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临床试验/NCT05104645
NCT05104645招募中不适用

Analysis of the Psychometric Properties of Kinematic Parameters of Locomotion Measured by Inertial Units. Validation in Healthy Volunteers and Stroke Patients

Centre Hospitalier Universitaire Dijon1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年9月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Walking speed

研究概览

简要总结

Stroke is the leading cause of acquired disability in adults in France, and more than 500,000 French people are currently living with the after-effects. Hemiparesis, which is a partial deficit of motor or muscular control affecting the right or left half of the body, is the most frequent motor disorder after a stroke. Currently, the management and treatment of stroke patients consists of a combination of pharmacological treatments (drugs, botulinum toxin, etc.), the fitting of devices (orthoses, etc.) and rehabilitation (physical therapy, adapted physical activity, occupational therapy, etc.). According to the French National Authority for Health, motor rehabilitation after a stroke must meet 3 criteria: early, intensive and continuous. Functional evaluations (with validated measurement scales or analysis of locomotor activities) make it possible to monitor rehabilitation and to verify that the intensity is adapted to the patient's needs. To date, technological advances have yielded numerous gait analysis devices, ranging from motion capture platforms to inertial measurement units (IMU) and the use of motion platforms with integrated sensors. Different systems embedding an IMU on the foot, for example, answer these problems of analysis of walking in real situation. The IMUs record the movements and orientation of the foot in space; the data are then processed by algorithms to recognize the walking steps and calculate the spatiotemporal locomotion parameters. Additional IMUs positioned on the body can be added to this system in order to access a more precise analysis of locomotion, in particular by calculating the movements of the various joints of the lower limb. The validation of systems integrating IMUs must be done according to a precise method widely documented by the COSMIN recommendations (COnsensus-based Standards for the selection of health Measurement INstruments). This project will be carried out in two stages, the first of which will evaluate the safety and psychometric properties of the spatiotemporal parameters of the IMU devices in healthy subjects. If these properties (safety, reproducibility and validity) are considered to be in conformity, the second phase will be initiated. These same parameters will be evaluated during the rehabilitation of a cohort of patients who have suffered a stroke.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
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

入选标准

  • Healthy volunteers:
  • Person who has given oral consent
  • man or woman 18 years or older
  • a person who is able to understand simple orders, instructions for locomotion
  • person living within a maximum radius of 50 km from the investigation site
  • Patients (in addition to the above):
  • persons who have had a stroke of any origin in the last 6 months
  • person included in a rehabilitation protocol

排除标准

  • persons who are not affiliated to national health insurance
  • persons subject to a legal protection measure (guardianship)
  • persons who are subject to a legal protection measure
  • pregnant women
  • adult unable to express consent
  • subject with a disarticulated hip
  • Subjects with diseases or disabilities that have an impact on walking other than those related to the stroke.

研究组 & 干预措施

Healthy Volunteering

Active Comparator

干预措施: Analysis of the walk (Other)

Patients after a Stroke

Experimental

干预措施: Analysis of the walk (Other)

Healthy Volunteering

Active Comparator

干预措施: Analysis of the race (Other)

Healthy Volunteering

Active Comparator

干预措施: Unipodal and bipodal jumps on flat ground (Other)

结局指标

主要结局

Walking speed

时间窗: Healthy volunteers: Change from baseline at 20 days after inclusion

Walking speed

时间窗: Patients: Change from baseline at week 6

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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