Development of a Static Balance Assessment Tool for High-Functioning Older Adults
Phase: NA
Conditions: Balance Assessment, Postural Balance, Older Adults, Balance
Sponsor: Jia-Ling Hong

 
 
 
 
 
Development of a Static Balance 
Assessment Tool for High-Functioning 
Older Adults 
 
 
 
 
NCT ID not yet assigned 
 
2025/07/26 
 
 

Study Protocol 
 
1. Official Study Title 
Development of a Static Balance Assessment Tool for High-Functioning 
Older Adults 
 
2. Background and Rationale 
Taiwan has entered an aged society since 2018 and is expected to become a 
super-aged society by 2025. Although average life expectancy has increased, the 
gap between life expectancy and healthy life expectancy (HALE) continues to 
widen. Older adults commonly face sarcopenia, osteoarthritis, osteoporosis, and 
impaired postural control, all of which increase the risk of frailty and falls. Falls in 
the elderly result in fractures, injuries, fear of falling, reduced activity, accelerated 
functional decline, and substantial healthcare burden. 
Long-term care policy (LTC 2.0) in Taiwan emphasizes preventive strategies 
for healthy aging, with community-based C-level long-term care stations widely 
incorporating exercise and functional training. However, commonly used balance 
measures, such as the Short Physical Performance Battery (SPPB) and open-eye 
single-leg stance, demonstrate ceiling effects among high-functioning older 
adults. These tools therefore fail to detect meaningful changes after training. 
The Balance Error Scoring System (BESS), originally designed for 
concussion and athletic balance assessment, includes more challenging postural 
tasks that require proprioceptive control and sensory integration. It incorporates 
both ﬁrm and foam surfaces and requires participants to maintain balance with 
closed eyes, thereby increasing task difficulty. BESS may overcome the ceiling 
effect observed in community-dwelling high-functioning older adults, yet its 
applicability and reliability in this population remain insufficiently studied. 
This study aims to establish an advanced static balance measurement 
protocol suitable for high-functioning older adults using BESS, and to examine its 

test–retest reliability, accuracy, and clinical feasibility. 
 
3. Study Objectives 
Primary Objectives 
1. To establish an advanced static balance assessment protocol for high-
functioning older adults using the Balance Error Scoring System (BESS). 
2. To evaluate the test–retest reliability of BESS in community-dwelling 
high-functioning older adults. 
Secondary Objectives 
3. To determine the clinical feasibility and accessibility of BESS in 
community settings. 
4. To compare BESS performance with traditional balance tests (SPPB and 
open/closed-eye single-leg stance) to assess construct validity. 
 
4. Study Design 
• 
Type: Cross-sectional reliability and validity study 
• 
Setting: 
o Kaohsiung Municipal United Hospital – Department of 
Rehabilitation 
o Kaohsiung community C-level long-term care stations 
• 
Population: High-functioning older adults aged ≥65 years 
• 
Sample Size: 50 participants 
• 
Study Duration: Approximately 12 months 
The study includes two testing sessions separated by 1 week to assess test–
retest reliability. 
 

5. Participant Eligibility 
Inclusion Criteria 
1. Age ≥ 65 years 
2. SPPB score = 12 (full score) 
3. Open-eye single-leg stance ≥ 10 seconds 
4. Able to follow instructions and provide consent 
Exclusion Criteria 
1. Lower-limb osteoarthritis (Kellgren–Lawrence ≥ grade 3) 
2. History of lower-limb surgery 
3. Lower-limb pain affecting standing balance within the past 3 months 
4. Neurological disease (e.g., stroke, TBI, cerebellar atrophy, Parkinson’s 
disease) 
5. Vertigo within the past 3 months (e.g., Ménière’s disease, BPPV) 
 
6. Study Procedures 
6.1 Baseline Assessment 
• 
Demographics: age, sex, education level, living status 
• 
Anthropometrics & body composition (BIA): body weight, segmental 
muscle mass, visceral fat 
• 
Physical activity habits 
• 
Dominant leg determined via ball-kick test 
• 
Medical history & fall history within past year 
 
6.2 Outcome Measures 
A. Open-eye and Closed-eye Single-Leg Stance 

• 
Barefoot, hands on hips, non-dominant leg lifted with toes resting against 
stance leg 
• 
Time up to maximum 30 seconds 
• 
Termination criteria include arm movement, stepping, excessive sway, or 
eyes opening (for closed-eye condition) 
 
B. Balance Error Scoring System (BESS) 
Six conditions (20 seconds each): 
Surface Stance 
Firm 
Double-leg stance 
Foam 
Double-leg stance 
Firm 
Tandem stance (dominant foot behind) 
Foam 
Tandem stance 
Firm 
Single-leg stance (dominant leg) 
Foam 
Single-leg stance 
Scoring: 
One point for each error (max 10 per condition): 
• 
Hands lifted off iliac crest 
• 
Eyes open 
• 
Hip abduction > 30° 
• 
Stepping or lifting heel/toe 
• 
Moving out of position > 5 seconds 
BESS total score = sum of errors across all six conditions. 
 

6.3 Dual Observational Method 
To enhance scoring reliability: 
1. Real-time scoring by trained physical therapist 
2. Video-based scoring from sagittal & frontal camera views 
A second licensed physical therapist, blinded to real-time results, will 
perform video scoring. 
 
6.4 Test–Retest 
All participants repeat: 
• 
Open/closed-eye single-leg stance 
• 
BESS 
One week later. 
 
7. Risk Assessment and Safety 
BESS and single-leg standing are low-risk clinical balance tests. 
Participants may experience mild fatigue or sway; a therapist will stand nearby 
for safety to prevent falls. 
No adverse events are expected. 
 
8. Ethical Considerations 
• 
Written informed consent obtained from all participants 
• 
Study approved by the Institutional Review Board (IRB) of Kaohsiung 
Municipal United Hospital 
• 
Data anonymized and stored securely 
• 
No identiﬁable personal information will appear in publications or 
submitted documents 

Statistical Analysis Plan (SAP) 
 
1. Overview 
All statistical analyses will be conducted using SPSS v21.0. 
Signiﬁcance level: p < 0.05. 
 
2. Descriptive Statistics 
• 
Mean ± SD for continuous variables 
• 
Frequencies & percentages for categorical variables 
Variables include age, sex, body composition, SPPB score, fall history, and stance 
time. 
 
3. Reliability Analysis 
3.1 Test–Retest Reliability 
Evaluate reliability of: 
• 
Open-eye single-leg stance 
• 
Closed-eye single-leg stance 
• 
BESS (real-time & video scores) 
Using Intraclass Correlation Coefficient (ICC3,2) 
Interpretation: 
• 
ICC ≥ 0.75 → High reliability 
• 
0.50–0.75 → Moderate 
• 
0.25–0.50 → Fair 
• 
< 0.25 → Low 

 
3.2 Minimal Detectable Change (MDC) 
MDC95 will be calculated using: 
MDC95=1.96×SDdifference×2MDC_{95} = 1.96 \times SD_{\text{difference}} 
\times \sqrt{2}MDC95=1.96×SDdifference×2  
 
4. Validity Analysis 
4.1 Construct Validity 
Examine correlation between: 
• 
BESS scores 
• 
Single-leg stance times (open/closed-eye) 
Using Spearman Rank Correlation. 
Expected relationships: 
• 
Higher BESS score → poorer balance 
• 
Shorter stance time → poorer balance 
Interpretation: 
• 
r > 0.75 → High 
• 
0.50–0.75 → Moderate 
• 
0.25–0.50 → Fair 
• 
< 0.25 → Low 
 
4.2 Predictive Validity 
Explore whether BESS predicts: 
• 
Fall history 

• 
Balance performance decline 
Binary logistic regression may be applied if fall history data is sufficient. 
 
5. Responsiveness Analysis 
Compare baseline vs. 1-week follow-up scores using: 
• 
Wilcoxon matched-pairs signed rank test 
(for non-normally distributed balance measures) 
Outcome: 
Identify whether BESS or single-leg stance can detect subtle changes over time. 
 
6. Handling Missing Data 
• 
Missing items will be reported 
• 
Participants with incomplete BESS recordings will be excluded from 
reliability analysis 
• 
No imputation will be used 
 
7. Subgroup Analysis (Exploratory) 
Based on body composition or age groups (e.g., 65–74 vs ≥75 years): 
• 
Compare BESS total score 
• 
Compare single-leg stance duration 
Using Mann–Whitney U or Kruskal–Wallis tests.