Clinical trial NCT06383195: The Reliability and Validity of the Ankylosing Spondylitis Performance Index (ASPI) in Enthesitis-Related Arthritis
Official title: The Reliability and Validity of the Ankylosing Spondylitis Performance Index (ASPI) Physical Function Test in Enthesitis-Related Arthritis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Enthesitis Related Arthritis
Enthesitis Related Arthritis, Juvenile
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2024-04-25
Enrollment: 40
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Enthesitis-related arthritis (ERA)

Brief 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).

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Ankylosing Spondylitis Performance Index (ASPI)
timeFrame: Baseline (First assessment)
Secondary outcomes:
measure: Childhood Health Assessment Questionnaire (CHAQ)
timeFrame: Baseline (First assessment)
measure: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
timeFrame: Baseline (First assessment)
measure: Bath Ankylosing Spondylitis Functional Index (BASFI)
timeFrame: Baseline (First assessment)
measure: Bath Ankylosing Spondylitis Metrology Index (BASMI)
timeFrame: Baseline (First assessment)
measure: Modified Paediatric Mini Mental Scale (MPMMS)
timeFrame: Baseline (First assessment)
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University Faculty of Physical Therapy and Rehabilitation
name: Sinan Buran, RA
role: PRINCIPAL_INVESTIGATOR
References: