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NCT Number: NCT06967883

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

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)

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Key information

Conditions

Ankylosing Spondylitis Ankylosis Arthritis Axial Spondyloarthritis Balance Balance Assessment Bone Diseases Bone Diseases, Infectious Infections Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylarthropathies; Spondylitis, Ankylosing Spondylitis Spondylitis, Ankylosing

Age range

18 year–65 year

Sex eligibility

Male

Study type

Observational

Primary location

Istanbul Physical Medicine and Rehabilitation Trainig and Research Hospital

Istanbul, Bahcelievler, 34100, Turkey (Türkiye)

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Diagnostic Test

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.

Primary outcomes

  1. Mean Bilateral Thickness of Cervical Multifidus Muscle Assessed by Ultrasonography

    Time frame: 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.

  2. Mean Bilateral Thickness of Cervical Longus Colli Muscle Assessed by Ultrasonography

    Time frame: 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.

  3. Limits of Stability (LOS) Test

    Time frame: 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 outcomes

  1. Sway Area on Balance Platform

    Time frame: 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.

  2. Romberg Quotient

    Time frame: 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.

  3. Trace Length on Balance Platform

    Time frame: 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.

  4. Medio-Lateral (ML) Sway Range

    Time frame: 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.

  5. Anterior-Posterior (AP) Sway Range

    Time frame: 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.

  6. Average Sway Velocity

    Time frame: 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.

  7. Timed Up and Go (TUG) Test Duration

    Time frame: 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.

  8. Berg Balance Scale Total Score

    Time frame: 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.

Other outcomes

  1. Isometric Cervical Flexion and Extension Strength Measured by Hand-Held Dynamometer

    Time frame: baseline

    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.

  2. Short Version of the Activities-Specific Balance Confidence Scale (ABC-6) Score

    Time frame: baseline

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ecem Cetin Atakan, MD

CONTACT

[email protected]

90+5353440933

Nurdan Paker, MD,Prof.

CONTACT

[email protected]

90+5326917591

Sponsors and collaborators

Lead sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Other Gov

Registry information

Official study title

The Relationship Between Ultrasonographic Measurements of Cervical Multifidus and Longus Colli Muscles and Balance in Male Patients With Ankylosing Spondylitis:Controlled Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 13, 2025
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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