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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.

調査の概要

状態

募集

条件

研究の種類

観察的

入学 (推定)

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

イタリア
- Milan
  - Milan、Milan、イタリア
    - 募集
    - IRCCS Ospedale Galeazzi-Sant'Ambrogio
    - コンタクト：
      
      Stefano Borghi, Md
      
      電話番号：0283502246
      
      メール：stefano.borghi@grupposandonato.it

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

高齢者

健康ボランティアの受け入れ

はい

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

この研究は何を測定していますか？

主要な結果の測定

結果測定	メジャーの説明	時間枠
Timed Up and Go (TUG) test 時間枠：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) 時間枠：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 時間枠：At baseline	balance assessment is conducted using Baiobit equipment from BTS Bioengineering. The maximal balance time in monopodalic will be considered (s)	At baseline

二次結果の測定

結果測定	メジャーの説明	時間枠
Response time assessment 時間枠：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 時間枠：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) 時間枠：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) 時間枠：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 時間枠：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) 時間枠：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) 時間枠：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 時間枠：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 時間枠：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) 時間枠：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) 時間枠：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) 時間枠：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) 時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

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

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年2月3日

一次修了 (推定)

2027年6月1日

研究の完了 (推定)

2028年4月1日

試験登録日

最初に提出

2026年7月3日

QC基準を満たした最初の提出物

2026年7月29日

最初の投稿 (実際)

2026年8月3日

学習記録の更新

投稿された最後の更新 (実際)