The Effect of Different Measurement-manufacturing Techniques on Load Distribution in Amputees
2020年3月27日 更新者：Marmara University
The Effect of Different Measurement-manufacturing Techniques on Stump and Soles Load Distribution in Transtibial Knee Prostheses
Alignment of the prosthesis with the stump is performed through the socket.
Good socket stump fit provides near-normal posture and weight-transfer pattern.
It also ensures that the walk is painless and low-energy.
Recently, studies have been carried out to use 3D printers in socket production.
3D method is accepted as an effective and reliable method in prosthetic socket production.
The purpose of this study is to compare the pressures distrubution in the sockets produced by conventional and 3D scanners and printers in the transtibial amputee.
研究概览
研究类型
观察性的
注册 (预期的)
30
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
-
-
-
Istanbul、火鸡、34000
- Marmara University
-
-
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 70年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
概率样本
研究人群
Unilateral transtibial amputees
描述
Inclusion Criteria:
- Being unilateral transtibial amputation
- To have enough perception level to understand and apply commands
Exclusion Criteria:
- To have orthopedic, neurological, etc. disorder other than amputation that will affect posture or gait
- The presence of pain that will affect the posture or walking pattern
- Wound / tenderness on the stump
- Visual impairment that will affect the posture or gait pattern
- Use of any assistive device (walking stick, canary, etc.) during walking
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 |
干预/治疗 |
|---|---|
|
Group 1
Unilateral transtibial amputees using conventinional manufactured socket
|
Presssure disturubition will be measured in conventional manufactured socket during walking and stairing up and down activities in unilateral transtibial amputees
|
|
Group 2
Unilateral transtibial amputees using 3D manufactured socket
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Presssure disturubition will be measured in 3D manufactured socket during walking and stairing up and down activities in unilateral transtibial amputees
|
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 |
|---|---|---|
|
Measurement of load distrubution on stump in conventional manufactured socket
大体时间：Change from load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during walking
|
Load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during walking.
|
Change from load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during walking
|
|
Measurement of load distrubution on stump in 3D manufactured socket
大体时间：Change from load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during walking
|
Load distrubution (mmHg/N/Kg) on stump will be measured with F-socket sensories during walking.
|
Change from load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during walking
|
|
Measurement of load distrubution on stump in conventional manufactured socket
大体时间：Change from load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during climbing up and down stairs.
|
Load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during climbing up and down stairs.
|
Change from load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during climbing up and down stairs.
|
|
Measurement of load distrubution on stump in 3D-manufactured socket
大体时间：Change from load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during climbing up and down stairs
|
Load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during climbing up and down stairs
|
Change from load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during climbing up and down stairs
|
|
Measurement of sole load distrubution (mmHg/N/Kg) in conventional manufactured socket
大体时间：Change from sole load distrubution (mmHg/N/Kg) will be measured with F-socket film sensories during walking
|
Sole load distrubution (mmHg/N/Kg) will be measured with F-scan sensories during walking
|
Change from sole load distrubution (mmHg/N/Kg) will be measured with F-socket film sensories during walking
|
|
Measurement of sole load distrubution (mmHg/N/Kg) in 3D-manufactured socket
大体时间：Change from sole load distrubution (mmHg/N/Kg) will be measured with F-socket film sensories during walking
|
Sole load distrubution (mmHg/N/Kg) will be measured with F-scan sensories during walking
|
Change from sole load distrubution (mmHg/N/Kg) will be measured with F-socket film sensories during walking
|
|
Measurement of sole load distrubution (mmHg/N/Kg) in conventional manufactured socket
大体时间：Change from sole load distrubution (mmHg/N/Kg) will be measured with F-socket film sensories during climbing up and down stairs
|
Sole load distrubution (mmHg/N/Kg) will be measured with F-scan sensories during climbing up and down stairs
|
Change from sole load distrubution (mmHg/N/Kg) will be measured with F-socket film sensories during climbing up and down stairs
|
|
Measurement of sole load distrubution (mmHg/N/Kg) in 3D-manufactured socket
大体时间：Change from sole load distrubution (mmHg/N/Kg) will be measured with F-socket film sensories during climbing up and down stairs
|
Sole load distrubution (mmHg/N/Kg) will be measured with F-scan sensories during climbing up and down stairs
|
Change from sole load distrubution (mmHg/N/Kg) will be measured with F-socket film sensories during climbing up and down stairs
|
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
- 研究主任：yasar tatar、Marmara University
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
- Dou P, Jia X, Suo S, Wang R, Zhang M. Pressure distribution at the stump/socket interface in transtibial amputees during walking on stairs, slope and non-flat road. Clin Biomech (Bristol, Avon). 2006 Dec;21(10):1067-73. doi: 10.1016/j.clinbiomech.2006.06.004. Epub 2006 Aug 17.
- Jia X, Suo S, Meng F, Wang R. Effects of alignment on interface pressure for transtibial amputee during walking. Disabil Rehabil Assist Technol. 2008 Nov;3(6):339-43. doi: 10.1080/17483100802044634.
- Xiaohong J, Xiaobing L, Peng D, Ming Z. The Influence of Dynamic Trans-tibial Prosthetic Alignment on Standing Plantar Foot Pressure. Conf Proc IEEE Eng Med Biol Soc. 2005;2005:6916-8. doi: 10.1109/IEMBS.2005.1616096.
- Lee VS, Solomonidis SE, Spence WD. Stump-socket interface pressure as an aid to socket design in prostheses for trans-femoral amputees--a preliminary study. Proc Inst Mech Eng H. 1997;211(2):167-80. doi: 10.1243/0954411971534287.
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)
2019年9月6日
初级完成 (预期的)
2020年4月10日
研究完成 (预期的)
2020年6月30日
研究注册日期
首次提交
2020年3月25日
首先提交符合 QC 标准的
2020年3月27日
首次发布 (实际的)
2020年3月30日
研究记录更新
最后更新发布 (实际的)
2020年3月30日
上次提交的符合 QC 标准的更新
2020年3月27日
最后验证
2019年4月1日
更多信息
与本研究相关的术语
其他研究编号
- 09.2019.359
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
未定
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不
研究美国 FDA 监管的设备产品
不
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