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Recruiting NCT07742397

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

— Observational Aging Asymmetry Fall Risk Factors Fall Prevention

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Aging, Asymmetry, Fall Risk Factors, Fall Prevention. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Primary outcome measures

  • Timed Up and Go (TUG) test [Time frame: At baseline]
  • 5-Repetition Sit-to-Stand Test (5-rep STS) [Time frame: At baseline]
  • Balance test [Time frame: At baseline]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Other

Study locations

Italy · 1 center
  • IRCCS Ospedale Galeazzi-Sant'Ambrogio — Milan

Identifiers

NCT: NCT07742397 · Asymmetry&Fall - L3060

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗