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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-80
SponsorJia-Ling Hong

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Static Balance Assessment Protocol

    Other intervention

    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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Static Balance Assessment GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Within 7 days after the first assessment
2

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.

Time frame
Within 7 days after the first assessment
3

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.

Time frame
Within 7 days after the first assessment

Secondary outcomes

1

Body Height

Unit of Measure: Centimeters (cm)

Time frame
At baseline (first assessment)
2

Body Weight

Unit of Measure: Kilograms (kg)

Time frame
At baseline (first assessment)
3

Body Mass Index (BMI)

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

Time frame
At baseline (first assessment)
4

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.

Time frame
At baseline (first assessment)

Other outcomes

1

Fall Frequency

Unit: Number of falls in past 12 months

Time frame
At baseline (first assessment)
2

Living Status

Unit: Categorical (living alone / with others)

Time frame
At baseline (first assessment)
3

Education Level

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

Time frame
At baseline (first assessment)
4

Exercise Habit

Unit: Categorical (Yes / No)

Time frame
At baseline (first assessment)

Sponsors and contacts

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Jia-Ling Hong

Lead sponsor

Kaohsiung Municipal United Hospital

Sponsor institution