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Clinical Trials in Italy / NCT06611618
Recruiting Not applicable

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

NCT06611618 · tracked via the Priya Life Science Italy tracker
Sponsor
Istituto Ortopedico Rizzoli
Phase
Not applicable
Started
2025-01-30
Last updated
2026-02-27

Condition(s) studied

Knee Osteoarthritis (Knee OA)Falls Prevention

Investigational drug(s) / intervention(s)

Muscle power assessmentMuscle force assessmentHome-based mobility monitoringMagnetic Resonance ImagingGait assessment

Muscle power assessment: Isokinetic dynamometry test Stair ascent/descent on instrumented stairs

Muscle force assessment: Isometric dynamometry (Maximal Voluntary Isometric Contraction)

Home-based mobility monitoring: Mobility monitoring with wearable sensors

Magnetic Resonance Imaging: Full lower limb MRI

Gait assessment: Motion capture, surface EMG and gorund reaction force data

Study 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

Eligibility

Sex
ALL
Min age
65 Years
Max age
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

Primary outcome measure(s)

  • Maximal muscle force — At baseline (Day 0) and all follow-up visits (Month 6, Month 12, Month 18, Month 24)
    Maximal Isometric muscle force from dynamometry test
  • Muscle power — 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
  • Muscle activations — 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)
  • Digital Mobility Outcomes — 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)

Trial sites (1)

FacilityCityRegionStatus
IRCCS Istituto Ortopedico Rizzoli Bologna Italy Recruiting

More Istituto Ortopedico Rizzoli trials in Italy

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Combined Use of PRP and Hyaluronic Acid for Infiltrative Treatment of Patients With Knee Osteoarthritis Recruiting
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Other trials for the same condition

Identify the Most Effective Rehabilitation Method Between a Treatment with a Sensorized Treadmill (Walker View) and a Treatment with Conventional Group Therapy in Balance Disorders and the Use of Artificial Intelligence to Identify Predictive Indices to Prevent Falls and Diagnose Promptly the Risk Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06611618 on ClinicalTrials.gov ↗ ← All trials in Italy