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临床试验/NCT07024368
NCT07024368已完成不适用

Reliability of the Sensory Organization Test Over Clinical Administration Time Intervals of Concussion Assessment

Hyung Rock Lee0 个研究点目标入组 124 人开始时间: 2008年12月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
124
主要终点
Practice effects: Serial Administration of the sensory organization test in health adults

研究概览

简要总结

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.

详细描述

Understanding Sport-Related Concussion and Postural Stability Assessment

Over the past two decades, sport-related concussion (SRC) has gained significant attention from the media, as well as the medical and scientific communities. Despite this, SRC remains one of the most complex and least understood neurological injuries faced by sports medicine clinicians. Many physical activities, especially contact sports, pose a high risk of SRC due to direct or indirect impacts to the head, neck, face, or body, which can transmit force to the brain.

Research has consistently shown that contact sports have a high incidence of concussion, and various tools for assessing SRC have been developed. Baseline testing is a key component of concussion management, ideally conducted before the start of the sports season and before contact drills begin. It serves as a reference point for an athlete's pre-injury performance, making it easier to identify and manage SRC when an injury occurs. Recommended baseline testing includes neurocognitive assessments, balance tests, and symptom evaluations.

Postural stability assessments are widely used to evaluate concussed athletes by measuring coordination between motor and sensory functions. Balance deficits can indicate impaired integration of the visual, vestibular, and somatosensory systems, which are crucial for maintaining an upright posture. Researchers have explored both computerized dynamic posturography and clinical balance tests as part of SRC management protocols. These methods have been validated to detect subtle declines in balance performance, with both clinical and computerized balance assessments commonly used to monitor postural stability in athletes three to five days after a concussion.

The use of postural stability testing in SRC management is becoming more common among sports medicine clinicians. Clinical and laboratory-based balance evaluations are now routinely integrated into concussion protocols. One of the most advanced tools for assessing postural stability is the Sensory Organization Test (SOT), which is designed to identify balance impairments related to sensory and motor function coordination. The SOT, performed using the SMART Balance Master®, provides a more detailed assessment of balance function under various conditions. While computerized balance testing systems like the SMART Balance Master® are expensive and time-intensive, they offer more precise and objective data for concussion evaluation and recovery monitoring.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 24 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

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

排除标准

  • •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

结局指标

主要结局

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

时间窗: From the time of enrollment until 60 days post-enrollment

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.

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

时间窗: From the time of enrollment until 60 days post-enrollment

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.

次要结局

  • 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)

研究者

发起方
Hyung Rock Lee
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hyung Rock Lee

Associate professor

University of Central Arkansas

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