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临床试验/NCT05521126
NCT05521126进行中(未招募)不适用

The Use of Micro-Doppler Radar to Identify Service Members at Risk for Musculoskeletal Injury: A Gold Standard Comparison

Milton S. Hershey Medical Center4 个研究点 分布在 1 个国家目标入组 181 人开始时间: 2023年2月21日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
181
试验地点
4
主要终点
accuracy and predictability of MDS differentiation between ACL repair and control group

研究概览

简要总结

The purpose of this study is to see if the study team can use micro-Doppler signal (MDS) technology to determine if someone has had an anterior cruciate ligament (ACL) reconstruction. The investigators will do this by comparing the movement data from a group of people who have had the surgery with a group who has not had the surgery to see if the micro-Doppler radar technology can accurately and predictably tell the difference.

详细描述

The objective of this research is to validate that radar MDS can accurately and predictably differentiate individuals at high-risk for MSKI from those who are low risk. The investigators hypothesize that MDS will identify individuals at a high-risk for MSKI more accurately than the gold-standard MC technologies. To test this hypothesis, the investigators propose a case control study that will compare adults who have undergone ACL reconstruction to a control group of healthy adults that has not. Patients who have undergone ACL reconstruction have a 6-24% chance of either re-tearing their ACL or having a subsequent knee surgery on either side within two years of successful completion of surgery and post-surgical rehabilitation. Despite being released for full activities, little is known about what makes this group at high-risk for re-tear. As such, the investigators will use this patient population as a model for identifying an at-risk population for musculoskeletal injury (MSKI). The researchers will simultaneously collect radar micro-Doppler signals and biomechanical motion capture (MC) data in a state-of-the-art human movement lab. Participants will be asked to perform a series of functional activities that will be captured by both the MDS radar and MC systems. The data sets will then be analyzed independently.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Other

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • High risk cohort
  • age 18-40
  • history of ACL reconstruction
  • no current musculoskeletal injuries
  • ACL repair between 9 and 24 months prior to recruitment
  • Control cohort
  • age 18-40
  • never had lower extremity surgery

排除标准

  • High risk cohort
  • age <18 or >40
  • pregnancy
  • institutionalization
  • history of cerebral vascular accident
  • unable to provide informed consent
  • inability to perform study activities
  • history of hip or knee replacement
  • inability to walk or jump without a limp
  • current neuromuscular disease
  • any surgery in the last 6 months
  • Control cohort
  • age < 18 or > 40
  • pregnancy
  • institutionalization
  • history of Cerebral Vascular Accident
  • unable to provide informed consent
  • inability to perform study activities
  • history of knee or hip replacement
  • inability to walk or jump without a limp
  • current neuromuscular disease
  • history of lower extremity surgery
  • any surgery in the last 6 months

结局指标

主要结局

accuracy and predictability of MDS differentiation between ACL repair and control group

时间窗: Day 1

The investigators hypothesize that MDS will differentiate subjects who have recovered from an ACL reconstruction from a control cohort with accuracy and predictability. Participants will perform drop jumps, sit to stand, and walk on a treadmill in the presence of the micro-Doppler radar. MDS will be obtained for the ACL group as well as control. The micro-Doppler signature projection algorithm (mD-SPA) will then be applied to the data sets showing what percentage of the MDS are successfully classified to the ACL group versus control.

次要结局

  • ability of micro-Doppler radar and deep learning algorithms to automatically produce predictive data(Day 1)
  • accuracy of MDS differentiation between ACL repair and control groups versus the motion capture system(Day 1)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cayce Onks

Associate Professor of Family Medicine and Orthopaedics

Milton S. Hershey Medical Center

研究点 (4)

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