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

Sport Injury Clinical Trial

— BIOS-ACL  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03840551
• Other study ID #: 28/18
• Status: Completed
• Phase: N/A
• Start date: December 15, 2018
• Est. completion date: October 1, 2020

Study information

• Verified date: February 2021
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: October 1, 2020
• Est. primary completion date: August 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Anterior Cruciate Ligament Injury
• Athletic Injuries
• Biomechanical; Lesion
• Sport Injury
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Rizzoli	Bologna	BO

Sponsors (2)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli	Isokinetic

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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