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Completed

NCT Number: NCT05091502

Personalised Modeling and Simulation Procedures for the Differential Diagnosis of Dynapenia: a Study on Healthy Volunteers

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.

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Key information

Conditions

Healthy

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Istituto Ortopedico Rizzoli

Bologna, Emilia-Romagna, 40136, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Personalised Musculoskeletal Modeling

Diagnostic Test

Magnetic resonance images, electromyography and dynamometry data will be used to develop personalised musculoskeletal models

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Oct 25, 2021
Registry last updated
Jan 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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