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A Comparison Between Ischial-Containment and Sub-Ischial Prosthetic Sockets to Determine Their Effects on Secondary Health Conditions

2026年8月12日 更新者:VA Office of Research and Development
Long-term above-knee prosthesis users are at an increased risk of developing secondary musculoskeletal conditions compared to the general able-bodied population. One secondary physical concern is low back pain (LBP), for which the development is not entirely understood, but in above-knee prosthesis users it is believed to relate to asymmetries and compensations that are typically demonstrated and required to stand and walk. Understanding spinal motion and compensations will enhance our knowledge of the factors contributing to LBP, and possibly lead to the development of new prosthetic and therapeutic interventions to prevent or alleviate LBP, thereby improving mobility and quality of life for prosthesis users.

研究概览

地位

尚未招聘

详细说明

The purpose of this study is to investigate and compare the effects of the standard ischial containment (IC) socket to a sub-ischial (SI) socket design on the spinal and pelvic motions and leg length (LLD) discrepancies of transfemoral prosthesis users. Data will be collected from 2 groups of transfemoral prosthesis users (15 SI socket wearers and 15 IC socket wearers) and a group of 15 able-bodied (AB) control participants. Gait and standing analyses will be conducted on each participant using a marker based motion capture system. Prosthesis users will wear their own conventional sockets for the gait and standing analyses. Kinematic and kinetic data will be analyzed for differences between the 2 groups of socket wearers and will also be compared to the control group.

The specific aims and hypotheses of this project are:

Aim 1: To measure dynamic leg length and kinematics of the pelvis and spinal segments in unilateral, transfemoral prosthesis users during gait. Quantitative motion analyses will be performed on two groups of 15 research participants with lower limb amputation using 2 different socket designs (IC and SI) walking over level ground at three self-selected walking speeds (normal, moderately fast, fastest). Data will be compared between socket type and to an AB control group. Hypothesis 1a-IC socket wearers will have a greater anterior pelvic tilt compared to SI socket wearers and AB controls, and they will exhibit considerably greater rotations of the pelvis and spinal segments during walking. Hypothesis 1b-The EMG activity of the lumbar erector spinae for SI socket users will better approximate the patterns of AB controls as compared to IC socket wearers. Hypothesis 1c-The dynamic LLD will be greater for IC socket users compared to SI socket wearers and AB controls.

Aim 2: To measure pelvic orientation and static leg length in unilateral, transfemoral prosthesis users during standing. A multi-segment model of the spine and pelvis will be used to determine neutral spinal, pelvis, and prosthetic alignment during standing for the research and AB control participants. Hypothesis 2a-IC socket wearers will demonstrate greater anterior pelvic tilt during standing compared to SI socket wearers and control participants. Hypothesis 2b-The prosthetic and sound leg lengths for both prosthesis user groups will be within 1.0 cm of each other during standing.

Aim 3: To estimate joint contact forces in the legs and lower back of unilateral, transfemoral prosthesis users and controls during gait. Computational musculoskeletal simulations will be used to comprehensively evaluate the data from Aim 1 to compare the lumbar joint loads between IC and SI socket wearers. Hypothesis 3-IC socket wearers will exhibit greater lumbar joint loads than SI socket wearers.

研究类型

观察性的

注册 (估计的)

45

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

研究联系人备份

学习地点

    • Illinois
      • Chicago、Illinois、美国、60612
        • Jesse Brown VA Medical Center, Chicago, IL
        • 接触:
        • 接触:
        • 首席研究员:
          • Rebecca Stine, MS

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

是的

取样方法

非概率样本

研究人群

Thirty unilateral transfemoral prosthesis users (15 with an ischial containment socket and 15 with a sub-ischial socket) and 15 able-bodied control participants.

描述

Inclusion Criteria:

For all participants:

  • Ability to complete the experimental protocol without undue fatigue or health risks
  • Low Back Pain scale assessment (0-10) less than 4 (activities of daily living or quality of life not impacted)

In addition for persons with lower limb amputation:

  • Prosthesis user for a minimum of 2 years with their current socket design
  • Good fit with either an ischial containment (IC) or sub-ischial (SI) socket
  • Good skin integrity on their residual limb upon visual inspection
  • Does not require the use of assistive devices to walk

Exclusion Criteria:

  • Previously diagnosed with a spine condition (e.g., pinched nerve, bulging disc, etc.)
  • Previously diagnosed with an orthopedic or neuromuscular condition that may affect walking or balance (e.g., ankle fusion, Parkinson's disease, stroke, etc.)

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

队列和干预

团体/队列
Ischial Containment Socket user
Person with unilateral transfemoral amputation wearing an ischial containment socket
Sub-Ischial Socket user
Person with unilateral transfemoral amputation wearing a sub-ischial socket
Able-bodied control
Person without an amputation

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
Anterior Pelvic Tilt Angle Between the IC Socket wearers and the SI Socket wearers/Able-Bodied Controls
大体时间:To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe
Anterior Pelvic Tilt will be calculated for all participants during the walking and standing trials. Participants will walk along a 10 meter walkway at varying speeds. Quantitative motion analysis using a marker based motion measurement system will be used to calculate anterior pelvic tilt.
To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe

次要结果测量

结果测量
措施说明
大体时间
Electromyography (EMG) Activity of the Lumbar Erector Spinae Between the IC Socket wearers and the SI Socket wearers/Able-bodied Controls
大体时间:To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe
EMG activity will be assessed using surface electrodes attached bilaterally to the erector spinae at and below T12/L1 and on the external oblique muscle. Data will be collected during the quantitative motion analysis.
To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe
Lumbar Flexion Between the IC Socket wearers and the SI Socket wearers/Able-bodied Controls
大体时间:To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe
Lumbar flexion will be calculated for all participants during the walking and standing trials. Participants will walk along a 10 meter walkway at varying speeds. Quantitative motion analysis using a marker based motion measurement system will be used to calculate anterior pelvic tilt.
To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe
Hip Joint Range of Motion (ROM) between the IC Socket wearers and the SI Socket wearers/Able-bodied Controls
大体时间:To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe
Hip Joint ROM will be calculated for all participants during the walking trials. Participants will walk along a 10 meter walkway at varying speeds. Quantitative motion analysis using a marker based motion measurement system will be used to calculate hip joint ROM.
To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe
Dynamic Leg Length Discrepancy (LLD) Between the IC Socket wearers and the SI Socket wearers/Able-bodied Controls
大体时间:To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe
Dynamic LLD will be calculated for all participants during the walking trials. Participants will walk along a 10 meter walkway at varying speeds. Quantitative motion analysis using a marker based motion measurement system will be used to calculated dynamic LLD.
To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe
Peak Lumbar Joint Loading Between the IC Socket wearers and the SI Socket wearers/Able-bodied Controls
大体时间:To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe
Lumbar joint loading during walking will be analyzed by performing musculoskeletal modeling simulations using data collected during the quantitative motion analysis.
To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe

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:Rebecca Stine, MS、Jesse Brown VA Medical Center, Chicago, IL

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)

2027年1月1日

初级完成 (估计的)

2030年7月1日

研究完成 (估计的)

2030年12月31日

研究注册日期

首次提交

2026年8月4日

首先提交符合 QC 标准的

2026年8月12日

首次发布 (实际的)

2026年8月17日

研究记录更新

最后更新发布 (实际的)

2026年8月17日

上次提交的符合 QC 标准的更新

2026年8月12日

最后验证

2026年8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)?

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

不

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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