Effect of Altered Mechanical Loading in ACLR
2017年4月17日 更新者：University of North Carolina, Chapel Hill
Effect of Altered Mechanical Loading on Lower Extremity Biomechanics and Biochemical Markers in Individuals With an Anterior Cruciate Ligament Reconstruction
Altered loading is a causative factor for the development of knee osteoarthritis following anterior cruciate ligament reconstruction (ACLR), and real-time biofeedback may be an effective intervention to manipulate altered mechanical loading about the knee.
The purpose of this study is to 1) determine if ACLR participants are able to acquire and retain various loading patterns using real-time biofeedback, 2) determine the effect of altered loading on lower extremity biomechanics during walking gait, and 3) determine the effect of altered loading on biochemical markers of collagen turnover and inflammation during walking gait.
研究概览
详细说明
Participants will attend 4 testing sessions.
Lower extremity biomechanical outcomes and blood samples will be taken before and following the participant walking at a self-selected speed for 20 minutes.
During the 20 minutes of treadmill walking real-time biofeedback will be displayed in an attempt to alter mechanical loading.
Participants will complete a control, overloading, under-loading, average loading testing session.
Order of loading condition will be randomized.
研究类型
介入性
注册 (实际的)
30
阶段
- 不适用
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 35年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Have a history of a primary, unilateral ACLR using either a hamstring or patellar tendon autograft, cleared by a physical for full return to physical activity with no limitations, and participate in at least 30 minutes of physical activity 3 times per week
Exclusion Criteria:
- History of injury to either leg, other than ACLR (e.g. ankle sprain, muscle strain), within 6 months prior to participation in the study, history of lower extremity surgery other than ACLR, history of osteoarthritis or current symptoms related to knee osteoarthritis (e.g. pain, swelling, stiffness), currently pregnant, or planning to become pregnant while enrolled in the study, cardiovascular restrictions that limit the participant's ability to participate in physical activity.
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：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Overloading
Participants will walk on a force-instrumented treadmill for 20 minutes and will be provided visual biofeedback consisting of bilateral vertical ground reaction force.
A target will be placed at 10% greater than the participant's baseline vertical ground reaction force.
Participants will be asked to alter their walking gait in an attempt to reach the target line with each step.
|
A custom written MatLab script will sample bilateral peak vertical ground reaction forces and display the magnitude in real time on a screen placed in front of the participant.
A target line will be placed in the middle of the screen which corresponds to one of the three loading conditions.
Participants will be instructed to alter their movement in an attempt to match each limb's vertical ground reaction force to the target line.
|
|
实验性的：Underloading
Participants will walk on a force-instrumented treadmill for 20 minutes and will be provided visual biofeedback consisting of bilateral vertical ground reaction force.
A target will be placed at 10% lower than the participant's baseline vertical ground reaction force.
Participants will be asked to alter their walking gait in an attempt to reach the target line with each step.
|
A custom written MatLab script will sample bilateral peak vertical ground reaction forces and display the magnitude in real time on a screen placed in front of the participant.
A target line will be placed in the middle of the screen which corresponds to one of the three loading conditions.
Participants will be instructed to alter their movement in an attempt to match each limb's vertical ground reaction force to the target line.
|
|
实验性的：Average
Participants will walk on a force-instrumented treadmill for 20 minutes and will be provided visual biofeedback consisting of bilateral vertical ground reaction force.
A target will be placed at the average of each participant's baseline vertical ground reaction force between limbs.
Participants will be asked to alter their walking gait in an attempt to reach the target line with each step.
|
A custom written MatLab script will sample bilateral peak vertical ground reaction forces and display the magnitude in real time on a screen placed in front of the participant.
A target line will be placed in the middle of the screen which corresponds to one of the three loading conditions.
Participants will be instructed to alter their movement in an attempt to match each limb's vertical ground reaction force to the target line.
|
|
无干预：Control
Participants will walk for 20 minutes on a force-instrumented treadmill and will not be provided biofeedback.
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Difference in acquisition as measured in root mean square error (RMSE) between loading conditions
大体时间：Change in acquisition over 20 minute intervention
|
Change in acquisition over 20 minute intervention
|
|
Difference in joint loading as measured in peak vertical ground reaction force normalized to body weight (xBW) between loading conditions
大体时间：Change in joint loading over 20 minute intervention
|
Change in joint loading over 20 minute intervention
|
|
Difference in cartilage turnover as measured in serum concentration of cartilage oligomeric matrix protein (pg/mL) between loading conditions
大体时间：Chance in cartilage turnover over 20 minute intervention
|
Chance in cartilage turnover over 20 minute intervention
|
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：Brian Pietrosimone, PhD、University of North Carolina, Chapel Hill
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Luc-Harkey BA, Franz J, Hackney AC, Blackburn JT, Padua DA, Schwartz T, Davis-Wilson H, Spang J, Pietrosimone B. Immediate Biochemical Changes After Gait Biofeedback in Individuals With Anterior Cruciate Ligament Reconstruction. J Athl Train. 2020 Oct 1;55(10):1106-1115. doi: 10.4085/1062-6050-0372.19.
- Luc-Harkey BA, Franz JR, Blackburn JT, Padua DA, Hackney AC, Pietrosimone B. Real-time biofeedback can increase and decrease vertical ground reaction force, knee flexion excursion, and knee extension moment during walking in individuals with anterior cruciate ligament reconstruction. J Biomech. 2018 Jul 25;76:94-102. doi: 10.1016/j.jbiomech.2018.05.043. Epub 2018 Jun 15.
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
2016年7月1日
初级完成 (实际的)
2017年2月1日
研究完成 (实际的)
2017年4月1日
研究注册日期
首次提交
2017年1月22日
首先提交符合 QC 标准的
2017年1月26日
首次发布 (估计)
2017年1月30日
研究记录更新
最后更新发布 (实际的)
2017年4月19日
上次提交的符合 QC 标准的更新
2017年4月17日
最后验证
2017年4月1日
更多信息
与本研究相关的术语
其他研究编号
- 16-0409
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
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