Kaohsiung Municipal United Hospital
Kaohsiung City, 813, Taiwan
Location status: Recruiting
NCT Number: NCT07300592
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.
Interested in participating?
Request Info60 year–80 year
All sexes
Interventional
Not applicable
Kaohsiung City, 813, Taiwan
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
Time frame: At baseline (first assessment)
Unit of Measure: Centimeters (cm)
Time frame: At baseline (first assessment)
Unit of Measure: Kilograms (kg)
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Time frame: At baseline (first assessment)
Unit: Number of falls in past 12 months
Time frame: At baseline (first assessment)
Unit: Categorical (living alone / with others)
Time frame: At baseline (first assessment)
Unit: Categorical (elementary, high school, etc.)
Time frame: At baseline (first assessment)
Unit: Categorical (Yes / No)
Time frame: At baseline (first assessment)
Unit: Hours per week (hr/week)
Contact information is provided by the study sponsor or research team.
Jia-Ling Hong
Other
Development of a Static Balance Assessment Tool for High-Functioning Older Adults
Acronym: KSVGH25-CT3-09
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.
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