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

NCT07742397 | Recruiting DMC

• 1 other identifier: Asymmetry&Fall - L3060
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aging; Asymmetry; Fall Risk Factors; Fall Prevention

Outcome Measures

Primary Outcomes (3)

• Timed Up and Go (TUG) test

  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)

  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

  balance assessment is conducted using Baiobit equipment from BTS Bioengineering. The maximal balance time in monopodalic will be considered (s)

  At baseline

Secondary Outcomes (13)

• Response time assessment

  At baseline

• Gait Analysis

  At baseline

• Physical Activity Questionnaire (IPAQ)

  At baseline

• Falls Efficacy Scale-International (FES-I)

  At baseline

• SARC-F questionnaire

  At baseline

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead

Study Sites (1)

IRCCS Ospedale Galeazzi-Sant'Ambrogio

Milan, Milan, Italy

RECRUITING

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2026
• First Posted: August 3, 2026
• Study Start: February 3, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: August 3, 2026

Record last verified: 2026-07

Locations

IT (1)