MULTİPLE SCLEROSİSNCT07307755
The Validity and Reliability of the Modified O'Sullivan Functional Balance (mOFB) Test for Multiple Sclerosis
An observational study of MULTİPLE SCLEROSİS and BALANCE, run by Sanko University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- MULTİPLE SCLEROSİS, BALANCE, VALİDİTY
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2025to 14 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the Neurology Outpatient Clinic of SANKO University Sani Konukoğlu Application and Research Hospital with a diagnosis of Multiple Sclerosis
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Application of the Validity and Reliability of the Modified O'Sullivan Functional Balance (mOFB) Test in Multiple Sclerosis Patients
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.
Read more
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.
Read the detailed description
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
- MULTİPLE SCLEROSİS, BALANCE, VALİDİTY, RELİABİLİTY
- Keywords
- MULTİPLE SCLEROSİS, BALANCE, VALİDİTY, RELİABİLİTY
- Medical subject headings
- Multiple Sclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 YEARS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start1 Aug 2025
- Primary completion1 Sep 2025
- Study completion14 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MULTİPLE SCLEROSİSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanko University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hakan Polat, Sanko University
- Investigators
- HAKAN POLAT, phd, Study director, Sanko University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07307755
- Sponsor's protocol ID
- hakanpolat8
- Status last verified
- Dec 2025
- First submitted
- 15 Dec 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: will be decided when the study is completed
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of the Validity and Reliability of the Modified O'Sullivan Functional Balance (mOFB) Test in Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT07307755
- Acronym / sponsor ID
- hakanpolat8
- Conditions
- MULTİPLE SCLEROSİS, BALANCE, VALİDİTY, RELİABİLİTY
- Keywords
- MULTİPLE SCLEROSİS, BALANCE, VALİDİTY, RELİABİLİTY
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Sanko UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 14 Dec 2025 (actual)
- First posted
- 29 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the Neurology Outpatient Clinic of SANKO University Sani Konukoğlu Application and Research Hospital with a diagnosis of Multiple Sclerosis
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Modified O'Sullivan Functional Balance (mOFB) Test
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Individual participant dataSharing planned: Undecided. will be decided when the study is completed
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
HAKAN POLAT, phd study director
Sanko University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of MULTİPLE SCLEROSİS and BALANCE, run by Sanko University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified O'Sullivan Functional Balance (mOFB) Test (time frame: 1 YEARS). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.