Axial SpondyloarthritisASFASTASNCT04489342
Advanced Sensor Based Functional ASsessmenTs in Axial Spondyloarthritis
An observational study of Axial Spondyloarthritis, run by Western Health and Social Care Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Axial Spondyloarthritis
- What is being tested?
- IMU sensor test
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2019to 7 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: Patients with active axSpA (BASDAI >4, Spinal Pain VAS >4)
Who may be able to join
- 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.
Who cannot join
- 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).
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- Safety contra-indication for MRI assessment.
- Previous biologic agent within 2 months.
- Pregnant or breast-feeding women.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Department of Rheumatology, Altnagelvin Hospital
Londonderry, N.Ireland, BT47 6SB
Philip V Gardiner, MD FRCP, 02871345171 ext. 213618, philip.gardiner@westerntrust.hscni.net
Philip V Gardiner, MB MD FRCP
About this study
Official 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
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.
Read the 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:
- 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
- Conditions
- Axial Spondyloarthritis
- Being tested
- IMU sensor test
- Medical subject headings
- Axial Spondyloarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMU sensor testDevice
Also called ViMove (DorsaVi)
Measurement of maximum range of movement in the spine; Ambulatory observational data while performing standardised functional tests
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Secondary outcomes (6)
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.
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start1 Jul 2019
- Primary completion7 Jan 2026 (estimated)
- Study completion7 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Axial SpondyloarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western Health and Social Care Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ulster
- Responsible party
- Principal investigator, Dr Philip Gardiner, Western Health and Social Care Trust
- Investigators
- Philip Gardiner, MD, Principal investigator, Western Health and Social Care Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04489342
- Sponsor's protocol ID
- WesternHSCT
- Acronym
- ASFASTAS
- Status last verified
- Jul 2024
- First submitted
- 24 Jul 2020
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Willing to share details of results and analyses with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04489342
- Acronym / sponsor ID
- ASFASTAS / WesternHSCT
- Conditions
- Axial Spondyloarthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Western Health and Social Care TrustUniversity, hospital or other
- Collaborators
- University of Ulster
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 7 Jan 2026 (estimated)
- Study completion
- 7 Feb 2026 (estimated)
- First posted
- 28 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with active axSpA (BASDAI >4, Spinal Pain VAS >4)
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMU sensor testAlso: ViMove (DorsaVi)Measurement of maximum range of movement in the spine; Ambulatory observational data while performing standardised functional tests | Device | – |
Primary outcome
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.
6 secondary outcomes
Change in Bath Ankylosing Spondylitis Metrology Index (BASMI)
Time frame: 4 months
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time frame: 4 months
Change in Assessment of Spondyloarthritis International Society Response Criteria (ASAS20)
Time frame: 4 months
Change in modified Stoke Ankylosing Spondylitis Spine Score (mSASSS)
Time frame: 4 months
Change in Bath Ankylosing Spondylitis Functional Index (BASFI)
Time frame: 4 months
Change in Sit to Stand Test Scores
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Individual participant dataSharing planned: Undecided. Willing to share details of results and analyses with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Gardiner, MD principal investigator
Western Health and Social Care Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Axial Spondyloarthritis, run by Western Health and Social Care Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dawn Small (02871345171, Dawn.Small@westerntrust.hscni.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in composite IMU sensor based metrology index (IMU-ASMI) (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.