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

Primary Purpose

Ankylosing Spondylitis, Axial Spondyloarthritis

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

ViMove Spinal Sensor

About this trial

This is an interventional device feasibility trial for Ankylosing Spondylitis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Department of Rheumatology, Altnagelvin Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Spinal Mobility Measurement: Rater A

Spinal Mobility Measurement: Rater B

Arm Description

All patients will undergo the same ViMove Spinal Sensor measurement protocol with independent raters.

Outcomes

Primary Outcome Measures

Inter-rater reliability for measurement of lumbar spine range of movement

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

ICC for spinal rotation expected to be >0.8

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

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.

Inter-rater reliability for measurement of cervical rotation range of movement

ICC for cervical rotation expected to be >0.8

Full Information

NCT ID

NCT03159767

First Posted

May 16, 2017

Last Updated

December 28, 2018

Sponsor

Dr Philip Gardiner

Collaborators

University of Ulster

1. Study Identification

Unique Protocol Identification Number

NCT03159767

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Completed

Study Start Date

May 24, 2017 (Actual)

Primary Completion Date

May 2, 2018 (Actual)

Study Completion Date

May 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Dr Philip Gardiner

Collaborators

University of Ulster

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ankylosing Spondylitis, Axial Spondyloarthritis

7. Study Design

Primary Purpose

Device Feasibility

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

Clinimetric study comparing repeated standardised spinal mobility test protocols by two independent raters on two occasions

Masking

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.

Allocation

Non-Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Spinal Mobility Measurement: Rater A

Arm Type

Experimental

Arm Description

All patients will undergo the same ViMove Spinal Sensor measurement protocol with independent raters.

Arm Title

Spinal Mobility Measurement: Rater B

Arm Type

Experimental

Arm Description

All patients will undergo the same ViMove Spinal Sensor measurement protocol with independent raters.

Intervention Type

Device

Intervention Name(s)

ViMove Spinal Sensor

Intervention Description

Sensors will be used to measure spinal movement

Primary Outcome Measure Information:

Title

Inter-rater reliability for measurement of lumbar spine range of movement

Description

ICC for lumbar side flexion and forward flexion expected to be >0.8

Time Frame

2 weeks

Secondary Outcome Measure Information:

Title

Inter-rater reliability for measurement of lumbar spine rotational range of movement

Description

ICC for spinal rotation expected to be >0.8

Time Frame

2 weeks

Title

Reliability of IMU metrology index non-inferior to reliability of BASMI

Description

Measurements obtained using IMUs are at least as reliable as the BASMI tape measure test

Time Frame

2 weeks

Title

Correlation with BASDAI: IMU metrology index non-inferior compared to BASMI

Description

We will compare the metrology indices in the strength of correlation with the BASDAI components of pain and stiffness.

Time Frame

2 weeks

Title

Inter-rater reliability for measurement of cervical rotation range of movement

Description

ICC for cervical rotation expected to be >0.8

Time Frame

2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Philip Gardiner, MD

Organizational Affiliation

Western HSCT

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Rheumatology, Altnagelvin Hospital

City

Londonderry

State/Province

N.Ireland

ZIP/Postal Code

BT47 6SB

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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