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

NCT ID: NCT03840551

Last Updated: 2021-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-15
• Study Completion Date: 2020-10-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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)

Group Type: OTHER

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

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Isokinetic

UNKNOWN

Sponsor Role: collaborator

Istituto Ortopedico Rizzoli

OTHER

Sponsor Role: lead

Responsible Party

Stefano Zaffagnini

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stefano Mr Zaffagnini, Professor

Role: PRINCIPAL_INVESTIGATOR

Istituto Ortopedico Rizzoli

Locations

Istituto Ortopedico Rizzoli

Bologna, BO, Italy

Countries

Italy

Other Identifiers

28/18

Identifier Type: -

Identifier Source: org_study_id