Knee Osteoarthritis (Knee OA)PowerAGINGNCT06611618
Analysis of the Loss of Muscle Force, Power and Motor Control to Predict the Risk of Falls in Patients With Knee OA
A study testing Muscle power assessment, Muscle force assessment and Home-based mobility monitoring in people with Knee Osteoarthritis (Knee OA) and Falls Prevention, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Knee Osteoarthritis (Knee OA), Falls Prevention
- What is being tested?
- Muscle power assessment, Muscle force assessment and Home-based mobility monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 30 Jan 2025to 12 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age between 65 and 80 years
- Kellgren score II e III
- No history of falls in the last 12 months
Who cannot join
- Any musculoskeletal, neurological, rheumatic or tumoral diseases
- Dementia
- Diabetes
- Inguinal or abdominal hernia
- Severe Hypertension (Level 3)
- Severe Cardio-pulmonary insufficiency
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Istituto Ortopedico Rizzoli
Bologna, 40136
About this study
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
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?
Read more
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
Read the 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.
- Conditions
- Knee Osteoarthritis (Knee OA), Falls Prevention
- Being tested
- Muscle power assessment, Muscle force assessment, Home-based mobility monitoring, Magnetic Resonance Imaging, Gait assessment
- Keywords
- Falls prevention, Knee osteoarthritis, Muscle power, Muscle force, Motor control degradation, digital twins, IMU, mobility monitoring, MRI
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle power assessmentOther
Isokinetic dynamometry test Stair ascent/descent on instrumented stairs
Muscle force assessmentOther
Isometric dynamometry (Maximal Voluntary Isometric Contraction)
Home-based mobility monitoringOther
Mobility monitoring with wearable sensors
Magnetic Resonance ImagingDiagnostic test
Full lower limb MRI
Gait assessmentOther
Motion capture, surface EMG and gorund reaction force data
| Study group | Role | What they receive |
|---|---|---|
| Knee Osteoarthritis | Experimental | Elderly patients with knee osteoarthritis, without a history of falls (in the 12 months prior to enrollment).
All subjects will be followed up for 24 months, every 6 months. Muscle force and power assessments, plus a home-based mobility monitoring, will be performed at all visits. Full lower limb MRI and a gait assessment will be performed at first and last visit. Receives: Other: Muscle power assessment; Other: Muscle force assessment; Other: Home-based mobility monitoring; Diagnostic Test: Magnetic Resonance Imaging; Other: Gait assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal muscle force
Maximal Isometric muscle force from dynamometry test
Measured: At baseline (Day 0) and all follow-up visits (Month 6, Month 12, Month 18, Month 24)
Muscle power
Assessed on the dynamometer and during dynamic tasks
Measured: At baseline (Day 0) and all follow-up visits (Month 6, Month 12, Month 18, Month 24)
Muscle activations
From surface EMG data collected on the dynamometer and during dynamic tasks (gait assessment and stair ascent/descent)
Measured: At baseline (Day 0) and all follow-up visits (Month 6, Month 12, Month 18, Month 24)
Digital Mobility Outcomes
Qualitative and quantiative measures of real-world mobility (e.g., gait speed, stride length)
Measured: At baseline (Day 0) and all follow-up visits (Month 6, Month 12, Month 18, Month 24)
Secondary outcomes (2)
Musculoskeletal model predictions
Estimates of muscle force and knee joint contact forces
Measured: At baseline (Day 0) and all follow-up visits (Month 6, Month 12, Month 18, Month 24)
Muscle volumes
Estimation of muscle volumes (cm3)
Measured: From first follow-up visit (Month 6) to last follow-up visit (Month 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start30 Jan 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion12 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Osteoarthritis (Knee OA)Studies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa Berti, Professor, Principal investigator, IRCCS Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06611618
- Sponsor's protocol ID
- CE-AVEC 204/2024/Sper/IOR
- Acronym
- PowerAGING
- Status last verified
- Feb 2026
- First submitted
- 17 Sep 2024
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06611618
- Acronym / sponsor ID
- PowerAGING / CE-AVEC 204/2024/Sper/IOR
- Conditions
- Knee Osteoarthritis (Knee OA), Falls Prevention
- Keywords
- Falls prevention, Knee osteoarthritis, Muscle power, Muscle force, Motor control degradation, digital twins, IMU, mobility monitoring
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 12 Dec 2026 (estimated)
- First posted
- 25 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Knee Osteoarthritis | Experimental | Other: Muscle power assessment, Other: Muscle force assessment, Other: Home-based mobility monitoring, Diagnostic Test: Magnetic Resonance Imaging, Other: Gait assessmentElderly patients with knee osteoarthritis, without a history of falls (in the 12 months prior to enrollment). All subjects will be followed up for 24 months, every 6 months. Muscle force and power assessments, plus a home-based mobility monitoring, will be performed at all visits. Full lower limb MRI and a gait assessment will be performed at first and last visit. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age between 65 and 80 years
- Kellgren score II e III
- No history of falls in the last 12 months
Key exclusion criteria (9 listed)
- Any musculoskeletal, neurological, rheumatic or tumoral diseases
- Dementia
- Diabetes
- Inguinal or abdominal hernia
- Severe Hypertension (Level 3)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Muscle power assessmentIsokinetic dynamometry test Stair ascent/descent on instrumented stairs | Other | Knee Osteoarthritis |
| Muscle force assessmentIsometric dynamometry (Maximal Voluntary Isometric Contraction) | Other | Knee Osteoarthritis |
| Home-based mobility monitoringMobility monitoring with wearable sensors | Other | Knee Osteoarthritis |
| Magnetic Resonance ImagingFull lower limb MRI | Diagnostic test | Knee Osteoarthritis |
| Gait assessmentMotion capture, surface EMG and gorund reaction force data | Other | Knee Osteoarthritis |
Primary outcome
Maximal muscle force
Time frame: At baseline (Day 0) and all follow-up visits (Month 6, Month 12, Month 18, Month 24)
Maximal Isometric muscle force from dynamometry test
Muscle power
Time frame: At baseline (Day 0) and all follow-up visits (Month 6, Month 12, Month 18, Month 24)
Assessed on the dynamometer and during dynamic tasks
Muscle activations
Time frame: At baseline (Day 0) and all follow-up visits (Month 6, Month 12, Month 18, Month 24)
From surface EMG data collected on the dynamometer and during dynamic tasks (gait assessment and stair ascent/descent)
Digital Mobility Outcomes
Time frame: At baseline (Day 0) and all follow-up visits (Month 6, Month 12, Month 18, Month 24)
Qualitative and quantiative measures of real-world mobility (e.g., gait speed, stride length)
2 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lisa Berti, Professor principal investigator
IRCCS Istituto Ortopedico Rizzoli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Muscle power assessment, Muscle force assessment and Home-based mobility monitoring in people with Knee Osteoarthritis (Knee OA) and Falls Prevention, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa Berti, Professor (+390516366529, lisa.berti@ior.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal muscle force (time frame: At baseline (Day 0) and all follow-up visits (Month 6, Month 12, Month 18, Month 24)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.