The Establishment of Advanced Brain Function Evaluation Model for Anterior Cruciate Ligament Reconstruction
The Establishment of Evaluation Model About Returning to Sports Post-operation of Anterior Cruciate Ligament Reconstruction by Resting State Functional Magnetic Resonance and Three-dimensional Gait Analysis
It is difficult to establish the standard of return to sports post anterior cruciate ligament (ACL) reconstruction.
The amplitude of low frequency fluctuation (ALFF) and functional connectivity (FC) of resting state functional magnetic resonance imaging (fMRI) can explore the differences in neural function of different populations, but have not been applied in the study of ACL postoperative return to sports.This project intends to use ALFF algorithm to calculate the changes of BLOD signals of coppers and non- coppers after ACL surgery in the subfrequency band and the functional network in the subfrequency band, explore the relationship between the default network (DMN) and the sensorimotor network (SMN), and use three-dimensional gait analysis to carry out accurate functional test..This project will explore the central strategy of ACL postoperative functional recovery from a new perspective, to provide a more reasonable high-level evaluation index for the timing of return to sports, and to reduce the incidence of postoperative re-tearing.
研究概览
研究类型
观察性的
注册 (预期的)
50
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
-
-
Zhejiang
-
Hangzhou、Zhejiang、中国
- 招聘中
- Hongyun song
-
接触：
- Hongyun Song, master
- 电话号码：+86 0571-87783684
- 邮箱：hedy.song@zju.edu.cn
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首席研究员：
- Hongyun Song, master
-
-
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
16年 至 50年 (孩子、成人)
接受健康志愿者
是的
有资格学习的性别
全部
取样方法
非概率样本
研究人群
patients post anteriorcruciate ligament (ACL) reconstruction
描述
Inclusion Criteria:
Patients who completed the same operation and completed phased home rehabilitation instruction and who underwent ACL reconstruction more than 2 years after the operation were recruited as the test subjects
Exclusion Criteria:
heart and nervous system diseases, Other sports injuries such as medial collateral ligament injury, meniscus repair, grade III-IV cartilage injury, ankle instability, metal implants in the body and medication were excluded
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
队列和干预
团体/队列 |
|---|
|
普通的
|
|
copper
|
|
no-copper
|
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 |
|---|---|---|
|
ALFF
大体时间：2 years post-operation
|
ALFF algorithm to calculate BLOD signals in the subfrequency band of resting state functional magnetic resonance imaging (fMRI)
|
2 years post-operation
|
|
FC
大体时间：2 years post-operation
|
functional connection between brain region of interest in the subfrequency band of resting state magnetic resonance imaging (fMRI)
|
2 years post-operation
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Lysholm
大体时间：2 years post-operation
|
Lysholm scale, which is used to measure the functional status of a patient's knee joint has a minimum value of 0 and a maximum value of 100, with the higher the score, the better the function
|
2 years post-operation
|
|
Tegner
大体时间：2 years post-operation
|
Tegner scale，which is used to measure the functional status of patients has a minimum value of 0 and a maximum value of 10, with the higher the score, the better of the function.
|
2 years post-operation
|
|
COP（center of pressure ）
大体时间：2 years post-operation
|
symmetry of center of pressure transfer path by using Plantar pressure testing system when patients are walking and running.
limb symmetry index =injury limb score/good limb score *100
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2 years post-operation
|
|
CR
大体时间：2 years post-operation
|
Hamstring Co-contraction ratio(CR) in the Single foot support phase by using the Surface electromyography when patients are walking and running.
|
2 years post-operation
|
|
single leg jump test
大体时间：2 years post-operation
|
Patient stands onhis or her leg , toe on starting line, try to jump forward and land on ipsilateral limb, measure the distance between starting line and patient's feet.
limb symmetry index =injury limb score/good limb score *100
|
2 years post-operation
|
|
6M timing single leg jump test
大体时间：2 years post-operation
|
The patient stood on his or her leg, with the toes on the starting line.
After the tester gave the command of "each in position, prepare, run", the chronograph was accurate to 0.01 seconds to start the time.
The patient's healthy limbs jump as soon as possible and stop the timing when reaching the 6m terminal.limb
symmetry index =injury limb score/good limb score *100
|
2 years post-operation
|
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。
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 (实际的)
2021年1月1日
初级完成 (预期的)
2022年12月31日
研究完成 (预期的)
2022年12月31日
研究注册日期
首次提交
2021年1月13日
首先提交符合 QC 标准的
2021年1月18日
首次发布 (实际的)
2021年1月20日
研究记录更新
最后更新发布 (实际的)
2021年1月20日
上次提交的符合 QC 标准的更新
2021年1月18日
最后验证
2021年1月1日
更多信息
与本研究相关的术语
其他研究编号
- 2020-144
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 共享支持信息类型
- 企业社会责任
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
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.