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Clinical Trials/NCT03159767
NCT03159767
Completed
Not Applicable

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

Dr Philip Gardiner1 site in 1 country40 target enrollmentMay 24, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ankylosing Spondylitis
Sponsor
Dr Philip Gardiner
Enrollment
40
Locations
1
Primary Endpoint
Inter-rater reliability for measurement of lumbar spine range of movement
Status
Completed
Last Updated
7 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
May 24, 2017
End Date
May 2, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Dr Philip Gardiner
Responsible Party
Sponsor Investigator
Principal Investigator

Dr Philip Gardiner

Consultant Rheumatologist

Western Health and Social Care Trust

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

Outcomes

Primary Outcomes

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

  • Inter-rater reliability for measurement of lumbar spine rotational range of movement(2 weeks)
  • Reliability of IMU metrology index non-inferior to reliability of BASMI(2 weeks)
  • Correlation with BASDAI: IMU metrology index non-inferior compared to BASMI(2 weeks)
  • Inter-rater reliability for measurement of cervical rotation range of movement(2 weeks)

Study Sites (1)

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