Clinical Trial: A Clinimetric Test of Spinal Sensors in Measuring Spinal Mobility in Axial Spondyloarthritis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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.

We will be using IMU spinal sensors to measure spinal ROM in a group of 40 patients with axial spondyloarthritis. We will be testing aspects of inter-rater and intra-rater reliability, comparing sensor reliability to the accuracy of the traditional tape measure test (BASMI).


Sponsor: Dr Philip Gardiner

Current Primary Outcome: Inter-rater reliability for measurement of lumbar spine range of movement [ Time Frame: 2 weeks ]

ICC for lumbar side flexion and forward flexion expected to be >0.8


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Inter-rater reliability for measurement of lumbar spine rotational range of movement [ Time Frame: 2 weeks ]
    ICC for spinal rotation expected to be >0.8
  • Reliability of IMU metrology index non-inferior to reliability of BASMI [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 2 weeks ]
    ICC for cervical rotation expected to be >0.8


Original Secondary Outcome: Same as current

Information By: Western Health and Social Care Trust

Dates:
Date Received: May 16, 2017
Date Started: May 2017
Date Completion: May 2018
Last Updated: May 16, 2017
Last Verified: May 2017