An observational study in Ankylosing Spondylitis, Balance Assessment and Balance, sponsored by Istanbul Physical Medicine Rehabilitation Training and Research Hospital. Recruiting at 1 site in Turkey. Open to male participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-13.
Sponsored by Istanbul Physical Medicine Rehabilitation Training and Research Hospital · Observational
The aim of this study is to evaluate the relationship between ultrasonographic measurements of the cervical muscles and balance parameters in patients diagnosed with ankylosing spondylitis (AS)
This study aims to investigate the relationship between cervical multifdus and longus Colli muscles and balance function in male patients diagnosed with Ankylosing Spondylitis (AS) according to the Modified New York Criteria. A total of 38 AS patients under regular follow-up at the Istanbul Physical Medicine and Rehabilitation Training and Research Hospital Rheumatology Clinic, along with 38 age-matched healthy male volunteers, will be included.
Ultrasonographic Imaging will be performed to assess the thickness and of the cervical multifidus and longus colli muscles.The HUR SmartBalance BTG4 (HUR-Labs Oy, Kokkola, Finland) balance platform will be used to measure postural sway, weight distribution, and the limit of stability (LOS) through a computerized system.The Berg Balance Scale (BBS), The Timed Up and Go (TUG) test,The Single-Leg Stance Test will be conducted, measuring the ability to maintain posture while standing on one leg. Disease Activity and Functional Assessment in AS Patients will be conducted by using The Bath Ankylosing Spondylitis Functional Index (BASFI), The Bath Ankylosing Spondylitis Metrology Index (BASMI) Additionally, the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) will be used to measure disease activity and quality of life will be assessed with Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL).Cervical Muscle Strength Measurement will be performed using a hand-held dynamometer, which will objectively assess isometric cervical flexion and extension strength.
531 studies on the registry are indexed under Spondylitis, Ankylosing; 98 are open to participants now.
This study's planned enrollment of 76 is below the median of 202 across 214 observational studies indexed under Spondylitis, Ankylosing.
Browse Spondylitis, Ankylosing studies →Istanbul Physical Medicine Rehabilitation Training and Research Hospital is the lead sponsor of 123 studies on the registry; 26 are open to participants now.
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Participants will be recruited from the Istanbul Physical Medicine and Rehabilitation Rheumatology Clinic, where they are under regular follow-up for Ankylosing Spondylitis (AS). The healthy control group will consist of hospital employees who meet the inclusion criteria and have no history of AS or other musculoskeletal disorders
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Exclusion Criteria:
Male patients aged 18-65 years diagnosed with Ankylosing Spondylitis according to the Modified New York Criteria, under regular follow-up at Istanbul Physical Medicine and Rehabilitation Rheumatology Clinic.
Diagnostic Test: Ultrasonographic assessment of Cervical Multifidus and Longus Colli Muscle Thickness, Postural Balance and Limit of Stability using the balance platform,Cervical Flexion and Extension Strength
Age-matched healthy male volunteers aged 18-65 years with cognitive ability sufficient to understand test instructions.
Diagnostic Test: Ultrasonographic assessment of Cervical Multifidus and Longus Colli Muscle Thickness, Postural Balance and Limit of Stability using the balance platform,Cervical Flexion and Extension Strength
Intervention Description Participants in both groups will undergo ultrasonographic measurement of cervical multifidus and longus colli muscle thickness. Postural sway, Limits of Stability (LOS), and a 6-direction balance test (ABC-6) will be assessed using the HUR SmartBalance BTG4 platform under stable and unstable conditions with eyes open and closed. Functional balance will be evaluated with the Berg Balance Scale (BBS), Timed Up and Go (TUG) Test, and Single-Leg Stance Test. Isometric cervical flexion and extension strength will be measured bilaterally using a hand-held dynamometer. Ankylosing Spondylitis patients will additionally complete BASFI, BASMI, BASDAI, and ASQoL questionnaires.
Mean Bilateral Thickness of Cervical Multifidus Muscle Assessed by Ultrasonography
Bilateral measurement of cervical multifidus muscle thickness using musculoskeletal ultrasound imaging. Results will be reported in millimeters (mm). Data will be summarized as mean ± standard deviation.
Time frame: baseline
Mean Bilateral Thickness of Cervical Longus Colli Muscle Assessed by Ultrasonography
Bilateral measurement of cervical longus colli muscle thickness using musculoskeletal ultrasound imaging. Results will be reported in millimeters (mm). Data will be summarized as mean ± standard deviation.
Time frame: baseline
Limits of Stability (LOS) Test
The Limits of Stability (LOS) test will be conducted using the HUR SmartBalance platform. Participants will be asked to lean maximally forward, backward, to the right, and to the left, each for a duration of 8 s without lifting the sole and heel of the foot or correcting their feet. Using these methods, the individual's stability limits will be tested in four directions. The LOS score quantifies the subject's ability to voluntarily control posture within their stability limits. The leaning angle is based on the person's height and how far the center of pressure move from the normal position. A lower LOS score indicates impaired postural control and balance performance.
Time frame: baseline
Sway Area on Balance Platform
Postural sway area measured as 90% confidence ellipse (C90) using the HUR SmartBalance BTG4 platform. Results will be reported in square millimeters (mm²). Data will be summarized as mean ± standard deviation.
Time frame: baseline
Romberg Quotient
Ratio of sway areas between eyes-open and eyes-closed conditions. Results will be reported as a dimensionless ratio. Data will be summarized as mean ± standard deviation.
Time frame: baseline
Trace Length on Balance Platform
Total trace length of center of pressure movement during static standing, measured using the HUR SmartBalance BTG4 platform. Results will be reported in millimeters (mm). Data will be summarized as mean ± standard deviation.
Time frame: baseline
Medio-Lateral (ML) Sway Range
Range of center of pressure displacement in the medio-lateral direction during standing balance tests. Results will be reported in millimeters (mm). Data will be summarized as mean ± standard deviation.
Time frame: baseline
Anterior-Posterior (AP) Sway Range
Range of center of pressure displacement in the anterior-posterior direction during standing balance tests. Results will be reported in millimeters (mm). Data will be summarized as mean ± standard deviation.
Time frame: baseline
Average Sway Velocity
Average sway velocity calculated by dividing the total trace length by the duration of the test. Results will be reported in millimeters per second (mm/s). Data will be summarized as mean ± standard deviation.
Time frame: baseline
Timed Up and Go (TUG) Test Duration
ime required to complete the Timed Up and Go (TUG) test. Results will be reported in seconds (s). Data will be summarized as mean ± standard deviation.
Time frame: baseline
Berg Balance Scale Total Score
Total score on the Berg Balance Scale (range 0-56 points) assessing functional balance. Results will be reported as a unitless total score. Data will be summarized as mean ± standard deviation.
Time frame: baseline
Isometric Cervical Flexion and Extension Strength Measured by Hand-Held Dynamometer
Isometric strength of cervical flexor and extensor muscles assessed bilaterally using a hand-held dynamometer. Results will be reported in Newtons (N). Data will be summarized as mean ± standard deviation.
Time frame: baseline
Short Version of the Activities-Specific Balance Confidence Scale (ABC-6) Score
Balance confidence will be assessed using the Short Version of the Activities-Specific Balance Confidence Scale (ABC-6), where participants rate their confidence in performing six common daily activities without losing balance. Each item is scored from 0 (no confidence) to 100 (complete confidence). The final score will be reported as the mean of all item scores. Results will be summarized as mean ± standard deviation.
Time frame: baseline
Plan to share: No
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