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

NCT06383195 | Recruiting

• 1 other identifier: SBA 24/189
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Enthesitis Related Arthritis; Enthesitis Related Arthritis, Juvenile

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Childhood Health Assessment Questionnaire (CHAQ)

  Baseline (First assessment)

• Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

  Baseline (First assessment)

• Bath Ankylosing Spondylitis Functional Index (BASFI)

  Baseline (First assessment)

• Bath Ankylosing Spondylitis Metrology Index (BASMI)

  Baseline (First assessment)

• Modified Paediatric Mini Mental Scale (MPMMS)

  Baseline (First assessment)

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Enthesitis-related arthritis (ERA)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Arthritis, Juvenile

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Sinan Buran, RA

  Hacettepe University Faculty of Physical Therapy and Rehabilitation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sinan Buran, RA

CONTACT

+903123052525; pt.sinanburan@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 25, 2024
• Study Start: March 21, 2024
• Primary Completion: March 20, 2026
• Study Completion: March 20, 2026
• Last Updated: April 25, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)