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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18-65
SponsorIstanbul Physical Medicine Rehabilitation Training and Research Hospital

About this trial

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)

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Orthopedic disorders affecting the spine or lower limbs.

Cardiovascular disorders.

Neurological disorders.

Visual or auditory impairments.

Trial population

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

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • 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.

Treatment groups

76 Participants
are divided into 2 treatment groups
Group A: Ankylosing Spondylitis Group1 intervention
Group B: Control Group1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

1

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
2

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

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