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Clinical Trials/NCT06383195
NCT06383195
Recruiting
Not Applicable

The Reliability and Validity of the Ankylosing Spondylitis Performance Index (ASPI) Physical Function Test in Enthesitis-Related Arthritis

Hacettepe University1 site in 1 country40 target enrollmentMarch 21, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Enthesitis Related Arthritis
Sponsor
Hacettepe University
Enrollment
40
Locations
1
Primary Endpoint
Ankylosing Spondylitis Performance Index (ASPI)
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 21, 2024
End Date
March 20, 2026
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sinan Buran

Principal Investigator

Hacettepe University

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

Outcomes

Primary Outcomes

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).

Secondary Outcomes

  • Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)(Baseline (First assessment))
  • Childhood Health Assessment Questionnaire (CHAQ)(Baseline (First assessment))
  • Bath Ankylosing Spondylitis Functional Index (BASFI)(Baseline (First assessment))
  • Modified Paediatric Mini Mental Scale (MPMMS)(Baseline (First assessment))
  • Bath Ankylosing Spondylitis Metrology Index (BASMI)(Baseline (First assessment))

Study Sites (1)

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