Definition of Biomechanical Indices Measurable During Sport Movements for the Prevention of Primary and Secondary ACL Injury

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 10, 2019

Interventions

  • Other: Biomechanical analysis with inertial sensors (XSENS) and motion capture (BTS)
    • The kinematics of lower limbs, trunk and upper limbs will be calculated both with inertial sensors (XSENS) and motion capture marker-based system (BTS ). Inertial sensors and markers will be placed on the subjects clothes and on the skin (totally non-invasive) to identify body segments. Then subjects will perform their motor tasks normally. Lately, through the data post-processing, the kinematics evaluated with both the systems will be used to describe how well the task is performed in terms of ACL prevention, through derived biomechanical parameters.

Arms, Groups and Cohorts

  • Other: Subjects
    • Subjects involved are required to do some specific motor tasks, commonly found in all main sports. Evaluated with inertial sensors (XSENS) and marker-based motion capture (BTS)

Clinical Trial Outcome Measures

Primary Measures

  • Lower limbs angles (extracted by inertial sensors/motion capture marker-based analysis): Hip, Knee, Ankle joint angles (all in degrees °)
    • Time Frame: 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 °)
    • Time Frame: 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 °)
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 10 months
    • Trunk Acceleration in all 3 directions (x,y,z). Expressed in m/s^2

Participating in This Clinical Trial

Inclusion Criteria

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

  • 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Istituto Ortopedico Rizzoli
  • Collaborator
    • Isokinetic
  • Provider of Information About this Clinical Study
    • Principal Investigator: Stefano Zaffagnini, Professor – Istituto Ortopedico Rizzoli
  • Overall Official(s)
    • Stefano Mr Zaffagnini, Professor, Principal Investigator, Istituto Ortopedico Rizzoli

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