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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• Test-Retest Reliability of Static Balance Assessment Scores [Срок оценки: Within 7 days after the first assessment]
• Short Physical Performance Battery (SPPB) - 4-Meter Walk Test [Срок оценки: Within 7 days after the first assessment]
• Short Physical Performance Battery (SPPB) - 5-Times Sit-to-Stand Test [Срок оценки: Within 7 days after the first assessment]

Вторичные конечные точки (12)

• Body Height [Срок оценки: At baseline (first assessment)]
• Body Weight [Срок оценки: At baseline (first assessment)]
• Body Mass Index (BMI) [Срок оценки: At baseline (first assessment)]
• Whole-Body Skeletal Muscle Mass [Срок оценки: At baseline (first assessment)]
• Single-Leg Stance Test - Eyes Open [Срок оценки: Within 7 days after the first assessment]
• Single-Leg Stance Test - Eyes Closed [Срок оценки: Within 7 days after the first assessment]
• Whole-Body Muscle Mass [Срок оценки: At baseline (first assessment)]
• Segmental Muscle Mass - Upper and Lower Limbs and Trunk [Срок оценки: At baseline (first assessment)]
• Whole-Body Body Fat Percentage [Срок оценки: At baseline (first assessment)]
• Segmental Body Fat Percentage [Срок оценки: At baseline (first assessment)]
• Visceral Fat Level [Срок оценки: At baseline (first assessment)]
• Basal Metabolic Rate [Срок оценки: At baseline (first assessment)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Тайвань · 1 центр

• Kaohsiung Municipal United Hospital — Kaohsiung City

Идентификаторы

NCT: NCT07300592 · KSVGH25-CT3-09

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗