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

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

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

Study Overview

• Status: Recruiting
• Conditions: Falls Prevention; Knee Osteoarthritis (Knee OA)
• Intervention / Treatment: Other: Muscle power assessment; Other: Muscle force assessment; Other: Home-based mobility monitoring; Diagnostic test: Magnetic Resonance Imaging; Other: 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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lisa Berti, Professor; Phone Number: +390516366529; Email: lisa.berti@ior.it
• Study Contact Backup: Name: Massimiliano Baleani, Engineer; Phone Number: +390516366865; Email: massimiliano.baleani@ior.it

Study Locations

• Italy
  • Bologna, Italy, 40136
    • Recruiting
    • IRCCS Istituto Ortopedico Rizzoli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Knee Osteoarthritis; Elderly patients with knee osteoarthritis, without a history of falls (in the 12 months prior to enrollment). All subjects will be followed up for 24 months, every 6 months. Muscle force and power assessments, plus a home-based mobility monitoring, will be performed at all visits. Full lower limb MRI and a gait assessment will be performed at first and last visit.

Other: Muscle power assessment; Isokinetic dynamometry test Stair ascent/descent on instrumented stairs; Other: Muscle force assessment; Isometric dynamometry (Maximal Voluntary Isometric Contraction); Other: Home-based mobility monitoring; Mobility monitoring with wearable sensors; Diagnostic test: Magnetic Resonance Imaging; Full lower limb MRI; Other: Gait assessment; Motion capture, surface EMG and gorund reaction force data

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal muscle force	Maximal Isometric muscle force from dynamometry test	At baseline (Day 0) and all follow-up visits (Month 6, Month 12, Month 18, Month 24)
Muscle power	Assessed on the dynamometer and during dynamic tasks	At baseline (Day 0) and all follow-up visits (Month 6, Month 12, Month 18, Month 24)
Muscle activations	From surface EMG data collected on the dynamometer and during dynamic tasks (gait assessment and stair ascent/descent)	At baseline (Day 0) and all follow-up visits (Month 6, Month 12, Month 18, Month 24)
Digital Mobility Outcomes	Qualitative and quantiative measures of real-world mobility (e.g., gait speed, stride length)	At baseline (Day 0) and all follow-up visits (Month 6, Month 12, Month 18, Month 24)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Musculoskeletal model predictions	Estimates of muscle force and knee joint contact forces	At baseline (Day 0) and all follow-up visits (Month 6, Month 12, Month 18, Month 24)
Muscle volumes	Estimation of muscle volumes (cm3)	From first follow-up visit (Month 6) to last follow-up visit (Month 24)

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli
• Investigators: Principal Investigator: Lisa Berti, Professor, IRCCS Istituto Ortopedico Rizzoli

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 12, 2026

Study Registration Dates

• First Submitted: September 17, 2024
• First Submitted That Met QC Criteria: September 20, 2024
• First Posted (Actual): September 25, 2024

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: MRI; Knee osteoarthritis; Muscle power; Falls prevention; Muscle force; IMU; digital twins; Motor control degradation; mobility monitoring
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Diagnostic Imaging; Magnetic Resonance Imaging
• Other Study ID Numbers: CE-AVEC 204/2024/Sper/IOR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No