AgingASY&FALLNCT07742397
Fall Risk in Adults Over 65: The Relevance of Morphological and Functional Lower Limb Asymmetries.
An observational study of Aging and Asymmetry, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial summary
Falls among older adults represent a major public health burden. Approximately 30% of individuals aged 65 and older experience at least one fall each year. These events can lead not only to increased anxiety, depression, and reduced quality of life but also to serious injuries or even death. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Asymmetry, Fall Risk Factors
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- 3 Feb 2026to Apr 2028
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Men and women between the ages of 65 yr, able to walk without assistance, lived independently, and had no major cardiovascular, muscular, skeletal or neurological conditions participated in the study.
Who may be able to join
- Male or female, of any ethnicity.
- Age ≥ 65 years.
- Cognitively intact.
- Independent ambulation.
- Signed and accepted informed consent to participate in all procedures required for the study.
Who cannot join
- Previous surgical treatments for orthopedic conditions performed within the six months prior to study inclusion.
- Severe cardiac, pulmonary, or musculoskeletal disorders that may influence the assessment outcomes.
- Comorbidities associated with increased fall risk, such as Parkinson's disease or stroke.
- Body Mass Index ≥ 30.0.
- Use of medications that affect motor coordination, balance, or bone and muscle metabolism.
- Active oncological disease.
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 Ospedale Galeazzi-Sant'Ambrogio
Milan, Milan
Stefano Borghi, Md, 0283502246, stefano.borghi@grupposandonato.it
About this study
Official title: Fall-risk Prevention in Adults Over 65: the Relevance of Morphological and Functional Asymmetries of the Lower Limbs.
Falls among older adults represent a major public health burden. Approximately 30% of individuals aged 65 and older experience at least one fall each year. These events can lead not only to increased anxiety, depression, and reduced quality of life but also to serious injuries or even death. Key risk factors include muscle weakness, gait disturbances, and balance impairments. Lower limb asymmetry-referring to differences in strength, flexibility, composition, or functional capacity between the two legs-has emerged as a potentially important yet underexplored contributor to fall risk in the elderly population. While asymmetry is frequently studied in the context of sports and physical performance, where it may affect both injury risk and athletic outcomes, its implications for balance and mobility in older adults remain insufficiently investigated. This study aims to examine the relationship between lower limb asymmetries and fall risk, with the goal of identifying predictive indicators and informing the development of more effective fall prevention strategies. Ultimately, a better understanding of this relationship could contribute to improved quality of life for older adults and a reduction in healthcare costs associated with fall-related hospitalizations.
- Conditions
- Aging, Asymmetry, Fall Risk Factors, Fall Prevention
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed Up and Go (TUG) test
A functional mobility test measuring dynamic balance and gait efficiency. Participants stand up from a chair, walk 3 meters, turn, return, and sit; longer times indicate higher fall risk.
Measured: At baseline
5-Repetition Sit-to-Stand Test (5-rep STS)
A lower-limb strength and functional performance test. Participants rise from a chair five times as quickly as possible; slower performance reflects reduced strength and increased fall risk.
Measured: At baseline
Balance test
balance assessment is conducted using Baiobit equipment from BTS Bioengineering. The maximal balance time in monopodalic will be considered (s)
Measured: At baseline
Secondary outcomes (13)
Response time assessment
A visual reaction-time assessment using programmable light pods. Participants respond as quickly as possible to randomly illuminated targets by tapping them, allowing measurement of response time, decision speed, and stimulus-reaction efficiency. Shorter reaction times indicate better neuromotor responsiveness, while longer delays may reflect reduced processing speed and increased fall-risk vulnerability.
Measured: At baseline
Gait Analysis
A biomechanical assessment of walking performance using motion-capture technology. Spatiotemporal parameters (e.g., step length, gait speed, foot clearance) are recorded to evaluate dynamic stability, movement symmetry, and functional mobility, providing objective indicators associated with fall risk in older adults.
Measured: At baseline
Physical Activity Questionnaire (IPAQ)
A self-reported measure of habitual physical activity. It quantifies weekly frequency and duration of walking, moderate activity, and vigorous activity, providing an estimate of overall activity level relevant to mobility and fall risk.
Measured: At baseline
Falls Efficacy Scale-International (FES-I)
A validated questionnaire assessing fear of falling and confidence in performing daily activities. Higher scores indicate greater concern about falling, which is associated with reduced mobility and increased fall risk.
Measured: At baseline
SARC-F questionnaire
A screening tool for sarcopenia evaluating strength, assistance in walking, rising from a chair, climbing stairs, and fall history. Higher scores reflect impaired physical function and greater vulnerability to falls.
Measured: At baseline
fall risk questionnaire (FRQ)
"The Fall Risk Questionnaire (FRQ) is a validated self-assessment tool. It has demonstrated good ability to identify older adults at risk of falling and to increase awareness of fall risk within this population.
Measured: At baseline
Dual-energy X-ray absorptiometry (DEXA)
Gold-standard method for assessing body composition. By using two X-ray energy levels, DEXA provides detailed information on bone mineral content, lean mass, and fat mass.
Measured: At baseline
Strength Assessment
Bilateral knee and ankle flexor and extensor strength is assessed using a pressure-based dynamometer. The protocol includes the measurement of Maximum Voluntary Contraction (MVC, N). All force signals are sampled at high frequency and processed through filtering and normalization procedures to ensure accurate extraction of mechanical parameters.
Measured: At baseline
Power assessment
Bilateral knee and ankle flexor and extensor power is assessed using a pressure-based dynamometer. The protocol includes the measurement of Rate of Force Development (RFD, kg/s through standardized isometric contractions. All force signals are sampled at high frequency and processed through filtering and normalization procedures to ensure accurate extraction of mechanical parameters.
Measured: At baseline
High-Density Surface electromyography Assessment (HD-sEMG)
Neuromuscular activity of the knee and ankle flexor and extensor are evaluated using high-density surface electromyography (HD-sEMG) with the Sessantaquattro+ system (OTBioelettronica). The electrode matrices allow spatially detailed mapping of muscle activation. EMG signals undergo preprocessing including filtering, artifact removal, and time-alignment with strength trials to provide an integrated characterization of neuromuscular function.
Measured: At baseline
Dominance test (Step-Up Test)
This test identifies lower-limb dominance by observing which limb the participant naturally uses first when stepping onto a raised platform.
Measured: At baseline
Dominance test (Kicking Test)
This test determines limb dominance based on the leg used to kick a ball or target. The dominant lower limb is the one the participant naturally selects for kicking.
Measured: At baseline
Dominance test (Balance Recovery Test)
This test identifies dominance by evaluating which limb the participant relies on to regain stability after a perturbation. The dominant limb is typically the one that steps first when balance is unexpectedly challenged.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start3 Feb 2026
- Primary completionJun 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07742397
- Sponsor's protocol ID
- Asymmetry&Fall - L3060
- Acronym
- ASY&FALL
- Status last verified
- Jul 2026
- First submitted
- 3 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fall-risk Prevention in Adults Over 65: the Relevance of Morphological and Functional Asymmetries of the Lower Limbs.
- ClinicalTrials.gov ID
- NCT07742397
- Acronym / sponsor ID
- ASY&FALL / Asymmetry&Fall - L3060
- Conditions
- Aging, Asymmetry, Fall Risk Factors, Fall Prevention
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 3 Feb 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 3 Aug 2026 (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.
Falls among older adults represent a major public health burden. Approximately 30% of individuals aged 65 and older experience at least one fall each year. These events can lead not only to increased anxiety, depression, and reduced quality of life but also to serious injuries or even death. Key risk factors include muscle weakness, gait disturbances, and balance impairments. Lower limb asymmetry-referring to differences in strength, flexibility, composition, or functional capacity between the two legs-has emerged as a potentially important yet underexplored contributor to fall risk in the elderly population. While asymmetry is frequently studied in the context of sports and physical performance, where it may affect both injury risk and athletic outcomes, its implications for balance and mobility in older adults remain insufficiently investigated. This study aims to examine the relationship between lower limb asymmetries and fall risk, with the goal of identifying predictive indicators and informing the development of more effective fall prevention strategies. Ultimately, a better understanding of this relationship could contribute to improved quality of life for older adults and a reduction in healthcare costs associated with fall-related hospitalizations.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Men and women between the ages of 65 yr, able to walk without assistance, lived independently, and had no major cardiovascular, muscular, skeletal or neurological conditions participated in the study.
Key inclusion criteria (5 listed)
- Male or female, of any ethnicity.
- Age ≥ 65 years.
- Cognitively intact.
- Independent ambulation.
- Signed and accepted informed consent to participate in all procedures required for the study.
Key exclusion criteria (6 listed)
- Previous surgical treatments for orthopedic conditions performed within the six months prior to study inclusion.
- Severe cardiac, pulmonary, or musculoskeletal disorders that may influence the assessment outcomes.
- Comorbidities associated with increased fall risk, such as Parkinson's disease or stroke.
- Body Mass Index ≥ 30.0.
- Use of medications that affect motor coordination, balance, or bone and muscle metabolism.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Timed Up and Go (TUG) test
Time frame: At baseline
A functional mobility test measuring dynamic balance and gait efficiency. Participants stand up from a chair, walk 3 meters, turn, return, and sit; longer times indicate higher fall risk.
5-Repetition Sit-to-Stand Test (5-rep STS)
Time frame: At baseline
A lower-limb strength and functional performance test. Participants rise from a chair five times as quickly as possible; slower performance reflects reduced strength and increased fall risk.
Balance test
Time frame: At baseline
balance assessment is conducted using Baiobit equipment from BTS Bioengineering. The maximal balance time in monopodalic will be considered (s)
13 secondary outcomes
Response time assessment
Time frame: At baseline
Gait Analysis
Time frame: At baseline
Physical Activity Questionnaire (IPAQ)
Time frame: At baseline
Falls Efficacy Scale-International (FES-I)
Time frame: At baseline
SARC-F questionnaire
Time frame: At baseline
fall risk questionnaire (FRQ)
Time frame: At baseline
Dual-energy X-ray absorptiometry (DEXA)
Time frame: At baseline
Strength Assessment
Time frame: At baseline
Power assessment
Time frame: At baseline
High-Density Surface electromyography Assessment (HD-sEMG)
Time frame: At baseline
Dominance test (Step-Up Test)
Time frame: At baseline
Dominance test (Kicking Test)
Time frame: At baseline
Dominance test (Balance Recovery Test)
Time frame: At baseline
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 3 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging and Asymmetry, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio 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 5 inclusion and 6 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 3 Aug 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed Up and Go (TUG) test (time frame: At baseline). The study lists 3 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 3 Aug 2026.