Relıabılıty and valıdıty of the Two-minute Test wıth Multiple Sclerosis

NCT06849960 | Enrolling By Invitation

• 1 other identifier: hakanpolatt
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  1 years

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

PATIENTS DIAGNOSED WITH MULTIPLE SCLEROSIS ADMITTED TO THE NEUROLOGY OUTPATIENT CLINIC OF SANKO UNİVERSİTESİ SANİ KONUKOĞLU APPLICATION AND RESEARCH HOSPITA

You may qualify if:

• 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.

You may not qualify if:

• having orthopedic, psychological, and other neurological disorders, having had -a relapse in the past 3 months
• having pregnancy.

Sponsors & Collaborators

• Sanko University: lead

Study Sites (2)

Sanko University

Şehitkamil, Gaziantep, 27500, Turkey (Türkiye)

Location

Sanko University

Gaziantep, Şehi̇tkami̇l, 27500, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 36471309 RESULT

• Braghieri 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.

  PMID: 34120695 RESULT

• Polat 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.

  PMID: 41038137 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapy and Rehabilitation Department, Assistant Professor

Study Record Dates

• First Submitted: February 23, 2025
• First Posted: February 27, 2025
• Study Start: February 1, 2025
• Primary Completion: February 15, 2025
• Study Completion: March 1, 2025
• Last Updated: February 27, 2025

Record last verified: 2025-02

Locations

TU (2)