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Analysis of the Loss of Muscle Force, Power and Motor Control to Predict the Risk of Falls in Patients With Knee OA

Analisi Della Perdita di Forza e Potenza Muscolare e Del Degrado Del Controllo Motorio Per la Predizione Delle Cadute in Una Popolazione Affetta da Artrosi di Ginocchio

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06611618
Acronym
PowerAGING
Enrollment
50
Registered
2024-09-25
Start date
2025-01-30
Completion date
2026-12-12
Last updated
2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis (Knee OA), Falls Prevention

Keywords

Falls prevention, Knee osteoarthritis, Muscle power, Muscle force, Motor control degradation, digital twins, IMU, mobility monitoring, MRI

Brief summary

The twofold goal of this study is to understand the link between muscle power, muscle strength, and muscle control degradation with the risk of falling, and to develop a framework for the comprehensive and quantitative assessment of muscle power (and strength) in an elderly population of patients with knee osteoarthritis, who are at higher risk of falling. The main question it aims to answer is: ● Are muscle power and motor control degradation better predictors of falls than muscle strength in the aging population? Participants will undergo: * Muscle force assessment on a dynamometer * Muscle power assessment on a dynamometer and on isntrumented stairs * Home-based mobility monitoring * Full lower limb MRI acquisition * Gait assessment

Detailed description

Falls are a critical yet common event among the elderly, with huge societal and economic impact (reduced quality of life and high costs for the healthcare system). Experimental measures to quantify the residual muscle strength and power may provide useful information to predict the risk of falls in the elderly. Isometric and isokinetic muscle contractions, performed on a dynamometer or during functional tasks can be collected, together with electromyography (to assess muscle activity) and imaging data (to quantify and characterize muscular tissue). Such data can be collected at different time points to monitor subjects over time, and to inform virtual representation of the human musculoskeletal system (digital twins) to identify possible motor control deficits. Moreover, this same information can be used to better characterize/assess elder individuals at risk of falling (e.g., subjects with knee osteoarthritis), to prevent future falls. All subjects enrolled in the PowerAGING study will be followed up for 24 months (5 visits in total: M0, M6, M12, M18 and M24 follow-up). At each visit, a series of experimental tests to quantify muscle power and muscle force, as well as a home-based mobility assessment (via single inertial sensor worn for 5 consecutive days), will be performed. In addition, only at start and end, the subjects will undergo a full lower limb MRI and a gait assessment.

Interventions

OTHERMuscle power assessment

Isokinetic dynamometry test Stair ascent/descent on instrumented stairs

OTHERMuscle force assessment

Isometric dynamometry (Maximal Voluntary Isometric Contraction)

OTHERHome-based mobility monitoring

Mobility monitoring with wearable sensors

DIAGNOSTIC_TESTMagnetic Resonance Imaging

Full lower limb MRI

Motion capture, surface EMG and gorund reaction force data

Sponsors

Istituto Ortopedico Rizzoli
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Age between 65 and 80 years * Kellgren score II e III * No history of falls in the last 12 months

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

Design outcomes

Primary

MeasureTime frameDescription
Maximal muscle forceAt baseline (Day 0) and all follow-up visits (Month 6, Month 12, Month 18, Month 24)Maximal Isometric muscle force from dynamometry test
Muscle powerAt baseline (Day 0) and all follow-up visits (Month 6, Month 12, Month 18, Month 24)Assessed on the dynamometer and during dynamic tasks
Muscle activationsAt baseline (Day 0) and all follow-up visits (Month 6, Month 12, Month 18, Month 24)From surface EMG data collected on the dynamometer and during dynamic tasks (gait assessment and stair ascent/descent)
Digital Mobility OutcomesAt baseline (Day 0) and all follow-up visits (Month 6, Month 12, Month 18, Month 24)Qualitative and quantiative measures of real-world mobility (e.g., gait speed, stride length)

Secondary

MeasureTime frameDescription
Musculoskeletal model predictionsAt baseline (Day 0) and all follow-up visits (Month 6, Month 12, Month 18, Month 24)Estimates of muscle force and knee joint contact forces
Muscle volumesFrom first follow-up visit (Month 6) to last follow-up visit (Month 24)Estimation of muscle volumes (cm3)

Countries

Italy

Contacts

CONTACTLisa Berti, Professor
lisa.berti@ior.it+390516366529
CONTACTMassimiliano Baleani, Engineer
massimiliano.baleani@ior.it+390516366865
PRINCIPAL_INVESTIGATORLisa Berti, Professor

IRCCS Istituto Ortopedico Rizzoli

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026