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临床试验/NCT03840551
NCT03840551已完成不适用

Definition of a Set of Biomechanical Indices Non-invasively Measurable During Basic Sport Movements Test Analysis Aimed to the Prevention of Primary and Secondary Anterior Cruciate Ligament Injury

Istituto Ortopedico Rizzoli2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2018年12月15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
34
试验地点
2
主要终点
Lower limbs angles (extracted by inertial sensors/motion capture marker-based analysis): Hip, Knee, Ankle joint angles (all in degrees °)

研究概览

简要总结

The aim of the study is to define a set of quantitative parameters related to articular biomechanics, which will be evaluated during some specific motor tasks. The goal is the prevention of primary and secondary anterior cruciate ligament injury in athletes.

Specifically, the validation of a new comparative methodology of biomechanics analysis will be performed, based on inertial sensors and musculoskeletal models. This way, brief but exhaustive description of functional characteristics of athletes could be created and easily used in ambulatory environment.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy subjects, men of women, 18 years old minimum and 50 maximum, which read and signed the informed consent

排除标准

  • evidence of any kind of musculoskeletal disease or impairment
  • evidence of past surgical intervention to either lower or upper limbs
  • age out of the inclusion range
  • cardiac or pulmonary diseases
  • inability to read and sign the informed consent
  • inability to perform the motor tasks required

结局指标

主要结局

Lower limbs angles (extracted by inertial sensors/motion capture marker-based analysis): Hip, Knee, Ankle joint angles (all in degrees °)

时间窗: 10 months

These quantitative parameters are the output of the inertial sensor and marker-based motion capture dedicated softwares, and will be then post processed and analyzed to find the range of motion, the maximum and the minimum angles for each joint. Every outcome angle is expressed in degrees (°) * Hip angles (flexion/extension, ab/adduction and intra/extra rotation) in degrees (°); * Knee angles (flexion/extension, varus/valgus and intra/extra rotation) in degrees (°); * Ankle angles (flexion/extension, ab/adduction and intra/extra rotation) in degrees (°).

Upper limbs angles (extracted by inertial sensors/motion capture marker-based analysis): Elbow, Wrist and Shoulder joint angles (all in degrees °)

时间窗: 10 months

These quantitative parameters are the output of the inertial sensor and marker-based motion capture dedicated softwares, and will be then post processed and analyzed to find the range of motion, the maximum and the minimum angles for each joint, and the interaction with lower limbs joint angles. Every outcome angle is expressed in degrees (°) * Elbow angles (flexion/extension, intra/extra rotation) in degrees (°); * Wrist angles (flexion/extension) in degrees (°); * Shoulder angles (flexion/extension, ab/adduction) in degrees (°).

Trunk angles (extracted by inertial sensors/motion capture marker-based analysis): Trunk sway and Trunk tilt (all in degrees °)

时间窗: 10 months

These quantitative parameters are the output of the inertial sensor and marker-based motion capture dedicated softwares, and will be then post processed and analyzed to find the range of motion, the maximum and the minimum angles for each joint, and the interaction with lower limbs joint angles. Every outcome angle is expressed in degrees (°) * Trunk sway in degrees (°) ; * Trunk tilt in degrees (°) .

Trunk velocity (in m/s) extracted by inertial sensors/motion capture marker-based analysis

时间窗: 10 months

Trunk velocity in all 3 directions (x,y,z). Expressed in m/s

Trunk acceleration (in m/s^2) extracted by inertial sensors/motion capture marker-based analysis

时间窗: 10 months

Trunk Acceleration in all 3 directions (x,y,z). Expressed in m/s\^2

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stefano Zaffagnini

Professor

Istituto Ortopedico Rizzoli

研究点 (2)

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