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临床试验/NCT02234505
NCT02234505已完成不适用

Physiologic Range of Step-by-step Variations in Lower Limb Prosthesis Forces

University of Pittsburgh1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2014年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
1
主要终点
Step-by-step variability

研究概览

简要总结

In human gait there is a certain amount of variation between steps; some considered physiological and owed to variations in environment or posture, and some severe enough to be indicative of gait instabilities that may lead to stumbling and falling. In users of lower limb prosthetics, such gait instabilities are of especially great interest.

The study investigates the correlation between socket alignment quality and gait step-by-step variability in users of trans-tibial-prosthetics. It is hypothesized that a clearly defined range of step-by-step variability exists, and that therefore step-by-step variability is suitable as an outcome variable for the assessment of socket alignment.

A sample of ten persons with trans-tibial amputation will be recruited for this pilot study. Subjects will be asked to walk on different natural surfaces while the socket alignment is successively perturbed. Step-by-step variations in horizontal ground reaction forces and torsional moments will be measured and statistically compared.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • •activity classification of K2 to K4
  • •experience in prosthesis use of at least one year
  • •stated ability to walk pain free for at least 30 minutes

排除标准

  • •age of less than 18 years
  • •acute or ongoing residual limb pain
  • •use of a prosthesis that is not suitable for installation of the load cell (e.g. is too short, or has non-removable cosmesis)

研究组 & 干预措施

Trans-tibial prosthesis users

Experimental

prosthetic alignment perturbation

干预措施: Prosthetic alignment perturbation (Procedure)

结局指标

主要结局

Step-by-step variability

时间窗: 2 hours

Peak horizontal ground reaction force (Fx and Fy) as well as peak axial torsion moment (Mz) will be extracted for 10 consecutive intermediary steps for each testing condition. Total range in Newtons over the 10 step sample, as well as maximal difference between consecutive steps in Newtons and percent will be reported for statistical analysis.

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

Goeran Fiedler

Assistant Professor

University of Pittsburgh

研究点 (1)

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