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临床试验/NCT04326712
NCT04326712Unknown不适用

The Effect of Different Measurement-manufacturing Techniques on Stump and Soles Load Distribution in Transtibial Knee Prostheses

Marmara University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年9月6日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
Measurement of load distrubution on stump in conventional manufactured socket

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being unilateral transtibial amputation
  • To have enough perception level to understand and apply commands

排除标准

  • 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

结局指标

主要结局

Measurement of load distrubution on stump in conventional manufactured socket

时间窗: 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.

Measurement of load distrubution on stump in 3D-manufactured socket

时间窗: 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

Measurement of load distrubution on stump in 3D manufactured socket

时间窗: 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.

Measurement of sole load distrubution (mmHg/N/Kg) in conventional manufactured socket

时间窗: 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

Measurement of sole load distrubution (mmHg/N/Kg) in 3D-manufactured socket

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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