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NCT Number: NCT07742397

Fall Risk in Adults Over 65: The Relevance of Morphological and Functional Lower Limb Asymmetries.

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Ospedale Galeazzi-Sant'Ambrogio

Milan, Italy

Location status: Recruiting

Location contact

Stefano Borghi, Md

CONTACT

[email protected]

0283502246

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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)

Secondary outcomes

  1. Response time assessment

    Time frame: At baseline

    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.

  2. Gait Analysis

    Time frame: At baseline

    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.

  3. Physical Activity Questionnaire (IPAQ)

    Time frame: At baseline

    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.

  4. Falls Efficacy Scale-International (FES-I)

    Time frame: At baseline

    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.

  5. SARC-F questionnaire

    Time frame: At baseline

    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.

  6. fall risk questionnaire (FRQ)

    Time frame: At baseline

    "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.

  7. Dual-energy X-ray absorptiometry (DEXA)

    Time frame: At baseline

    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.

  8. Strength Assessment

    Time frame: At baseline

    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.

  9. Power assessment

    Time frame: At baseline

    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.

  10. High-Density Surface electromyography Assessment (HD-sEMG)

    Time frame: At baseline

    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.

  11. Dominance test (Step-Up Test)

    Time frame: At baseline

    This test identifies lower-limb dominance by observing which limb the participant naturally uses first when stepping onto a raised platform.

  12. Dominance test (Kicking Test)

    Time frame: At baseline

    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.

  13. Dominance test (Balance Recovery Test)

    Time frame: At baseline

    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.

Sponsors and collaborators

Lead sponsor

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Other

Registry information

Official study title

Fall-risk Prevention in Adults Over 65: the Relevance of Morphological and Functional Asymmetries of the Lower Limbs.

Acronym: ASY&FALL

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Aug 3, 2026
Registry last updated
Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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