Advanced Sensor Based Functional ASsessmenTs in Axial Spondyloarthritis

NCT04489342 | Recruiting

• 1 other identifier: WesternHSCT
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is an observational study using Inertial Measurement Unit (IMU) sensors to measure the effects of biological therapy on spinal mobility and function in axial spondyloarthritis. Participants will undergo MRI scans before and after therapy in parallel to the sensor tests to establish correlation between changes in inflammatory signs and changes in spinal mobility.

Conditions

Axial Spondyloarthritis

Outcome Measures

Primary Outcomes (1)

• Change in composite IMU sensor based metrology index (IMU-ASMI)

  Change in AxSpA metrology index based on sensor tests of Range of Movement (i.e. spinal mobility). Scale 0-10, with 10 being severe loss of spinal mobility.

  4 months

Secondary Outcomes (6)

• Change in Bath Ankylosing Spondylitis Metrology Index (BASMI)

  4 months

• Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

  4 months

• Change in Assessment of Spondyloarthritis International Society Response Criteria (ASAS20)

  4 months

• Change in modified Stoke Ankylosing Spondylitis Spine Score (mSASSS)

  4 months

• Change in Bath Ankylosing Spondylitis Functional Index (BASFI)

  4 months

Interventions

IMU sensor test DEVICE

Measurement of maximum range of movement in the spine; Ambulatory observational data while performing standardised functional tests

Also known as: ViMove (DorsaVi)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with active axSpA (BASDAI \>4, Spinal Pain VAS \>4)

You may qualify if:

• Diagnosis of axial spondyloarthritis fulfilling ASAS classification criteria.
• Age ≥18 years old and \<80 years.
• Fulfilment of local criteria for biologic therapy for axSpA.
• The subjects should be able to read, write, understand and complete study questionnaires.
• Each subject must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study.

You may not qualify if:

• Safety contra-indication for biologic drug therapy.
• Severely restricted hip movement (less than 20 degrees rotation in either hip).
• History of previous clinical (symptomatic) vertebral fracture.
• History of previous spinal surgery.
• History of previous hip replacement surgery.
• Major scoliosis deformity (in the opinion of the investigator).
• Safety contra-indication for MRI assessment.
• Previous biologic agent within 2 months.
• Pregnant or breast-feeding women.

Sponsors & Collaborators

• Western Health and Social Care Trust: lead
• University of Ulster: collaborator

Study Sites (1)

Department of Rheumatology, Altnagelvin Hospital

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

RECRUITING

MeSH Terms

Conditions

Axial Spondyloarthritis

Condition Hierarchy (Ancestors)

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

Study Officials

• Philip Gardiner, MD

  Western Health and Social Care Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dawn Small

CONTACT

02871345171; Dawn.Small@westerntrust.hscni.net

Aaron Peace, MD

CONTACT

02871345171; aaron.peace@westerntrust.hscni.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Rheumatologist

Study Record Dates

• First Submitted: July 24, 2020
• First Posted: July 28, 2020
• Study Start: July 1, 2019
• Primary Completion: January 7, 2026
• Study Completion: February 7, 2026
• Last Updated: July 25, 2024

Record last verified: 2024-07

Locations

GB (1)