RecruitingNot Applicable

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

Italy50 participantsStarted 2025-01-30

Plain-language 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

Who can participate

Age range65 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Maximal muscle force

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

Muscle power

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

Muscle activations

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

Digital Mobility Outcomes

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

Trial details

NCT IDNCT06611618

SponsorIstituto Ortopedico Rizzoli

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-30

Contact for this trial

Lisa Berti, Professor

+390516366529 lisa.berti@ior.it

View on ClinicalTrials.gov More Knee Osteoarthritis (Knee OA) trials

Plain-language summary

Who can participate

Age range65 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Maximal muscle force

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

Muscle power

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

Muscle activations

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

Digital Mobility Outcomes

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