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NCT Number: NCT05854316

Protocols and Guidelines for the Use of Digital Twins in Frail Older People

The Proto-Aging study aims to define experimental protocols and guidelines to enable the development of musculoskeletal models (digital twins) of elderly people, with the ultimate goal to comprehensively characterize frail elders from a biomechanical standpoint.

It is typical for the elderly to present with weakness, slowed movements and reduced levels of physical activity, all of which may be related to the loss of muscle force (dynapenia). Unfortunately, to date, the primary cause for dynapenia is difficult to identify. Digital twins may help to this end, but their development remains critical as it requires a specialized skillset and experimental data for model personalisation.

In this study, where the investigators will recruit a small group of frail elders and a cohort of healthy young individuals, all participants will undergo the following examinations: (i) gait assessment, (ii) maximal voluntary isometric contraction (MVIC) test, (iii) superimposed neuromuscular electrical stimulation, and (iv) full lower limb magnetic resonance imaging. Surface electromyography data will further be collected while the subjects perform both the gait assessment and the MVIC test. Last, clinical questionnaires will be administered, and the subjects will be asked to perform additional clinical measures (i.e., hand-grip test, bioelectrical impedance analysis).

At the end of the study, a reduced version of the experimental protocol will be developed, with the intent to provide clinicians with a protocol that can be deployed in clinical settings, accounting for the observed reliability and repeatability of each measure, the required level of expertise, and the associated costs and time expenditure.

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Key information

Conditions

Frail Elderly Syndrome Frailty Muscle Weakness Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age: 65-80 years
  • Body Mass Index between 18.5 and 30 kg/m2
  • Frailty syndrome diagnosed according to Fried's criteria (i.e., at least three of the following items: unintended loss of weight, weakness, self-reported exhaustion, slow walking speed, low level of physical activity)

Exclusion criteria

  • Any musculoskeletal, neurological, rheumatic or tumoral diseases
  • Dementia
  • Diabetes
  • Inguinal or abdominal hernia
  • Severe Hypertension (Level 3)
  • Severe Cardio-pulmonary insufficiency
  • Diagnosis of Osteonecrosis in the lower limb joints
  • 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)
  • Previous interventions or traumas to the joints of the lower limb

NOTE: A group of healthy volunteers, who meet the following criteria, will be enrolled in the study:

Inclusion criteria

  • Age: 20-40 years;
  • Body Mass Index: 15-30 kg/m²;
  • Physical activity level (Saltin-Grimby): 2-4
  • No previous or known musculoskeletal, neurological, rheumatic or tumoral diseases

Treatment and study plan

Comprehensive Biomechanical assessment

Diagnostic Test

Magnetic resonance images, electromyography and dynamometry data will be used, together with data from the gait assessment and clinical questionnaires/measures, to characterize the biomechanics of the participants, and to develop and inform 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.

  2. 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

  3. Muscle Inhibition level

    Time frame: at baseline (Day 0)

    The difference between the maximal force exerted during the MVIC test (voluntary contraction) and that achieved when the muscles are electrically stimulated (involuntary contraction) will be computed

  4. 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).

  5. Body kinematics

    Time frame: at baseline (Day 0)

    A standard gait assessment will be performed where motion capture data will be collected. Joint angles will be extracted to identify abnormal gait patterns.

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Acronym: Proto-Aging

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 11, 2023
Registry last updated
May 18, 2025

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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