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

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

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.

Study Overview

• Status: Completed
• Conditions: Ankylosing Spondylitis; Axial Spondyloarthritis
• Intervention / Treatment: Device: ViMove Spinal Sensor

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • N.Ireland
    • Londonderry, N.Ireland, United Kingdom, BT47 6SB
      • Department of Rheumatology, Altnagelvin Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Spinal Mobility Measurement: Rater A; All patients will undergo the same ViMove Spinal Sensor measurement protocol with independent raters.	Device: ViMove Spinal Sensor; Sensors will be used to measure spinal movement
Experimental: Spinal Mobility Measurement: Rater B; All patients will undergo the same ViMove Spinal Sensor measurement protocol with independent raters.	Device: ViMove Spinal Sensor; Sensors will be used to measure spinal movement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inter-rater reliability for measurement of lumbar spine rotational range of movement	ICC for spinal rotation expected to be >0.8	2 weeks
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
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
Inter-rater reliability for measurement of cervical rotation range of movement	ICC for cervical rotation expected to be >0.8	2 weeks

Collaborators and Investigators

• Sponsor: Dr Philip Gardiner
• Collaborators: University of Ulster
• Investigators: Principal Investigator: Philip Gardiner, MD, Western HSCT

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2017
• Primary Completion (Actual): May 2, 2018
• Study Completion (Actual): May 2, 2018

Study Registration Dates

• First Submitted: May 16, 2017
• First Submitted That Met QC Criteria: May 16, 2017
• First Posted (Actual): May 19, 2017

Study Record Updates

• Last Update Posted (Actual): January 2, 2019
• Last Update Submitted That Met QC Criteria: December 28, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Spondylarthropathies; Bone Diseases, Infectious; Ankylosis; Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
• Other Study ID Numbers: WT 15/28

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No