跳至主要内容
临床试验/NCT06138925
NCT06138925招募中不适用

Analysis of the Psychometric Properties of Kinematic Parameters of Locomotion Measured by Inertial Measurement Units. Validation in Healthy Children and Children with Cerebral Palsy

Centre Hospitalier Universitaire Dijon2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年1月31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
80
试验地点
2
主要终点
Walking speed

研究概览

简要总结

Cerebral palsy (CP) is currently one of the major causes of disability in children. The presence of various disorders (muscle stiffness, architectural bone defects, spasticity) leads to a number of functional impacts, including severe impairment of mobility, particularly locomotion. Locomotion can be assessed using a motion capture system that enables 3-dimensional analysis, in order to help make treatment decisions and quantify them. Although these systems are currently considered to be the gold standard, the fact remains that they cause a certain amount of patient fatigue (long set-up times) and that walking is assessed in a laboratory rather than in real life.

Today, technological advances have brought to the fore other gait analysis devices, such as inertial measurement units (IMUs). Various systems incorporating IMUs in the feet, for example, respond to these problems of analysing walking in real-life situations. The IMUs record the movements and orientation of the foot in space; the data is then processed by algorithms to recognise walking steps and calculate the spatio-temporal parameters of locomotion. Additional IMUs positioned on the body can be grafted onto this system to provide a more precise analysis of locomotion, in particular by calculating the movements of the various joints of the lower limb. However, before such devices can be used in a pathological paediatric population, they must be validated in a healthy population. This validation must be conducted using a precise method that has been widely documented in the COSMIN recommendations (Consensus-based Standards for the selection of health Measurement Instruments). The first stage will assess the safety of the IMU devices in a healthy paediatric population, and the validity of the spatio-temporal parameters. If these properties are deemed to be compliant, these same parameters will be assessed in a paediatric population with cerebral palsy in the second stage.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
7 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children who have given their consent and whose legal representatives have given their consent
  • Age between 7 and 17 years,
  • Children able to understand simple commands and instructions.
  • Children living within a maximum radius of 50 km of the investigation site.
  • Child covered by national health insurance.
  • PATIENT GROUP (IN ADDITION TO THOSE ABOVE)
  • Children with proven cerebral palsy resulting in locomotor impairment but able to move around without technical aids (cane, wheelchair).
  • Child covered by national health insurance.

排除标准

  • Children with a condition other than cerebral palsy that affects their ability to walk.
  • Child subject to a measure of legal protection
  • A child unable to give consent
  • Pregnant, parturient or breast-feeding participant

结局指标

主要结局

Walking speed

时间窗: During the study visit

participants' walking speed measured jointly by an IMU system in the shoe and a 3D locomotion analysis system

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 (2)

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