Ultrasound Assessment of Neck Muscles and Balance in Male Patients With Ankylosing Spondylitis

Recruiting

• Conditions: Ankylosing Spondylitis; Balance Assessment; Balance; Spondylarthropathies; Spondylitis, Ankylosing

• Registration Number: NCT06967883
• Lead Sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Brief Summary

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)

Detailed Description

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.

Study Timeline

• Study Start: 2025-01-01
• Study First Submitted: 2025-02-23
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-08
• Last Update Submitted: 2025-05-08
• Study First Posted: 2025-05-13
• Last Update Posted: 2025-05-13
• Primary Completion: 2025-09-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 76

Inclusion Criteria

• Age between 18 and 65 years.
• Diagnosed with Ankylosing Spondylitis according to the Modified New York Criteria (for patient group).
• Cognitive ability sufficient to understand and follow test instructions.

Exclusion Criteria

• Orthopedic disorders affecting the spine or lower limbs.
• Cardiovascular disorders.
• Neurological disorders.
• Visual or auditory impairments.
• History of surgery involving the spine or lower limbs.
• Psychiatric disorders.
• Cognitive impairment.
• Clinical signs or symptoms of cervical radiculopathy.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean Bilateral Thickness of Cervical Multifidus Muscle Assessed by Ultrasonography	baseline	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.
Mean Bilateral Thickness of Cervical Longus Colli Muscle Assessed by Ultrasonography	baseline	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.
Limits of Stability (LOS) Test	baseline	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.

Secondary Outcome Measures

Name	Time	Method
Sway Area on Balance Platform	baseline	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.
Romberg Quotient	baseline	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.
Trace Length on Balance Platform	baseline	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.
Medio-Lateral (ML) Sway Range	baseline	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.
Anterior-Posterior (AP) Sway Range	baseline	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.
Average Sway Velocity	baseline	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.
Timed Up and Go (TUG) Test Duration	baseline	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.
Berg Balance Scale Total Score	baseline	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.

Trial Locations

Locations (1)

Istanbul Physical Medicine and Rehabilitation Trainig and Research Hospital; 🇹🇷 Istanbul, Bahcelievler, Turkey