跳至主要内容
临床试验/NCT04030650
NCT04030650招募中不适用

Study of Locomotor Expectations for Ascending/Descending Slope and Stairs in Patients With Limb Amputations

Centre Hospitalier Universitaire Dijon1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2019年9月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
70
试验地点
1
主要终点
The error rate of the algorithm

研究概览

简要总结

Patients with lower limb amputations are equipped with prostheses that can be mechanical and/or electronic. These prostheses can be mono-articular (only the ankle) or bi-articular (knee and ankle for example). For amputee patients, situations that may seem trivial, such as climbing and descending stairs, become complex. Thus during the descent of stairs, an unamputated person will slow down the descent by contracting the thigh muscles, which are obviously lacking in the amputee patient. Current prostheses, known as "intelligent" (or "microprocessor") prostheses, make it possible to adjust the locomotion only once the first step has been taken and to assist the patient during ascent/descent situations on slopes and stairs. The next technological challenge in the development of lower limb equipment is to be able to anticipate these complex environmental situations, in order to secure and facilitate movement even before the obstacle is crossed or the terrain changed.

This project plans to use the locomotor expectations commonly made during walking as a means of regulating the locomotor pattern. We believe that these expectations will depend on the situation, i.e. a particular anticipation when climbing or descending a slope, or when approaching a staircase, etc. To understand and describe these locomotor expectations, we plan to use recent techniques called supervised machine learning. These will make it possible to classify locomotor behaviour when walking on a slope or stairs. In the second phase, we would like to describe precisely the characteristics of the movements of the joints, and of the muscles during these adaptations. The final objective of this work is to create an autonomous sensor system to control the anticipatory behaviour of a lower limb prosthesis.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

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

入选标准

  • Healthy volunteers:
  • person who has given oral consent
  • male or female adult
  • person being able to understand simple orders, locomotion instructions
  • Lower limb amputee patients:
  • person who has given oral consent
  • male or female adult
  • patient with unilateral major lower limb amputation of any origin (traumatic, vascular, infectious, congenital or neoplastic) with definitive equipment used routinely for at least 3 months.
  • person able to understand simple orders, locomotion instructions

排除标准

  • person not affiliated or not benefiting from a heath insurance system
  • person subject to a legal protection measure (curatorship, guardianship)
  • person with a legal guardian
  • pregnant or breastfeeding woman
  • adult unable to consent
  • person with a dislocated hip
  • subject with conditions or disabilities other than amputation that affect walking

结局指标

主要结局

The error rate of the algorithm

时间窗: 2 months

The error rate of the algorithm for predicting the situation encountered in the next step

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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