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

Sponsor

Dr Philip Gardiner (Other)

Overall Status

Completed

CT.gov ID

NCT03159767

Collaborator

University of Ulster (Other)

Enrollment

Location

Arms

11.3

Actual Duration (Months)

3.5

Patients Per Site Per Month

Study Details

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	N/A

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

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 occasionsClinimetric 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

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

Inter-rater reliability for measurement of lumbar spine range of movement [2 weeks]
ICC for lumbar side flexion and forward flexion expected to be >0.8

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Jan 2, 2019

Last Verified:

Dec 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Spondylitis

Spondylarthritis

Spondylitis, Ankylosing

Study Results

No Results Posted as of Jan 2, 2019