Ankylosing Spondylitis, Axial Spondyloarthritis
Conditions
Brief summary
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
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).
Interventions
DEVICEViMove Spinal Sensor
Sensors will be used to measure spinal movement
Sponsors
University of Ulster
Dr Philip Gardiner
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DEVICE_FEASIBILITY
Masking
SINGLE (Outcomes Assessor)
Masking description
Each physiotherapist rater will have to independently attach the sensors to the participant's spine before testing, and no positioning marks will be left on the patient in between tests or between visits. They will work in different rooms and will not have access to earlier results.
Intervention model description
Clinimetric study comparing repeated standardised spinal mobility test protocols by two independent raters on two occasions
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inter-rater reliability for measurement of lumbar spine range of movement | 2 weeks | ICC for lumbar side flexion and forward flexion expected to be \>0.8 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inter-rater reliability for measurement of lumbar spine rotational range of movement | 2 weeks | ICC for spinal rotation expected to be \>0.8 |
| Reliability of IMU metrology index non-inferior to reliability of BASMI | 2 weeks | Measurements obtained using IMUs are at least as reliable as the BASMI tape measure test |
| Correlation with BASDAI: IMU metrology index non-inferior compared to BASMI | 2 weeks | We will compare the metrology indices in the strength of correlation with the BASDAI components of pain and stiffness. |
| Inter-rater reliability for measurement of cervical rotation range of movement | 2 weeks | ICC for cervical rotation expected to be \>0.8 |
Countries
United Kingdom
Outcome results
None listed