Multiple SclerosisNCT05182398
Validity and Reliability of the Modified Four Square Step Test in Multiple Sclerosis Patients
An observational study of Multiple Sclerosis, run by Kahramanmaras Sutcu Imam University.
Trial summary
Balance disorder is common in people with MS. As the disease worsens, it is associated with impaired balance, difficulty walking, decreased mobility, and an increased risk of falling. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Assesment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2022to 15 Aug 2022
- How long will I take part?
- 1 Day
- 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
- Adult, Older adult
Study population: Multiple Sclerosis Patients
Who may be able to join
- Having an EDSS score of 4 and below,
- Being between the ages of 18-65
- Willingness to participate in the study
Who cannot join
- Being pregnant or within the first 3 months after giving birth,
- Receiving corticosteroid therapy in the last 1 month,
- Using drugs that will affect walking in the last 1 month
About this study
Official title: Investigation of Validity and Reliability of the Modified Four Square Step Test in Multiple Sclerosis Patients
Balance disorder is common in people with MS. As the disease worsens, it is associated with impaired balance, difficulty walking, decreased mobility, and an increased risk of falling. Given the prevalence and clinical significance of balance dysfunction in individuals with MS, the assessment of balance has become an important focus in MS clinical practice and research. The Four Square Step Test is a standard clinical measure used to assess dynamic standing balance. It is a timed test in which the individual is instructed to step rapidly forward, backward, and to the right and left over a low obstacle (a cane). The test assesses the ability to quickly change direction of movement and is a timed test involving the use of assistive devices.
In the modified four-square stepping test, the floor is divided into four equal squares with tape instead of a cane. Performing the test with tape, instead of patients at risk of being stuck with a cane, will ensure its applicability to a wider patient population.
The aim of the study is to examine the validity and reliability of the modified four-frame stepping test in MS patients.
Read the detailed description
Multiple sclerosis (MS) is a progressive disease of the central nervous system characterized by demyelination and destruction of motor and sensory axons. As the disease worsens, it is associated with impaired balance, difficulty walking, decreased mobility, and an increased risk of falling. The prevalence of balance dysfunction in individuals with MS and Given its clinical relevance, the assessment of balance has become an important focus in MS clinical practice and research.The Four Square Step Test is a standard clinical measure used to assess dynamic standing balance.The individual rapidly forwards over a low obstacle (a cane), is a timed test in which instructed to step backward and to the right and left.The four-frame stepping test was developed to document deficiencies in stance balance, predict falls, assess self-perceived limitations in walking, and compare changes in standing balance following exercise training. Compared to other standardized tests, scoring is not dependent on the subjectivity of the examiner, can be administered by a person with minimal training, and requires minimal time, space, and equipment. In the modified four-square stepping test, the floor is divided into four equal squares with tape instead of a cane. Performing the test with tape, instead of patients at risk of being stuck with a cane, will ensure its applicability to a wider patient population.
- Conditions
- Multiple Sclerosis
- Being tested
- Assesment
- Keywords
- Fall, Modified Four Square Step Test, Multiple sclerosis, Balance
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AssesmentOther
Modified Four Square Step Test, Berg Balance Scale, Dynamic Gait Index ,Activity-Specific Balance Confidence Scale
| Study group | Role | What they receive |
|---|---|---|
| Multiple sclerosis patient | First day, first evaluator will perform all tests, and second day, second evaluator will perform Modified Four Square Step Test. Receives: Other: Assesment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Four Square Step Test
The square drawn on the floor is divided by tape into 4 equal parts. The number 1 is written in the lower right corner, and the number 4 is written clockwise. With the start command, individuals are asked to step on the numbers in order. First of all, he is asked to take a step forward (to the number 1 and 2), then to the left (to the number 3), then to the back (to the number 4). Then he is asked to take steps from 4 to 1 again. Time is saved
Measured: First day
Modified Four Square Step Test
The square drawn on the floor is divided by tape into 4 equal parts. The number 1 is written in the lower right corner, and the number 4 is written clockwise. With the start command, individuals are asked to step on the numbers in order. First of all, he is asked to take a step forward (to the number 1 and 2), then to the left (to the number 3), then to the back (to the number 4). Then he is asked to take steps from 4 to 1 again. Time is saved
Measured: second day
Secondary outcomes (3)
Berg Balance scale
It is a 14-item scale that measures the ability to maintain balance while performing functional tasks. Each item is scored between 0 and 4. Balance is considered good if the total score is 45 and above.
Measured: First day
Dynamic Gait Index
It consists of 8 walking activities: normal walking, fast-slow walking, walking with horizontal and vertical head movements, walking by jumping from the disabled floor and walking around the obstacle, and turning 360 degrees abruptly on command, going up and down the stairs. During these 8 activities, the patient's performance is scored between 0-3 (0=severe, 3=normal) and the total score is recorded.
Measured: First day
Activity-Specific Balance Confidence Scale
It is a scale that evaluates how confidently people can do 16 activities outside and inside the home. Activities are scored between 0 (unsafe) and 100 (completely confident). A score is obtained by dividing the total score by 16. A higher score indicates greater confidence.
Measured: First day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start15 May 2022 (estimated)
- Primary completion15 Jul 2022 (estimated)
- Study completion15 Aug 2022 (estimated)
Why it stopped: The study was stopped because the validity and reliability study of the test method was published in the same patient group.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zekiye İpek KATIRCI KIRMACI, Kahramanmaras Sutcu Imam University
- Investigators
- Zekiye İpek Katırcı Kırmacı, Principal investigator, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05182398
- Sponsor's protocol ID
- ipekkatircikirmaci
- Status last verified
- Mar 2025
- First submitted
- 15 Dec 2021
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Validity and Reliability of the Modified Four Square Step Test in Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT05182398
- Acronym / sponsor ID
- ipekkatircikirmaci
- Conditions
- Multiple Sclerosis
- Keywords
- Fall, Modified Four Square Step Test, Multiple sclerosis, Balance
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study was stopped because the validity and reliability study of the test method was published in the same patient group.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 15 May 2022 (estimated)
- Primary completion
- 15 Jul 2022 (estimated)
- Study completion
- 15 Aug 2022 (estimated)
- First posted
- 10 Jan 2022 (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.
Balance disorder is common in people with MS. As the disease worsens, it is associated with impaired balance, difficulty walking, decreased mobility, and an increased risk of falling. Given the prevalence and clinical significance of balance dysfunction in individuals with MS, the assessment of balance has become an important focus in MS clinical practice and research. The Four Square Step Test is a standard clinical measure used to assess dynamic standing balance. It is a timed test in which the individual is instructed to step rapidly forward, backward, and to the right and left over a low obstacle (a cane). The test assesses the ability to quickly change direction of movement and is a timed test involving the use of assistive devices.
In the modified four-square stepping test, the floor is divided into four equal squares with tape instead of a cane. Performing the test with tape, instead of patients at risk of being stuck with a cane, will ensure its applicability to a wider patient population.
The aim of the study is to examine the validity and reliability of the modified four-frame stepping test in MS patients.
Detailed description
Multiple sclerosis (MS) is a progressive disease of the central nervous system characterized by demyelination and destruction of motor and sensory axons. As the disease worsens, it is associated with impaired balance, difficulty walking, decreased mobility, and an increased risk of falling. The prevalence of balance dysfunction in individuals with MS and Given its clinical relevance, the assessment of balance has become an important focus in MS clinical practice and research.The Four Square Step Test is a standard clinical measure used to assess dynamic standing balance.The individual rapidly forwards over a low obstacle (a cane), is a timed test in which instructed to step backward and to the right and left.The four-frame stepping test was developed to document deficiencies in stance balance, predict falls, assess self-perceived limitations in walking, and compare changes in standing balance following exercise training. Compared to other standardized tests, scoring is not dependent on the subjectivity of the examiner, can be administered by a person with minimal training, and requires minimal time, space, and equipment. In the modified four-square stepping test, the floor is divided into four equal squares with tape instead of a cane. Performing the test with tape, instead of patients at risk of being stuck with a cane, will ensure its applicability to a wider patient population.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiple sclerosis patient | – | Other: AssesmentFirst day, first evaluator will perform all tests, and second day, second evaluator will perform Modified Four Square Step Test. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Multiple Sclerosis Patients
Key inclusion criteria (3 listed)
- Having an EDSS score of 4 and below,
- Being between the ages of 18-65
- Willingness to participate in the study
Key exclusion criteria (3 listed)
- Being pregnant or within the first 3 months after giving birth,
- Receiving corticosteroid therapy in the last 1 month,
- Using drugs that will affect walking in the last 1 month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AssesmentModified Four Square Step Test, Berg Balance Scale, Dynamic Gait Index ,Activity-Specific Balance Confidence Scale | Other | Multiple sclerosis patient |
Primary outcome
Modified Four Square Step Test
Time frame: First day
The square drawn on the floor is divided by tape into 4 equal parts. The number 1 is written in the lower right corner, and the number 4 is written clockwise. With the start command, individuals are asked to step on the numbers in order. First of all, he is asked to take a step forward (to the number 1 and 2), then to the left (to the number 3), then to the back (to the number 4). Then he is asked to take steps from 4 to 1 again. Time is saved
Modified Four Square Step Test
Time frame: second day
The square drawn on the floor is divided by tape into 4 equal parts. The number 1 is written in the lower right corner, and the number 4 is written clockwise. With the start command, individuals are asked to step on the numbers in order. First of all, he is asked to take a step forward (to the number 1 and 2), then to the left (to the number 3), then to the back (to the number 4). Then he is asked to take steps from 4 to 1 again. Time is saved
3 secondary outcomes
Berg Balance scale
Time frame: First day
Dynamic Gait Index
Time frame: First day
Activity-Specific Balance Confidence Scale
Time frame: First day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
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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.
Zekiye İpek Katırcı Kırmacı principal investigator
Kahramanmaras Sutcu Imam University
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Kahramanmaras Sutcu Imam University.
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 3 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: withdrawn, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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 Four Square Step Test (time frame: First day). The study lists 2 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 10 Mar 2025.