Multiple SclerosisNCT06849960
Relıabılıty and valıdıty of the Two-minute Test wıth Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Sanko University at 2 sites in Turkey (Türkiye).
Trial summary
The study will include 50 MS patients who were examined by a specialist neurologist diagnosed according to McDonalds criteria in the Neurology Outpatient Clinic of SANKO University Sani Konukoğlu Application and Research Hospital and whose informed consent was obtained. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 50 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Feb 2025to 1 Mar 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: PATIENTS DIAGNOSED WITH MULTIPLE SCLEROSIS ADMITTED TO THE NEUROLOGY OUTPATIENT CLINIC OF SANKO UNİVERSİTESİ SANİ KONUKOĞLU APPLICATION AND RESEARCH HOSPITA
Who may be able to join
- being diagnosed with revised 2017 McDonald criteria,
- aged older than 18 years,
- ability to walk with or without aid,
- no medication changes in the last 2 months,
- volunteering to participate in the research,
- not having any obstacles to verbal and cognitive communication.
Who cannot join
- having orthopedic, psychological, and other neurological disorders, having had -a relapse in the past 3 months
- having pregnancy.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites
Sanko University
Gaziantep, Şehi̇tkami̇l, 27500
Sanko University
Şehitkamil, Gaziantep, 27500
About this study
Official title: Reliabilitiy and Validity of the Two-minute Step Test in Patients With Multiple Sclerosis
The study will include 50 MS patients who were examined by a specialist neurologist diagnosed according to McDonalds criteria in the Neurology Outpatient Clinic of SANKO University Sani Konukoğlu Application and Research Hospital and whose informed consent was obtained. Ethical approval of the study was obtained from SANKO University Non-Interventional Clinical Research Ethics Committee (No:2025/01- ethics committee decision No:2).
MS patients between the ages of 18-65 years, with an Expanded Disability Status Scale (EDSS) score ≤ 4, who are not pregnant, who have not had an attack in the last 1 month and who have not received corticosteroid treatment will be included in the study. Individuals who have taken any medication that may affect walking and balance ability in the last month, have orthopedic, other neurologic diseases and cognitive problems will not be included in the study.
Demographic information (age, height, weight, body mass index and gender) of individuals with MS will be recorded. Firstly, the tests will be explained to the individuals in detail.Assessments will be performed by a physiotherapist with 10 years of experience in this field.
Read the detailed description
Multiple Sclerosis (MS) is a demyelinating, inflammatory, neurodegenerative and progressive disease with a complex etiology. the symptoms of the disease vary according to the lesion site and generally include problems such as balance and fall problems, fatigue, loss of strength and spasticity in the lower extremities, and sensory disturbances.
The study will include 50 MS patients who were examined by a specialist neurologist diagnosed according to McDonalds criteria in the Neurology Outpatient Clinic of SANKO University Sani Konukoğlu Application and Research Hospital and whose informed consent was obtained. Ethical approval of the study was obtained from SANKO University Non-Interventional Clinical Research Ethics Committee (No:2025/01- ethics committee decision No:2).
MS patients between the ages of 18-65 years, with an Expanded Disability Status Scale (EDSS) score ≤ 4, who are not pregnant, who have not had an attack in the last 1 month and who have not received corticosteroid treatment will be included in the study. Individuals who have taken any medication that may affect walking and balance ability in the last month, have orthopedic, other neurologic diseases and cognitive problems will not be included in the study.
Demographic information (age, height, weight, body mass index and gender) of individuals with MS will be recorded. Firstly, the tests will be explained to the individuals in detail.Assessments will be performed by a physiotherapist with 10 years of experience in this field.
Assessments will be performed separately by two physiotherapists on two consecutive days. Each physiotherapist will administer the tests in two separate sessions on one day. The time to complete the activities during the tests will be recorded with a stopwatch. Patients will be unaware of the recorded time. Individuals will be rested before the tests. On the first day, the first assessor will administer the 2MST in the first session. Then 2MWT and Single Leg Stance tests will be performed respectively. In the next session, the second evaluator will perform the 2MST. On the 2nd day of the assessment, the second assessor will first perform the 2MST. Then, the first assessor will perform the 2MST. In both sessions, individuals will be assessed in the same environment to minimize the influence of environmental factors. This environment has adequate lighting and the floor of the room has a hard surface as a safety precaution due to the risk of falling. Due to the risk of heat intolerance problem in MS, attention was paid to the room temperature and the room temperature will be at normal room temperature.
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis
- Medical subject headings
- Multiple Sclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
2 min step test (2MST)
The 2MST is a test used to measure physical performance. Before starting the test, the wall was marked with tape at the midpoint between the spina iliaca anteriosuperior and the patella. The participant was asked to start walking in place without running when the signal was given. During the test, the number of right and left knee lifts reaching the mark within 2 minutes was recorded . The most affected side's results of patients were used for analysis.
Measured: 1 years
2-min walk test (2MWT)
This test measures the distance that individuals walk in 2 minutes and assesses their functional capacity. The person walks for 2 minutes at maximum speed between two cones placed by measuring 15 meters. If an assistive device is used, the person can walk with the device. Since 6-minute walk test may cause fatigue in MS patients, 2MWT is recommended. Its validity in MS was demonstrated by Scalzitti et al.
Measured: 1 years
One-leg stand test (OLSTS)
OLSTS measured the time that the person could maintain the posture without losing balance in a standing position on one leg with eyes open. It was repeated for both feet. The most affected side's results of patients were used for analysis.
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 posted27 Feb 2025
- Study start1 Feb 2025
- Primary completion15 Feb 2025
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanko University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hakan Polat, Sanko University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06849960
- Sponsor's protocol ID
- hakanpolatt
- Status last verified
- Feb 2025
- First submitted
- 23 Feb 2025
- Last updated
- 27 Feb 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
Publications
de Jesus SFC, Bassi-Dibai D, Pontes-Silva A, da Silva de Araujo A, de Freitas Faria Silva S, Veneroso CE, de Paula Gomes CAF, Dibai-Filho AV. Construct validity and reliability of the 2-Minute Step Test (2MST) in individuals with low back pain. BMC Musculoskelet Disord. 2022 Dec 5;23(1):1062. doi: 10.1186/s12891-022-06050-w.
PubMed 36471309Braghieri HA, Kanegusuku H, Corso SD, Cucato GG, Monteiro F, Wolosker N, Correia MA, Ritti-Dias RM. Validity and reliability of 2-min step test in patients with symptomatic peripheral artery disease. J Vasc Nurs. 2021 Jun;39(2):33-38. doi: 10.1016/j.jvn.2021.02.004. Epub 2021 Mar 19.
PubMed 34120695Polat H, Katirci-Kirmaci ZI, Uzun M, Ekmekyapar-Firat Y, Erel S, Neyal AM. Validity, intra-rater and inter-rater reliability, and minimal detectable change of the two-minute step test in patients with multiple sclerosis. Mult Scler Relat Disord. 2025 Dec;104:106773. doi: 10.1016/j.msard.2025.106773. Epub 2025 Sep 19.
PubMed 41038137
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliabilitiy and Validity of the Two-minute Step Test in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06849960
- Acronym / sponsor ID
- hakanpolatt
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sanko UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 15 Feb 2025 (actual)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 27 Feb 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.
The study will include 50 MS patients who were examined by a specialist neurologist diagnosed according to McDonalds criteria in the Neurology Outpatient Clinic of SANKO University Sani Konukoğlu Application and Research Hospital and whose informed consent was obtained. Ethical approval of the study was obtained from SANKO University Non-Interventional Clinical Research Ethics Committee (No:2025/01- ethics committee decision No:2).
MS patients between the ages of 18-65 years, with an Expanded Disability Status Scale (EDSS) score ≤ 4, who are not pregnant, who have not had an attack in the last 1 month and who have not received corticosteroid treatment will be included in the study. Individuals who have taken any medication that may affect walking and balance ability in the last month, have orthopedic, other neurologic diseases and cognitive problems will not be included in the study.
Demographic information (age, height, weight, body mass index and gender) of individuals with MS will be recorded. Firstly, the tests will be explained to the individuals in detail.Assessments will be performed by a physiotherapist with 10 years of experience in this field.
Detailed description
Multiple Sclerosis (MS) is a demyelinating, inflammatory, neurodegenerative and progressive disease with a complex etiology. the symptoms of the disease vary according to the lesion site and generally include problems such as balance and fall problems, fatigue, loss of strength and spasticity in the lower extremities, and sensory disturbances.
The study will include 50 MS patients who were examined by a specialist neurologist diagnosed according to McDonalds criteria in the Neurology Outpatient Clinic of SANKO University Sani Konukoğlu Application and Research Hospital and whose informed consent was obtained. Ethical approval of the study was obtained from SANKO University Non-Interventional Clinical Research Ethics Committee (No:2025/01- ethics committee decision No:2).
MS patients between the ages of 18-65 years, with an Expanded Disability Status Scale (EDSS) score ≤ 4, who are not pregnant, who have not had an attack in the last 1 month and who have not received corticosteroid treatment will be included in the study. Individuals who have taken any medication that may affect walking and balance ability in the last month, have orthopedic, other neurologic diseases and cognitive problems will not be included in the study.
Demographic information (age, height, weight, body mass index and gender) of individuals with MS will be recorded. Firstly, the tests will be explained to the individuals in detail.Assessments will be performed by a physiotherapist with 10 years of experience in this field.
Assessments will be performed separately by two physiotherapists on two consecutive days. Each physiotherapist will administer the tests in two separate sessions on one day. The time to complete the activities during the tests will be recorded with a stopwatch. Patients will be unaware of the recorded time. Individuals will be rested before the tests. On the first day, the first assessor will administer the 2MST in the first session. Then 2MWT and Single Leg Stance tests will be performed respectively. In the next session, the second evaluator will perform the 2MST. On the 2nd day of the assessment, the second assessor will first perform the 2MST. Then, the first assessor will perform the 2MST. In both sessions, individuals will be assessed in the same environment to minimize the influence of environmental factors. This environment has adequate lighting and the floor of the room has a hard surface as a safety precaution due to the risk of falling. Due to the risk of heat intolerance problem in MS, attention was paid to the room temperature and the room temperature will be at normal room temperature.
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 DIAGNOSED WITH MULTIPLE SCLEROSIS ADMITTED TO THE NEUROLOGY OUTPATIENT CLINIC OF SANKO UNİVERSİTESİ SANİ KONUKOĞLU APPLICATION AND RESEARCH HOSPITA
Key inclusion criteria (6 listed)
- being diagnosed with revised 2017 McDonald criteria,
- aged older than 18 years,
- ability to walk with or without aid,
- no medication changes in the last 2 months,
- volunteering to participate in the research,
Key exclusion criteria (2 listed)
- having orthopedic, psychological, and other neurological disorders, having had -a relapse in the past 3 months
- having pregnancy.
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
2 min step test (2MST)
Time frame: 1 years
The 2MST is a test used to measure physical performance. Before starting the test, the wall was marked with tape at the midpoint between the spina iliaca anteriosuperior and the patella. The participant was asked to start walking in place without running when the signal was given. During the test, the number of right and left knee lifts reaching the mark within 2 minutes was recorded . The most affected side's results of patients were used for analysis.
2-min walk test (2MWT)
Time frame: 1 years
This test measures the distance that individuals walk in 2 minutes and assesses their functional capacity. The person walks for 2 minutes at maximum speed between two cones placed by measuring 15 meters. If an assistive device is used, the person can walk with the device. Since 6-minute walk test may cause fatigue in MS patients, 2MWT is recommended. Its validity in MS was demonstrated by Scalzitti et al.
One-leg stand test (OLSTS)
Time frame: 1 years
OLSTS measured the time that the person could maintain the posture without losing balance in a standing position on one leg with eyes open. It was repeated for both feet. The most affected side's results of patients were used for analysis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Results publication: PubMed 36471309de Jesus SFC, Bassi-Dibai D, Pontes-Silva A, da Silva de Araujo A, de Freitas Faria Silva S, Veneroso CE, de Paula Gomes CAF, Dibai-Filho AV. Construct validity and reliability of the 2-Minute Step Test (2MST) in individuals with low back pain. BMC Musculoskelet Disord. 2022 Dec 5;23(1):1062. doi: 10.1186/s12891-022-06050-w.
- Results publication: PubMed 34120695Braghieri HA, Kanegusuku H, Corso SD, Cucato GG, Monteiro F, Wolosker N, Correia MA, Ritti-Dias RM. Validity and reliability of 2-min step test in patients with symptomatic peripheral artery disease. J Vasc Nurs. 2021 Jun;39(2):33-38. doi: 10.1016/j.jvn.2021.02.004. Epub 2021 Mar 19.
- Derived from this study: PubMed 41038137Polat H, Katirci-Kirmaci ZI, Uzun M, Ekmekyapar-Firat Y, Erel S, Neyal AM. Validity, intra-rater and inter-rater reliability, and minimal detectable change of the two-minute step test in patients with multiple sclerosis. Mult Scler Relat Disord. 2025 Dec;104:106773. doi: 10.1016/j.msard.2025.106773. Epub 2025 Sep 19.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Sanko University at 2 sites 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 2 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: enrolling by invitation, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
2 min step test (2MST) (time frame: 1 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06849960, which also lists 3 linked publications.
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 27 Feb 2025.