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

Not Applicable

Completed

• Conditions: Axial Spondyloarthritis; Ankylosing Spondylitis
• Interventions: Device: ViMove Spinal Sensor

• Registration Number: NCT03159767
• Lead Sponsor: Dr Philip Gardiner

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).

Study Timeline

• Study First Submitted: 2017-05-16
• Study First Submitted QC: 2017-05-16
• Study First Posted: 2017-05-19
• Study Start: 2017-05-24
• Primary Completion: 2018-05-02
• Study Completion: 2018-05-02
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-28
• Last Update Posted: 2019-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Spinal Mobility Measurement: Rater A	ViMove Spinal Sensor	All patients will undergo the same ViMove Spinal Sensor measurement protocol with independent raters.
Spinal Mobility Measurement: Rater B	ViMove Spinal Sensor	All patients will undergo the same ViMove Spinal Sensor measurement protocol with independent raters.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Rheumatology, Altnagelvin Hospital; 🇬🇧 Londonderry, N.Ireland, United Kingdom