Advanced Sensor Based Functional ASsessmenTs in Axial Spondyloarthritis

  • STATUS
    Recruiting
  • days left to enroll
    11
  • participants needed
    20
  • sponsor
    Western Health and Social Care Trust
Updated on 16 October 2021
MRI Scan
biological therapy

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 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 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 and after therapy:

  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

Details
Condition Axial Spondyloarthritis
Treatment ViMove IMU sensor test, IMU sensor test
Clinical Study IdentifierNCT04489342
SponsorWestern Health and Social Care Trust
Last Modified on16 October 2021

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

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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