Using sensors to assess spinal mobility in patients with axial spondyloarthritis

An Investigation Into the Responsiveness of Inertial Measurement Unit (IMU) Sensor-based Tests in Measuring Changes in Spinal Mobility and Function in Axial Spondyloarthritis Patients Treated With Biologic Drug

This study is testing how a new treatment for axial spondyloarthritis affects spinal movement and function in people starting biologic therapy by using special sensors to track changes.

Quick facts

• Study type: Observational
• Enrollment: 20 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Western Health and Social Care Trust (Academic / other)
• Locations: 1 site (Londonderry, N.Ireland)
• Trial ID: NCT04489342 on ClinicalTrials.gov

What this trial studies

This observational study evaluates the impact of biological therapy on spinal mobility and function in patients with axial spondyloarthritis using Inertial Measurement Unit (IMU) sensors. Twenty participants who are about to start biologic therapy will undergo MRI scans and various patient-reported outcomes before and after treatment. The study aims to correlate changes in inflammatory signs with improvements in spinal mobility as measured by both clinical assessments and sensor tests. This comprehensive approach will help in understanding the effectiveness of the therapy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with a diagnosis of axial spondyloarthritis who meet local criteria for biologic therapy.

Not a fit: Patients with severe hip movement restrictions, previous spinal surgeries, or contraindications for biologic therapy or MRI assessments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the effectiveness of biological therapies for improving spinal mobility in axial spondyloarthritis patients.

How similar studies have performed: While the use of IMU sensors in this context is relatively novel, similar studies have shown promise in assessing mobility and function in other rheumatological conditions.

Eligibility criteria

Inclusion Criteria:

1. Diagnosis of axial spondyloarthritis fulfilling ASAS classification 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:

1. Safety contra-indication for biologic drug therapy.
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.

Where this trial is running

Londonderry, N.Ireland

• Department of Rheumatology, Altnagelvin Hospital — Londonderry, N.Ireland, United Kingdom (Recruiting)

Study contacts

• Principal investigator: Philip Gardiner, MD — Western Health and Social Care Trust
• Study coordinator: Dawn Small

Conditions Axial Spondyloarthritis