Balance AssessmentKSVGH25-CT3-09NCT07300592
Development of a Static Balance Assessment Tool for High-Functioning Older Adults (KSVGH25-CT3-09)
A study testing Static Balance Assessment Protocol in people with Balance Assessment and Postural Balance, run by Jia-Ling Hong at 1 site in Taiwan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Balance Assessment, Postural Balance, Older Adults, Balance
- What is being tested?
- Static Balance Assessment Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Aug 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Municipal United Hospital
Kaohsiung City, Kaohsiung City, 813
Jia-Ling Hong Physiotherapist, +886-7-5552565 ext 51705, daben610357@gmail.com
About this study
Official title: Development of a Static Balance Assessment Tool for High-Functioning Older Adults
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.
Read the 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.
- Conditions
- Balance Assessment, Postural Balance, Older Adults, Balance
- Being tested
- Static Balance Assessment Protocol
- Keywords
- Static balance assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Static Balance Assessment ProtocolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Static Balance Assessment Group | Experimental | Participants will undergo body composition measurement, open-eyes and closed-eyes single-leg stance test, and Balance Error Scoring System 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 to determine test-retest reliability. Receives: Other: Static Balance Assessment Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 7 days after the first assessment
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.
Measured: Within 7 days after the first assessment
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.
Measured: Within 7 days after the first assessment
Secondary outcomes (12)
Body Height
Unit of Measure: Centimeters (cm)
Measured: At baseline (first assessment)
Body Weight
Unit of Measure: Kilograms (kg)
Measured: At baseline (first assessment)
Body Mass Index (BMI)
Unit of Measure: Kilograms per square meter (kg/m²) Calculated as weight in kilograms divided by height in meters squared.
Measured: At baseline (first assessment)
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.
Measured: At baseline (first assessment)
Single-Leg Stance Test - Eyes Open
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.
Measured: Within 7 days after the first assessment
Single-Leg Stance Test - Eyes Closed
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.
Measured: Within 7 days after the first assessment
Whole-Body Muscle Mass
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.
Measured: At baseline (first assessment)
Segmental Muscle Mass - Upper and Lower Limbs and Trunk
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.
Measured: At baseline (first assessment)
Whole-Body Body Fat Percentage
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.
Measured: At baseline (first assessment)
Segmental Body Fat Percentage
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.
Measured: At baseline (first assessment)
Visceral Fat Level
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.
Measured: At baseline (first assessment)
Basal Metabolic Rate
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.
Measured: At baseline (first assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start10 Aug 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Balance AssessmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive the same assessment procedures, including body composition measurement, open-eyes/closed-eyes single-leg stance, and the Balance Error Scoring System under firm and foam surface conditions. Two identical assessment sessions will be conducted 5-7 days apart to evaluate test-retest reliability.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jia-Ling Hong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jia-Ling Hong, Kaohsiung Municipal United Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07300592
- Sponsor's protocol ID
- KSVGH25-CT3-09
- Acronym
- KSVGH25-CT3-09
- Status last verified
- Aug 2025
- First submitted
- 22 Nov 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data (IPD) will be shared. The decision is based on institutional policy and the need to protect participant privacy and confidentiality. Only aggregated results will be reported in publications.
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Static Balance Assessment Tool for High-Functioning Older Adults
- ClinicalTrials.gov ID
- NCT07300592
- Acronym / sponsor ID
- KSVGH25-CT3-09 / KSVGH25-CT3-09
- Conditions
- Balance Assessment, Postural Balance, Older Adults, Balance
- Keywords
- Static balance assessment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Jia-Ling HongUniversity, hospital or other
- Study start
- 10 Aug 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive the same assessment procedures, including body composition measurement, open-eyes/closed-eyes single-leg stance, and the Balance Error Scoring System under firm and foam surface conditions. Two identical assessment sessions will be conducted 5-7 days apart to evaluate test-retest reliability.
| Arm | Type | Receives |
|---|---|---|
| Static Balance Assessment Group | Experimental | Other: Static Balance Assessment ProtocolParticipants will undergo body composition measurement, open-eyes and closed-eyes single-leg stance test, and Balance Error Scoring System 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 to determine test-retest reliability. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Static Balance Assessment ProtocolParticipants 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. | Other | Static Balance Assessment Group |
Primary outcome
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.
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.
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.
12 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: No. No individual participant data (IPD) will be shared. The decision is based on institutional policy and the need to protect participant privacy and confidentiality. Only aggregated results will be reported in publications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Static Balance Assessment Protocol in people with Balance Assessment and Postural Balance, run by Jia-Ling Hong at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jia-Ling Hong Physiotherapist (+886-7-5552565 ext 51705, daben610357@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test-Retest Reliability of Static Balance Assessment Scores (time frame: Within 7 days after the first assessment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025; AzTrials last refreshed its copy on 30 Oct 2026.