NCT06849882

Brief 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 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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2025

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 27, 2025

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

March 3, 2025

Status Verified

February 1, 2025

Enrollment Period

19 days

First QC Date

February 17, 2025

Last Update Submit

February 27, 2025

Conditions

Keywords

Multiple SclerosisDubousset Functional TestValidityReliability

Outcome Measures

Primary Outcomes (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).

    Day 1

Secondary Outcomes (6)

  • TUG (Timed Up and Go) Test

    Day 1

  • Dual Task TUG (Additional Cognitive Task)

    Day 1

  • Tinetti POMA

    Day 1

  • Berg Balance Scale (BBS)

    Day 1

  • 3 Meter Backward Walking Test (3MBWT)

    Day 1

  • +1 more secondary outcomes

Study Arms (1)

Dubousset Functional Test: Individuals with Multiple Sclerosis

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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,

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erciyes University

Kayseri, Kayseri, 38080, Turkey (Türkiye)

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

samples will not be stored and DNA will not be used within the scope of the study.

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

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

Central Study Contacts

betül erciyes university

CONTACT

Study Design

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

Study Record Dates

First Submitted

February 17, 2025

First Posted

February 27, 2025

Study Start

February 10, 2025

Primary Completion

March 1, 2025

Study Completion

May 1, 2025

Last Updated

March 3, 2025

Record last verified: 2025-02

Locations