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

Ankylosing Spondylitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03159767
• Other study ID #: WT 15/28
• Status: Completed
• Phase: N/A
• Start date: May 24, 2017
• Est. completion date: May 2, 2018

Study information

• Verified date: December 2018
• Source: Western Health and Social Care Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2, 2018
• Est. primary completion date: May 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Axial Spondyloarthritis
• Spondylarthritis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Device:
• ViMove Spinal Sensor
Sensors will be used to measure spinal movement

Locations

Country	Name	City	State
United Kingdom	Department of Rheumatology, Altnagelvin Hospital	Londonderry	N.Ireland

Sponsors (2)

Lead Sponsor	Collaborator
Dr Philip Gardiner	University of Ulster

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Inter-rater reliability for measurement of lumbar spine rotational range of movement	ICC for spinal rotation expected to be >0.8	2 weeks
Secondary	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
Secondary	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
Secondary	Inter-rater reliability for measurement of cervical rotation range of movement	ICC for cervical rotation expected to be >0.8	2 weeks