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

Dr Philip Gardiner

Status: Completed

Conditions: Axial Spondyloarthritis; Ankylosing Spondylitis

Treatments: Device: ViMove Spinal Sensor

Study type: Interventional

Funder types: Other

Identifiers

NCT03159767

WT 15/28

Details and patient eligibility

About

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.

Full 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).

Enrollment: 40 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Spinal Mobility Measurement: Rater A

Experimental group

Description:

All patients will undergo the same ViMove Spinal Sensor measurement protocol with independent raters.

Treatment:

Device: ViMove Spinal Sensor

Spinal Mobility Measurement: Rater B

Experimental group

Description:

All patients will undergo the same ViMove Spinal Sensor measurement protocol with independent raters.

Treatment:

Device: ViMove Spinal Sensor