HealthyNCT05091502
Personalised Modeling and Simulation Procedures for the Differential Diagnosis of Dynapenia: a Study on Healthy Volunteers
A study testing Personalised musculoskeletal modeling in people with Healthy, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
The ForceLoss study aims to develop personalised modeling and simulation procedures to enable the differential diagnosis for the loss of muscle force, namely dynapenia. Dynapenia can be caused by diffuse or selective sarcopenia, lack of activation, or improper motor control. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Personalised musculoskeletal modeling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 2 Sep 2022to 11 Nov 2022
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) between 15 and 30 kg / m²
Who cannot join
- Neurological, rheumatic or tumoral diseases;
- Pathologies or physical conditions incompatible with the use of magnetic resonance imaging and electrostimulation (i.e., active and passive implanted biomedical devices, epilepsy, severe venous insufficiency in the lower limbs, pregnancy);
- Previous interventions or traumas to the joints of the lower limb.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ForceLoss: Part I - Healthy Volunteers. Development and Validation of Methods to Generate Personalised Models for the Differential Diagnosis of the Loss of Muscle Force
The ForceLoss study aims to develop personalised modeling and simulation procedures to enable the differential diagnosis for the loss of muscle force, namely dynapenia. Dynapenia can be caused by diffuse or selective sarcopenia, lack of activation, or improper motor control. Each of these causes requires different interventions, but a reliable differential diagnosis is currently impossible. While instrumental methods can provide information on each of these possible causes, it is left to the experience of the single clinician to integrate such information into a complete diagnostic picture. But an accurate diagnosis for dynapenia is important in a number of pathologies, including neurological diseases, age-related frailty, diabetes, and orthopaedic conditions. The hypothesis is that the use of a mechanistic, subject-specific model of maximum isometric knee extension, informed by a number of instrumental information can provide a robust differential diagnosis of dynapenia.
In this preliminary study, on healthy volunteers, the investigators will develop and optimize (i) the experimental protocol and (ii) the modeling and simulation framework, assessing both feasibility and reliability of the proposed procedures. Medical imaging, electromyography (EMG) and dynamometry data will be collected and combined to inform a personalised musculoskeletal model of each participant. Biomechanical computer simulations of a Maximal Voluntary Isometric Contraction (MVIC) task will then be performed. To validate the proposed approach, the models' estimates will be compared to in vivo dynamometry measurements and experimental EMG data.
- Conditions
- Healthy
- Being tested
- Personalised musculoskeletal modeling
- Keywords
- Musculoskeletal modeling, In silico medicine, Maximal Voluntary Isometric Contraction, Electromyography, Healthy volunteers, Dynapenia, Dynamometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalised musculoskeletal modelingDiagnostic test
Magnetic resonance images, electromyography and dynamometry data will be used to develop personalised musculoskeletal models
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Other | Not described Receives: Diagnostic Test: Personalised musculoskeletal modeling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle volume
Full lower limb MRI data will be acquired with subjects in supine position. Individual muscle volumes (in cm3) will be segmented using commercial software and stored in anonymized form. Such data will serve as normative dataset/threshold in future studies that aim to assess (the severity of) sarcopenia in a patient population.
Measured: at baseline (Day 0)
Co-contraction index (CCI)
Experimental EMG data will be recorded from the major lower limb muscles involved in the knee extension, while participants perform a maximal voluntary isometric contraction on a dynamometer (i.e., MVIC test to quantify muscle strength).
The co-contraction index, defined as the relative activation of agonist and antagonist muscles (for this task: quadriceps and hamstrings) in the act of kicking (MVIC test), will be computed according to Li et al (2020).
EMG patterns (mV) will additionally be stored and will constitute a normative dataset, for qualitative comparisons to identify suboptimal muscle control or altered muscle activation patterns in dynapenic patients in future studies that aim to assess (the severity of) dynapenia in a patient population.
Measured: at baseline (Day 0)
MVIC Torque
Dynamometry data will be acquired while participants perform a MVIC leg extension test. The maximum torque values (Nm) measured over three repetitions will be recorded. These correspond to the values observed in correspondence of the plateaux of force, developed over a sustained contraction.
Such data will serve as normative dataset/threshold in future studies that aim to assess (the severity of) dynapenia in a patient population.
Measured: at baseline (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start2 Sep 2022
- Primary completion10 Nov 2022
- Study completion11 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marco Viceconti, Professor, Principal investigator, IRCCS Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05091502
- Sponsor's protocol ID
- ForceLoss I
- Status last verified
- Sep 2022
- First submitted
- 23 Sep 2021
- Last updated
- 23 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share a database of normative experimental data representative of a healthy adult population. The dataset will include the force profiles and the EMG data recorded during the MVIC test, and may include Magnetic Resonance Imaging data. All data will be irreversibly anonymized.
Publications
Pons C, Borotikar B, Garetier M, Burdin V, Ben Salem D, Lempereur M, Brochard S. Quantifying skeletal muscle volume and shape in humans using MRI: A systematic review of validity and reliability. PLoS One. 2018 Nov 29;13(11):e0207847. doi: 10.1371/journal.pone.0207847. eCollection 2018.
PubMed 30496308Nishikawa Y, Watanabe K, Takahashi T, Hosomi N, Orita N, Mikami Y, Maruyama H, Kimura H, Matsumoto M. Sex differences in variances of multi-channel surface electromyography distribution of the vastus lateralis muscle during isometric knee extension in young adults. Eur J Appl Physiol. 2017 Mar;117(3):583-589. doi: 10.1007/s00421-017-3559-3. Epub 2017 Feb 20.
PubMed 28220239
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ForceLoss: Part I - Healthy Volunteers. Development and Validation of Methods to Generate Personalised Models for the Differential Diagnosis of the Loss of Muscle Force
- ClinicalTrials.gov ID
- NCT05091502
- Acronym / sponsor ID
- ForceLoss I
- Conditions
- Healthy
- Keywords
- Musculoskeletal modeling, In silico medicine, Maximal Voluntary Isometric Contraction, Electromyography, Healthy volunteers, Dynapenia, Dynamometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 2 Sep 2022 (actual)
- Primary completion
- 10 Nov 2022 (actual)
- Study completion
- 11 Nov 2022 (actual)
- First posted
- 25 Oct 2021 (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 ForceLoss study aims to develop personalised modeling and simulation procedures to enable the differential diagnosis for the loss of muscle force, namely dynapenia. Dynapenia can be caused by diffuse or selective sarcopenia, lack of activation, or improper motor control. Each of these causes requires different interventions, but a reliable differential diagnosis is currently impossible. While instrumental methods can provide information on each of these possible causes, it is left to the experience of the single clinician to integrate such information into a complete diagnostic picture. But an accurate diagnosis for dynapenia is important in a number of pathologies, including neurological diseases, age-related frailty, diabetes, and orthopaedic conditions. The hypothesis is that the use of a mechanistic, subject-specific model of maximum isometric knee extension, informed by a number of instrumental information can provide a robust differential diagnosis of dynapenia.
In this preliminary study, on healthy volunteers, the investigators will develop and optimize (i) the experimental protocol and (ii) the modeling and simulation framework, assessing both feasibility and reliability of the proposed procedures. Medical imaging, electromyography (EMG) and dynamometry data will be collected and combined to inform a personalised musculoskeletal model of each participant. Biomechanical computer simulations of a Maximal Voluntary Isometric Contraction (MVIC) task will then be performed. To validate the proposed approach, the models' estimates will be compared to in vivo dynamometry measurements and experimental EMG data.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Other | Diagnostic Test: Personalised musculoskeletal modeling |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Body mass index (BMI) between 15 and 30 kg / m²
Key exclusion criteria (3 listed)
- Neurological, rheumatic or tumoral diseases;
- Pathologies or physical conditions incompatible with the use of magnetic resonance imaging and electrostimulation (i.e., active and passive implanted biomedical devices, epilepsy, severe venous insufficiency in the lower limbs, pregnancy);
- Previous interventions or traumas to the joints of the lower limb.
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 |
|---|---|---|
| Personalised musculoskeletal modelingMagnetic resonance images, electromyography and dynamometry data will be used to develop personalised musculoskeletal models | Diagnostic test | Healthy volunteers |
Primary outcome
Muscle volume
Time frame: at baseline (Day 0)
Full lower limb MRI data will be acquired with subjects in supine position. Individual muscle volumes (in cm3) will be segmented using commercial software and stored in anonymized form. Such data will serve as normative dataset/threshold in future studies that aim to assess (the severity of) sarcopenia in a patient population.
Co-contraction index (CCI)
Time frame: at baseline (Day 0)
Experimental EMG data will be recorded from the major lower limb muscles involved in the knee extension, while participants perform a maximal voluntary isometric contraction on a dynamometer (i.e., MVIC test to quantify muscle strength). The co-contraction index, defined as the relative activation of agonist and antagonist muscles (for this task: quadriceps and hamstrings) in the act of kicking (MVIC test), will be computed according to Li et al (2020). EMG patterns (mV) will additionally be stored and will constitute a normative dataset, for qualitative comparisons to identify suboptimal muscle control or altered muscle activation patterns in dynapenic patients in future studies that aim to assess (the severity of) dynapenia in a patient population.
MVIC Torque
Time frame: at baseline (Day 0)
Dynamometry data will be acquired while participants perform a MVIC leg extension test. The maximum torque values (Nm) measured over three repetitions will be recorded. These correspond to the values observed in correspondence of the plateaux of force, developed over a sustained contraction. Such data will serve as normative dataset/threshold in future studies that aim to assess (the severity of) dynapenia in a patient population.
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 23 Jan 2023.
- Background: PubMed 30496308Pons C, Borotikar B, Garetier M, Burdin V, Ben Salem D, Lempereur M, Brochard S. Quantifying skeletal muscle volume and shape in humans using MRI: A systematic review of validity and reliability. PLoS One. 2018 Nov 29;13(11):e0207847. doi: 10.1371/journal.pone.0207847. eCollection 2018.
- Background: PubMed 28220239Nishikawa Y, Watanabe K, Takahashi T, Hosomi N, Orita N, Mikami Y, Maruyama H, Kimura H, Matsumoto M. Sex differences in variances of multi-channel surface electromyography distribution of the vastus lateralis muscle during isometric knee extension in young adults. Eur J Appl Physiol. 2017 Mar;117(3):583-589. doi: 10.1007/s00421-017-3559-3. Epub 2017 Feb 20.
- Individual participant dataSharing planned: Yes. We plan to share a database of normative experimental data representative of a healthy adult population. The dataset will include the force profiles and the EMG data recorded during the MVIC test, and may include Magnetic Resonance Imaging data. All data will be irreversibly anonymized.
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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.
Marco Viceconti, Professor principal investigator
IRCCS 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 Personalised musculoskeletal modeling in people with Healthy, 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 3 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 23 Jan 2023. 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?
Muscle volume (time frame: at baseline (Day 0)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05091502, which also lists 2 linked publications.
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 23 Jan 2023.