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Insole Sensor to Determine Optimal Limb Loading

2017年10月24日 更新者：David Rothberg、University of Utah

Development and Clinical Trial of an Insole Sensor to Determine Optimal Limb Loading in the Rehabilitation of OTA Type 42IIIB and IIIC Lower Extremity Fractures

The purpose of this study is to use a novel load monitoring technology to correlate limb loading to OTA type 42IIIB and IIIC tibial fracture outcomes. This study will be the first to collect continuous limb loading data and will provide the first objective insight into how limb loading directs fracture healing. To meet this purpose, two specific aims have been developed.

Specific Aim 1: Preclinical validation of a load-monitoring insole

The Hitchcock laboratory has overcome the greatest technical hurdle for continuous limb load monitoring: development of load sensor technology that is affordable, accurate and capable of monitoring for over four weeks. To develop this sensor technology into a load-monitoring insole, the Hitchcock lab will incorporate consumer type electronics into the design, including a microprocessor, battery, and data storage media.

Following construction of a functional load-monitoring insole, a pilot human study with orthopaedic trauma patients from the University of Utah (N=20) will be conducted to identify modes of device failure, improve device interfacing and develop data handling protocols and software for the clinical arm of the proposed study.

Specific Aim 2: Conduct a prospective, direct observational cohort study.

Thirty (30) open tibial fracture patients will be recruited at two centers: University of Utah (N=15) and William Beaumont Army Medical Center (N=15). Participants will wear a walking boot instrumented with the load-monitoring insole that will continuously record limb loading and serve as a step counter. X-rays collected at standard-of-care follow-up visits will be used by Drs. Kubiak and Orr to subjectively evaluate fracture healing. A questionnaire regarding subjective perception of patient compliance will be collected at the first and last follow-up visits. Data collected from the insole sensor will be correlated to objective measures of fracture healing and subjective measures of patient compliance to determine the effect of patient limb loading on injury outcome. The Hitchcock laboratory will develop software to process and summarize data from the load monitoring insole and continually improve human interfacing factors of the load monitoring insole based off of feedback from the clinical team and study participants.

研究概览

地位

完全的

条件

研究类型

观察性的

注册 (实际的)

19

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

  • 美国
    • Utah
      • Salt Lake City、Utah、美国、84108
        • University of Utah

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 90年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients who present to the University of Utah with an Open Tibial Fractures.

描述

Inclusion Criteria:

Specific Aim 1 Inclusion Criteria

  • Patient is 18 years of age or older
  • Patient has below the knee fracture
  • Patient speaks English
  • Patient weighs between 100 and 250 pounds
  • Patient lives in close enough proximity to the the hospital to return for all appointments (~100 miles)

Specific Aim 2 Inclusion Criteria

  • Patient is 18 years of age or older
  • Patient has a tibia fracture
  • Patient speaks English
  • Patient weighs between 100 and 250 pounds
  • Patient lives in close enough proximity to the the hospital to return for all appointments (~100 miles)

Exclusion Criteria:

Specific Aim 1 Exclusion Criteria

  • Patient is younger than 18 years of age
  • Patient does not have a below the knee fracture
  • Patient does not speak English
  • Patient weighs less than 100 pounds or more than 250 pounds
  • Patient does not live in close enough proximity to the hospital to return for all appointments (~100 miles)
  • Patient has another fracture that will alter his/her weight bearing status

Specific Aim 2 Exclusion Criteria

  • Patient is younger than 18 years of age
  • Patient does not have a tibia fracture
  • Patient does not speak English
  • Patient weighs less than 100 pounds or more than 250 pounds
  • Patient does not live in close enough proximity to the hospital to return for all appointments (~100 miles)
  • Patient has another fracture that will alter his/her weight bearing status

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

  • 观测模型：队列
  • 时间观点：预期

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
Patient Activity Measure (PAM-13) Questionnaire
大体时间：Follow Up Visits up to 1-Year
A subjective evaluation of perceived compliance with physician instruction
Follow Up Visits up to 1-Year

次要结果测量

结果测量
措施说明
大体时间
X-ray (AP and Lateral)
大体时间：Follow Up Visits up to 1 Year
Subjectively evaluate fracture healing
Follow Up Visits up to 1 Year

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 Utah

合作者

William Beaumont Army Medical Center

调查人员

  • 首席研究员：David Rothberg, MD、Orthopedic Surgery

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

2013年1月1日

初级完成 (实际的)

2017年7月10日

研究完成 (实际的)

2017年7月10日

研究注册日期

首次提交

2014年6月18日

首先提交符合 QC 标准的

2014年6月20日

首次发布 (估计)

2014年6月23日

研究记录更新

最后更新发布 (实际的)

2017年10月26日

上次提交的符合 QC 标准的更新

2017年10月24日

最后验证

2017年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 58956

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