<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03840551</url>
  </required_header>
  <id_info>
    <org_study_id>28/18</org_study_id>
    <nct_id>NCT03840551</nct_id>
  </id_info>
  <brief_title>Definition of Biomechanical Indices Measurable During Sport Movements for the Prevention of Primary and Secondary ACL Injury</brief_title>
  <acronym>BIOS-ACL</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istituto Ortopedico Rizzoli</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Isokinetic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Istituto Ortopedico Rizzoli</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to define a set of quantitative parameters related to articular&#xD;
      biomechanics, which will be evaluated during some specific motor tasks. The goal is the&#xD;
      prevention of primary and secondary anterior cruciate ligament injury in athletes.&#xD;
&#xD;
      Specifically, the validation of a new comparative methodology of biomechanics analysis will&#xD;
      be performed, based on inertial sensors and musculoskeletal models. This way, brief but&#xD;
      exhaustive description of functional characteristics of athletes could be created and easily&#xD;
      used in ambulatory environment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 15, 2018</start_date>
  <completion_date type="Actual">October 1, 2020</completion_date>
  <primary_completion_date type="Actual">August 10, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Lower limbs angles (extracted by inertial sensors/motion capture marker-based analysis): Hip, Knee, Ankle joint angles (all in degrees °)</measure>
    <time_frame>10 months</time_frame>
    <description>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 (°)&#xD;
Hip angles (flexion/extension, ab/adduction and intra/extra rotation) in degrees (°);&#xD;
Knee angles (flexion/extension, varus/valgus and intra/extra rotation) in degrees (°);&#xD;
Ankle angles (flexion/extension, ab/adduction and intra/extra rotation) in degrees (°).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Upper limbs angles (extracted by inertial sensors/motion capture marker-based analysis): Elbow, Wrist and Shoulder joint angles (all in degrees °)</measure>
    <time_frame>10 months</time_frame>
    <description>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 (°)&#xD;
Elbow angles (flexion/extension, intra/extra rotation) in degrees (°);&#xD;
Wrist angles (flexion/extension) in degrees (°);&#xD;
Shoulder angles (flexion/extension, ab/adduction) in degrees (°).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Trunk angles (extracted by inertial sensors/motion capture marker-based analysis): Trunk sway and Trunk tilt (all in degrees °)</measure>
    <time_frame>10 months</time_frame>
    <description>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 (°)&#xD;
Trunk sway in degrees (°) ;&#xD;
Trunk tilt in degrees (°) .</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Trunk velocity (in m/s) extracted by inertial sensors/motion capture marker-based analysis</measure>
    <time_frame>10 months</time_frame>
    <description>Trunk velocity in all 3 directions (x,y,z). Expressed in m/s</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Trunk acceleration (in m/s^2) extracted by inertial sensors/motion capture marker-based analysis</measure>
    <time_frame>10 months</time_frame>
    <description>Trunk Acceleration in all 3 directions (x,y,z). Expressed in m/s^2</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Sport Injury</condition>
  <condition>Anterior Cruciate Ligament Injury</condition>
  <condition>Biomechanical; Lesion</condition>
  <arm_group>
    <arm_group_label>Subjects</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>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)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Biomechanical analysis with inertial sensors (XSENS) and motion capture (BTS)</intervention_name>
    <description>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.</description>
    <arm_group_label>Subjects</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy subjects, men of women, 18 years old minimum and 50 maximum, which read and&#xD;
             signed the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  evidence of any kind of musculoskeletal disease or impairment&#xD;
&#xD;
          -  evidence of past surgical intervention to either lower or upper limbs&#xD;
&#xD;
          -  age out of the inclusion range&#xD;
&#xD;
          -  cardiac or pulmonary diseases&#xD;
&#xD;
          -  inability to read and sign the informed consent&#xD;
&#xD;
          -  inability to perform the motor tasks required&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stefano Mr Zaffagnini, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Istituto Ortopedico Rizzoli</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Istituto Ortopedico Rizzoli</name>
      <address>
        <city>Bologna</city>
        <state>BO</state>
        <zip>40136</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>February 6, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>February 9, 2021</last_update_submitted>
  <last_update_submitted_qc>February 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istituto Ortopedico Rizzoli</investigator_affiliation>
    <investigator_full_name>Stefano Zaffagnini</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>injury prevention</keyword>
  <keyword>biomechanical indices</keyword>
  <keyword>inertial sensors</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
    <mesh_term>Anterior Cruciate Ligament Injuries</mesh_term>
    <mesh_term>Athletic Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03840551
org study id: 28/18
nct id: NCT03840551
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Lower limbs angles (extracted by inertial sensors/motion capture marker-based analysis): Hip, Knee, Ankle joint angles (all in degrees °)
time frame: 10 months
description: 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 (°).
measure: Upper limbs angles (extracted by inertial sensors/motion capture marker-based analysis): Elbow, Wrist and Shoulder joint angles (all in degrees °)
time frame: 10 months
description: 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 (°).
measure: Trunk angles (extracted by inertial sensors/motion capture marker-based analysis): Trunk sway and Trunk tilt (all in degrees °)
time frame: 10 months
description: 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 (°) .
measure: Trunk velocity (in m/s) extracted by inertial sensors/motion capture marker-based analysis
time frame: 10 months
description: Trunk velocity in all 3 directions (x,y,z). Expressed in m/s
measure: Trunk acceleration (in m/s^2) extracted by inertial sensors/motion capture marker-based analysis
time frame: 10 months
description: Trunk Acceleration in all 3 directions (x,y,z). Expressed in m/s^2
arm group label: Subjects
arm group type: Other
description: 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)
intervention type: Other
intervention name: Biomechanical analysis with inertial sensors (XSENS) and motion capture (BTS)
description: 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.
arm group label: Subjects
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Stefano Mr Zaffagnini, Professor
role: Principal Investigator
affiliation: Istituto Ortopedico Rizzoli
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Istituto Ortopedico Rizzoli
investigator full name: Stefano Zaffagnini
investigator title: Professor
mesh term: Wounds and Injuries
mesh term: Anterior Cruciate Ligament Injuries
mesh term: Athletic Injuries
sharing ipd: Undecided