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Recruiting NCT06611618

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

No phase Interventional Knee Osteoarthritis (Knee OA) Falls Prevention

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Muscle power assessment, Muscle force assessment, Home-based mobility monitoring, Magnetic Resonance Imaging.
Who it may be relevant to
Registry conditions: Knee Osteoarthritis (Knee OA), Falls Prevention. Basic parameters: 65 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Maximal muscle force [Time frame: At baseline (Day 0) and all follow-up visits (Month 6, Month 12, Month 18, Month 24)]
  • Muscle power [Time frame: At baseline (Day 0) and all follow-up visits (Month 6, Month 12, Month 18, Month 24)]
  • Muscle activations [Time frame: At baseline (Day 0) and all follow-up visits (Month 6, Month 12, Month 18, Month 24)]
  • Digital Mobility Outcomes [Time frame: At baseline (Day 0) and all follow-up visits (Month 6, Month 12, Month 18, Month 24)]
Secondary outcome measures (2)
  • Musculoskeletal model predictions [Time frame: At baseline (Day 0) and all follow-up visits (Month 6, Month 12, Month 18, Month 24)]
  • Muscle volumes [Time frame: From first follow-up visit (Month 6) to last follow-up visit (Month 24)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

Italy · 1 center
  • IRCCS Istituto Ortopedico Rizzoli — Bologna

Identifiers

NCT: NCT06611618 · CE-AVEC 204/2024/Sper/IOR

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗