- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07742397
Fall Risk in Adults Over 65: The Relevance of Morphological and Functional Lower Limb Asymmetries. (ASY&FALL)
2026년 7월 29일 업데이트: 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.
연구 개요
연구 유형
관찰
등록 (추정된)
90
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Milan
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Milan, Milan, 이탈리아
- 모병
- IRCCS Ospedale Galeazzi-Sant'Ambrogio
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연락하다:
- Stefano Borghi, Md
- 전화번호: 0283502246
- 이메일: stefano.borghi@grupposandonato.it
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 고령자
건강한 자원 봉사자를 받아들입니다
예
샘플링 방법
비확률 샘플
연구 인구
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.
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Timed Up and Go (TUG) test
기간: 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)
기간: 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
기간: At baseline
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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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Response time assessment
기간: At baseline
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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
기간: 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)
기간: 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)
기간: 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
기간: 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)
기간: 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)
기간: At baseline
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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
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 2월 3일
기본 완료 (추정된)
2027년 6월 1일
연구 완료 (추정된)
2028년 4월 1일
연구 등록 날짜
최초 제출
2026년 7월 3일
QC 기준을 충족하는 최초 제출
2026년 7월 29일
처음 게시됨 (실제)
2026년 8월 3일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 3일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 29일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- Asymmetry&Fall - L3060
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
미정
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .