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

NCT06611618 | Recruiting

• 1 other identifier: CE-AVEC 204/2024/Sper/IOR
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Musculoskeletal model predictions

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

• Muscle volumes

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

Study Arms (1)

Knee Osteoarthritis

EXPERIMENTAL

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; Other: Muscle force assessment; Other: Home-based mobility monitoring; Diagnostic Test: Magnetic Resonance Imaging; Other: Gait assessment

Interventions

Muscle power assessment OTHER

Isokinetic dynamometry test Stair ascent/descent on instrumented stairs

Knee Osteoarthritis

Muscle force assessment OTHER

Isometric dynamometry (Maximal Voluntary Isometric Contraction)

Knee Osteoarthritis

Home-based mobility monitoring OTHER

Mobility monitoring with wearable sensors

Knee Osteoarthritis

Magnetic Resonance Imaging DIAGNOSTIC_TEST

Full lower limb MRI

Knee Osteoarthritis

Gait assessment OTHER

Motion capture, surface EMG and gorund reaction force data

Knee Osteoarthritis

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

IRCCS Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Lisa Berti, Professor

  IRCCS Istituto Ortopedico Rizzoli

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Berti, Professor

CONTACT

+390516366529; lisa.berti@ior.it

Massimiliano Baleani, Engineer

CONTACT

+390516366865; massimiliano.baleani@ior.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: September 25, 2024
• Study Start: January 30, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 12, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

IT (1)