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

NCT03159767 | Completed

• 1 other identifier: WT 15/28
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankylosing Spondylitis; Axial Spondyloarthritis

Outcome Measures

Primary Outcomes (1)

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

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

  2 weeks

Secondary Outcomes (4)

• 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 Arms (2)

Spinal Mobility Measurement: Rater A

EXPERIMENTAL

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

Device: ViMove Spinal Sensor

Spinal Mobility Measurement: Rater B

EXPERIMENTAL

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

Device: ViMove Spinal Sensor

Interventions

ViMove Spinal Sensor DEVICE

Sensors will be used to measure spinal movement

Spinal Mobility Measurement: Rater A; Spinal Mobility Measurement: Rater B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of axSpA according to the ASAS criteria

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr Philip Gardiner: lead
• University of Ulster: collaborator

Study Sites (1)

Department of Rheumatology, Altnagelvin Hospital

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

Location

MeSH Terms

Conditions

Spondylitis, Ankylosing; Axial Spondyloarthritis

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Study Officials

• Philip Gardiner, MD

  Western HSCT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant Rheumatologist

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

Study Record Dates

• First Submitted: May 16, 2017
• First Posted: May 19, 2017
• Study Start: May 24, 2017
• Primary Completion: May 2, 2018
• Study Completion: May 2, 2018
• Last Updated: January 2, 2019

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)