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

Not Applicable

Completed

• Conditions: Anterior Cruciate Ligament Injury; Biomechanical; Lesion; Sport Injury
• Interventions: Other: Biomechanical analysis with inertial sensors (XSENS) and motion capture (BTS)

• Registration Number: NCT03840551
• Lead Sponsor: Istituto Ortopedico Rizzoli

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-15
• Study First Submitted: 2019-02-06
• Study First Submitted QC: 2019-02-12
• Study First Posted: 2019-02-15
• Primary Completion: 2019-08-10
• Study Completion: 2020-10-01
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-09
• Last Update Posted: 2021-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subjects	Biomechanical analysis with inertial sensors (XSENS) and motion capture (BTS)	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)

Primary Outcome Measures

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

Trial Locations

Locations (1)

Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, BO, Italy