The Validity and Reliability of the Modified O'Sullivan Functional Balance (mOFB) Test for Multiple Sclerosis

NCT ID: NCT07307755

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

44 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-01

Study Completion Date

2025-12-14

Brief Summary

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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.

Detailed Description

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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.

Prof. Dr. Suat Erel and Assoc. Prof. Dr. Emel Taşvuran Horata will be responsible for the planning of the study, formulation of hypotheses, interpretation of results, and preparation of the scientific manuscript.

All collected data will be coded using project identification numbers to ensure participant confidentiality. Data will be stored and managed using Microsoft Excel, and access will be restricted exclusively to the research team members involved in the project.

Conditions

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MULTİPLE SCLEROSİS BALANCE VALİDİTY RELİABİLİTY

Keywords

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MULTİPLE SCLEROSİS BALANCE VALİDİTY RELİABİLİTY

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanko University

OTHER

Sponsor Role lead

Responsible Party

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Hakan Polat

Sanko University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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HAKAN POLAT, phd

Role: STUDY_DIRECTOR

Sanko University

Locations

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Sanko Unıversıty

Gaziantep, şehitkamil, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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hakanpolat8

Identifier Type: -

Identifier Source: org_study_id