Ankylosing SpondylitisNCT04820725
The Effects of Postural Changes on Plantar Pressure in Patients With Ankylosing Spondylitis
A study testing Plantar pressure and gait in people with Ankylosing Spondylitis, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Ankylosing Spondlitis (AS) is a chronic, rheumatic disease. Foot and ankle involvement may stem from both postural changes in patients seen spinal deformity with the progress of the disease and enthesitis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- Plantar pressure and gait
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Oct 2021to 2 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are aged between 18-55 years,
- Patients who got diagnosed according to Modified New York criteria
- Patients who are being followed at Firat University Department of Rheumatology.
Who cannot join
- Patients who have exercise habits
- Incooperation
- Malignancy
- Pregnancy
- Patients who have changes of medical treatment in the last 3 months
- Patients who have another disease that can effect pulmonary functions
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Songul Baglan Yentur
Elâzığ, 23000
Songul B Yentur, +90 506 272 6511, songulbaglan23@hotmail.com
About this study
Ankylosing Spondlitis (AS) is a chronic, rheumatic disease. Foot and ankle involvement may stem from both postural changes in patients seen spinal deformity with the progress of the disease and enthesitis. The purpose of the study is to investigate the relationship plantar pressure distribution and balance, mobility and disease activity in AS patients and to compare AS patients with and without postural changes and healthy subjects.
Read the detailed description
Ankylosing Spondlitis (AS) is a chronic, rheumatic disease. Reduction in flexibility and mobility is important factors that can cause impairment quality of life, reduction of exercise tolerance and pulmonary capacity with the progression of AS. Extra articular symptoms such as neurologic, cardiovascular and pulmonary involvement affect morbidity and mortality rate. Foot and ankle involvement may stem from both postural changes in patients seen spinal deformity with the progress of the disease and enthesitis. Şahlı et al. concluded that 52% of AS patients had foot involvement but 35% of the patients had symptoms. To be determined plantar pressure distribution is important to be decided body weight distribution, postural control and selection of shoes. The purpose of the study is to investigate the relationship plantar pressure distribution and balance, mobility and disease activity in AS patients and to compare AS patients with and without postural changes and healthy subjects.
- Conditions
- Ankylosing Spondylitis
- Being tested
- Plantar pressure and gait
- Keywords
- Ankylosing Spondylitis,, posture, plantar pressure
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plantar pressure and gaitDiagnostic test
Gait analyses (cadence, stride length, swing phase duration, step duration and double stand duration) will be evaluated using Win-Track platform (MEDICAPTEURS Technology, France).
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Patients whose BASMI score is 2 will be included in the study Receives: Diagnostic Test: Plantar pressure and gait |
| Control group | Experimental | Patients whose BASMI score is 0 and 1 will be included in the study Receives: Diagnostic Test: Plantar pressure and gait |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait analyses
plantar pressure distribution
Measured: 3 minutes
Secondary outcomes (3)
Bath Ankylosing Spondylitis Metrology Index
Spinal mobility will assessed and scored by Bath Ankylosing Spondylitis Metrology Index (BASMI). There are five measurements including lateral lumbar flexion, tragus-to-wall distance, lumbar flexion (Modified Schober), maximal intermalleolar distance and cervical rotation according to the index. Each subscale is scored between 0 and 10. All points are then averaged to calculate total score. Higher values represent worse outcomes.
Measured: 5 minutes
Bath Ankylosing Spondylitis Disease Activity Index
Bath Ankylosing Spondylitis Disease Activity Index which consists of 6 questions will be used to evaluate disease activity. BASDAI is a composite index, consisting of an assessment on a 10 cm horizontal visual analog scale of fatigue, axial pain, peripheral pain, enthesopathy and stiffness. Fifth and sixth questions are averaged. Addition to this score, other questions are averaged. Total score is between 0 and 10. Higher score represent worse outcome.
Measured: 1 minute
Time up and go test
The patient starts in a seated position. The patient stands up upon therapist's command: walks 3 meters, turns around, walks back to the chair and sits down. The time stops when the patient is seated.
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start31 Oct 2021 (estimated)
- Primary completion17 Aug 2022 (estimated)
- Study completion2 Dec 2022 (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.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Songul Baglan Yentur, Firat University
- Investigators
- Süleyman S Koca, Study director, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04820725
- Sponsor's protocol ID
- 05-06
- Status last verified
- Jan 2021
- First submitted
- 25 Mar 2021
- Last updated
- 29 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sahli H, Bachali A, Tekaya R, Mahmoud I, Sedki Y, Saidane O, Abdelmoula L. Involvement of foot in patients with spondyloarthritis: Prevalence and clinical features. Foot Ankle Surg. 2019 Apr;25(2):226-230. doi: 10.1016/j.fas.2017.10.016. Epub 2017 Nov 10.
PubMed 29409278Aydin E, Turan Y, Tastaban E, Kurt Omurlu I, Sendur OF. Plantar pressure distribution in patients with ankylosing spondylitis. Clin Biomech (Bristol). 2015 Mar;30(3):238-42. doi: 10.1016/j.clinbiomech.2015.02.003. Epub 2015 Feb 8.
PubMed 25684149
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Postural Changes on Plantar Pressure in Patients With Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT04820725
- Acronym / sponsor ID
- 05-06
- Conditions
- Ankylosing Spondylitis
- Keywords
- Ankylosing Spondylitis,, posture, plantar pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 31 Oct 2021 (estimated)
- Primary completion
- 17 Aug 2022 (estimated)
- Study completion
- 2 Dec 2022 (estimated)
- First posted
- 29 Mar 2021 (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.
Ankylosing Spondlitis (AS) is a chronic, rheumatic disease. Foot and ankle involvement may stem from both postural changes in patients seen spinal deformity with the progress of the disease and enthesitis. The purpose of the study is to investigate the relationship plantar pressure distribution and balance, mobility and disease activity in AS patients and to compare AS patients with and without postural changes and healthy subjects.
Detailed description
Ankylosing Spondlitis (AS) is a chronic, rheumatic disease. Reduction in flexibility and mobility is important factors that can cause impairment quality of life, reduction of exercise tolerance and pulmonary capacity with the progression of AS. Extra articular symptoms such as neurologic, cardiovascular and pulmonary involvement affect morbidity and mortality rate. Foot and ankle involvement may stem from both postural changes in patients seen spinal deformity with the progress of the disease and enthesitis. Şahlı et al. concluded that 52% of AS patients had foot involvement but 35% of the patients had symptoms. To be determined plantar pressure distribution is important to be decided body weight distribution, postural control and selection of shoes. The purpose of the study is to investigate the relationship plantar pressure distribution and balance, mobility and disease activity in AS patients and to compare AS patients with and without postural changes and healthy subjects.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Diagnostic Test: Plantar pressure and gaitPatients whose BASMI score is 2 will be included in the study |
| Control group | Experimental | Diagnostic Test: Plantar pressure and gaitPatients whose BASMI score is 0 and 1 will be included in the study |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who are aged between 18-55 years,
- Patients who got diagnosed according to Modified New York criteria
- Patients who are being followed at Firat University Department of Rheumatology.
Key exclusion criteria (6 listed)
- Patients who have exercise habits
- Incooperation
- Malignancy
- Pregnancy
- Patients who have changes of medical treatment in the last 3 months
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 |
|---|---|---|
| Plantar pressure and gaitGait analyses (cadence, stride length, swing phase duration, step duration and double stand duration) will be evaluated using Win-Track platform (MEDICAPTEURS Technology, France). | Diagnostic test | Control group, Study group |
Primary outcome
Gait analyses
Time frame: 3 minutes
plantar pressure distribution
3 secondary outcomes
Bath Ankylosing Spondylitis Metrology Index
Time frame: 5 minutes
Bath Ankylosing Spondylitis Disease Activity Index
Time frame: 1 minute
Time up and go test
Time frame: 1 minute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2021.
- Background: PubMed 29409278Sahli H, Bachali A, Tekaya R, Mahmoud I, Sedki Y, Saidane O, Abdelmoula L. Involvement of foot in patients with spondyloarthritis: Prevalence and clinical features. Foot Ankle Surg. 2019 Apr;25(2):226-230. doi: 10.1016/j.fas.2017.10.016. Epub 2017 Nov 10.
- Background: PubMed 25684149Aydin E, Turan Y, Tastaban E, Kurt Omurlu I, Sendur OF. Plantar pressure distribution in patients with ankylosing spondylitis. Clin Biomech (Bristol). 2015 Mar;30(3):238-42. doi: 10.1016/j.clinbiomech.2015.02.003. Epub 2015 Feb 8.
- 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. This study is not recruiting at the moment.
Süleyman S Koca study director
Firat University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plantar pressure and gait in people with Ankylosing Spondylitis, run by Gazi University 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 6 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: status not confirmed, as of the sponsor's last update on 29 Mar 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Songul B Yentur (0424 237 8282, songulbaglan23@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait analyses (time frame: 3 minutes). 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 NCT04820725, 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 29 Mar 2021.