Back to resultsDefinition of Biomechanical Indices Measurable During Sport Movements for the Prevention of Primary and Secondary ACL Injury (BIOS-ACL)
Primary Purpose
Sport Injury, Anterior Cruciate Ligament Injury, Biomechanical; Lesion
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Biomechanical analysis with inertial sensors (XSENS) and motion capture (BTS)
Sponsored by
About this trial
This is an interventional health services research trial for Sport Injury focused on measuring injury prevention, biomechanical indices, inertial sensors
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
Sites / Locations
- Istituto Ortopedico Rizzoli
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Subjects
Arm 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)
Outcomes
Primary Outcome Measures
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 (°).
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 (°).
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 (°) .
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03840551
First Posted
February 6, 2019
Last Updated
February 9, 2021
Sponsor
Istituto Ortopedico Rizzoli
Collaborators
Isokinetic
1. Study Identification
Unique Protocol Identification Number
NCT03840551
Brief Title
Definition of Biomechanical Indices Measurable During Sport Movements for the Prevention of Primary and Secondary ACL Injury
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
December 15, 2018 (Actual)
Primary Completion Date
August 10, 2019 (Actual)
Study Completion Date
October 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istituto Ortopedico Rizzoli
Collaborators
Isokinetic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sport Injury, Anterior Cruciate Ligament Injury, Biomechanical; Lesion
Keywords
injury prevention, biomechanical indices, inertial sensors
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Subjects
Arm Type
Other
Arm 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(s)
Biomechanical analysis with inertial sensors (XSENS) and motion capture (BTS)
Intervention 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.
Primary Outcome Measure Information:
Title
Lower limbs angles (extracted by inertial sensors/motion capture marker-based analysis): Hip, Knee, Ankle joint angles (all in degrees °)
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 (°).
Time Frame
10 months
Title
Upper limbs angles (extracted by inertial sensors/motion capture marker-based analysis): Elbow, Wrist and Shoulder joint angles (all in degrees °)
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 (°).
Time Frame
10 months
Title
Trunk angles (extracted by inertial sensors/motion capture marker-based analysis): Trunk sway and Trunk tilt (all in degrees °)
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 (°) .
Time Frame
10 months
Title
Trunk velocity (in m/s) extracted by inertial sensors/motion capture marker-based analysis
Description
Trunk velocity in all 3 directions (x,y,z). Expressed in m/s
Time Frame
10 months
Title
Trunk acceleration (in m/s^2) extracted by inertial sensors/motion capture marker-based analysis
Description
Trunk Acceleration in all 3 directions (x,y,z). Expressed in m/s^2
Time Frame
10 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefano Mr Zaffagnini, Professor
Organizational Affiliation
Istituto Ortopedico Rizzoli
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituto Ortopedico Rizzoli
City
Bologna
State/Province
BO
ZIP/Postal Code
40136
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Definition of Biomechanical Indices Measurable During Sport Movements for the Prevention of Primary and Secondary ACL Injury
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