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

NCT ID: NCT06611618

Last Updated: 2025-03-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-30
• Study Completion Date: 2026-12-12

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.

Conditions

Knee Osteoarthritis (Knee OA); Falls Prevention

Study Design

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

Study Groups

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.

Group Type: EXPERIMENTAL

Muscle power assessment

Intervention Type: OTHER

Isokinetic dynamometry test Stair ascent/descent on instrumented stairs

Muscle force assessment

Intervention Type: OTHER

Isometric dynamometry (Maximal Voluntary Isometric Contraction)

Home-based mobility monitoring

Intervention Type: OTHER

Mobility monitoring with wearable sensors

Magnetic Resonance Imaging

Intervention Type: DIAGNOSTIC_TEST

Full lower limb MRI

Gait assessment

Intervention Type: OTHER

Motion capture, surface EMG and gorund reaction force data

Interventions

Muscle power assessment

Isokinetic dynamometry test Stair ascent/descent on instrumented stairs

Intervention Type: OTHER

Muscle force assessment

Isometric dynamometry (Maximal Voluntary Isometric Contraction)

Intervention Type: OTHER

Home-based mobility monitoring

Mobility monitoring with wearable sensors

Intervention Type: OTHER

Magnetic Resonance Imaging

Full lower limb MRI

Intervention Type: DIAGNOSTIC_TEST

Gait assessment

Motion capture, surface EMG and gorund reaction force data

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Ortopedico Rizzoli

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IRCCS Istituto Ortopedico Rizzoli

Bologna, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Lisa Berti, Professor

Role: CONTACT

lisa.berti@ior.it

+390516366529

Massimiliano Baleani, Engineer

Role: CONTACT

massimiliano.baleani@ior.it

+390516366865

Other Identifiers

CE-AVEC 204/2024/Sper/IOR

Identifier Type: -

Identifier Source: org_study_id