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临床试验/NCT07307755
NCT07307755已完成不适用

Application of the Validity and Reliability of the Modified O'Sullivan Functional Balance (mOFB) Test in Multiple Sclerosis Patients

Sanko University1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2025年8月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
44
试验地点
1
主要终点
Modified O'Sullivan Functional Balance (mOFB) Test

研究概览

简要总结

This study aims to investigate the validity and reliability of the Modified O'Sullivan Functional Balance (OFB) Test, which is used to assess balance in individuals diagnosed with Multiple Sclerosis (MS).

Multiple Sclerosis is a chronic nervous system disease that can cause symptoms such as balance problems, difficulty walking, and fatigue, which negatively affect daily life. Balance disorders are common in MS patients, increasing the risk of falls and leading to a decrease in physical activity levels. Therefore, the accurate and reliable assessment of balance in MS patients is of great importance.

This study will include volunteer MS patients treated at the Physical Therapy and Rehabilitation Department of SANKO University Sani Konukoğlu Application and Research Hospital who meet the inclusion criteria. After recording the participants' demographic and disease-related information, their balance, body control, and walking skills will be assessed using various clinical tests. These tests include the Berg Balance Test, Mini-BESTest, O'Sullivan Functional Balance Test, Modified O'Sullivan Functional Balance Test, Trunk Instability Scale, and L Test.

Assessments will be conducted taking into account the fatigue commonly seen in MS patients, and participants will be allowed to rest when needed. The results obtained will reveal whether the Modified O'Sullivan Functional Balance Test is a reliable and applicable method for assessing balance in MS patients.

It is anticipated that the results of this study will contribute to clinical practice in the assessment of balance in MS patients and assist in the more effective planning of the rehabilitation process.

详细描述

This study is a methodological research designed to evaluate the validity and reliability of the Modified O'Sullivan Functional Balance (OFB) Test in individuals diagnosed with Multiple Sclerosis (MS).

Before the assessments, all participants will receive a practical explanation and demonstration of how each test is performed. Considering the high prevalence of fatigue in individuals with MS, the assessment protocol will be planned to allow adequate rest periods, and participants will be seated and rested prior to the administration of the Modified O'Sullivan Functional Balance (OFB) Test.

Assessments will be conducted on two separate days with a one-week interval, consisting of two sessions per day. On the first day, during the first session, the Modified O'Sullivan Functional Balance (OFB) Test will be administered by the first assessor (Dr. PT Meltem Uzun). In the same session, the Berg Balance Scale, Mini-BESTest, Trunk Impairment Scale, and L Test will also be applied. During the second session on the first day, the Modified O'Sullivan Functional Balance (OFB) Test will be administered by the second assessor (Dr. PT Hakan Polat).

On the second assessment day, the Modified O'Sullivan Functional Balance (OFB) Test will be administered sequentially by Dr. PT Meltem Uzun and Dr. PT Hakan Polat. This assessment protocol will allow the evaluation of both inter-rater reliability and test-retest reliability by performing the same measurements on different days and by different physiotherapists.

All assessments will be carried out in the Application and Research Laboratory of the Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, SANKO University. Participants will be evaluated in the same environment during all sessions to minimize the effects of environmental factors on performance. The assessment room will be maintained at normal room temperature, adequately illuminated, and have a firm surface floor. Each assessment session will last approximately 25-30 minutes, while the total duration of the first session, including interviews and evaluations, will be approximately 40-45 minutes.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants aged 18-65 years
  • Volunteers participating in the study
  • Individuals not using any assistive devices
  • Individuals unable to maintain the tandem stance test for more than 10 seconds
  • Individuals with an Expanded Disability Status Scale (EDSS) score ≤ 5.5

排除标准

  • Pregnant or within the first 3 months postpartum
  • Received corticosteroid treatment within the last month
  • Took any medication affecting walking ability within the last month

结局指标

主要结局

Modified O'Sullivan Functional Balance (mOFB) Test

时间窗: 1 YEARS

The mOFB is a modified version of the OFB that incorporates adjusted grading criteria, combined with external resistance to challenge static balance and weight shifting to challenge dynamic balance. A previous study found that this modified test had low to moderate reliability due to the lack of clear test instructions and scoring criteria. To address these limitations, we developed standardised test instructions and scoring criteria, as summarised in the Supplementary Material , before evaluating the psychometric properties of the mOFB. The assessment takes approximately 5 minutes and can be performed on a fixed bed or chair using only a stopwatch. The test condition consists of static sitting balance, dynamic sitting balance, static standing balance, and dynamic standing balance. Scoring is based on observing the patient's ability to maintain balance while sitting or standing quietly for 60 seconds, respond to external disturbances, and reach in various directions beyond

O'Sullivan Functional Balance Test

时间窗: 1 YEARS

The OFB is a scoring tool used to assess both static and dynamic balance in various positions. This test highlights the ability to maintain postural stability and make postural adjustments in response to voluntary movements such as turning the head or torso, reaching for an object on the ground, and shifting body weight. The OFB test uses a 5-level ordinal rating scale: zero, poor, fair, good, and normal. A zero score indicates an inability to maintain balance, while a 'normal' score reflects normal balance performance . This study converted the rating scale into sequential scores ranging from 0 to 4, where 0 indicates an inability to maintain balance independently and 4 indicates normal balance, assessed across four components: static sitting balance, dynamic sitting balance, static standing balance, and dynamic standing balance. The total OFB score is 16, and sub-scores can be given for individual test positions. For example, the static sitting balance sub-score ranges from 0 to 4.

Berg Balance Scale (BBS)

时间窗: 1 YEARS

The BBS is widely used and is currently accepted as the reference standard for assessing balance in individuals who have suffered a stroke. The BBS consists of 14 functional balance tasks that focus on the ability to maintain a position and make postural adjustments based on voluntary movements. It is simple to administer and requires minimal equipment and time to complete. Each item is scored between 0 and 4; 0 indicates inability to perform the task, while 4 indicates optimal performance. The maximum score is 56, and scores below 45 indicate a high risk of falling.

Trunk Impairment Scale (TIS)

时间窗: 1 YEARS

The Trunk Impairment Scale (TIS) is designed to measure motor impairment of the trunk by assessing static and dynamic sitting balance and trunk coordination. The original TIS assesses three components: static sitting balance (maximum score = 7), dynamic sitting balance (maximum score = 10), and trunk coordination (maximum score = 6), with a total of 23 points possible. A key advantage of the TIS is its minimal equipment requirement, making it highly practical for use in clinical settings.

L test

时间窗: 1 YEARS

This test indirectly assesses walking speed and dynamic balance during walking and turning activities. It is a modified version of the TUG test. The walking path is L-shaped. The L test is a more comprehensive test than the TUG test as it involves a greater walking distance and turning activity in both directions. The L test assesses the fundamental components of functional mobility, such as balance, transfer, walking, and turning. During the test, the individual stands up from the chair, walks 3 metres, turns right, walks 7 metres, then turns back and walks along the same path to sit down on the chair. The measured distance will be recorded in metres.

Mini Best Test

时间窗: 1 YEARS

This is one of the clinical tests used to assess walking and balance. It consists of four sub-parameters: preparatory movement, reactive postural control, sensory orientation, and dynamic walking, comprising a total of 14 items. It is a test scored out of a total of 28 points, taking an average of 10-15 minutes to complete. A high score indicates high function.

次要结局

未报告次要终点

研究者

发起方
Sanko University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hakan Polat

Sanko University

Sanko University

研究点 (1)

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