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Recruiting NCT07300592

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

No phase Interventional Balance Assessment Postural Balance Older Adults, Balance

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Static Balance Assessment Protocol.
Who it may be relevant to
Registry conditions: Balance Assessment, Postural Balance, Older Adults, Balance. Basic parameters: 60 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

  • 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.

Primary outcome measures

  • Test-Retest Reliability of Static Balance Assessment Scores [Time frame: Within 7 days after the first assessment]
  • Short Physical Performance Battery (SPPB) - 4-Meter Walk Test [Time frame: Within 7 days after the first assessment]
  • Short Physical Performance Battery (SPPB) - 5-Times Sit-to-Stand Test [Time frame: Within 7 days after the first assessment]
Secondary outcome measures (12)
  • Body Height [Time frame: At baseline (first assessment)]
  • Body Weight [Time frame: At baseline (first assessment)]
  • Body Mass Index (BMI) [Time frame: At baseline (first assessment)]
  • Whole-Body Skeletal Muscle Mass [Time frame: At baseline (first assessment)]
  • Single-Leg Stance Test - Eyes Open [Time frame: Within 7 days after the first assessment]
  • Single-Leg Stance Test - Eyes Closed [Time frame: Within 7 days after the first assessment]
  • Whole-Body Muscle Mass [Time frame: At baseline (first assessment)]
  • Segmental Muscle Mass - Upper and Lower Limbs and Trunk [Time frame: At baseline (first assessment)]
  • Whole-Body Body Fat Percentage [Time frame: At baseline (first assessment)]
  • Segmental Body Fat Percentage [Time frame: At baseline (first assessment)]
  • Visceral Fat Level [Time frame: At baseline (first assessment)]
  • Basal Metabolic Rate [Time frame: At baseline (first assessment)]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Taiwan · 1 center
  • Kaohsiung Municipal United Hospital — Kaohsiung City

Identifiers

NCT: NCT07300592 · KSVGH25-CT3-09

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗