Department of Rheumatology, Altnagelvin Hospital
Londonderry, N.Ireland, BT47 6SB, United Kingdom
Location status: Recruiting
NCT Number: NCT04489342
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Observational
Londonderry, N.Ireland, BT47 6SB, United Kingdom
Location status: Recruiting
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:
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Measurement of maximum range of movement in the spine; Ambulatory observational data while performing standardised functional tests
Other names: ViMove (DorsaVi)
Time frame: 4 months
Change in AxSpA metrology index based on sensor tests of Range of Movement (i.e. spinal mobility). Scale 0-10, with 10 being severe loss of spinal mobility.
Time frame: 4 months
Change in traditional metrology index of spinal mobility. Scale 0-10, with 10 being severe loss of spinal mobility.
Time frame: 4 months
Change in axSpA disease activity. BASDAI scale 0-10, 10 representing high disease activity
Time frame: 4 months
Change in axSpA disease activity response - 20% improvement is regarded as minimum improvement in at least three of Patient global assessment, Pain assessment, BASFI and Inflammation (last two questions of BASDAI)
Time frame: 4 months
Change in MRI score of inflammation. Range 0-72 the sum of scores for 24 vertebral edges in the lumbar and cervical regions, higher represents more spinal damage.
Time frame: 4 months
Change in traditional questionnaire function assessment 0-10 scale, 10 representing a high degree of functional impairment
Time frame: 4 months
Change in standardised function score. Time taken to complete 5 sit to stand actions from a seated position on a chair at standard height.
Interested in participating?
Request InfoWestern Health and Social Care Trust
Other
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
Acronym: ASFASTAS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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