Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04489342

Advanced Sensor Based Functional ASsessmenTs in Axial Spondyloarthritis

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Axial Spondyloarthritis Ankylosis Arthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Rheumatology, Altnagelvin Hospital

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

Location status: Recruiting

Location contact

Philip V Gardiner, MB MD FRCP

PRINCIPAL_INVESTIGATOR

Philip V Gardiner, MD FRCP

CONTACT

[email protected]

02871345171 ext. 213618

About this study

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:

  • MRI of spine and Sacroiliac (SI) joints - modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) scoring
  • 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),
  • Erythrocyte sedimentation rate (ESR), C-reactive protein (CRP)
  • IMU sensor tests in clinic for range of motion (ROM) in cervical, thoracic and lumbar spine.
  • IMU sensor tests at home for standardised function testing

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

IMU sensor test

Device

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

Other names: ViMove (DorsaVi)

Primary outcomes

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

    Time frame: 4 months

    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.

Secondary outcomes

  1. Change in Bath Ankylosing Spondylitis Metrology Index (BASMI)

    Time frame: 4 months

    Change in traditional metrology index of spinal mobility. Scale 0-10, with 10 being severe loss of spinal mobility.

  2. Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

    Time frame: 4 months

    Change in axSpA disease activity. BASDAI scale 0-10, 10 representing high disease activity

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

    Time frame: 4 months

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

    Time frame: 4 months

    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.

  5. Change in Bath Ankylosing Spondylitis Functional Index (BASFI)

    Time frame: 4 months

    Change in traditional questionnaire function assessment 0-10 scale, 10 representing a high degree of functional impairment

  6. Change in Sit to Stand Test Scores

    Time frame: 4 months

    Change in standardised function score. Time taken to complete 5 sit to stand actions from a seated position on a chair at standard height.

Study contacts

Contact information is provided by the study sponsor or research team.

Aaron Peace, MD

CONTACT

[email protected]

02871345171

Dawn Small

CONTACT

[email protected]

02871345171

Sponsors and collaborators

Lead sponsor

Western Health and Social Care Trust

Other

Collaborators

  • University of Ulster

Registry information

Official study title

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

Acronym: ASFASTAS

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Jul 28, 2020
Registry last updated
Jul 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.