Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-01-05 @ 11:55 PM
Study NCT ID:
NCT03159767
Status:
COMPLETED
Last Update Posted:
2019-01-02
First Post:
2017-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinimetric Test of Spinal Sensors in Measuring Spinal Mobility in Axial Spondyloarthritis
Sponsor:
Dr Philip Gardiner
Organization:
Study Overview
Official Title:
Validation of a New Method of Measuring Spinal Flexibility in Axial Spondyloarthritis Using Inertial Motion (IMU) Sensors
Status:
COMPLETED
Status Verified Date:
2018-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: