Actively Recruiting
Investigation of IMU Sensor-Based Tests Measuring Spinal Mobility Changes in Axial Spondyloarthritis Patients Treated With Biologic Therapy
Led by Western Health and Social Care Trust · Updated on 2024-07-25
20
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
W
Western Health and Social Care Trust
Lead Sponsor
U
University of Ulster
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how Inertial Measurement Unit (IMU) sensors can measure changes in spinal mobility and function in people with active axial spondyloarthritis who are starting biologic therapy. This observational study aims to compare sensor data with MRI scans to see how changes in inflammation relate to spinal movement. The study includes adults aged 18 to under 80 who meet certain criteria for biologic treatment. Participants will undergo assessments before and after starting biologic therapy as part of their routine care. These assessments include MRI scans of the spine and sacroiliac joints scored by a specific method, various patient-reported outcome questionnaires, blood tests for inflammation markers, and both in-clinic and at-home IMU sensor tests to measure spinal range of motion and function. During the study, participants will be evaluated using multiple standardized tools and questionnaires related to disease activity and physical function. Researchers will track changes in a composite IMU sensor index as the primary outcome after four months of therapy. Additional measures include changes in disease activity scores, functional indices, spine imaging scores, and physical performance tests. The study will monitor participants over this period to understand the relationship between biologic therapy and spinal mobility.
CONDITIONS
Brief Title
Advanced Sensor Based Functional ASsessmenTs in Axial Spondyloarthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of axial spondyloarthritis fulfilling ASAS classification criteria
- Age 18 years or older and under 80 years
- Meeting local criteria for biologic therapy for axial spondyloarthritis
- Ability to read, write, understand, and complete study questionnaires
- Signed informed consent indicating understanding and willingness to participate
You will not qualify if you...
- Safety contraindications 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 as judged by the investigator
- Safety contraindications for MRI assessment
- Use of a biologic agent within 2 months prior to the study
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 months
Participants who are starting biologic therapy as part of routine care are observed. Measurements including MRI scans, blood tests, patient-reported outcomes, and IMU sensor tests in clinic and at home are collected before and after therapy to assess spinal mobility changes.
Assessments occur before therapy and after 4 months
Trial Site Locations
Total: 1 location
1
Department of Rheumatology, Altnagelvin Hospital
Londonderry, N.Ireland, United Kingdom, BT47 6SB
Actively Recruiting
Research Team
D
Dawn Small
A
Aaron Peace, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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