- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05091502
Personalised Modeling and Simulation Procedures for the Differential Diagnosis of Dynapenia: a Study on Healthy Volunteers
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Emilia-Romagna
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Bologna, Emilia-Romagna, Italy, 40136
- IRCCS Istituto Ortopedico Rizzoli
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Body mass index (BMI) between 15 and 30 kg / m²
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Healthy volunteers
|
Magnetic resonance images, electromyography and dynamometry data will be used to develop personalised musculoskeletal models
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
at baseline (Day 0)
|
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. |
at baseline (Day 0)
|
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. |
at baseline (Day 0)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marco Viceconti, Professor, IRCCS Istituto Ortopedico Rizzoli
Publications and helpful links
General 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.
- Nishikawa 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ForceLoss I
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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