Status:
RECRUITING
Advanced Sensor Based Functional ASsessmenTs in Axial Spondyloarthritis
Lead Sponsor:
Western Health and Social Care Trust
Collaborating Sponsors:
University of Ulster
Conditions:
Axial Spondyloarthritis
Eligibility:
All Genders
18-80 years
Brief Summary
This is an observational study using Inertial Measurement Unit (IMU) sensors to measure the effects of biological therapy on spinal mobility and function in axial spondyloarthritis. Participants will ...
Detailed Description
We will study 20 participants with active axial spondyloarthritis (axSpA) who are about to start biologic therapy as part of routine care. In brief, we will carry out the following assessments before ...
Eligibility Criteria
Inclusion
- Diagnosis of axial spondyloarthritis fulfilling ASAS classification criteria.
- Age ≥18 years old and \<80 years.
- Fulfilment of local criteria for biologic therapy for axSpA.
- The subjects should be able to read, write, understand and complete study questionnaires.
- 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
- Safety contra-indication for biologic drug therapy.
- Severely restricted hip movement (less than 20 degrees rotation in either hip).
- History of previous clinical (symptomatic) vertebral fracture.
- History of previous spinal surgery.
- History of previous hip replacement surgery.
- Major scoliosis deformity (in the opinion of the investigator).
- Safety contra-indication for MRI assessment.
- Previous biologic agent within 2 months.
- Pregnant or breast-feeding women.
Key Trial Info
Start Date :
July 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 7 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04489342
Start Date
July 1 2019
End Date
February 7 2026
Last Update
July 25 2024
Active Locations (1)
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1
Department of Rheumatology, Altnagelvin Hospital
Londonderry, N.Ireland, United Kingdom, BT47 6SB