Normative Dynamic & Magnetic Spine (NDMS)
Normative Dynamic & Magnetic Spine. Musculoskeletal Characteristics Static and Dynamic of Spine in Healthy Subject
研究概览
详细说明
Spinal diseases and deformities in adults (degenerative or traumatic) and children (scoliosis and kyphosis) are major public health issues.
Postural imbalance due to spinal deformity is usually measured on static radiographs, using standard X-rays. However, bipedal walk is characteristic from human being and the trunk is the main stabilizer.
Pathogenesis of spinal deformities remains undefined. To understand the different mechanisms involved in the pathological field, normal musculoskeletal performances of the spine, in static and dynamic conditions must be identified.
Ultra-low doses stereoradiography using the EOS system allows the acquisition of full-spine images in standing position. Furthermore, 3D reconstruction can also be create from both anteroom-posterior and lateral side view. Stereoradiography is used in clinical routine especially in children spinal deformities.
High resolution muscular MRI is the only device that can provide a detailed muscular analysis, with detection of abnormalities at an early stage. No mapping of normal paraspinal muscles has been yet realized, particularly regarding to rotatores muscles.
Motion analysis is the reference exam to analyse dynamic stability during gait. Several parameters reflecting stability during gait can be collected in different conditions. Recently, the "Dynamic Stability Margin" has been developed but no standard values especially in healthy children has been published.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Ile De France
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Garches、Ile De France、法国、92380
- APHP Hôpital Raymond Poincaré
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Informed consent signed by adult or by the holders of parental authority for the children and adolescents
- Child or teenager, male or female, aged from 8 years to 17 years inclusive
- Adult, male or female, aged from 18 years to 40 years inclusive
- Realization of a preliminary medical examination
Exclusion Criteria:
- Refuse to participate to the study
- Patient under guardianship or curatorship
- Inability to cooperate
- Pregnant woman
- Non affiliation to social security
- Subject with spinal and/or lower limbs affection
- Subject with antecedent of spinal and/or lower limbs surgery
- Subject with contraindication to MRI
- Refusal of the parent or the subject to be informed about a fortuitous discovery during the examinations of the exams
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 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 |
|---|---|
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实验性的：healthy volunteers
EOS full-spine, MRI, gait analysis
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full-spine stereoradiography, high-resolution spine muscle MRI and 3D gait analysis will be performed
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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 |
|---|---|---|
|
Normal dynamic stability margin (DSM) in children and adults
大体时间：2 hours
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DSM= xCoM (extrapolated center of mass)- BoS (Base of Support).
Unit = meters Normalized on body height (m)
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2 hours
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
number of rotatores muscles
大体时间：2 hours
|
counting every rotatore muscle (from MRI data), no unit
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2 hours
|
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volume of back muscles
大体时间：2 hours
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from segmentation of each muscle group, unit = voxel
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2 hours
|
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
- 2016-A01825-46
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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