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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03159767
Recruitment Status : Completed
First Posted : May 19, 2017
Last Update Posted : January 2, 2019
Sponsor:
Collaborator:
University of Ulster
Information provided by (Responsible Party):
Dr Philip Gardiner, Western Health and Social Care Trust

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).

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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

Resource links provided by the National Library of Medicine


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




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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03159767


Locations
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United Kingdom
Department of Rheumatology, Altnagelvin Hospital
Londonderry, N.Ireland, United Kingdom, BT47 6SB
Sponsors and Collaborators
Dr Philip Gardiner
University of Ulster
Investigators
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Principal Investigator: Philip Gardiner, MD Western HSCT
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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    Key Record Dates
Last Update Posted: January 2, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spondylitis
Spondylitis, Ankylosing
Spondylarthritis
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Ankylosis
Joint Diseases
Arthritis