Validity And Reliability Of The Four Square Step Test In Individuals With Rheumatoid Arthritis

NCT07264101 | Recruiting

• 1 other identifier: 1001
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This cross-sectional observational study aims to evaluate the validity and reliability of the Four Square Step Test (FSST) in individuals with rheumatoid arthritis. In addition, the study will investigate the associations between FSST performance and clinical parameters including disease activity, quality of life, pain, and muscle strength. All assessments will be conducted according to a pre-defined standardized protocol. The order of measurement tools will be randomized to minimize potential bias, and sufficient rest intervals will be provided between tests to prevent fatigue and performance effects. Participants will include individuals aged 18-65 years with a diagnosis of rheumatoid arthritis according to the ACR/EULAR 2010 classification criteria, who have been followed for at least 6 months, have had no major changes in treatment regimen in the last 4 weeks (e.g., initiation or change of DMARDs/biologics, high-dose steroid increase), can walk at least 10 meters independently, have a Mini-Mental State Examination score of 24 or higher, and are able to follow verbal instructions in Turkish to comply with study procedures. Appropriate statistical methods will be applied to assess validity, reliability, and associations between FSST and clinical parameters.

Conditions

Rheumatoid Arthritis (RA)

Keywords

Rheumatoid Arthritis (RA); Four Square Step Test (FSST); Balance

Outcome Measures

Primary Outcomes (1)

• Four Square Step Test (FSST)

  The Four Square Step Test (FSST) is used to assess dynamic balance, specifically the ability to rapidly step over obstacles and change direction in a clinical setting. FSST is a quick and easily administered test that evaluates an individual's capacity to step in multiple directions over low obstacles. Four squares are created by intersecting lines at right angles, with each side approximately 90 cm in length. Low obstacles of 2.5 cm height are placed along the square boundaries. The participant starts in the lower-left square with feet together. In the first phase, the participant steps clockwise through each square-forward, right, backward, and left-returning to the starting position. The same sequence is then repeated counterclockwise. Participants must step into each square with both feet. After one practice trial, the test is performed twice, and completion times are recorded in seconds. The fastest time is considered the FSST score, with lower times indicating better dynamic bal

  Two assesstment ( one at baseline and one in the afternoon)

Secondary Outcomes (7)

• Disease Activity Score-28 (DAS-28)

  Baseline (First assessment)

• Numeric Rating Scale (NRS)

  Baseline (First assesstment)

• Rheumatoid Arthritis Quality of Life (RAQoL) scale

  Baseline (First assesstment)

• Mini-Balance Evaluation Systems Test (Mini-BESTest)

  Baseline (First assesstment)

• Berg Balance Test(BBS)

  Baseline ( First assessment)

Study Arms (1)

Rheumatoid Arthritis Group

Participants will consist of adult individuals aged 18-65 years with a diagnosis of rheumatoid arthritis based on the ACR/EULAR classification criteria. Clinical assessments will include the Four Square Step Test (FSST), Berg Balance Scale, Mini-BESTest, handgrip strength using a dynamometer. Disease activity (DAS28), pain intensity, quality of life, and history of falls will also be recorded. This study is purely observational and cross-sectional in nature, and no therapeutic intervention will be applied to participants.

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

Participants aged 18-65 years with rheumatoid arthritis (RA) will be included in this study.

You may qualify if:

• Age between 18 and 65 years
• Diagnosis of rheumatoid arthritis according to ACR/EULAR 2010 criteria
• No major changes in treatment regimen (e.g., initiation or modification of DMARDs/biologics, high-dose steroid increase) within the last 4 weeks
• Ability to walk at least 10 meters without assistance
• Mini-Mental State Examination (MMSE) score ≥ 24
• Ability to understand and follow instructions in Turkish

You may not qualify if:

• Participants who cannot understand or follow verbal instructions in Turkish
• Participants with a history of neurological, vestibular, or serious orthopedic disease
• Participants whose physical participation is limited due to acute infection or systemic disease
• Participants who have had lower extremity surgery or a history of serious injury within the last 6 months

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Inonu University Turgut Ozal Medical Center

Malatya, Turkey (Türkiye)

RECRUITING

Related Publications (20)

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MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Zeynal Yasacı

  Inonü University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emine Tonak

CONTACT

+905372994319; eminetonak4006@gmail.com

Zeynal Yasacı

CONTACT

+905075409791; zeynal.yasaci@inonu.edu.tr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor lecturer

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 4, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): May 15, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)