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Fall Risk in Adults Over 65: The Relevance of Morphological and Functional Lower Limb Asymmetries. (ASY&FALL)

29. juli 2026 opdateret af: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

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.

Studieoversigt

Status

Rekruttering

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Anslået)

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Italien
- Milan
  - Milan, Milan, Italien
    - Rekruttering
    - IRCCS Ospedale Galeazzi-Sant'Ambrogio
    - Kontakt:
      
      Stefano Borghi, Md
      
      Telefonnummer: 0283502246
      
      E-mail: stefano.borghi@grupposandonato.it

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Ældre voksen

Tager imod sunde frivillige

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Timed Up and Go (TUG) test Tidsramme: 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.	At baseline
5-Repetition Sit-to-Stand Test (5-rep STS) Tidsramme: 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.	At baseline
Balance test Tidsramme: At baseline	balance assessment is conducted using Baiobit equipment from BTS Bioengineering. The maximal balance time in monopodalic will be considered (s)	At baseline

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Response time assessment Tidsramme: 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.	At baseline
Gait Analysis Tidsramme: 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.	At baseline
Physical Activity Questionnaire (IPAQ) Tidsramme: 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.	At baseline
Falls Efficacy Scale-International (FES-I) Tidsramme: 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.	At baseline
SARC-F questionnaire Tidsramme: 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.	At baseline
fall risk questionnaire (FRQ) Tidsramme: 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.	At baseline
Dual-energy X-ray absorptiometry (DEXA) Tidsramme: 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.	At baseline
Strength Assessment Tidsramme: 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.	At baseline
Power assessment Tidsramme: 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.	At baseline
High-Density Surface electromyography Assessment (HD-sEMG) Tidsramme: 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.	At baseline
Dominance test (Step-Up Test) Tidsramme: At baseline	This test identifies lower-limb dominance by observing which limb the participant naturally uses first when stepping onto a raised platform.	At baseline
Dominance test (Kicking Test) Tidsramme: 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.	At baseline
Dominance test (Balance Recovery Test) Tidsramme: 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.	At baseline

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

3. februar 2026

Primær færdiggørelse (Anslået)

1. juni 2027

Studieafslutning (Anslået)

1. april 2028

Datoer for studieregistrering

Først indsendt

3. juli 2026

Først indsendt, der opfyldte QC-kriterier

29. juli 2026

Først opslået (Faktiske)

3. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)