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临床试验/NCT05751408
NCT05751408招募中不适用

Technical Evaluation of Commercial IMUs Within Clinical Gait Analysis in Adult Patients With Neurological Disorders

Roessingh Research and Development2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年1月25日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
2
主要终点
Hip angle assessed by IMU sensors

研究概览

简要总结

A standard clinical gait analysis consists of observing walking with video (2D) or advanced equipment (VICON 3D). This 3D method provides detailed information about the gait pattern, but is time-consuming in implementation and data analysis. There are commercial 3D systems on the market that are used in healthy individuals and in sports. These so-called Inertial Measurement Units (IMUs) may also be suitable for use in the clinic. In this research protocol, the aim is to test the usability of commercial sensors and technically compare them with standard clinical 3D gait analysis in adult patients with a neurological disorder.

详细描述

Measurements will include subjects that perform routine clinical 3D gait analysis because of a clinical question related to stiff knee gait or surgical intervention of the foot. During routine clinical gait analysis, Vicon markers and EMG-measurements of specified muscles is included. IMU-sensors will be included to this routine measurements to measure accelorometer, gyroscope and magnetometer data of both feet, both upper and lower legs, the sternum and the sacrum.

研究设计

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

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

  • Subjects referred for clinical gait analysis at Roessingh Centre for Rehabilition in Enschede, the Netherlands:
  • Inclusion Criteria:
  • Disorders affecting walking, including amongst others stroke, traumatic brain injury, MS, incomplete spinal cord injury, CP, Spina Bifida, neuromuscular diseases
  • age minimum 18 years
  • Viosca score minimum 2; meaning minimal independent walking ability indoors
  • increased fall risk or increased effort of walking because of: 1) decreased stability during stance; and/or 2) decreased foot clearance during swing; and/or 3) not able to walk on bare feet because of equinovarus; and/or 4) fatigue during walking because of compansatory strategies.

排除标准

  • subjects referred for clinical gait analysis because of problems other than stiff knee gait or foot surgery
  • severe deficits in communication, memory and understanding at such a level that it would affect instructions during the measurements

结局指标

主要结局

Hip angle assessed by IMU sensors

时间窗: 1 year

IMU sensors will be used to assess knee angles (in degrees) during walking. Angles will be defined from the moment the foot hits the ground (initial contact) until the foot hits the ground again (second initial contact)

Ankle angle assessed by Vicon

时间窗: 1 year

Vicon 3D analysis will be used to assess ankle angles (in degrees) during walking. Angles will be defined from the moment the foot hits the ground (initial contact) until the foot hits the ground again (second initial contact)

Knee angle assessed by Vicon

时间窗: 1 year

Vicon 3D analysis will be used to assess knee angles (in degrees) during walking. Angles will be defined from the moment the foot hits the ground (initial contact) until the foot hits the ground again (second initial contact)

Hip angle assessed by Vicon

时间窗: 1 year

Vicon 3D analysis will be used to assess hip angles (in degrees) during walking. Angles will be defined from the moment the foot hits the ground (initial contact) until the foot hits the ground again (second initial contact)

Ankle angle assessed by IMU sensors

时间窗: 1 year

IMU sensors will be used to assess ankle angles (in degrees) during walking. Angles will be defined from the moment the foot hits the ground (initial contact) until the foot hits the ground again (second initial contact)

Knee angle assessed by IMU sensors

时间窗: 1 year

IMU sensors will be used to assess knee angles (in degrees) during walking. Angles will be defined from the moment the foot hits the ground (initial contact) until the foot hits the ground again (second initial contact)

次要结局

  • Height(at inclusion)
  • Age(at inclusion)
  • Weight(at inclusion)
  • FAC-score(at inclusion)

研究者

发起方
Roessingh Research and Development
申办方类型
Other
责任方
Sponsor

研究点 (2)

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