Using the Four Square Step Test to measure balance in people with rheumatoid arthritis
Validity And Reliability Of The Four Square Step Test In Individuals With Rheumatoid Arthritis
This project will test whether the Four Square Step Test reliably measures balance and links to disease activity, pain, strength, and quality of life in adults with rheumatoid arthritis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Inonu University Academic / other |
| Locations | 1 site (Malatya) |
| Trial ID | NCT07264101 on ClinicalTrials.gov |
What this trial studies
This cross-sectional observational project will apply a standardized protocol to measure Four Square Step Test (FSST) performance in adults with rheumatoid arthritis and compare results to clinical measures including disease activity scores, pain scales, muscle strength tests, and quality-of-life questionnaires. Measurement tools will be administered in randomized order with rest intervals to reduce fatigue and minimize bias, and inter- and intra-rater reliability of the FSST will be examined. Participants are ambulatory adults aged 18–65 with RA, no recent major treatment changes, and sufficient cognition and language ability to follow instructions. The analysis will determine correlations between FSST performance and clinical parameters and quantify the test's reliability in this patient group.
Who should consider this trial
Good fit: Ideal candidates are adults 18–65 with rheumatoid arthritis per ACR/EULAR 2010 criteria, followed for at least six months, able to walk 10 meters unaided, with no major treatment changes in the past four weeks, MMSE ≥24, and able to understand Turkish.
Not a fit: Patients with significant neurological, vestibular, or serious orthopedic disease, recent lower-extremity surgery or serious injury within six months, acute systemic illness, inability to walk 10 meters, or inability to follow instructions in Turkish are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, clinicians could use a quick, standardized FSST to identify balance problems and guide fall-prevention or rehabilitation strategies for people with RA.
How similar studies have performed: The FSST has shown validity and reliability in older adults and various neurological and musculoskeletal populations, but specific validation work in rheumatoid arthritis is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Malatya
- Inonu University Turgut Ozal Medical Center — Malatya, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Zeynal Yasacı — Inonü University
- Study coordinator: Emine Tonak
- Email: eminetonak4006@gmail.com
- Phone: +905372994319
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.