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

Sponsor
Istituto Ortopedico Rizzoli (Other)
Overall Status
Completed
CT.gov ID
NCT03840551
Collaborator
Isokinetic (Other)
34
1
1
21.6
1.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Biomechanical analysis with inertial sensors (XSENS) and motion capture (BTS)
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
34 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
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
Actual Study Start Date :
Dec 15, 2018
Actual Primary Completion Date :
Aug 10, 2019
Actual Study Completion Date :
Oct 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Other: 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)

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.

Outcome Measures

Primary Outcome Measures

  1. 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 (°).

  2. 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 (°).

  3. 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 (°) .

  4. 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

  5. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istituto Ortopedico Rizzoli Bologna BO Italy 40136

Sponsors and Collaborators

  • Istituto Ortopedico Rizzoli
  • Isokinetic

Investigators

  • Principal Investigator: Stefano Mr Zaffagnini, Professor, Istituto Ortopedico Rizzoli

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Stefano Zaffagnini, Professor, Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier:
NCT03840551
Other Study ID Numbers:
  • 28/18
First Posted:
Feb 15, 2019
Last Update Posted:
Feb 10, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Stefano Zaffagnini, Professor, Istituto Ortopedico Rizzoli
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 10, 2021