Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07300592

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Municipal United Hospital

Kaohsiung City, 813, Taiwan

Location status: Recruiting

Location contact

Jia-Ling Hong Physiotherapist

CONTACT

[email protected]

+886-7-5552565 ext 51705

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Test-Retest Reliability of Static Balance Assessment Scores

    Time frame: Within 7 days after the first assessment

    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.

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

    Time frame: Within 7 days after the first assessment

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

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

    Time frame: Within 7 days after the first assessment

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

Secondary outcomes

  1. Body Height

    Time frame: At baseline (first assessment)

    Unit of Measure: Centimeters (cm)

  2. Body Weight

    Time frame: At baseline (first assessment)

    Unit of Measure: Kilograms (kg)

  3. Body Mass Index (BMI)

    Time frame: At baseline (first assessment)

    Unit of Measure: Kilograms per square meter (kg/m²) Calculated as weight in kilograms divided by height in meters squared.

  4. Whole-Body Skeletal Muscle Mass

    Time frame: At baseline (first assessment)

    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.

  5. Single-Leg Stance Test - Eyes Open

    Time frame: Within 7 days after the first assessment

    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.

  6. Single-Leg Stance Test - Eyes Closed

    Time frame: Within 7 days after the first assessment

    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.

  7. Whole-Body Muscle Mass

    Time frame: At baseline (first assessment)

    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.

  8. Segmental Muscle Mass - Upper and Lower Limbs and Trunk

    Time frame: At baseline (first assessment)

    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.

  9. Whole-Body Body Fat Percentage

    Time frame: At baseline (first assessment)

    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.

  10. Segmental Body Fat Percentage

    Time frame: At baseline (first assessment)

    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.

  11. Visceral Fat Level

    Time frame: At baseline (first assessment)

    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.

  12. Basal Metabolic Rate

    Time frame: At baseline (first assessment)

    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.

Other outcomes

  1. Fall Frequency

    Time frame: At baseline (first assessment)

    Unit: Number of falls in past 12 months

  2. Living Status

    Time frame: At baseline (first assessment)

    Unit: Categorical (living alone / with others)

  3. Education Level

    Time frame: At baseline (first assessment)

    Unit: Categorical (elementary, high school, etc.)

  4. Exercise Habit

    Time frame: At baseline (first assessment)

    Unit: Categorical (Yes / No)

  5. Exercise Duration

    Time frame: At baseline (first assessment)

    Unit: Hours per week (hr/week)

Study contacts

Contact information is provided by the study sponsor or research team.

Jia-Ling Hong Physiotherapist

CONTACT

[email protected]

+886-7-5552565 ext 51705

Sponsors and collaborators

Lead sponsor

Jia-Ling Hong

Other

Registry information

Official study title

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

Acronym: KSVGH25-CT3-09

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 24, 2025
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.