Knee Indentation for Soft Tissues Mechanical Characterization and Modeling (KneeDent)
Indentation for the Mechanical Characterization of Soft Tissues in Contact With a Knee Orthosis: Towards Simulation of the Leg-Orthosis Interface.
Knee osteoarthritis is a common cause of disability, affecting more than 650 million people aged 40 and over worldwide in 2020. To relieve pain and improve mobility, some patients use knee orthoses . However, the effectiveness of these devices is not universally agreed upon, and users report widely varying levels of satisfaction.
This study aims to understand how the body responds to these orthoses from a biomechanical perspective, and in particular to quantify the interactions with soft tissues (skin, adipose tissue and muscles). To better understand this interaction, the authors propose to characterize soft tissue behavior on an individual basis using an indentation technique. In practice, this involves pressing on the soft tissues with an ultrasound probe to measure their stiffness at the interface between the leg and the orthosis.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Ille-et-Vilaine
-
Bruz、Ille-et-Vilaine、法国、35170
- Ens Rennes
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria
Participant whose skin is intact on at least one of the two legs, in the tested area.
Participant able to understand simple instructions, conditioning guidelines, and to provide informed consent.
Adult over the age of 50, not under guardianship. Participant having signed the study participation consent form.
Non-inclusion Criteria
Persons covered by articles L. 1121-5 to L. 1121-8 and L. 1122-1-2 (minors, protected adults, etc.) Skin lesions, inflammation, or acute local pain on the tested leg. Neuromuscular pathology preventing controlled muscle contraction. Joint pain preventing the performance of everyday activities (e.g., walking, rising from a chair, climbing stairs…).
学习计划
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Knee indentation
under different level of thigh and shank muscles contraction, we indent specific zones of the knee region to assess its stiffness and define a mechanical model of response for knee orthosis design
|
we push the soft tissue in the indentation zone with an instrumented elastographic probe, allowing to assess force vs tissue thickness.
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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 |
|---|---|---|
|
force-displacement curves
大体时间：through study completion, an average of 1 year
|
Using the force below and displacement below, this a construction of the relative displacement with regard to the applied force
|
through study completion, an average of 1 year
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Indentation force (N)
大体时间：through study completion, an average of 1 year
|
Force being applied by the indenter on the zone to be indented
|
through study completion, an average of 1 year
|
|
Displacement (mm)
大体时间：through study completion, an average of 1 year
|
using motion capture, this is the assessment of the relative displacement of the probe with regard to the resting position during an indentation
|
through study completion, an average of 1 year
|
|
Height (m)
大体时间：through study completion, an average of 1 year
|
Height of the subject, measured with a standard ruler
|
through study completion, an average of 1 year
|
|
Weight (kg)
大体时间：through study completion, an average of 1 year
|
measured with a standard scale
|
through study completion, an average of 1 year
|
|
Muscle activity (mV)
大体时间：through study completion, an average of 1 year
|
from the main flexors and extensors of the thigh, using EMGs
|
through study completion, an average of 1 year
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- InriaRennes
- Étude N°26.00181.001002 (其他标识符：Comité de protection des personnes Ile de France III)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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