Ignite Creation Date:
2025-12-24 @ 1:49 PM
Ignite Modification Date:
2025-12-30 @ 11:33 PM
Study NCT ID:
NCT06383195
Status:
RECRUITING
Last Update Posted:
2024-04-25
First Post:
2024-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Reliability and Validity of the Ankylosing Spondylitis Performance Index (ASPI) in Enthesitis-Related Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001171', 'term': 'Arthritis, Juvenile'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2026-03-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-20', 'studyFirstSubmitDate': '2024-04-17', 'studyFirstSubmitQcDate': '2024-04-20', 'lastUpdatePostDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ankylosing Spondylitis Performance Index (ASPI)', 'timeFrame': 'Baseline (First assessment)', 'description': "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)."}], 'secondaryOutcomes': [{'measure': 'Childhood Health Assessment Questionnaire (CHAQ)', 'timeFrame': 'Baseline (First assessment)', 'description': '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).'}, {'measure': 'Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)', 'timeFrame': 'Baseline (First assessment)', 'description': '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).'}, {'measure': 'Bath Ankylosing Spondylitis Functional Index (BASFI)', 'timeFrame': 'Baseline (First assessment)', 'description': '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).'}, {'measure': 'Bath Ankylosing Spondylitis Metrology Index (BASMI)', 'timeFrame': 'Baseline (First assessment)', 'description': "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."}, {'measure': 'Modified Paediatric Mini Mental Scale (MPMMS)', 'timeFrame': 'Baseline (First assessment)', 'description': "MPMMS is a scale developed to determine children's cognitive skills and is recommended for use by professionals in various healthcare settings."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Enthesitis Related Arthritis', 'Enthesitis Related Arthritis, Juvenile']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': "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.\n\nThe 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.\n\nASPI 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '7 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Enthesitis-related arthritis (ERA)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being diagnosed with Enthesitis-Related Arthritis (ERA) according to The International League of Associations for Rheumatology (ILAR) classification\n* Being between the ages of 7-18\n* Volunteering to participate in research\n\nExclusion Criteria:\n\n* Advanced heart/lung/liver/kidney disease, neurological disease and malignancies\n* Having undergone major orthopedic surgery\n* The presence of moderate to severe mental problems that will negatively affect participation\n* Not volunteering to participate in the study'}, 'identificationModule': {'nctId': 'NCT06383195', 'briefTitle': 'The Reliability and Validity of the Ankylosing Spondylitis Performance Index (ASPI) in Enthesitis-Related Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'The Reliability and Validity of the Ankylosing Spondylitis Performance Index (ASPI) Physical Function Test in Enthesitis-Related Arthritis', 'orgStudyIdInfo': {'id': 'SBA 24/189'}}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Sinan Buran, RA', 'role': 'CONTACT', 'email': 'pt.sinanburan@gmail.com'}], 'facility': 'Hacettepe University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Sinan Buran, RA', 'role': 'CONTACT', 'email': 'pt.sinanburan@gmail.com', 'phone': '+903123052525'}], 'overallOfficials': [{'name': 'Sinan Buran, RA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hacettepe University Faculty of Physical Therapy and Rehabilitation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sinan Buran', 'investigatorAffiliation': 'Hacettepe University'}}}}