Sensor based Tests in Axial Spondyloarthritis V1
Research type
Research Study
Full title
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 drugs
IRAS ID
253003
Contact name
Philip Gardiner
Contact email
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 4 days
Research summary
Spondyloarthritis (SpA) is an umbrella term for a group of diseases sharing genetic, molecular, immunological, clinical and imaging features. Arthritis of the spine is characterised by symptoms such as pain, stiffness and loss of function. Eventually some patients lose all of their spinal mobility, progressing to complete and permanent fusion of the spine. Spinal mobility has been recognised to be one of the most important outcomes to measure in SpA clinical trials. The current recommended measurement test, the Bath Ankylosing Spondylitis Metrology Index (BASMI), is applied infrequently in clinical practice and in clinical trials its responsiveness is rated as poor. There is now evidence to suggest that motion capture methods may be more responsive to change. This study is part of a three-year project that seeks to validate the use of sensors to measure spinal mobility. The main objective of the project as a whole is to develop and validate a sensor based Inertial Measurement Unit axial Spondyloarthritis Metrology Index (IMU-ASMI) based on recording the spinal range of movement in clinic. This particular study is designed to assess the responsiveness to treatment of the IMU-ASMI and the functional tests.
This is a longitudinal prospective non-interventional study in patients with axSpA. Patients will be recruited over a 3-year period. The study schedule is comprised of 2 visits: The first pre-treatment visit will take place 0 to 8 weeks before the first dose of biologic therapy and the post-treatment visit will take place 20 to 28 weeks after the first dose of biologic therapy.REC name
HSC REC B
REC reference
19/NI/0105
Date of REC Opinion
21 Jun 2019
REC opinion
Further Information Favourable Opinion