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

NCT03840551 | Completed

• 1 other identifier: 28/18
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sport Injury; Anterior Cruciate Ligament Injury; Biomechanical; Lesion

Keywords

injury prevention; biomechanical indices; inertial sensors

Outcome Measures

Primary Outcomes (5)

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

  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 (°).

  10 months

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

  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 (°).

  10 months

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

  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 (°) .

  10 months

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

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

  10 months

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

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

  10 months

Study Arms (1)

Subjects

OTHER

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)

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

Interventions

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.

Subjects

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead
• Isokinetic: collaborator

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, BO, 40136, Italy

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Motion Capture

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Diagnostic Tests, Routine; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Stefano Mr Zaffagnini, Professor

  Istituto Ortopedico Rizzoli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 6, 2019
• First Posted: February 15, 2019
• Study Start: December 15, 2018
• Primary Completion: August 10, 2019
• Study Completion: October 1, 2020
• Last Updated: February 10, 2021

Record last verified: 2021-02

Locations

IT (1)