Analysis of the Loss of Muscle Force, Power and Motor Control to Predict the Risk of Falls in Pat… (NCT06611618) | Clinical Trial Compass
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 range
65 Years – 80 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximal muscle force
Timeframe: At baseline (Day 0) and all follow-up visits (Month 6, Month 12, Month 18, Month 24)
2
Muscle power
Timeframe: At baseline (Day 0) and all follow-up visits (Month 6, Month 12, Month 18, Month 24)
3
Muscle activations
Timeframe: At baseline (Day 0) and all follow-up visits (Month 6, Month 12, Month 18, Month 24)
4
Digital Mobility Outcomes
Timeframe: At baseline (Day 0) and all follow-up visits (Month 6, Month 12, Month 18, Month 24)