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

NCT ID: NCT05854316

Last Updated: 2025-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-28
• Study Completion Date: 2023-07-27

Brief Summary

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.

Conditions

Frail Elderly Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Frail elders

Frail elders; Age: 65-80 years; Body Mass Index: 18.5-30 kg/m²; Frailty 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).

Group Type: EXPERIMENTAL

Comprehensive Biomechanical assessment

Intervention Type: 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

Interventions

Comprehensive Biomechanical assessment

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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)

• 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

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:

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Istituto Ortopedico Rizzoli

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria Grazia Benedetti, Professor

Role: PRINCIPAL_INVESTIGATOR

IRCCS Istituto Ortopedico Rizzoli

Locations

IRCCS Istituto Ortopedico Rizzoli

Bologna, , Italy

Countries

Italy

Other Identifiers

Proto-Aging

Identifier Type: -

Identifier Source: org_study_id