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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-80
SponsorIstituto Ortopedico Rizzoli

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 65 and 80 years

Kellgren score II e III

No history of falls in the last 12 months

Disqualifiers

Any musculoskeletal, neurological, rheumatic or tumoral diseases

Dementia

Diabetes

Inguinal or abdominal hernia

Trial design

Design model

Single group

Treatments tested in this trial

  • Muscle power assessment

    Other intervention

    Isokinetic dynamometry test Stair ascent/descent on instrumented stairs

  • Muscle force assessment

    Other intervention

    Isometric dynamometry (Maximal Voluntary Isometric Contraction)

  • Home-based mobility monitoring

    Other intervention

    Mobility monitoring with wearable sensors

  • Magnetic Resonance Imaging

    Diagnostic test

    Full lower limb MRI

  • Gait assessment

    Other intervention

    Motion capture, surface EMG and gorund reaction force data

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Knee OsteoarthritisExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Maximal muscle force

Maximal Isometric muscle force from dynamometry test

Time frame
At baseline (Day 0) and all follow-up visits (Month 6, Month 12, Month 18, Month 24)
2

Muscle power

Assessed on the dynamometer and during dynamic tasks

Time frame
At baseline (Day 0) and all follow-up visits (Month 6, Month 12, Month 18, Month 24)
3

Muscle activations

From surface EMG data collected on the dynamometer and during dynamic tasks (gait assessment and stair ascent/descent)

Time frame
At baseline (Day 0) and all follow-up visits (Month 6, Month 12, Month 18, Month 24)
4

Digital Mobility Outcomes

Qualitative and quantiative measures of real-world mobility (e.g., gait speed, stride length)

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

Secondary outcomes

1

Musculoskeletal model predictions

Estimates of muscle force and knee joint contact forces

Time frame
At baseline (Day 0) and all follow-up visits (Month 6, Month 12, Month 18, Month 24)
2

Muscle volumes

Estimation of muscle volumes (cm3)

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

Other outcomes

Sponsors and contacts

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