Advanced Sensor Based Functional ASsessmenTs in Axial Spondyloarthritis
NCT ID: NCT04489342
Last Updated: 2024-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
20 participants
OBSERVATIONAL
2019-07-01
2026-02-07
Brief Summary
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Detailed Description
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1. MRI of spine and Sacroiliac (SI) joints - modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) scoring
2. Record standard Patient recorded outcomes (PROs): Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Global (BASG), Bath Ankylosing Spondylitis Metrology Index (BASMI), Bath Ankylosing Spondylitis Functional Index (BASFI), Ankylosing Spondylitis Disease Activity Score (ASDAS), Ankylosing Spondylitis Disease Activity Score Health Index (ASAS-HI), Euroquol 3 level health assessment (EQ5D-3L), work productivity and activity impairment questionnaire (WPAI), Short QUestionnaire to ASsess Health enhancing physical activity (SQUASH),
3. Erythrocyte sedimentation rate (ESR), C-reactive protein (CRP)
4. IMU sensor tests in clinic for range of motion (ROM) in cervical, thoracic and lumbar spine.
5. IMU sensor tests at home for standardised function testing
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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IMU sensor test
Measurement of maximum range of movement in the spine; Ambulatory observational data while performing standardised functional tests
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age ≥18 years old and \<80 years.
3. Fulfilment of local criteria for biologic therapy for axSpA.
4. The subjects should be able to read, write, understand and complete study questionnaires.
5. Each subject must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study.
Exclusion Criteria
2. Severely restricted hip movement (less than 20 degrees rotation in either hip).
3. History of previous clinical (symptomatic) vertebral fracture.
4. History of previous spinal surgery.
5. History of previous hip replacement surgery.
6. Major scoliosis deformity (in the opinion of the investigator).
7. Safety contra-indication for MRI assessment.
8. Previous biologic agent within 2 months.
9. Pregnant or breast-feeding women.
18 Years
80 Years
ALL
No
Sponsors
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University of Ulster
OTHER
Western Health and Social Care Trust
OTHER
Responsible Party
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Dr Philip Gardiner
Consultant Rheumatologist
Principal Investigators
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Philip Gardiner, MD
Role: PRINCIPAL_INVESTIGATOR
Western Health and Social Care Trust
Locations
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Department of Rheumatology, Altnagelvin Hospital
Londonderry, N.Ireland, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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WesternHSCT
Identifier Type: -
Identifier Source: org_study_id
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