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

29. Juli 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme	Maßnahmenbeschreibung	Zeitfenster
Timed Up and Go (TUG) test Zeitfenster: 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) Zeitfenster: 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 Zeitfenster: At baseline	balance assessment is conducted using Baiobit equipment from BTS Bioengineering. The maximal balance time in monopodalic will be considered (s)	At baseline

Sekundäre Ergebnismessungen

Ergebnis Maßnahme	Maßnahmenbeschreibung	Zeitfenster
Response time assessment Zeitfenster: 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 Zeitfenster: 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) Zeitfenster: 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) Zeitfenster: 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 Zeitfenster: 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) Zeitfenster: 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) Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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) Zeitfenster: 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) Zeitfenster: 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) Zeitfenster: 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) Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

3. Februar 2026

Primärer Abschluss (Geschätzt)

1. Juni 2027

Studienabschluss (Geschätzt)

1. April 2028

Studienanmeldedaten

Zuerst eingereicht

3. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

29. Juli 2026

Zuerst gepostet (Tatsächlich)

3. August 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)