NCT07307755

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 15, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 29, 2025

Completed
Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

1 month

First QC Date

December 15, 2025

Last Update Submit

December 15, 2025

Conditions

Keywords

MULTİPLE SCLEROSİSBALANCEVALİDİTYRELİABİLİTY

Outcome Measures

Primary Outcomes (6)

  • Modified O'Sullivan Functional Balance (mOFB) Test

    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

    1 YEARS

  • O'Sullivan Functional Balance Test

    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.

    1 YEARS

  • Berg Balance Scale (BBS)

    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.

    1 YEARS

  • Trunk Impairment Scale (TIS)

    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.

    1 YEARS

  • L test

    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.

    1 YEARS

  • Mini Best Test

    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.

    1 YEARS

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients admitted to the Neurology Outpatient Clinic of SANKO University Sani Konukoğlu Application and Research Hospital with a diagnosis of Multiple Sclerosis

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanko Unıversıty

Gaziantep, şehitkamil, 27090, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • HAKAN POLAT, phd

    Sanko University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Sanko University

Study Record Dates

First Submitted

December 15, 2025

First Posted

December 29, 2025

Study Start

August 1, 2025

Primary Completion

September 1, 2025

Study Completion

December 14, 2025

Last Updated

December 29, 2025

Record last verified: 2025-12

Locations