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NCT Number: NCT06611618

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

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

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Key information

Age range

65 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Muscle power assessment

Other

Isokinetic dynamometry test Stair ascent/descent on instrumented stairs

Muscle force assessment

Other

Isometric dynamometry (Maximal Voluntary Isometric Contraction)

Home-based mobility monitoring

Other

Mobility monitoring with wearable sensors

Magnetic Resonance Imaging

Diagnostic Test

Full lower limb MRI

Gait assessment

Other

Motion capture, surface EMG and gorund reaction force data

Primary outcomes

  1. Maximal muscle force

    Time frame: At baseline (Day 0) and all follow-up visits (Month 6, Month 12, Month 18, Month 24)

    Maximal Isometric muscle force from dynamometry test

  2. Muscle power

    Time frame: At baseline (Day 0) and all follow-up visits (Month 6, Month 12, Month 18, Month 24)

    Assessed on the dynamometer and during dynamic tasks

  3. Muscle activations

    Time frame: At 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)

  4. Digital Mobility Outcomes

    Time frame: At 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 outcomes

  1. Musculoskeletal model predictions

    Time frame: At 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

  2. Muscle volumes

    Time frame: From first follow-up visit (Month 6) to last follow-up visit (Month 24)

    Estimation of muscle volumes (cm3)

Study contacts

Contact information is provided by the study sponsor or research team.

Lisa Berti, Professor

CONTACT

[email protected]

+390516366529

Massimiliano Baleani, Engineer

CONTACT

[email protected]

+390516366865

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

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

Acronym: PowerAGING

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 25, 2024
Registry last updated
Feb 27, 2026

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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