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临床试验/NCT06586762
NCT06586762已完成不适用

Symmetry in Sagittal Knee Kinematics of Transtibial Amputee: Daily-Use Prosthesis Vs Running-Specific Prosthesis

Baskent University1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2024年9月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
1
主要终点
Sagital Knee Kinematics of intact and residual knee with Daily-Use Prosthesis (DUP)

研究概览

简要总结

Introduction: People with transtibial amputation often suffer musculoskeletal deformities in the form of knee osteoarthritis or osteophytosis due to asymmetric movement patterns and often complain of associated symptoms. Therefore, this study aims to evaluate the sagittal kinematics of the intact and residual knee in the use of Running-Specific Prostheses (RSP), which are increasing in popularity and use among amputees.

Materials and Methods: Participants will be video recorded in the sagittal plane to convert knee flexion motion into angles for the amputee and intact knee and to make measurements using the software's virtual goniometer. Recordings will be taken under the following two conditions: 1) walking at a self-selected walking speed with a Daily Use Prosthesis (DUP); 2) Slow running with RSP. The peak flexion during the swing phase and the initial flexion during the first contact of the stance phase will be recorded as angles in both conditions.

研究设计

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

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • body mass index below 30 kg/m2,
  • Having unilateral transtibial amputation,
  • Being at K4 functional level,
  • Having an existing running blade,
  • Being able to use RSP integrating it into their DUP,
  • Having no self-reported problems with the residual limb or prosthesis, pain or skin lesions,
  • Being active recreational runners (at least once a week) for at least 1 and up to 3 months without injury.

排除标准

  • Having a history of knee surgery or contracture in the intact/amputee knee.

结局指标

主要结局

Sagital Knee Kinematics of intact and residual knee with Daily-Use Prosthesis (DUP)

时间窗: Baseline

In the sagittal plan, knee flexion motion for the amputated and intact knee will be recorded during walking at self-selected walking speed with Daily-Use Prosthesis (DUP). The peak flexion during swing phase and the initial flexion during initial contact of the stance phase were recorded as angle.

Sagital Knee Kinematics of intact and residual knee with Running-Specific Prosthesis (RSP)

时间窗: Same day as baseline; 10 minutes after RSP integrated to prosthesis.

In the sagittal plan, knee flexion motion for the amputated and intact knee will be recorded during slow-running (jogging) with Running-Specific Prosthesis (RSP). The peak flexion during swing phase and the initial flexion during initial contact of the stance phase were recorded as angle.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Senay Cerezci Duygu

Asst. Prof.

Istanbul Saglik Bilimleri University

研究点 (1)

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