Fall Risk in Adults Over 65: The Relevance of Morphological and Functional Lower Limb Asymmetries. (ASY&FALL)
29 de julio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Tipo de estudio
De observación
Inscripción (Estimado)
90
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Milan
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Milan, Milan, Italia
- Reclutamiento
- IRCCS Ospedale Galeazzi-Sant'Ambrogio
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Contacto:
- Stefano Borghi, Md
- Número de teléfono: 0283502246
- Correo electrónico: stefano.borghi@grupposandonato.it
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Método de muestreo
Muestra no probabilística
Población de estudio
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.
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Timed Up and Go (TUG) test
Periodo de tiempo: At baseline
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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.
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At baseline
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5-Repetition Sit-to-Stand Test (5-rep STS)
Periodo de tiempo: At baseline
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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.
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At baseline
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Balance test
Periodo de tiempo: At baseline
|
balance assessment is conducted using Baiobit equipment from BTS Bioengineering.
The maximal balance time in monopodalic will be considered (s)
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At baseline
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Response time assessment
Periodo de tiempo: 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.
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At baseline
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Gait Analysis
Periodo de tiempo: At baseline
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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.
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At baseline
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Physical Activity Questionnaire (IPAQ)
Periodo de tiempo: At baseline
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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.
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At baseline
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Falls Efficacy Scale-International (FES-I)
Periodo de tiempo: At baseline
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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.
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At baseline
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SARC-F questionnaire
Periodo de tiempo: At baseline
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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.
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At baseline
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fall risk questionnaire (FRQ)
Periodo de tiempo: At baseline
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"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.
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At baseline
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Dual-energy X-ray absorptiometry (DEXA)
Periodo de tiempo: 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.
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At baseline
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Strength Assessment
Periodo de tiempo: At baseline
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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.
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At baseline
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Power assessment
Periodo de tiempo: At baseline
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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.
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At baseline
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High-Density Surface electromyography Assessment (HD-sEMG)
Periodo de tiempo: At baseline
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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.
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At baseline
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Dominance test (Step-Up Test)
Periodo de tiempo: At baseline
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This test identifies lower-limb dominance by observing which limb the participant naturally uses first when stepping onto a raised platform.
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At baseline
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Dominance test (Kicking Test)
Periodo de tiempo: At baseline
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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.
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At baseline
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Dominance test (Balance Recovery Test)
Periodo de tiempo: At baseline
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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.
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At baseline
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
3 de febrero de 2026
Finalización primaria (Estimado)
1 de junio de 2027
Finalización del estudio (Estimado)
1 de abril de 2028
Fechas de registro del estudio
Enviado por primera vez
3 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
29 de julio de 2026
Publicado por primera vez (Actual)
3 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
3 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
29 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- Asymmetry&Fall - L3060
Plan de datos de participantes individuales (IPD)
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INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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