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NCT Number: NCT03159767

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Rheumatology, Altnagelvin Hospital

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

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ViMove Spinal Sensor

Device

Sensors will be used to measure spinal movement

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Dr Philip Gardiner

Other

Collaborators

  • University of Ulster

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 19, 2017
Registry last updated
Jan 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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