Frail Elderly SyndromeProto-AgingNCT05854316
Protocols and Guidelines for the Use of Digital Twins in Frail Older People
A study testing Comprehensive Biomechanical assessment in people with Frail Elderly Syndrome, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Frail Elderly Syndrome
- What is being tested?
- Comprehensive Biomechanical assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- 28 Mar 2023to 27 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Any musculoskeletal, neurological, rheumatic or tumoral diseases
- Dementia
- Diabetes
- Inguinal or abdominal hernia
- Severe Hypertension (Level 3)
- Severe Cardio-pulmonary insufficiency
Show all 10Show fewer
- 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:
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Comprehensive Biomechanical assessment
- Keywords
- Elderly, Frailty, Dynapenia, Muscle weakness, Maximal Voluntary Isometric Contraction, Superimposed Neuromuscular Electrical Stimulation, Dynamometry, Electromyography, Clinical questionnaires, Hand-grip test
- Medical subject headings
- Frailty, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Biomechanical assessmentDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Frail elders | Experimental | 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). Receives: Diagnostic Test: Comprehensive Biomechanical assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle volume
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.
Measured: at baseline (Day 0)
MVIC Torque
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
Measured: at baseline (Day 0)
Muscle Inhibition level
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
Measured: at baseline (Day 0)
Co-contraction index (CCI)
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).
Measured: at baseline (Day 0)
Body kinematics
A standard gait assessment will be performed where motion capture data will be collected. Joint angles will be extracted to identify abnormal gait patterns.
Measured: at baseline (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start28 Mar 2023
- Primary completion1 Jun 2023
- Study completion27 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frail Elderly SyndromeStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Grazia Benedetti, Professor, Principal investigator, IRCCS Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05854316
- Sponsor's protocol ID
- Proto-Aging
- Acronym
- Proto-Aging
- Status last verified
- May 2025
- First submitted
- 19 Apr 2023
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocols and Guidelines for the Use of Digital Twins in Frail Older People
- ClinicalTrials.gov ID
- NCT05854316
- Acronym / sponsor ID
- Proto-Aging / Proto-Aging
- Conditions
- Frail Elderly Syndrome
- Keywords
- Elderly, Frailty, Dynapenia, Muscle weakness, Maximal Voluntary Isometric Contraction, Superimposed Neuromuscular Electrical Stimulation, Dynamometry, Electromyography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 28 Mar 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 27 Jul 2023 (actual)
- First posted
- 11 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Frail elders | Experimental | Diagnostic Test: Comprehensive Biomechanical assessmentFrail 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). |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (10 listed)
- Any musculoskeletal, neurological, rheumatic or tumoral diseases
- Dementia
- Diabetes
- Inguinal or abdominal hernia
- Severe Hypertension (Level 3)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive Biomechanical assessmentMagnetic 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 | Diagnostic test | Frail elders |
Primary outcome
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.
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
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
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).
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Grazia Benedetti, Professor principal investigator
IRCCS Istituto Ortopedico Rizzoli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive Biomechanical assessment in people with Frail Elderly Syndrome, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle volume (time frame: at baseline (Day 0)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.