Ignite Creation Date:
2024-05-06 @ 2:59 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04489342
Status:
RECRUITING
Last Update Posted:
2023-04-28
First Post:
2020-07-24
Brief Title:
Advanced Sensor Based Functional ASsessmenTs in Axial Spondyloarthritis
Sponsor:
Western Health and Social Care Trust
Organization:
Western Health and Social Care Trust
Study Overview
Official 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 Drug
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ASFASTAS
Brief 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
Detailed 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None