Reliability of the SOT Over Clinical Administration Time Intervals of Concussion Assessment

NCT07024368 | Completed

• 1 other identifier: UGA 2009-10347-5
• Study Type: observational
• Target: 124
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this study has two parts. First, it examines whether performing multiple Sensory Organization Tests (SOT) on the SMART Balance Master, using two different testing orders, leads to different levels of practice effects-meaning improvements in balance scores with repeated testing. Second, the study evaluates how reliable the SOT is over time by using two different postural stability measures and two different testing orders. The testing schedule follows the same time intervals commonly used in pre- and post-concussion assessments. The main hypothesis is that the order of testing-whether done in a blocked or random sequence-affects practice effects on composite and sub-composite balance scores over five repeated SOT sessions. The second hypothesis is that the multiscale entropy (MSE) complexity index will show consistent test-retest reliability across both blocked and random testing groups when following clinical concussion management timelines. Participants will complete five SOT sessions on the SMART Balance Master: three tests in one day with 20-minute breaks in between, followed by a test on day 45 and another on day 50.

Conditions

Healthy; Concussion (Diagnosis); Balance Assessment

Outcome Measures

Primary Outcomes (2)

• Practice effects: Serial Administration of the sensory organization test in health adults

  The Sensory Organization Test (SOT), administered using the SMART Balance Master®, generates one overall Composite Equilibrium Score (ES) and four sub-composite scores: somatosensory (SOM), visual (VIS), vestibular (VEST), and preference (PREF). The primary outcome measure will be the Composite ES, which reflects the overall balance performance and is expressed as a score ranging from 0 to 100, with higher scores indicating better balance. The sub-composite scores represent specific components of the balance system-somatosensory, visual, vestibular, and sensory integration preference-and are also scored on a scale from 0 to 100. Higher sub-composite scores similarly indicate better function in each respective domain. All scores are calculated by the software embedded within the SMART Balance Master® system. The Composite ES and sub-composite scores will be reported as the primary outcome measure to ensure consistency in units of measurement.

  From the time of enrollment until 60 days post-enrollment

• Test-Retest Reliability of the SOT using Mutlscal Entropy values and Equilibrium Scores in Heathy Adults

  The SMART Balance Master® provides a composite equilibrium score and four sub-composite scores (somatosensory, visual, vestibular, and preference), each ranging from 0 to 100, with higher scores indicating better balance performance. Additionally, Complexity Index (CI) scores are computed from raw center of pressure (COP) data exported from the SMART system and analyzed using MATLAB. CI, ranging from 0 to 20, quantifies postural complexity based on filtered COP data in the anterior-posterior and medial-lateral directions. Higher values indicate greater balance complexity. Although the outcomes involve two different units, this is not a concern, as the study focuses on test-retest reliability. Reliability coefficients (e.g., ICC) and standard error of measurement are unitless or interpreted within the context of each score type.

  From the time of enrollment until 60 days post-enrollment

Secondary Outcomes (1)

• Normative Sensory Organization Test and Multiscale Entropy Scores for Concussion Evaluation in a Healthy Young Population

  From the time of enrollment until 60 days post-enrollment

Study Arms (1)

Test-retest reliability of the Sensory Organization Test across clinically relevant time intervals

Participants were randomly assigned to one of two groups. Those in the block group completed the SOT following the manufacturer's recommended order, progressing in difficulty from Condition 1 to Condition 6. Those in the random group completed the SOT with conditions presented in a randomized order, generated using MS Excel software. These groups will be tested at clinically relevant time intervals: baseline (three tests), Day 45 (follow-up), and Day 50 (additional follow-up).

Device: Reliability of the Sensory Organization Test on the SMART Balance Master across multiple administrations

Interventions

Reliability of the Sensory Organization Test on the SMART Balance Master across multiple administrations DEVICE

The Sensory Organization Test (SOT) on the SMART Balance Master® will be administered a total of five times. On the first day, participants will complete three SOT sessions, each separated by a 20-minute break. An additional SOT will be conducted on day 45, followed by a final SOT on day 50. SOT test scores will be analyzed using Equilibrium Scores (ESs), which provide information on the integration of multiple sensory systems involved in balance through a linear measurement method. Additionally, scores will be evaluated using Multiscale Entropy (MSE), a non-linear model for assessing complexity in postural stability.

Test-retest reliability of the Sensory Organization Test across clinically relevant time intervals

Eligibility Criteria

• Age: 20 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteer college students without concussion

You may qualify if:

• Age 20-24
• Healthy young adults without balance problems

You may not qualify if:

• Self-reported history of concussion or head injury within the past 6 months
• Current musculoskeletal injuries in the lower extremities and/or other body parts that may affect postural stability
• Physical illnesses including visual or vestibular pathologies
• Consumption of any pharmacological substances affecting balance, recreational drugs, or alcoholic beverages within 24 hours prior to the balance test
• Self-reported severe tiredness or fatigue

Sponsors & Collaborators

• Hyung Rock Lee: lead

MeSH Terms

Conditions

Brain Concussion; Disease

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: June 17, 2025
• Study Start: December 3, 2008
• Primary Completion: December 31, 2011
• Study Completion: April 16, 2014
• Last Updated: June 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share