Rheumatoid Arthritis (RA)NCT07264101
Validity And Reliability Of The Four Square Step Test In Individuals With Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis (RA), run by Inonu University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2025to 10 Aug 2026
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Participants aged 18-65 years with rheumatoid arthritis (RA) will be included in this study.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Inonu University Turgut Ozal Medical Center
Malatya
About this study
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.
Read more
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.
Read the detailed description
Rheumatoid arthritis (RA) is a chronic, autoimmune connective tissue disease that affects approximately 0.5-1% of the global population. The disease is characterized by symmetrical joint pain, swelling, and restricted mobility. Synovial inflammation in its pathogenesis leads to structural damage, cartilage erosion, joint deformities, and irreversible functional impairments. Beyond joint involvement, RA significantly affects daily living activities, work capacity, and overall quality of life through its impact on the musculoskeletal system. Muscle weakness, reduced joint range of motion, and impaired proprioception occurring during the disease process particularly compromise lower extremity function and contribute to impaired postural control. Consequently, balance deficits, an increased risk of falls, and fall-related injuries are observed more frequently in individuals with RA compared to the healthy population.
Balance is generally divided into static and dynamic balance. Static balance refers to the ability to maintain the center of mass within the base of support while standing still, whereas dynamic balance denotes the ability to sustain the center of mass safely and in a controlled manner within the base of support during movement. In RA, balance impairments become especially evident in daily activities such as walking, changing direction, and climbing stairs. These difficulties elevate fall risk and adversely influence both physical independence and social participation.
Several assessment tools have been developed to evaluate balance in RA. The Berg Balance Scale (BBS), Tinetti Balance Test, Timed Up and Go Test (TUG), and Mini-BESTest are among the most widely used instruments in this field. However, many of these tools require lengthy administration, specialized equipment, or advanced clinical expertise. Such limitations can complicate rapid patient assessment, particularly in busy outpatient clinical settings.
The Four Square Step Test (FSST) is a practical assessment that can be administered within a short period of time using simple materials, measuring an individual's ability to step in multiple directions. The reliability and validity of FSST have been established in various clinical populations, including those with ankle injuries, hemophilia, cerebral palsy, Duchenne muscular dystrophy, Down syndrome, hip arthroplasty, and anterior cruciate ligament reconstruction. Nevertheless, no validity and reliability study of the FSST has yet been conducted in individuals with RA.
The primary objective of this study is to determine the validity and reliability of the Four Square Step Test (FSST) in individuals with rheumatoid arthritis. The secondary objective is to examine the relationship between FSST outcomes and clinical indicators such as disease activity, quality of life, pain and muscle strength.
First, demographic and clinical data of all participants will be collected, including age, height, weight, smoking and alcohol consumption, dominant side, use of assistive devices, age at diagnosis, comorbidities, medications, and history of falls within the past 1-2 years. Body mass index (BMI) will be calculated.
All analyses will be conducted as two-tailed, with a significance level set at α = 0.05, and results will be reported with 95% confidence intervals. The distribution of continuous variables will be assessed using the Shapiro-Wilk test. Normally distributed variables will be presented as mean ± standard deviation, while non-normally distributed variables will be reported as median values. Categorical variables will be presented as frequency (percentage).
The relationships between FSST time and the scores of the Berg Balance Scale (BBS) and Mini-BESTest will be examined using Pearson's or Spearman's correlation coefficients, depending on data distribution. The predictive ability of FSST for poor balance status will be evaluated with receiver operating characteristic (ROC) curve analysis, and results will be reported in terms of area under the curve (AUC), sensitivity, specificity, Youden's index, and optimal cutoff values.
Test-retest reliability will be determined using the intraclass correlation coefficient (ICC[3,1]) based on repeated FSST measurements performed by the same rater. Measurement error and minimal detectable change will be calculated as follows: SEM = SD × √(1 - ICC) and MDC95 = SEM × 1.96 × √2. Agreement between repeated measures will be illustrated using Bland-Altman plots (mean bias and ±1.96 SD limits).
Comparisons of FSST times between clinical subgroups (e.g., disease activity level, history of falls) will be performed using independent-samples t-test/ANOVA if normality assumptions are met, or Mann-Whitney U/Kruskal-Wallis tests otherwise. Effect sizes will be reported as Hedges' g, r, and η²/partial η².
Reporting will follow the STROBE guidelines for observational cross-sectional studies.
The sample size was calculated using the G*Power software with α = 0.05 and 1-β = 0.80. Previous studies have reported that the FSST demonstrates moderate to high levels of validity in different clinical populations. For example, in patients with hip osteoarthritis and total hip arthroplasty, correlations between FSST and other balance scales were found to range between r = 0.60 and r = 0.70. In individuals with total knee arthroplasty, FSST was reported to correlate with the TUG at r = 0.65 and with the HSS at r = -0.40. Furthermore, studies conducted in populations with hemophilia and Parkinson's disease indicated excellent reliability of FSST and modified FSST, with ICC values approximately between 0.96 and 0.99. Such studies have typically been conducted with sample sizes ranging from 17 to 28 participants.
In light of these findings, it was determined that including approximately 40 participants in the present study would be sufficient to ensure adequate statistical power for the planned validity analyses.
- Conditions
- Rheumatoid Arthritis (RA)
- Keywords
- Rheumatoid Arthritis (RA), Four Square Step Test (FSST), Balance
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Two assesstment ( one at baseline and one in the afternoon)
Secondary outcomes (7)
Disease Activity Score-28 (DAS-28)
DAS28 is a widely used instrument for evaluating disease activity in individuals with rheumatoid arthritis. This index incorporates the number of tender and swollen joints out of 28, the patient's self-assessment of general health using a 100-mm visual analog scale (VAS), and acute-phase reactants, including erythrocyte sedimentation rate (ESR, mm/h) or C-reactive protein (CRP, mg/L). The resulting total score provides a quantitative measure of disease activity, with lower scores indicating remission and higher scores reflecting active disease
Measured: Baseline (First assessment)
Numeric Rating Scale (NRS)
The NRS is a unidimensional measure of pain intensity commonly used in adults. Multiple versions exist, but the 11-point scale (0-10) is the most widely employed. Patients are asked to select a number that best represents their pain intensity, where 0 indicates no pain and 10 represents the worst imaginable pain experienced over the past 24 hours.
Measured: Baseline (First assesstment)
Rheumatoid Arthritis Quality of Life (RAQoL) scale
The Rheumatoid Arthritis Quality of Life (RAQoL) questionnaire is a disease-specific self-report instrument designed to assess quality of life in individuals with rheumatoid arthritis. The scale consists of 30 items with "yes/no" response options. Each "yes" response is scored as 1 point and each "no" response as 0 points, resulting in a total score ranging from 0 to 30. Lower scores indicate better quality of life, whereas higher scores reflect greater impairment in quality of life.
Measured: Baseline (First assesstment)
Mini-Balance Evaluation Systems Test (Mini-BESTest)
The Mini-Balance Evaluation Systems Test (Mini-BESTest) is designed to assess dynamic balance using 14 items organized into four subscales: anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait. Each item is scored on a 3-point ordinal scale, with 0 indicating inability or need for assistance and 2 representing normal function. Total scores range from 0 to 28. Two items are evaluated for both the right and left sides, and only the lower score is included in the total score calculation.
Measured: Baseline (First assesstment)
Berg Balance Test(BBS)
The Berg Balance Scale (BBS) is a balance assessment tool that evaluates an individual's ability to maintain stability while performing 14 functional tasks commonly encountered in daily activities. Each item is rated on a 5-point ordinal scale ranging from 0 to 4, where 0 indicates inability to perform the task and 4 represents the ability to complete the task independently. The maximum possible total score is 56. Administration of the test typically requires approximately 15-20 minutes.
Measured: Baseline ( First assessment)
Baseline Hydraulic Hand Dynamometer
Participants are seated upright on a chair with their feet supported. The tested upper extremity is positioned with the shoulder in adduction and neutral rotation, the elbow at 90° flexion, the forearm in neutral position, and the wrist at 0-30° extension and 0-15° ulnar deviation. Participants are instructed to place their fingers around the dynamometer handle and squeeze with maximal force. The test is repeated three times, and the highest value obtained is used for analysis.
Measured: Baseline (First assesstment)
5 Times Sit To Stand Test (5TSTS)
To assess quadriceps muscle strength and functional lower limb strength, the Five Times Sit-to-Stand Test (5TSTS) will be used.
In the 5TSTS, participants are instructed to stand up and sit down five times as quickly as possible. A stopwatch is started with the command "start" and stopped upon completion of the fifth full standing position.
Measured: Baseline (First assesstment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start15 Dec 2025
- Primary completion10 Aug 2026
- Study completion10 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid Arthritis (RA)Studies 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 (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynal Yasacı, Inonu University
- Investigators
- Zeynal Yasacı, Principal investigator, Inonü University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07264101
- Sponsor's protocol ID
- 1001
- Status last verified
- Dec 2025
- First submitted
- 20 Nov 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant data will be securely stored by the investigators and may be shared with authorized personnel if deemed necessary, in accordance with applicable privacy regulations.
Publications
Vilarinho R, Montes AM, Noites A, Silva F, Melo C. Reference values for the 1-minute sit-to-stand and 5 times sit-to-stand tests to assess functional capacity: a cross-sectional study. Physiotherapy. 2024 Sep;124:85-92. doi: 10.1016/j.physio.2024.01.004. Epub 2024 Jan 20.
PubMed 38875841Du W, Cornett KMD, Donlevy GA, Burns J, McKay MJ. Variability between Different Hand-Held Dynamometers for Measuring Muscle Strength. Sensors (Basel). 2024 Mar 14;24(6):1861. doi: 10.3390/s24061861.
PubMed 38544123Zonzini Gaino J, Barros Bertolo M, Silva Nunes C, de Morais Barbosa C, Sachetto Z, Davitt M, de Paiva Magalhaes E. Disease-related outcomes influence prevalence of falls in people with rheumatoid arthritis. Ann Phys Rehabil Med. 2019 Mar;62(2):84-91. doi: 10.1016/j.rehab.2018.09.003. Epub 2018 Sep 29.
PubMed 30278237Wagner S, Bring A, Asenlof P. Construct validity of the Mini-BESTest in individuals with chronic pain in specialized pain care. BMC Musculoskelet Disord. 2023 May 17;24(1):391. doi: 10.1186/s12891-023-06504-9.
PubMed 37198616Tijhuis GJ, de Jong Z, Zwinderman AH, Zuijderduin WM, Jansen LM, Hazes JM, Vliet Vlieland TP. The validity of the Rheumatoid Arthritis Quality of Life (RAQoL) questionnaire. Rheumatology (Oxford). 2001 Oct;40(10):1112-9. doi: 10.1093/rheumatology/40.10.1112.
PubMed 11600740Robinson CL, Phung A, Dominguez M, Remotti E, Ricciardelli R, Momah DU, Wahab S, Kim RS, Norman M, Zhang E, Hasoon J, Orhurh V, Viswanath O, Yazdi C, Chen GH, Simopoulos TT, Gill J. Pain Scales: What Are They and What Do They Mean. Curr Pain Headache Rep. 2024 Jan;28(1):11-25. doi: 10.1007/s11916-023-01195-2. Epub 2023 Dec 7.
PubMed 38060102Wells G, Becker JC, Teng J, Dougados M, Schiff M, Smolen J, Aletaha D, van Riel PL. Validation of the 28-joint Disease Activity Score (DAS28) and European League Against Rheumatism response criteria based on C-reactive protein against disease progression in patients with rheumatoid arthritis, and comparison with the DAS28 based on erythrocyte sedimentation rate. Ann Rheum Dis. 2009 Jun;68(6):954-60. doi: 10.1136/ard.2007.084459. Epub 2008 May 19.
PubMed 18490431Kim J, Kim I, Kim YE, Koh SB. The Four Square Step Test for Assessing Cognitively Demanding Dynamic Balance in Parkinson's Disease Patients. J Mov Disord. 2021 Sep;14(3):208-213. doi: 10.14802/jmd.20146. Epub 2021 May 26.
PubMed 34030434Kocaman H, Canli M, Alkan H, Yildirim H, Yildiz NT. The Reliability and Validity of the Modified Four Square Step Test in Individuals with Anterior Cruciate Ligament Reconstruction. Indian J Orthop. 2023 Sep 13;57(11):1819-1825. doi: 10.1007/s43465-023-00993-5. eCollection 2023 Nov.
PubMed 37881277Horata ET, Eken F, Yesil M, Ozcan O. Validity and reliability of the modified four square step test in total HIP arthroplasty. J Bodyw Mov Ther. 2024 Oct;40:345-349. doi: 10.1016/j.jbmt.2024.04.028. Epub 2024 Apr 16.
PubMed 39593608Verma A, Samuel AJ, Aranha VP. The four square step test in children with Down syndrome: Reliability and concurrent validity. J Pediatr Neurosci. 2014 Sep-Dec;9(3):221-6. doi: 10.4103/1817-1745.147573.
PubMed 25624923Aldirmaz E, Ugur F, Yilmaz O, Karaduman A, Alemdaroglu-Gurbuz I. A New Instrument to Assess Dynamic Balance in Children with Duchenne Muscular Dystrophy: Four Square Step Test and Its Validity, Reliability and Feasibility. Dev Neurorehabil. 2023 Jan;26(1):27-36. doi: 10.1080/17518423.2022.2143924. Epub 2022 Nov 11.
PubMed 36367327Tanrıöğer Soyuer F. Valıdıty And Relıabılıty Of "Four-Square Step Test" In Adolescent Cerebral Palsy2018.
Taylor S, Pemberton S, Barker K. Validity of the four-square step test in persons with haemophilia. Haemophilia. 2022 Mar;28(2):334-342. doi: 10.1111/hae.14482. Epub 2022 Jan 12.
PubMed 35020243Toprak CS, Duruoz MT, Gunduz OH. Static and Dynamic Balance Disorders in Patients With Rheumatoid Arthritis and Relationships With Lower Extremity Function and Deformities: A Prospective Controlled Study. Arch Rheumatol. 2018 Jan 15;33(3):328-334. doi: 10.5606/ArchRheumatol.2018.6720. eCollection 2018 Sep.
PubMed 30632523
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity And Reliability Of The Four Square Step Test In Individuals With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT07264101
- Acronym / sponsor ID
- 1001
- Conditions
- Rheumatoid Arthritis (RA)
- Keywords
- Rheumatoid Arthritis (RA), Four Square Step Test (FSST), Balance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 10 Aug 2026 (actual)
- Study completion
- 10 Aug 2026 (actual)
- First posted
- 4 Dec 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.
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.
Detailed description
Rheumatoid arthritis (RA) is a chronic, autoimmune connective tissue disease that affects approximately 0.5-1% of the global population. The disease is characterized by symmetrical joint pain, swelling, and restricted mobility. Synovial inflammation in its pathogenesis leads to structural damage, cartilage erosion, joint deformities, and irreversible functional impairments. Beyond joint involvement, RA significantly affects daily living activities, work capacity, and overall quality of life through its impact on the musculoskeletal system. Muscle weakness, reduced joint range of motion, and impaired proprioception occurring during the disease process particularly compromise lower extremity function and contribute to impaired postural control. Consequently, balance deficits, an increased risk of falls, and fall-related injuries are observed more frequently in individuals with RA compared to the healthy population.
Balance is generally divided into static and dynamic balance. Static balance refers to the ability to maintain the center of mass within the base of support while standing still, whereas dynamic balance denotes the ability to sustain the center of mass safely and in a controlled manner within the base of support during movement. In RA, balance impairments become especially evident in daily activities such as walking, changing direction, and climbing stairs. These difficulties elevate fall risk and adversely influence both physical independence and social participation.
Several assessment tools have been developed to evaluate balance in RA. The Berg Balance Scale (BBS), Tinetti Balance Test, Timed Up and Go Test (TUG), and Mini-BESTest are among the most widely used instruments in this field. However, many of these tools require lengthy administration, specialized equipment, or advanced clinical expertise. Such limitations can complicate rapid patient assessment, particularly in busy outpatient clinical settings.
The Four Square Step Test (FSST) is a practical assessment that can be administered within a short period of time using simple materials, measuring an individual's ability to step in multiple directions. The reliability and validity of FSST have been established in various clinical populations, including those with ankle injuries, hemophilia, cerebral palsy, Duchenne muscular dystrophy, Down syndrome, hip arthroplasty, and anterior cruciate ligament reconstruction. Nevertheless, no validity and reliability study of the FSST has yet been conducted in individuals with RA.
The primary objective of this study is to determine the validity and reliability of the Four Square Step Test (FSST) in individuals with rheumatoid arthritis. The secondary objective is to examine the relationship between FSST outcomes and clinical indicators such as disease activity, quality of life, pain and muscle strength.
First, demographic and clinical data of all participants will be collected, including age, height, weight, smoking and alcohol consumption, dominant side, use of assistive devices, age at diagnosis, comorbidities, medications, and history of falls within the past 1-2 years. Body mass index (BMI) will be calculated.
All analyses will be conducted as two-tailed, with a significance level set at α = 0.05, and results will be reported with 95% confidence intervals. The distribution of continuous variables will be assessed using the Shapiro-Wilk test. Normally distributed variables will be presented as mean ± standard deviation, while non-normally distributed variables will be reported as median values. Categorical variables will be presented as frequency (percentage).
The relationships between FSST time and the scores of the Berg Balance Scale (BBS) and Mini-BESTest will be examined using Pearson's or Spearman's correlation coefficients, depending on data distribution. The predictive ability of FSST for poor balance status will be evaluated with receiver operating characteristic (ROC) curve analysis, and results will be reported in terms of area under the curve (AUC), sensitivity, specificity, Youden's index, and optimal cutoff values.
Test-retest reliability will be determined using the intraclass correlation coefficient (ICC[3,1]) based on repeated FSST measurements performed by the same rater. Measurement error and minimal detectable change will be calculated as follows: SEM = SD × √(1 - ICC) and MDC95 = SEM × 1.96 × √2. Agreement between repeated measures will be illustrated using Bland-Altman plots (mean bias and ±1.96 SD limits).
Comparisons of FSST times between clinical subgroups (e.g., disease activity level, history of falls) will be performed using independent-samples t-test/ANOVA if normality assumptions are met, or Mann-Whitney U/Kruskal-Wallis tests otherwise. Effect sizes will be reported as Hedges' g, r, and η²/partial η².
Reporting will follow the STROBE guidelines for observational cross-sectional studies.
The sample size was calculated using the G*Power software with α = 0.05 and 1-β = 0.80. Previous studies have reported that the FSST demonstrates moderate to high levels of validity in different clinical populations. For example, in patients with hip osteoarthritis and total hip arthroplasty, correlations between FSST and other balance scales were found to range between r = 0.60 and r = 0.70. In individuals with total knee arthroplasty, FSST was reported to correlate with the TUG at r = 0.65 and with the HSS at r = -0.40. Furthermore, studies conducted in populations with hemophilia and Parkinson's disease indicated excellent reliability of FSST and modified FSST, with ICC values approximately between 0.96 and 0.99. Such studies have typically been conducted with sample sizes ranging from 17 to 28 participants.
In light of these findings, it was determined that including approximately 40 participants in the present study would be sufficient to ensure adequate statistical power for the planned validity analyses.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants aged 18-65 years with rheumatoid arthritis (RA) will be included in this study.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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
Four Square Step Test (FSST)
Time frame: Two assesstment ( one at baseline and one in the afternoon)
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
7 secondary outcomes
Disease Activity Score-28 (DAS-28)
Time frame: Baseline (First assessment)
Numeric Rating Scale (NRS)
Time frame: Baseline (First assesstment)
Rheumatoid Arthritis Quality of Life (RAQoL) scale
Time frame: Baseline (First assesstment)
Mini-Balance Evaluation Systems Test (Mini-BESTest)
Time frame: Baseline (First assesstment)
Berg Balance Test(BBS)
Time frame: Baseline ( First assessment)
Baseline Hydraulic Hand Dynamometer
Time frame: Baseline (First assesstment)
5 Times Sit To Stand Test (5TSTS)
Time frame: Baseline (First assesstment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Background: PubMed 38875841Vilarinho R, Montes AM, Noites A, Silva F, Melo C. Reference values for the 1-minute sit-to-stand and 5 times sit-to-stand tests to assess functional capacity: a cross-sectional study. Physiotherapy. 2024 Sep;124:85-92. doi: 10.1016/j.physio.2024.01.004. Epub 2024 Jan 20.
- Background: PubMed 38544123Du W, Cornett KMD, Donlevy GA, Burns J, McKay MJ. Variability between Different Hand-Held Dynamometers for Measuring Muscle Strength. Sensors (Basel). 2024 Mar 14;24(6):1861. doi: 10.3390/s24061861.
- Background: PubMed 30278237Zonzini Gaino J, Barros Bertolo M, Silva Nunes C, de Morais Barbosa C, Sachetto Z, Davitt M, de Paiva Magalhaes E. Disease-related outcomes influence prevalence of falls in people with rheumatoid arthritis. Ann Phys Rehabil Med. 2019 Mar;62(2):84-91. doi: 10.1016/j.rehab.2018.09.003. Epub 2018 Sep 29.
- Background: PubMed 37198616Wagner S, Bring A, Asenlof P. Construct validity of the Mini-BESTest in individuals with chronic pain in specialized pain care. BMC Musculoskelet Disord. 2023 May 17;24(1):391. doi: 10.1186/s12891-023-06504-9.
- Background: PubMed 11600740Tijhuis GJ, de Jong Z, Zwinderman AH, Zuijderduin WM, Jansen LM, Hazes JM, Vliet Vlieland TP. The validity of the Rheumatoid Arthritis Quality of Life (RAQoL) questionnaire. Rheumatology (Oxford). 2001 Oct;40(10):1112-9. doi: 10.1093/rheumatology/40.10.1112.
- Background: PubMed 38060102Robinson CL, Phung A, Dominguez M, Remotti E, Ricciardelli R, Momah DU, Wahab S, Kim RS, Norman M, Zhang E, Hasoon J, Orhurh V, Viswanath O, Yazdi C, Chen GH, Simopoulos TT, Gill J. Pain Scales: What Are They and What Do They Mean. Curr Pain Headache Rep. 2024 Jan;28(1):11-25. doi: 10.1007/s11916-023-01195-2. Epub 2023 Dec 7.
- Background: PubMed 18490431Wells G, Becker JC, Teng J, Dougados M, Schiff M, Smolen J, Aletaha D, van Riel PL. Validation of the 28-joint Disease Activity Score (DAS28) and European League Against Rheumatism response criteria based on C-reactive protein against disease progression in patients with rheumatoid arthritis, and comparison with the DAS28 based on erythrocyte sedimentation rate. Ann Rheum Dis. 2009 Jun;68(6):954-60. doi: 10.1136/ard.2007.084459. Epub 2008 May 19.
- Background: PubMed 34030434Kim J, Kim I, Kim YE, Koh SB. The Four Square Step Test for Assessing Cognitively Demanding Dynamic Balance in Parkinson's Disease Patients. J Mov Disord. 2021 Sep;14(3):208-213. doi: 10.14802/jmd.20146. Epub 2021 May 26.
- Background: PubMed 37881277Kocaman H, Canli M, Alkan H, Yildirim H, Yildiz NT. The Reliability and Validity of the Modified Four Square Step Test in Individuals with Anterior Cruciate Ligament Reconstruction. Indian J Orthop. 2023 Sep 13;57(11):1819-1825. doi: 10.1007/s43465-023-00993-5. eCollection 2023 Nov.
- Background: PubMed 39593608Horata ET, Eken F, Yesil M, Ozcan O. Validity and reliability of the modified four square step test in total HIP arthroplasty. J Bodyw Mov Ther. 2024 Oct;40:345-349. doi: 10.1016/j.jbmt.2024.04.028. Epub 2024 Apr 16.
- Background: PubMed 25624923Verma A, Samuel AJ, Aranha VP. The four square step test in children with Down syndrome: Reliability and concurrent validity. J Pediatr Neurosci. 2014 Sep-Dec;9(3):221-6. doi: 10.4103/1817-1745.147573.
- Background: PubMed 36367327Aldirmaz E, Ugur F, Yilmaz O, Karaduman A, Alemdaroglu-Gurbuz I. A New Instrument to Assess Dynamic Balance in Children with Duchenne Muscular Dystrophy: Four Square Step Test and Its Validity, Reliability and Feasibility. Dev Neurorehabil. 2023 Jan;26(1):27-36. doi: 10.1080/17518423.2022.2143924. Epub 2022 Nov 11.
- Individual participant dataSharing planned: No. Participant data will be securely stored by the investigators and may be shared with authorized personnel if deemed necessary, in accordance with applicable privacy regulations.
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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.
Zeynal Yasacı principal investigator
Inonü University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis (RA), run by Inonu University at 1 site 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 4 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: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Four Square Step Test (FSST) (time frame: Two assesstment ( one at baseline and one in the afternoon)). 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 NCT07264101, which also lists 20 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 9 Sep 2026.