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

Development of a Static Balance Assessment Tool for High-Functioning Older Adults

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.

Study Overview

• Status: Recruiting
• Conditions: Older Adults, Balance; Postural Balance; Balance Assessment
• Intervention / Treatment: Other: Static Balance Assessment Protocol

Detailed Description

The study is conducted at Kaohsiung Municipal United Hospital, Taiwan, with the objective of creating a static balance assessment tool specifically designed for older adults who are physically high-functioning. Traditional balance tests, such as the open-eyes single-leg stance with a 30-second limit, often produce ceiling effects in this population, making it difficult to detect subtle differences in balance ability or evaluate the benefits of exercise programs. To address this limitation, the current study extends the open-eyes single-leg stance to a maximum of 60 seconds and incorporates a closed-eyes condition to increase task difficulty.

In addition, the Balance Error Scoring System, originally developed for concussion assessment, will be adapted for older adults. Balance Error Scoring System testing will be conducted under six conditions: double-leg stance, tandem stance, and single-leg stance, each performed on both firm and foam surfaces with eyes closed. This design simulates balance challenges encountered in daily life while minimizing fall risk.

Eligible participants (n=50) will be community-dwelling older adults aged ≥65 years, with perfect Short Physical Performance Battery scores and no recent lower limb injuries or neurological conditions. Each participant will complete two identical assessment sessions, spaced 5-7 days apart. Both on-site evaluators and independent assessors reviewing video recordings will score performance. The primary outcome is the test-retest reliability of each balance measure, quantified through statistical analysis.

The anticipated benefit of this study is to establish a reliable, sensitive, and practical balance assessment protocol that can be implemented in community health programs, long-term care facilities, and research settings. This tool aims to improve early detection of balance decline, guide intervention planning, and ultimately contribute to fall prevention and healthy aging initiatives in aging societies.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jia-Ling Hong Physiotherapist; Phone Number: +886-7-5552565 ext 51705; Email: daben610357@gmail.com

Study Locations

• Taiwan
  • Kaohsiung City
    • Kaohsiung City, Kaohsiung City, Taiwan, 813
      • Recruiting
      • Kaohsiung Municipal United Hospital
      • Contact: Jia-Ling Hong Physiotherapist; Phone Number: +886-7-5552565 ext 51705; Email: daben610357@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Static Balance Assessment Group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Height	Unit of Measure: Centimeters (cm)	At baseline (first assessment)
Body Weight	Unit of Measure: Kilograms (kg)	At baseline (first assessment)
Body Mass Index (BMI)	Unit of Measure: Kilograms per square meter (kg/m²) Calculated as weight in kilograms divided by height in meters squared.	At baseline (first assessment)
Whole-Body Skeletal Muscle Mass	Unit of Measure: Kilograms (kg) Description: Whole-body skeletal muscle mass will be measured using bioelectrical impedance analysis (BIA) with the TANITA BC-545N body composition analyzer. Participants will stand barefoot and hold hand electrodes during the assessment.	At baseline (first assessment)
Single-Leg Stance Test - Eyes Open	Test Name: Single-Leg Stance Test (Eyes Open) Unit of Measure: Seconds (s) Description: Participant stands unassisted on one leg with eyes open. The time is recorded until balance is lost or foot touches the ground. Interpretation: Longer time indicates better static balance performance.	Within 7 days after the first assessment
Single-Leg Stance Test - Eyes Closed	Test Name: Single-Leg Stance Test (Eyes Closed) Unit of Measure: Seconds (s) Description: Participant stands unassisted on one leg with eyes closed. The time is recorded until balance is lost or foot touches the ground. Interpretation: Longer time indicates better static balance performance.	Within 7 days after the first assessment
Whole-Body Muscle Mass	Unit of Measure: Kilograms (kg) Description: Whole-body muscle mass will be assessed using bioelectrical impedance analysis (BIA) with the TANITA BC-545N body composition analyzer.	At baseline (first assessment)
Segmental Muscle Mass - Upper and Lower Limbs and Trunk	Unit of Measure: Kilograms (kg) Description: Segmental muscle mass of the right upper limb, left upper limb, trunk, right lower limb, and left lower limb will be measured using bioelectrical impedance analysis (BIA) with the TANITA BC-545N body composition analyzer.	At baseline (first assessment)
Whole-Body Body Fat Percentage	Unit of Measure: Percentage (%) Description: Whole-body body fat percentage will be measured using bioelectrical impedance analysis (BIA) with the TANITA BC-545N body composition analyzer.	At baseline (first assessment)
Segmental Body Fat Percentage	Unit of Measure: Percentage (%) Description: Segmental body fat percentage of the right upper limb, left upper limb, trunk, right lower limb, and left lower limb will be measured using bioelectrical impedance analysis (BIA) with the TANITA BC-545N body composition analyzer.	At baseline (first assessment)
Visceral Fat Level	Unit of Measure: Arbitrary units (BIA-derived level) Description: Visceral fat level will be estimated using bioelectrical impedance analysis (BIA) with the TANITA BC-545N body composition analyzer.	At baseline (first assessment)
Basal Metabolic Rate	Unit of Measure: Kilocalories per day (kcal/day) Description: Basal metabolic rate will be estimated using bioelectrical impedance analysis (BIA) with the TANITA BC-545N body composition analyzer.	At baseline (first assessment)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fall Frequency	Unit: Number of falls in past 12 months	At baseline (first assessment)
Living Status	Unit: Categorical (living alone / with others)	At baseline (first assessment)
Education Level	Unit: Categorical (elementary, high school, etc.)	At baseline (first assessment)
Exercise Habit	Unit: Categorical (Yes / No)	At baseline (first assessment)
Exercise Duration	Unit: Hours per week (hr/week)	At baseline (first assessment)

Collaborators and Investigators

• Sponsor: Jia-Ling Hong

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 22, 2025
• First Submitted That Met QC Criteria: December 17, 2025
• First Posted (Actual): December 24, 2025

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Static balance assessment
• Other Study ID Numbers: KSVGH25-CT3-09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual participant data (IPD) will be shared. The decision is based on institutional policy and the need to protect participant privacy and confidentiality. Only aggregated results will be reported in publications.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No