Clinical Trials Directory

Trials / Completed

CompletedNCT05091502

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
20 (actual)
Sponsor
Istituto Ortopedico Rizzoli · Academic / Other
Sex
All
Age
20 Years – 40 Years
Healthy volunteers
Accepted

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. 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

Interventions

TypeNameDescription
DIAGNOSTIC_TESTPersonalised musculoskeletal modelingMagnetic resonance images, electromyography and dynamometry data will be used to develop personalised musculoskeletal models

Timeline

Start date
2022-09-02
Primary completion
2022-11-10
Completion
2022-11-11
First posted
2021-10-25
Last updated
2023-01-23

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT05091502. Inclusion in this directory is not an endorsement.