salford. Reflective markers will be placed on the body and prosthesis to allow three-dimensional motion analysis. Participants will also wear an in-shoe pressure measurement system.

Participants will complete a series of walking tasks while wearing four footwear conditions: their own preferred footwear, an Oxford shoe, a running/walking shoe, and a shoe with a forefoot rocker profile. The order of the footwear conditions will be randomised. Walking tasks will include straight-line walking, walking on an incline and decline, and walking along an S-shaped path involving turns.

Outcome measures will include gait speed, stride length, cadence, prosthetic foot clearance, stance phase duration, ground reaction forces, ankle power variables, and plantar pressure measurements. Participants will also rate the comfort and stability of each footwear condition using visual analogue scales and provide additional comments about their experience.

Data will be analysed to determine whether footwear type influences gait performance, stability, and perceived comfort in people with unilateral transtibial amputations. The findings may contribute to future clinical guidance and footwear recommendations for prosthetic users.

研究类型

介入性

注册 (估计的)

15

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

  • 英国
    • Greate Manchester
      • Manchester、Greate Manchester、英国、M6 6PU
        • 招聘中
        • University of Salford
        • 接触：
        • 首席研究员：
          • Richard Jones, Professor

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

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Individuals with a unilateral transtibial amputation.
  • Age 18 to 65 years.
  • Participants must use an energy-storing and return (ESAR) prosthetic foot.
  • Able to walk and stand without the use of walking aids.
  • Absence of comorbidities known to impact balance and mobility.

Exclusion Criteria:

  • Bilateral amputees or individuals with amputation levels other than transtibial.
  • Individuals under 18 years or over 65 years of age.
  • Use of any prosthetic foot type other than ESAR.
  • Individuals unable to provide informed consent.

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：随机化
  • 介入模型：交叉作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
有源比较器：Own Footwear
Participants complete walking and balance assessments while wearing their own regularly used footwear.
设备：Own Footwear
Participants wear their own regularly used footwear while completing gait and standing assessments in a motion analysis laboratory.
实验性的：Oxford Shoe
Participants complete walking and balance assessments while wearing a standard Oxford shoe.
设备：Oxford Shoe
Participants wear a standard Oxford shoe while completing gait and standing assessments in a motion analysis laboratory.
实验性的：Walking/Running Shoe
Participants complete walking and balance assessments while wearing a walking/running shoe.
设备：Walking/Running Shoe
Participants wear a walking/running shoe while completing gait and standing assessments in a motion analysis laboratory.
实验性的：Rocker Shoe
Participants complete walking and balance assessments while wearing a rocker shoe.
设备：Rocker Shoe
Participants wear a rocker shoe while completing gait and standing assessments in a motion analysis laboratory.

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
Gait speed
大体时间：Baseline (single laboratory assessment)
Gait speed measured using three-dimensional motion capture and force plate analysis during walking under each footwear condition.
Baseline (single laboratory assessment)
Stride length
大体时间：Baseline (single laboratory assessment)
Stride length measured using three-dimensional motion capture during walking under each footwear condition.
Baseline (single laboratory assessment)
Cadence
大体时间：Baseline (single laboratory assessment)
Cadence measured using three-dimensional motion capture during walking under each footwear condition.
Baseline (single laboratory assessment)
Prosthetic foot clearance during swing phase
大体时间：Baseline (single laboratory assessment)
Prosthetic foot clearance during swing phase measured using three-dimensional motion capture under each footwear condition.
Baseline (single laboratory assessment)
Foot clearance time
大体时间：Baseline (single laboratory assessment)
Foot clearance time measured using three-dimensional motion capture under each footwear condition.
Baseline (single laboratory assessment)
Ground reaction forces
大体时间：Baseline (single laboratory assessment)
Ground reaction forces measured using force plate analysis during walking under each footwear condition.
Baseline (single laboratory assessment)
Stance phase duration
大体时间：Baseline (single laboratory assessment)
Stance phase duration measured using three-dimensional motion capture and force plate analysis under each footwear condition.
Baseline (single laboratory assessment)
Ankle power generated by the prosthetic foot
大体时间：Baseline (single laboratory assessment)
Ankle power generated by the prosthetic foot measured using three-dimensional motion capture and force plate analysis during walking under each footwear condition.
Baseline (single laboratory assessment)

次要结果测量

结果测量
措施说明
大体时间
Perceived footwear comfort
大体时间：Immediately after each footwear condition during the baseline laboratory assessment.
Participant-rated comfort for each footwear condition using a 100 mm Visual Analogue Scale (VAS), anchored from "Extremely Uncomfortable" to "Extremely Comfortable".
Immediately after each footwear condition during the baseline laboratory assessment.
Perceived footwear stability
大体时间：Immediately after each footwear condition during the baseline laboratory assessment.
Participant-rated stability for each footwear condition using a 100 mm Visual Analogue Scale (VAS), anchored from "Very Unstable" to "Very Stable".
Immediately after each footwear condition during the baseline laboratory assessment.

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。

赞助

University of Salford

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 (估计的)

2026年9月1日

初级完成 (估计的)

2026年12月15日

研究完成 (估计的)

2027年1月15日

研究注册日期

首次提交

2026年6月23日

首先提交符合 QC 标准的

2026年7月1日

首次发布 (实际的)

2026年7月6日

研究记录更新

最后更新发布 (实际的)

2026年8月19日

上次提交的符合 QC 标准的更新

2026年8月17日

最后验证

2026年8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

  • 365897

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

IPD 计划说明

The study team has not yet made a final decision regarding the sharing of individual participant data (IPD). Any future data sharing will be subject to participant consent, ethical approval requirements, institutional policies, and data protection regulations. If data are shared, all information will be de-identified to protect participant confidentiality.

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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