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

Enthesitis Related Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06383195
• Other study ID #: SBA 24/189
• Status: Recruiting
• Start date: March 21, 2024
• Est. completion date: March 20, 2026

Study information

• Verified date: April 2024
• Source: Hacettepe University
• Contact: Sinan Buran, RA
• Phone: +903123052525
• Email: pt.sinanburan[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 20, 2026
• Est. primary completion date: March 20, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Enthesitis Related Arthritis
• Enthesopathy
• Spondylitis
• Spondylitis, Ankylosing

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline (First assessment)
Secondary	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).	Baseline (First assessment)
Secondary	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).	Baseline (First assessment)
Secondary	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).	Baseline (First assessment)
Secondary	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.	Baseline (First assessment)
Secondary	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.	Baseline (First assessment)