Development of a Static Balance Assessment Tool for High-Functioning Older Adults (KSVGH25-CT3-09)

NCT07300592 | Recruiting

• 1 other identifier: KSVGH25-CT3-09
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This single-center interventional study aims to develop and validate a static balance assessment tool tailored for high-functioning older adults. Participants aged 65 years or older, who achieve a perfect score on the Short Physical Performance Battery and can maintain an open-eyes single-leg stance for at least 10 seconds, will be recruited. The assessment includes body composition measurement, open-eyes/closed-eyes single-leg stance, and the Balance Error Scoring System under firm and foam surface conditions. Each participant will undergo two testing sessions, 5-7 days apart, with both on-site and video-based scoring to determine test-retest reliability. The expected outcome is the development of an accurate and highly applicable static balance measurement tool to support healthy aging and fall prevention in community and long-term care settings.

Conditions

Balance Assessment; Postural Balance; Older Adults, Balance

Keywords

Static balance assessment

Outcome Measures

Primary Outcomes (3)

• Test-Retest Reliability of Static Balance Assessment Scores

  Description: Reliability will be evaluated using intra-class correlation coefficient (ICC) and Spearman correlation coefficient (ρ) between session 1 and session 2 scores for the following static balance tests: Single-leg stance with eyes open Single-leg stance with eyes closed Balance Error Scoring System (BESS) under various surface conditions Scale Name: Balance Error Scoring System (BESS) Score Range: 0 (best balance) to 60 (worst balance) Interpretation: Higher BESS scores indicate worse balance performance.

  Within 7 days after the first assessment

• Short Physical Performance Battery (SPPB) - 4-Meter Walk Test

  Unit of Measure: Seconds (s) Description: Measures usual gait speed over a 4-meter distance. Interpretation: Lower time indicates better performance.

  Within 7 days after the first assessment

• Short Physical Performance Battery (SPPB) - 5-Times Sit-to-Stand Test

  Unit of Measure: Seconds (s) Description: Measures lower-limb strength and functional mobility. Interpretation: Lower time indicates better performance.

  Within 7 days after the first assessment

Secondary Outcomes (12)

• Body Height

  At baseline (first assessment)

• Body Weight

  At baseline (first assessment)

• Body Mass Index (BMI)

  At baseline (first assessment)

• Whole-Body Skeletal Muscle Mass

  At baseline (first assessment)

• Single-Leg Stance Test - Eyes Open

  Within 7 days after the first assessment

Other Outcomes (5)

• Fall Frequency

  At baseline (first assessment)

• Living Status

  At baseline (first assessment)

• Education Level

  At baseline (first assessment)

Study Arms (1)

Static Balance Assessment Group

EXPERIMENTAL

Participants will undergo body composition measurement, open-eyes and closed-eyes single-leg stance test, and Balance Error Scoring System testing under firm and foam surface conditions. Each participant will complete two identical sessions, 5-7 days apart, with both on-site scoring and video-based scoring to determine test-retest reliability.

Other: Static Balance Assessment Protocol

Interventions

Static Balance Assessment Protocol OTHER

Participants will undergo a standardized static balance assessment protocol, including open-eyes and closed-eyes single-leg stance tests, as well as Balance Error Scoring System (BESS) testing under firm and foam surface conditions. Each participant will complete two identical sessions, 5-7 days apart, with both on-site scoring and video-based scoring performed by trained assessors to determine test-retest reliability.

Static Balance Assessment Group

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 60 to 85 years
• Able to walk independently without assistive devices
• No self-reported balance disorders or history of recurrent falls in the past 6 months
• Cognitively intact (Mini-Mental State Examination score ≥ 24)
• Willing and able to provide informed consent

You may not qualify if:

• Diagnosed neurological disorders affecting balance (e.g., Parkinson's disease, stroke with residual deficits)
• Diagnosed neurological disorders affecting balance (e.g., Parkinson's disease, stroke with residual deficits)
• Severe visual or vestibular impairment uncorrected by aids
• Lower limb musculoskeletal disorders that limit mobility
• Current participation in other interventional clinical trials
• Unstable cardiovascular conditions (e.g., uncontrolled hypertension, recent myocardial infarction)
• Severe visual or vestibular impairment uncorrected by aids
• Lower limb musculoskeletal disorders that limit mobility
• Current participation in other interventional clinical trials
• Unstable cardiovascular conditions (e.g., uncontrolled hypertension, recent myocardial infarction)

Sponsors & Collaborators

• Jia-Ling Hong: lead

Study Sites (1)

Kaohsiung Municipal United Hospital

Kaohsiung City, Kaohsiung City, 813, Taiwan

RECRUITING

Central Study Contacts

Jia-Ling Hong Physiotherapist

CONTACT

+886-7-5552565 ext 51705; daben610357@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Outcome assessors who review video recordings will be blinded to the on-site assessment results to reduce scoring bias.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Kaohsiung Municipal United Hospital

Model Details: All participants will receive the same assessment procedures, including body composition measurement, open-eyes/closed-eyes single-leg stance, and the Balance Error Scoring System under firm and foam surface conditions. Two identical assessment sessions will be conducted 5-7 days apart to evaluate test-retest reliability.

Study Record Dates

• First Submitted: November 22, 2025
• First Posted: December 24, 2025
• Study Start: August 10, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)