跳至主要内容
临床试验/NCT03260530
NCT03260530已完成不适用

Overall Functional Evaluation After Amputation of the Lower Limb; Locomotion, Energy Efficiency and Strategies to Adapt to the Prosthesis

Centre Hospitalier Universitaire Dijon1 个研究点 分布在 1 个国家实际入组 26 人开始时间: 2017年5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
26
试验地点
1
主要终点
Evolution of self-selected gait speed test, before and after the change or modification of the prosthesis

研究概览

简要总结

It appears necessary to confront the reality of the contribution of technological progress in the creation of prostheses with the specific features of lower limb amputees. These contributions must be clearly identified in their different functional dimensions. This justifies a quantitative approach to the locomotor abilities of these patients, with regard to bioenergy parameters (consumption of oxygen while walking) and motor biomechanical parameters (quantified analysis of movement), so as to measure the real impact of the proposed prosthesis technology, as a complement to classical qualitative approaches.

In this context, Dijon CHU, thanks to its Technological Investigation Platform (PIT, CIC 1432), and the company PROTEOR established a research partnership aiming to:

  • Refine the indications for the prescription of new products, by ensuring that they correspond to the profiles of the patients concerned and their true needs,
  • Study the underlying adaptive mechanisms, and establish new recommendations for their use, depending on the profiles of the users,
  • And ultimately, better evaluate, in a more rigorous and systematic manner, the prostheses available on the market.

The research protocol presented in this document aims to provide a framework for part of the explorations that will be conducted in the context of this partnership. Lower-limb amputees who will be evaluated in this research will wear these prostheses (foot and/or knee prostheses), which bear the CE logo, and thus present all of the safety and performance conditions required for their use by these patients (prostheses destined for usual prescriptions), the objective of the study was not to evaluate the prostheses as such, but to explore and quantify the impact of these prostheses and their eventual modifications on the locomotor abilities of the patients concerned.

The investigations will be conducted using non-invasive evaluation tools available on the PIT platform, with no modification in the usual management of these voluntary patients.

研究设计

研究类型
观察性
观察模型
队列研究
时间视角
前瞻性

入排标准

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

入选标准

  • Patients able to understand simple instructions, the fitting instructions and to provide informed consent
  • Man or woman aged > 18 years)
  • Lower-limb amputee, transtibial or transfemoral amputation

排除标准

  • Adult under guardianship
  • Subject without national insurance cover
  • Pregnant or breast-feeding women
  • Patients with hip desarticulation
  • Subjects presenting severe associated diseases affecting gait

结局指标

主要结局

Evolution of self-selected gait speed test, before and after the change or modification of the prosthesis

时间窗: 12 months

次要结局

未报告次要终点

研究者

申办方类型
其他
责任方
申办方

研究点 (1)

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标识符

NCT 编号
NCT03260530
其他研究编号
CASILLAS PROTEOR 2016

日期

首次提交
(9年前)
首次发布
(9年前)
主要完成日期
(3年前)
研究完成日期
(3年前)
最近核实
最近更新
(2年前)

监管与共享

FDA 监管药物
否
是否有结果
否

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