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Recruiting NCT06967883

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

Observational Ankylosing Spondylitis Balance Assessment Balance Spondylarthropathies; Spondylitis, Ankylosing

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 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.
Who it may be relevant to
Registry conditions: Ankylosing Spondylitis, Balance Assessment, Balance, Spondylarthropathies; Spondylitis, Ankylosing. Basic parameters: 18 years — 65 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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 cervi

Primary outcome measures

  • Mean Bilateral Thickness of Cervical Multifidus Muscle Assessed by Ultrasonography [Time frame: baseline]
  • Mean Bilateral Thickness of Cervical Longus Colli Muscle Assessed by Ultrasonography [Time frame: baseline]
  • Limits of Stability (LOS) Test [Time frame: baseline]
Secondary outcome measures (8)
  • Sway Area on Balance Platform [Time frame: baseline]
  • Romberg Quotient [Time frame: baseline]
  • Trace Length on Balance Platform [Time frame: baseline]
  • Medio-Lateral (ML) Sway Range [Time frame: baseline]
  • Anterior-Posterior (AP) Sway Range [Time frame: baseline]
  • Average Sway Velocity [Time frame: baseline]
  • Timed Up and Go (TUG) Test Duration [Time frame: baseline]
  • Berg Balance Scale Total Score [Time frame: baseline]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Turkey (Türkiye) · 1 center
  • Istanbul Physical Medicine and Rehabilitation Trainig and Research Hospital — Istanbul

Publications

  • Ozen T, Tonga E, Polat MG, Bayraktar D, Akar S. Cervical proprioception accuracy is impaired in patients with axial spondyloarthritis. Musculoskelet Sci Pract. 2021 Feb;51:102304. doi: 10.1016/j.msksp.2020.102304. Epub 2020 Nov 16. PMID 33227676
  • Turk E, Yurdakul FG, Guler T, Bodur H. Posture, balance and gait in axial spondyloarthritis: a case-control study. Rheumatol Int. 2024 Nov;44(11):2527-2538. doi: 10.1007/s00296-024-05710-5. Epub 2024 Sep 4. PMID 39230687

Identifiers

NCT: NCT06967883 · ISTPMRTRH2024-80

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗