Sport InjuryBIOS-ACLNCT03840551
Definition of Biomechanical Indices Measurable During Sport Movements for the Prevention of Primary and Secondary ACL Injury
A study testing Biomechanical analysis with inertial sensors (XSENS) and motion capture (BTS) in people with Sport Injury and Anterior Cruciate Ligament Injury, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Sport Injury, Anterior Cruciate Ligament Injury, Biomechanical; Lesion
- What is being tested?
- Biomechanical analysis with inertial sensors (XSENS) and motion capture (BTS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteItaly
- Study dates
- 15 Dec 2018to 1 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects, men of women, 18 years old minimum and 50 maximum, which read and signed the informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- Biomechanical analysis with inertial sensors (XSENS) and motion capture (BTS)
- Keywords
- injury prevention, biomechanical indices, inertial sensors
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomechanical analysis with inertial sensors (XSENS) and motion capture (BTS)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Subjects | Other | 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) Receives: Other: Biomechanical analysis with inertial sensors (XSENS) and motion capture (BTS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (°).
Measured: 10 months
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 (°).
Measured: 10 months
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 (°) .
Measured: 10 months
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
Measured: 10 months
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
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start15 Dec 2018
- Primary completion10 Aug 2019
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sport InjuryStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Collaborators
- Isokinetic
- Responsible party
- Principal investigator, Stefano Zaffagnini, Istituto Ortopedico Rizzoli
- Investigators
- Stefano Mr Zaffagnini, Professor, Principal investigator, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03840551
- Sponsor's protocol ID
- 28/18
- Acronym
- BIOS-ACL
- Status last verified
- Feb 2021
- First submitted
- 6 Feb 2019
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03840551
- Acronym / sponsor ID
- BIOS-ACL / 28/18
- Keywords
- injury prevention, biomechanical indices, inertial sensors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Collaborators
- Isokinetic
- Study start
- 15 Dec 2018 (actual)
- Primary completion
- 10 Aug 2019 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects | Other | Other: 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) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy subjects, men of women, 18 years old minimum and 50 maximum, which read and signed the informed consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Subjects |
Primary outcome
Lower limbs angles (extracted by inertial sensors/motion capture marker-based analysis): Hip, Knee, Ankle joint angles (all in degrees °)
Time frame: 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 °)
Time frame: 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 °)
Time frame: 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 velocity (in m/s) extracted by inertial sensors/motion capture marker-based analysis
Time frame: 10 months
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
Time frame: 10 months
Trunk Acceleration in all 3 directions (x,y,z). Expressed in m/s^2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefano Mr Zaffagnini, Professor principal investigator
Istituto Ortopedico Rizzoli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biomechanical analysis with inertial sensors (XSENS) and motion capture (BTS) in people with Sport Injury and Anterior Cruciate Ligament Injury, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2021.