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MS (Multiple Sclerosis)NCT06849882

Dubousset Functional Test: an Investigation of Its Validity and Reliability in Individuals with Multiple Sclerosis

An observational study of MS (Multiple Sclerosis), run by Inonu University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Multiple sclerosis (MS) is an autoimmune disease characterized by neuroinflammation and neurodegeneration in the central nervous system. The disease affects the white matter, cortex and deep gray matter of the central nervous system and is characterized by inflammatory-demyelinating lesions and neuronal/axonal… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
MS (Multiple Sclerosis)
How many people
33 participants
Where
1 siteTurkey (Türkiye)
Study dates
10 Feb 2025to May 2025
Phase
Observational
Are there results?
Not yet: the study is under way

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: Thirty-three individuals with MS who met the inclusion criteria will be included in the study. G-Power 3.1.9.2 program was used to estimate the required sample size and it was observed that the effect obtained in the reference study was strong (d = 0.731) (17). As a result of the power analysis performed with the assumption that this effect size could be obtained again, it was calculated that 95% statistical power would be obtained at 95% confidence level if at least 33 people were included in the study.

Who may be able to join

  • Being diagnosed with MS,
  • Over 18 years of age and under 65 years of age,
  • To be able to balance independently in standing position.
  • EDSS score of 3.5 and below
  • At the appropriate cognitive level to adapt to the tests to be performed in the study,
  • Completed primary school level,

Who cannot join

  • Relapse within the last 30 days,
  • Loss of balance or gait disturbance affected by a condition other than MS,
  • Being pregnant for female individuals,
  • An attack of optic neuritis in the last month
  • Individuals who are unable to perform the task due to sensory, cognitive or other problems will be excluded.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

betül erciyes university contact

+905061514082

bonerdiir@gmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Erciyes University

    Kayseri, Kayseri, 38080

    betül erciyes university, 03522076666, bonerdiir@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Multiple sclerosis (MS) is an autoimmune disease characterized by neuroinflammation and neurodegeneration in the central nervous system. The disease affects the white matter, cortex and deep gray matter of the central nervous system and is characterized by inflammatory-demyelinating lesions and neuronal/axonal degeneration. Demyelination associated with these lesions and the accompanying axonal degeneration are responsible for neurological disability in MS. There are many scales and mobility and functional performance tests in the literature to assess balance, such as the Sit Reach Test, Timed Up and Go (TUG) test, Tinetti Performance Oriented Mobility Assessment (POMA), Berg Balance Scale (BBS) (5) and Balance Evaluation System Test (BESTest). The most appropriate balance assessment scales for individuals with MS are those that assess static and dynamic sitting balance while standing and dynamic balance only. Since balance in individuals with MS is a dynamic process that changes gradually, new measurement methods that can record these changes and determine the appropriate treatment for these variables are needed.

The Dubousset Functional Test (DFT) was developed by Dr. Jean Dubousset as a four-component practical assessment to evaluate the physical function and balance capacity of individuals with spinal deformity. The DFT consists of four components: getting up from an armless chair and walking 5 meters forward and backward, ascending and descending steps, transition from standing to sitting position, and gait assessment with a dual task test (counting backwards from 50). The difference of this test from the others is that it evaluates the spinopelvic muscle groups that are directly related to functionality, maintains the global trunk alignment of the individual and provides objective results about functional performance and balance. In addition, unlike other functional performance tests, the DFT assesses the neurophysiological effects of the process that requires individuals to perform two tasks at the same time by measuring their coordination, balance, attention and thinking skills during functioning through a dual task component. The validity and reliability of this test has been previously investigated in low back pain, stroke, parkinson's disease, elderly individuals and hemiplegia. In this study, it was aimed to examine the validity and reliability of the Dubousset functional test in individuals with multiple sclerosis.

Read the detailed description

Socio-demographic characteristics, physical characteristics (age, body weight, height), educational status, occupation, duration of MS, age at onset of MS, clinical type of MS, number and site of attacks, presence of optic neuritis, EDSS score, medications, chronic diseases, and smoking will be recorded.

Expanded Disability Status Scale (EDSS): All volunteers participating in the study will undergo a neurologic examination and the disability rate will be evaluated using the EDSS for each individual with MS. The EDSS is scored between 0 and 10, with higher scores indicating more disability. A score of zero indicates completely normal functioning, while a score of 10 indicates death due to MS. Individuals with a score of 3.5 and below will be included in the study.

Test Procedures Demographic data will be recorded at the baseline assessment. Our study will be conducted in a "test-retest" design and the psychometric properties of the Dubousset Function Test (DFT) will be examined in individuals with MS. The DFT, TUG, dual-task TUG, Tinetti Performance Oriented Mobility Assessment (POMA), Berg Balance Scale (BBS), Functional Reach Test and 3-meter backward walking test (3MBWT) will be administered to individuals. The completion times of the DFT will be performed by the same physiotherapist. The second assessment (retest) will be performed 7 days after the first assessment (test) by the same physiotherapist to determine the reliability of the DFT. Rest periods of 2 minutes will be given between assessments to minimize the effects of fatigue. Participants will not receive any treatment for 7 days and the test-retest will be performed at the same time.

Dubousset Functional Test (DFT):

A conceptual four-component global functional assessment test - Dubousset Functional Test (DFT) will be applied to objectively measure the functional capacity of individuals (11). These four components are as follows;

  1. Get Up and Walk Test: Individuals with MS will stand up unassisted from a seated position in a chair without arms, walk 5 meters (500 cm), turn around, walk back 5 meters and sit down again unassisted.
  2. Step Test: individuals with MS will climb three steps of stairs from a starting position 50 cm away, turn around on the third step and walk back down.
  3. Sit and stand test: Individuals with MS will sit on the floor from a standing position with assistance if necessary and stand up again with assistance if necessary.
  4. Dual Task Test: Individuals with MS will walk 5 meters forward, turn around and walk 5 meters backward while performing a memory exercise (counting down from 50 in 2 intervals).

TUG (Timed Up and Go) Test: The TUG test is a tool designed to assess dynamic balance, walking speed and mobility. To complete the test, participants are required to get up from a chair with armrests, walk 3 m, turn, walk back and sit on the chair. The completion time of the test is recorded with a stopwatch (3).

Dual Task TUG (Additional Cognitive Task): During the TUG test, counting backwards by twos from 50 will be used as an additional cognitive task. When the test had to be repeated, individuals continued counting from the number they had left off. Counting errors will be ignored (12).

Tinetti POMA: It is also called the Tinetti Mobility Test and is a reliable and valid clinical test used to measure balance and walking abilities. It consists of a total POMA scale (POMA-T), a balance subscale (POMA-B) and a gait subscale (POMA-G). Each step is scored between 0 (maximum inability) and 2 (complete independence) (13).

Berg Balance Scale (BBS): It is a widely used measurement tool to assess functional balance. The BBS consists of 14 items and each item is scored between 0 and 4 according to the level of balance impairment. Higher scores on the BDI indicate better balance performance (14).

3 Meter Backward Walking Test (3MBWT): A distance of 3 meters (m) is measured and marked with black tape. Patients are asked to follow the black tape with their heels. When the "Start" command is given, they are asked to walk backwards quickly. When a distance of 3 meters is completed, they are told to stop (15).

Functional Reach Test (FRT) : It is a test that evaluates dynamic bilateral postural balance. At the beginning of the test, the dominant arm is placed in a 90° flexion position and the distance between the feet is set to 10 cm. The maximum distance a person can extend their arm horizontally forward without moving their feet is measured in centimeters. The maximum distance he/she can reach and return to the starting position without losing balance is recorded. The test will be repeated three times and the average of these three values will be taken (16).

Keywords
Multiple Sclerosis, Dubousset Functional Test, Validity, Reliability
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06849882
Study groupRoleWhat they receive
Dubousset Functional Test: Individuals with Multiple SclerosisNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dubousset Functional Testing in Individuals with MS

    The aim of this study is to investigate the validity and reliability of the Dubousset functional test in individuals with multiple sclerosis.The Dubousset Functional Test consists of four components;

    1. Get Up and Walk Test: Individuals with MS will stand up unassisted from a seated position in a chair without arms, walk 5 meters (500 cm), turn around, walk back 5 meters and sit down again unassisted.
    2. Step Test: individuals with MS will climb three steps of stairs from a starting position 50 cm away, turn around on the third step and walk back down.
    3. Sit and stand test: Individuals with MS will sit on the floor from a standing position with assistance if necessary and stand up again with assistance if necessary.
    4. Dual Task Test: Individuals with MS will walk 5 meters forward, turn around and walk 5 meters backward while performing a memory exercise (counting down from 50 in 2 intervals).

    Measured: Day 1

Secondary outcomes (6)
  1. TUG (Timed Up and Go) Test

    The TUG test is a tool designed to assess dynamic balance, walking speed and mobility. To complete the test, participants are required to get up from a chair with armrests, walk 3 m, turn, walk back and sit on the chair. The completion time of the test is recorded with a stopwatch (3).

    Measured: Day 1

  2. Dual Task TUG (Additional Cognitive Task)

    During the TUG test, counting backwards by twos from 50 will be used as an additional cognitive task. When the test had to be repeated, individuals continued counting from the number they had left off. Counting errors will be ignored.

    Measured: Day 1

  3. Tinetti POMA

    It is also called the Tinetti Mobility Test and is a reliable and valid clinical test used to measure balance and walking abilities. It consists of a total POMA scale (POMA-T), a balance subscale (POMA-B) and a gait subscale (POMA-G). Each step is scored between 0 (maximum inability) and 2 (complete independence).

    Measured: Day 1

  4. Berg Balance Scale (BBS)

    It is a widely used measurement tool to assess functional balance. The BBS consists of 14 items and each item is scored between 0 and 4 according to the level of balance impairment. Higher scores on the BDI indicate better balance performance.

    Measured: Day 1

  5. 3 Meter Backward Walking Test (3MBWT)

    A distance of 3 meters (m) is measured and marked with black tape. Patients are asked to follow the black tape with their heels. When the "Start" command is given, they are asked to walk backwards quickly. When the 3-meter distance is completed, they are told to stop.

    Measured: Day 1

  6. Functional Reach Test (FRT)

    : It is a test that evaluates dynamic bilateral postural balance. At the beginning of the test, the dominant arm is placed in a 90° flexion position and the distance between the feet is set to 10 cm. The maximum distance a person can extend their arm horizontally forward without moving their feet is measured in centimeters. The maximum distance he/she can reach and return to the starting position without losing balance is recorded. The test will be repeated three times and the average of these three values will be taken.

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2025
  2. Study start10 Feb 2025
  3. Primary completionMar 2025 (estimated)
  4. Study completionMay 2025 (estimated)

Resources

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
33 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06849882
Sponsor's protocol ID
Dubousset -MS
Status last verified
Feb 2025
First submitted
17 Feb 2025
Last updated
3 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of MS (Multiple Sclerosis), run by Inonu 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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 3 Mar 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact betül erciyes university (+905061514082, bonerdiir@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dubousset Functional Testing in Individuals with MS (time frame: Day 1). 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 3 Mar 2025.

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