Ankylosing SpondylitisNCT06967883
Ultrasound Assessment of Neck Muscles and Balance in Male Patients With Ankylosing Spondylitis
An observational study of Ankylosing Spondylitis and Balance Assessment, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Ankylosing Spondylitis, Balance Assessment, Balance
- What is being tested?
- 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
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 1 Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study 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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Physical Medicine and Rehabilitation Trainig and Research Hospital
Istanbul, Bahcelievler, 34100
About this study
Official title: The Relationship Between Ultrasonographic Measurements of Cervical Multifidus and Longus Colli Muscles and Balance in Male Patients With Ankylosing Spondylitis:Controlled Study
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)
Read the 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.
- Conditions
- Ankylosing Spondylitis, Balance Assessment, Balance, Spondylarthropathies; Spondylitis, Ankylosing
- Being tested
- 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
- Keywords
- ankylosing spondylitis, balance, deep cervical muscles
- Medical subject headings
- Spondylitis, Ankylosing, Spondylarthropathies, Spondylitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonographic assessment of Cervical Multifidus and Longus Colli Muscle Thickness, Postural Balance and Limit of Stability using the balance platform,Cervical Flexion and Extension StrengthDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Ankylosing Spondylitis Group | 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. Receives: 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 | |
| Control Group | Age-matched healthy male volunteers aged 18-65 years with cognitive ability sufficient to understand test instructions. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: baseline
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start1 Jan 2025
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Nurdan Paker, MD, Prof., Study director, Istanbul Physical Medicine and Rehabilitation Training Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06967883
- Sponsor's protocol ID
- ISTPMRTRH2024-80
- Status last verified
- May 2025
- First submitted
- 23 Feb 2025
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33227676Turk 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.
PubMed 39230687
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Ultrasonographic Measurements of Cervical Multifidus and Longus Colli Muscles and Balance in Male Patients With Ankylosing Spondylitis:Controlled Study
- ClinicalTrials.gov ID
- NCT06967883
- Acronym / sponsor ID
- ISTPMRTRH2024-80
- Conditions
- Ankylosing Spondylitis, Balance Assessment, Balance, Spondylarthropathies; Spondylitis, Ankylosing
- Keywords
- ankylosing spondylitis, balance, deep cervical muscles
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 13 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ankylosing Spondylitis Group | – | 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 StrengthMale 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. |
| Control Group | – | 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 StrengthAge-matched healthy male volunteers aged 18-65 years with cognitive ability sufficient to understand test instructions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasonographic assessment of Cervical Multifidus and Longus Colli Muscle Thickness, Postural Balance and Limit of Stability using the balance platform,Cervical Flexion and Extension StrengthIntervention 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. | Diagnostic test | Ankylosing Spondylitis Group, Control Group |
Primary outcome
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.
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.
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.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Background: PubMed 33227676Ozen 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.
- Background: PubMed 39230687Turk 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.
- Sonographic Comparison of Neck Extensor Muscle Thickness of Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis Patients with Healthy VolunteersLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nurdan Paker, MD, Prof. study director
Istanbul Physical Medicine and Rehabilitation Training Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankylosing Spondylitis and Balance Assessment, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ecem Cetin Atakan, MD (90+5353440933, ecemcetin1995@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Bilateral Thickness of Cervical Multifidus Muscle Assessed by Ultrasonography (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06967883, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.