Advanced Sensor Based Functional ASsessmenTs in Axial Spondyloarthritis

STATUS

Recruiting
participants needed

20
sponsor

Western Health and Social Care Trust

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Updated on 19 February 2024

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MRI

MRI Scan

biological therapy

axial spondyloarthritis

spondylarthritis

Summary

This is an observational study using IMU sensors to measure the effects of biological therapy on spinal mobility and function in axial spondyloarthritis. Participants will undergo MRI scans before and after therapy in parallel to the sensor tests to establish correlation between changes in inflammatory signs and changes in spinal mobility.

Description

We will study 20 participants with active axSpA who are about to start biologic therapy as part of routine care. In brief, we will carry out the following assessments before and after

therapy

MRI of spine and SI joints - mSASSS scoring
Record standard PROs: BASDAI, BASG, BASMI, BASFI, ASDAS, ASAS-HI, EQ5D-3L, WPAI, SQUASH,
ESR, CRP
IMU sensor tests in clinic for ROM in cervical, thoracic and lumbar spine.
IMU sensor tests at home for standardised function testing

Details

Condition	Axial Spondyloarthritis
Age	18years - 80years
Treatment	ViMove IMU sensor test
Clinical Study Identifier	NCT04489342
Sponsor	Western Health and Social Care Trust
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	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 Criteria
	EC1. Safety contra-indication for biologic drug therapy. EC2. Severely
	restricted hip movement (less than 20 degrees rotation in either hip)
	EC3. History of previous clinical (symptomatic) vertebral fracture. EC4
	History of previous spinal surgery. EC5. History of previous hip replacement
	surgery. EC6. Major scoliosis deformity (in the opinion of the investigator)
	EC7. Safety contra-indication for MRI assessment. EC8. Previous biologic agent
	within 2 months. EC9. Pregnant or breast-feeding women

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Advanced Sensor Based Functional ASsessmenTs in Axial Spondyloarthritis