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

• ClinicalTrials.gov Identifier: NCT03159767
• Recruitment Status: Completed
• First Posted: May 19, 2017
• Last Update Posted: January 2, 2019
• Sponsor: Dr Philip Gardiner
• Collaborator: University of Ulster
• Information provided by (Responsible Party): Dr Philip Gardiner, Western Health and Social Care Trust

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Ankylosing Spondylitis; Axial Spondyloarthritis	Device: ViMove Spinal Sensor	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Clinimetric study comparing repeated standardised spinal mobility test protocols by two independent raters on two occasions
• Masking: Single (Outcomes Assessor)
• Masking Description: Each physiotherapist rater will have to independently attach the sensors to the participant's spine before testing, and no positioning marks will be left on the patient in between tests or between visits. They will work in different rooms and will not have access to earlier results.
• Primary Purpose: Device Feasibility
• Official Title: Validation of a New Method of Measuring Spinal Flexibility in Axial Spondyloarthritis Using Inertial Motion (IMU) Sensors
• Actual Study Start Date: May 24, 2017
• Actual Primary Completion Date: May 2, 2018
• Actual Study Completion Date: May 2, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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
2. 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
3. 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.
4. Inter-rater reliability for measurement of cervical rotation range of movement [ Time Frame: 2 weeks ]
   ICC for cervical rotation expected to be >0.8

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United Kingdom

Department of Rheumatology, Altnagelvin Hospital

Londonderry, N.Ireland, United Kingdom, BT47 6SB

Sponsors and Collaborators

Dr Philip Gardiner

University of Ulster

Investigators

• Principal Investigator: Philip Gardiner, MD; Western HSCT

More Information

• Responsible Party: Dr Philip Gardiner, Consultant Rheumatologist, Western Health and Social Care Trust
• ClinicalTrials.gov Identifier: NCT03159767
• Other Study ID Numbers: WT 15/28
• First Posted: May 19, 2017
• Last Update Posted: January 2, 2019
• Last Verified: December 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Spondylitis; Spondylitis, Ankylosing; Spondylarthritis; Bone Diseases, Infectious; Infection; Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Spondylarthropathies; Ankylosis; Joint Diseases; Arthritis