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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Maximal muscle force [Срок оценки: At baseline (Day 0) and all follow-up visits (Month 6, Month 12, Month 18, Month 24)]
• Muscle power [Срок оценки: At baseline (Day 0) and all follow-up visits (Month 6, Month 12, Month 18, Month 24)]
• Muscle activations [Срок оценки: At baseline (Day 0) and all follow-up visits (Month 6, Month 12, Month 18, Month 24)]
• Digital Mobility Outcomes [Срок оценки: At baseline (Day 0) and all follow-up visits (Month 6, Month 12, Month 18, Month 24)]

Вторичные конечные точки (2)

• Musculoskeletal model predictions [Срок оценки: At baseline (Day 0) and all follow-up visits (Month 6, Month 12, Month 18, Month 24)]
• Muscle volumes [Срок оценки: From first follow-up visit (Month 6) to last follow-up visit (Month 24)]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Италия · 1 центр

• IRCCS Istituto Ortopedico Rizzoli — Bologna

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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