A Clinimetric Test of Spinal Sensors in Measuring Spinal Mobility in Axial Spondyloarthritis

Study Overview
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Brief Summary
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This is a clinimetric study to validate the use of IMU spinal sensors to measure the range of spinal movement in a group of patients with axial spondyloarthritis.

Detailed Description
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One of the most important goals of therapy in axial spondyloarthritis is to improve and/or preserve spinal mobility. In the early stages of the disease, spinal stiffness is reversible but eventually the spine can fuse causing permanent loss of flexion. Traditional tests for spinal mobility using tape measures are inaccurate and do not capture many aspects of kinematics such as spinal rotation or speed of movement. There is also a need for wearable sensors to give patients feedback and encourage more regular exercise. The investigators will be using IMU spinal sensors to measure spinal ROM in a group of 40 patients with axial spondyloarthritis. The investigators will be testing aspects of inter-rater and intra-rater reliability, comparing sensor reliability to the accuracy of the traditional tape measure test (BASMI).

Official Title
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Validation of a New Method of Measuring Spinal Flexibility in Axial Spondyloarthritis Using Inertial Motion (IMU) Sensors

Conditions
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Ankylosing Spondylitis, Axial Spondyloarthritis

Intervention / Treatment
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* Device: ViMove Spinal Sensor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -Confirmed diagnosis of axSpA according to the ASAS criteria Exclusion Criteria: Severe joint or spinal pain at the time of the study Severely restricted hip movement History of previous vertebral fracture History of previous spinal surgery Major scoliosis deformity Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Clinimetric study comparing repeated standardised spinal mobility test protocols by two independent raters on two occasions
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spinal Mobility Measurement: Rater A<br>All patients will undergo the same ViMove Spinal Sensor measurement protocol with independent raters. | Device: ViMove Spinal Sensor<br>* Sensors will be used to measure spinal movement<br>|
| Experimental: Spinal Mobility Measurement: Rater B<br>All patients will undergo the same ViMove Spinal Sensor measurement protocol with independent raters. | Device: ViMove Spinal Sensor<br>* Sensors will be used to measure spinal movement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inter-rater reliability for measurement of lumbar spine range of movement | ICC for lumbar side flexion and forward flexion expected to be >0.8 | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inter-rater reliability for measurement of lumbar spine rotational range of movement | ICC for spinal rotation expected to be >0.8 | 2 weeks | 
| Reliability of IMU metrology index non-inferior to reliability of BASMI | Measurements obtained using IMUs are at least as reliable as the BASMI tape measure test | 2 weeks | 
| Correlation with BASDAI: IMU metrology index non-inferior compared to BASMI | We will compare the metrology indices in the strength of correlation with the BASDAI components of pain and stiffness. | 2 weeks | 
| Inter-rater reliability for measurement of cervical rotation range of movement | ICC for cervical rotation expected to be >0.8 | 2 weeks |