Enthesitis Related ArthritisNCT06383195
The Reliability and Validity of the Ankylosing Spondylitis Performance Index (ASPI) in Enthesitis-Related Arthritis
An observational study of Enthesitis Related Arthritis and Enthesitis Related Arthritis, Juvenile, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
This study assesses the test-retest reliability, construct validity, and minimal detectable change of the Ankylosing Spondylitis Performance Index (ASPI) in assessing the physical function of patients with Enthesitis-related arthritis (ERA). Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Enthesitis Related Arthritis, Enthesitis Related Arthritis, Juvenile
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Mar 2024to 20 Mar 2026
- Phase
- Observational
- 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 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Enthesitis-related arthritis (ERA)
Who may be able to join
- Being diagnosed with Enthesitis-Related Arthritis (ERA) according to The International League of Associations for Rheumatology (ILAR) classification
- Being between the ages of 7-18
- Volunteering to participate in research
Who cannot join
- Advanced heart/lung/liver/kidney disease, neurological disease and malignancies
- Having undergone major orthopedic surgery
- The presence of moderate to severe mental problems that will negatively affect participation
- Not volunteering to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe University
Ankara
Sinan Buran, RA, pt.sinanburan@gmail.com
About this study
Official title: The Reliability and Validity of the Ankylosing Spondylitis Performance Index (ASPI) Physical Function Test in Enthesitis-Related Arthritis
This study assesses the test-retest reliability, construct validity, and minimal detectable change of the Ankylosing Spondylitis Performance Index (ASPI) in assessing the physical function of patients with Enthesitis-related arthritis (ERA).
Read the detailed description
Enthesitis-related arthritis (ERA), which is considered the counterpart of adult spondyloarthropathies, is a human leukocyte antigen (HLA) B27-related subtype of juvenile idiopathic arthritis (JIA) characterized by enthesitis and arthritis, which can also affect the sacroiliac joints and axial spine. Compared to other JIA categories, ERA patients tend to have higher pain intensity, lower physical functionality, and poorer health status. Maintaining or improving physical functionality is one of the primary treatment goals for ERA patients. Physical functionality is also considered an important outcome measure for assessing disease course and effectiveness of treatment. When the literature is examined, it is seen that self-report-based questionnaires are used more frequently, and performance-based measurements are used less in the evaluation of ERA patients.
The Ankylosing Spondylitis Performance Index (ASPI) is a physical performance test that consists of a combination of three reliable tests (bending, putting on socks, and standing up from the floor) developed from the Bath Ankylosing Spondylitis Functional Index (BASFI). It is reported that applying ASPI can provide more objective information about the improvement in physical functionality and a better estimate of the patients' abilities.
ASPI has significant potential in this disease group, considering factors such as the fact that it was developed in adult spondyloarthropathy patients, which is the equivalent of ERA. However, its psychometric properties must be appropriate for the ASPI to be used in clinical settings and research. To our knowledge, no studies have been conducted in the current literature on the validity and reliability of the ASPI in ERA patients. Therefore, this study aimed to evaluate the test-retest reliability, construct validity, and minimal detectable change of the ASPI in assessing the physical function of patients with ERA.
- Medical subject headings
- Arthritis, Juvenile
What is being measured
The primary outcome is the main question the study is designed to answer.
Ankylosing Spondylitis Performance Index (ASPI)
The ASPI is performed in a common consultation room and consists of 3 standardized performance tasks: (1) bending to pick up 6 pencils from the floor (one by one); (2) putting on socks (mean of 3 times); and (3) getting up from the floor (mean of 3 times). The completion time for each task in the test will be recorded in seconds. The pain the patient feels during each task in the test will be evaluated using the Numeric Rating Scale (NRS) (0: no pain and 10: extreme pain). In addition, the patient's exertion in each task in the test will be evaluated using the Borg scale (0: no exertion and 10: extreme exertion).
Measured: Baseline (First assessment)
Secondary outcomes (5)
Childhood Health Assessment Questionnaire (CHAQ)
The CHAQ assesses the functional abilities of children with JIA in activities of daily living. It comprises eight sections (dressing and grooming, arising, eating, walking, hygiene, reaching, griping, and activities) and evaluates pain (0: no pain and 10: extreme pain) and general well-being (0: no problem and 10: extreme problem) using a Visual Analog Scale. The total CHAQ score ranges from 0 to 3 (higher scores reflect low functionality).
Measured: Baseline (First assessment)
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
The BASDAI was used to determine the disease activity levels of the patients. This index consists of 6 items related to 5 symptoms that occurred during the previous week: fatigue, spinal pain, joint pain/swelling, tenderness, and morning stiffness. The total BASDAI score ranges from 0 to 10 (higher scores reflect greater disease activity).
Measured: Baseline (First assessment)
Bath Ankylosing Spondylitis Functional Index (BASFI)
The BASFI was used to determine the functional levels of the patients. This index has 10 questions evaluating the daily living activities. The total BASFI score ranges from 0 to 10 (higher scores reflect a greater impairment).
Measured: Baseline (First assessment)
Bath Ankylosing Spondylitis Metrology Index (BASMI)
The BASMI is composed of five measurements: cervical rotation, tragus-to-wall distance, lateral flexion, modified Schober's distance, and intermalleolar distance. Each measurement indicates either 0 (mild disease involvement), 1 (moderate disease involvement), or 2 (severe disease involvement) points, resulting in a total BASMI score of 0-10.
Measured: Baseline (First assessment)
Modified Paediatric Mini Mental Scale (MPMMS)
MPMMS is a scale developed to determine children's cognitive skills and is recommended for use by professionals in various healthcare settings.
Measured: Baseline (First assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start21 Mar 2024
- Primary completion20 Mar 2026 (estimated)
- Study completion20 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enthesitis Related ArthritisStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sinan Buran, Hacettepe University
- Investigators
- Sinan Buran, RA, Principal investigator, Hacettepe University Faculty of Physical Therapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06383195
- Sponsor's protocol ID
- SBA 24/189
- Status last verified
- Apr 2024
- First submitted
- 17 Apr 2024
- Last updated
- 25 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Reliability and Validity of the Ankylosing Spondylitis Performance Index (ASPI) Physical Function Test in Enthesitis-Related Arthritis
- ClinicalTrials.gov ID
- NCT06383195
- Acronym / sponsor ID
- SBA 24/189
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 21 Mar 2024 (actual)
- Primary completion
- 20 Mar 2026 (estimated)
- Study completion
- 20 Mar 2026 (estimated)
- First posted
- 25 Apr 2024 (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.
This study assesses the test-retest reliability, construct validity, and minimal detectable change of the Ankylosing Spondylitis Performance Index (ASPI) in assessing the physical function of patients with Enthesitis-related arthritis (ERA).
Detailed description
Enthesitis-related arthritis (ERA), which is considered the counterpart of adult spondyloarthropathies, is a human leukocyte antigen (HLA) B27-related subtype of juvenile idiopathic arthritis (JIA) characterized by enthesitis and arthritis, which can also affect the sacroiliac joints and axial spine. Compared to other JIA categories, ERA patients tend to have higher pain intensity, lower physical functionality, and poorer health status. Maintaining or improving physical functionality is one of the primary treatment goals for ERA patients. Physical functionality is also considered an important outcome measure for assessing disease course and effectiveness of treatment. When the literature is examined, it is seen that self-report-based questionnaires are used more frequently, and performance-based measurements are used less in the evaluation of ERA patients.
The Ankylosing Spondylitis Performance Index (ASPI) is a physical performance test that consists of a combination of three reliable tests (bending, putting on socks, and standing up from the floor) developed from the Bath Ankylosing Spondylitis Functional Index (BASFI). It is reported that applying ASPI can provide more objective information about the improvement in physical functionality and a better estimate of the patients' abilities.
ASPI has significant potential in this disease group, considering factors such as the fact that it was developed in adult spondyloarthropathy patients, which is the equivalent of ERA. However, its psychometric properties must be appropriate for the ASPI to be used in clinical settings and research. To our knowledge, no studies have been conducted in the current literature on the validity and reliability of the ASPI in ERA patients. Therefore, this study aimed to evaluate the test-retest reliability, construct validity, and minimal detectable change of the ASPI in assessing the physical function of patients with ERA.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Enthesitis-related arthritis (ERA)
Key inclusion criteria (3 listed)
- Being diagnosed with Enthesitis-Related Arthritis (ERA) according to The International League of Associations for Rheumatology (ILAR) classification
- Being between the ages of 7-18
- Volunteering to participate in research
Key exclusion criteria (4 listed)
- Advanced heart/lung/liver/kidney disease, neurological disease and malignancies
- Having undergone major orthopedic surgery
- The presence of moderate to severe mental problems that will negatively affect participation
- Not volunteering to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ankylosing Spondylitis Performance Index (ASPI)
Time frame: Baseline (First assessment)
The ASPI is performed in a common consultation room and consists of 3 standardized performance tasks: (1) bending to pick up 6 pencils from the floor (one by one); (2) putting on socks (mean of 3 times); and (3) getting up from the floor (mean of 3 times). The completion time for each task in the test will be recorded in seconds. The pain the patient feels during each task in the test will be evaluated using the Numeric Rating Scale (NRS) (0: no pain and 10: extreme pain). In addition, the patient's exertion in each task in the test will be evaluated using the Borg scale (0: no exertion and 10: extreme exertion).
5 secondary outcomes
Childhood Health Assessment Questionnaire (CHAQ)
Time frame: Baseline (First assessment)
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time frame: Baseline (First assessment)
Bath Ankylosing Spondylitis Functional Index (BASFI)
Time frame: Baseline (First assessment)
Bath Ankylosing Spondylitis Metrology Index (BASMI)
Time frame: Baseline (First assessment)
Modified Paediatric Mini Mental Scale (MPMMS)
Time frame: Baseline (First assessment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- 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.
Sinan Buran, RA principal investigator
Hacettepe University Faculty of Physical Therapy and Rehabilitation
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 Enthesitis Related Arthritis and Enthesitis Related Arthritis, Juvenile, run by Hacettepe 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 4 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 25 Apr 2024. 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 Sinan Buran, RA (+903123052525, pt.sinanburan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ankylosing Spondylitis Performance Index (ASPI) (time frame: Baseline (First assessment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Apr 2024.