Advanced Sensor Based Functional ASsessmenTs in Axial Spondyloarthritis (ASFASTAS)

An Investigation Into the Responsiveness of Inertial Measurement Unit (IMU) Sensor-based Tests in Measuring Changes in Spinal Mobility and Function in Axial Spondyloarthritis Patients Treated With Biologic Drug

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.

Study Overview

• Status: Recruiting
• Conditions: Axial Spondyloarthritis
• Intervention / Treatment: Device: IMU sensor test

Detailed Description

We will study 20 participants with active axial spondyloarthritis (axSpA) who are about to start biologic therapy as part of routine care. In brief, we will carry out the following assessments before and after therapy:

1. MRI of spine and Sacroiliac (SI) joints - modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) scoring
2. Record standard Patient recorded outcomes (PROs): Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Global (BASG), Bath Ankylosing Spondylitis Metrology Index (BASMI), Bath Ankylosing Spondylitis Functional Index (BASFI), Ankylosing Spondylitis Disease Activity Score (ASDAS), Ankylosing Spondylitis Disease Activity Score Health Index (ASAS-HI), Euroquol 3 level health assessment (EQ5D-3L), work productivity and activity impairment questionnaire (WPAI), Short QUestionnaire to ASsess Health enhancing physical activity (SQUASH),
3. Erythrocyte sedimentation rate (ESR), C-reactive protein (CRP)
4. IMU sensor tests in clinic for range of motion (ROM) in cervical, thoracic and lumbar spine.
5. IMU sensor tests at home for standardised function testing

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

• Study Contact: Name: Dawn Small; Phone Number: 02871345171; Email: Dawn.Small@westerntrust.hscni.net
• Study Contact Backup: Name: Aaron Peace, MD; Phone Number: 02871345171; Email: aaron.peace@westerntrust.hscni.net

Study Locations

• United Kingdom
  • N.Ireland
    • Londonderry, N.Ireland, United Kingdom, BT47 6SB
      • Recruiting
      • Department of Rheumatology, Altnagelvin Hospital
      • Contact: Philip V Gardiner, MD FRCP; Phone Number: 213618 02871345171; Email: philip.gardiner@westerntrust.hscni.net
      • Principal Investigator: Philip V Gardiner, MB MD FRCP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

1. Diagnosis of axial spondyloarthritis fulfilling ASAS classification criteria.
2. Age ≥18 years old and <80 years.
3. Fulfilment of local criteria for biologic therapy for axSpA.
4. The subjects should be able to read, write, understand and complete study questionnaires.
5. 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Bath Ankylosing Spondylitis Metrology Index (BASMI)	Change in traditional metrology index of spinal mobility. Scale 0-10, with 10 being severe loss of spinal mobility.	4 months
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)	Change in axSpA disease activity. BASDAI scale 0-10, 10 representing high disease activity	4 months
Change in Assessment of Spondyloarthritis International Society Response Criteria (ASAS20)	Change in axSpA disease activity response - 20% improvement is regarded as minimum improvement in at least three of Patient global assessment, Pain assessment, BASFI and Inflammation (last two questions of BASDAI)	4 months
Change in modified Stoke Ankylosing Spondylitis Spine Score (mSASSS)	Change in MRI score of inflammation. Range 0-72 the sum of scores for 24 vertebral edges in the lumbar and cervical regions, higher represents more spinal damage.	4 months
Change in Bath Ankylosing Spondylitis Functional Index (BASFI)	Change in traditional questionnaire function assessment 0-10 scale, 10 representing a high degree of functional impairment	4 months
Change in Sit to Stand Test Scores	Change in standardised function score. Time taken to complete 5 sit to stand actions from a seated position on a chair at standard height.	4 months

Collaborators and Investigators

• Sponsor: Western Health and Social Care Trust
• Collaborators: University of Ulster
• Investigators: Principal Investigator: Philip Gardiner, MD, Western Health and Social Care Trust

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Anticipated): January 7, 2025
• Study Completion (Anticipated): February 7, 2025

Study Registration Dates

• First Submitted: July 24, 2020
• First Submitted That Met QC Criteria: July 24, 2020
• First Posted (Actual): July 28, 2020

Study Record Updates

• Last Update Posted (Actual): April 28, 2023
• Last Update Submitted That Met QC Criteria: April 27, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Bone Diseases, Infectious; Spondylitis; Spondylarthritis
• Other Study ID Numbers: WesternHSCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Willing to share details of results and analyses with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No