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

April 20, 2024 updated by: Sinan Buran, Hacettepe University

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).

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Enthesitis-related arthritis (ERA)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline (First assessment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Childhood Health Assessment Questionnaire (CHAQ)
Time Frame: Baseline (First assessment)
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)
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time Frame: Baseline (First assessment)
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)
Bath Ankylosing Spondylitis Functional Index (BASFI)
Time Frame: Baseline (First assessment)
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)
Bath Ankylosing Spondylitis Metrology Index (BASMI)
Time Frame: Baseline (First assessment)
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)
Modified Paediatric Mini Mental Scale (MPMMS)
Time Frame: Baseline (First assessment)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Investigators

  • Principal Investigator: Sinan Buran, RA, Hacettepe University Faculty of Physical Therapy and Rehabilitation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2024

Primary Completion (Estimated)

March 20, 2026

Study Completion (Estimated)

March 20, 2026

Study Registration Dates

First Submitted

April 17, 2024

First Submitted That Met QC Criteria

April 20, 2024

First Posted (Actual)

April 25, 2024

Study Record Updates

Last Update Posted (Actual)

April 25, 2024

Last Update Submitted That Met QC Criteria

April 20, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBA 24/189

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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