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Completed

NCT Number: NCT03840551

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

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.

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Key information

Conditions

Sport Injury Anterior Cruciate Ligament Injuries Anterior Cruciate Ligament Injury Biomechanical; Lesion Knee Injuries Leg Injuries Wounds and Injuries

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Ortopedico Rizzoli

Bologna, BO, 40136, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biomechanical analysis with inertial sensors (XSENS) and motion capture (BTS)

Other

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.

Primary outcomes

  1. 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 (°).

  2. 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 (°).

  3. 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 (°) .

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Collaborators

  • Isokinetic

Registry information

Official study title

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

Acronym: BIOS-ACL

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Feb 15, 2019
Registry last updated
Feb 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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