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

2026年7月29日 更新者: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.

研究概览

地位

招聘中

研究类型

观察性的

注册 (估计的)

90

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 年长者

接受健康志愿者

是的

取样方法

非概率样本

研究人群

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.

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Timed Up and Go (TUG) test
大体时间: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)
大体时间: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
大体时间:At baseline
balance assessment is conducted using Baiobit equipment from BTS Bioengineering. The maximal balance time in monopodalic will be considered (s)
At baseline

次要结果测量

结果测量
措施说明
大体时间
Response time assessment
大体时间: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
大体时间: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)
大体时间: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)
大体时间: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
大体时间: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)
大体时间: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)
大体时间: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
大体时间: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
大体时间: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)
大体时间: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)
大体时间: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)
大体时间: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)
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年2月3日

初级完成 (估计的)

2027年6月1日

研究完成 (估计的)

2028年4月1日

研究注册日期

首次提交

2026年7月3日

首先提交符合 QC 标准的

2026年7月29日

首次发布 (实际的)

2026年8月3日

研究记录更新

最后更新发布 (实际的)

2026年8月3日

上次提交的符合 QC 标准的更新

2026年7月29日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • Asymmetry&Fall - L3060

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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