<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04489342</url>
  </required_header>
  <id_info>
    <org_study_id>WesternHSCT</org_study_id>
    <nct_id>NCT04489342</nct_id>
  </id_info>
  <brief_title>Advanced Sensor Based Functional ASsessmenTs in Axial Spondyloarthritis</brief_title>
  <acronym>ASFASTAS</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Western Health and Social Care Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Ulster</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Western Health and Social Care Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an observational study using Inertial Measurement Unit (IMU) sensors to measure the&#xD;
      effects of biological therapy on spinal mobility and function in axial spondyloarthritis.&#xD;
      Participants will undergo MRI scans before and after therapy in parallel to the sensor tests&#xD;
      to establish correlation between changes in inflammatory signs and changes in spinal&#xD;
      mobility.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We will study 20 participants with active axial spondyloarthritis (axSpA) who are about to&#xD;
      start biologic therapy as part of routine care. In brief, we will carry out the following&#xD;
      assessments before and after therapy:&#xD;
&#xD;
        1. MRI of spine and Sacroiliac (SI) joints - modified Stoke Ankylosing Spondylitis Spine&#xD;
           Score (mSASSS) scoring&#xD;
&#xD;
        2. Record standard Patient recorded outcomes (PROs): Bath Ankylosing Spondylitis Disease&#xD;
           Activity Index (BASDAI), Bath Ankylosing Global (BASG), Bath Ankylosing Spondylitis&#xD;
           Metrology Index (BASMI), Bath Ankylosing Spondylitis Functional Index (BASFI),&#xD;
           Ankylosing Spondylitis Disease Activity Score (ASDAS), Ankylosing Spondylitis Disease&#xD;
           Activity Score Health Index (ASAS-HI), Euroquol 3 level health assessment (EQ5D-3L),&#xD;
           work productivity and activity impairment questionnaire (WPAI), Short QUestionnaire to&#xD;
           ASsess Health enhancing physical activity (SQUASH),&#xD;
&#xD;
        3. Erythrocyte sedimentation rate (ESR), C-reactive protein (CRP)&#xD;
&#xD;
        4. IMU sensor tests in clinic for range of motion (ROM) in cervical, thoracic and lumbar&#xD;
           spine.&#xD;
&#xD;
        5. IMU sensor tests at home for standardised function testing&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 1, 2019</start_date>
  <completion_date type="Anticipated">February 7, 2025</completion_date>
  <primary_completion_date type="Anticipated">January 7, 2025</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in composite IMU sensor based metrology index (IMU-ASMI)</measure>
    <time_frame>4 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Bath Ankylosing Spondylitis Metrology Index (BASMI)</measure>
    <time_frame>4 months</time_frame>
    <description>Change in traditional metrology index of spinal mobility. Scale 0-10, with 10 being severe loss of spinal mobility.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)</measure>
    <time_frame>4 months</time_frame>
    <description>Change in axSpA disease activity. BASDAI scale 0-10, 10 representing high disease activity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Assessment of Spondyloarthritis International Society Response Criteria (ASAS20)</measure>
    <time_frame>4 months</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in modified Stoke Ankylosing Spondylitis Spine Score (mSASSS)</measure>
    <time_frame>4 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Bath Ankylosing Spondylitis Functional Index (BASFI)</measure>
    <time_frame>4 months</time_frame>
    <description>Change in traditional questionnaire function assessment 0-10 scale, 10 representing a high degree of functional impairment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Sit to Stand Test Scores</measure>
    <time_frame>4 months</time_frame>
    <description>Change in standardised function score. Time taken to complete 5 sit to stand actions from a seated position on a chair at standard height.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Axial Spondyloarthritis</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>IMU sensor test</intervention_name>
    <description>Measurement of maximum range of movement in the spine; Ambulatory observational data while performing standardised functional tests</description>
    <other_name>ViMove (DorsaVi)</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with active axSpA (BASDAI &gt;4, Spinal Pain VAS &gt;4)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosis of axial spondyloarthritis fulfilling ASAS classification criteria.&#xD;
&#xD;
          2. Age ≥18 years old and &lt;80 years.&#xD;
&#xD;
          3. Fulfilment of local criteria for biologic therapy for axSpA.&#xD;
&#xD;
          4. The subjects should be able to read, write, understand and complete study&#xD;
             questionnaires.&#xD;
&#xD;
          5. Each subject must sign an informed consent form (ICF) indicating that he or she&#xD;
             understands the purpose of and procedures required for the study and are willing to&#xD;
             participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Safety contra-indication for biologic drug therapy.&#xD;
&#xD;
          2. Severely restricted hip movement (less than 20 degrees rotation in either hip).&#xD;
&#xD;
          3. History of previous clinical (symptomatic) vertebral fracture.&#xD;
&#xD;
          4. History of previous spinal surgery.&#xD;
&#xD;
          5. History of previous hip replacement surgery.&#xD;
&#xD;
          6. Major scoliosis deformity (in the opinion of the investigator).&#xD;
&#xD;
          7. Safety contra-indication for MRI assessment.&#xD;
&#xD;
          8. Previous biologic agent within 2 months.&#xD;
&#xD;
          9. Pregnant or breast-feeding women.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Philip Gardiner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Western Health and Social Care Trust</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dawn Small</last_name>
    <phone>02871345171</phone>
    <email>Dawn.Small@westerntrust.hscni.net</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Aaron Peace, MD</last_name>
    <phone>02871345171</phone>
    <email>aaron.peace@westerntrust.hscni.net</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of Rheumatology, Altnagelvin Hospital</name>
      <address>
        <city>Londonderry</city>
        <state>N.Ireland</state>
        <zip>BT47 6SB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Philip V Gardiner, MD FRCP</last_name>
      <phone>02871345171</phone>
      <phone_ext>213618</phone_ext>
      <email>philip.gardiner@westerntrust.hscni.net</email>
    </contact>
    <investigator>
      <last_name>Philip V Gardiner, MB MD FRCP</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>July 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>April 27, 2023</last_update_submitted>
  <last_update_submitted_qc>April 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Western Health and Social Care Trust</investigator_affiliation>
    <investigator_full_name>Dr Philip Gardiner</investigator_full_name>
    <investigator_title>Consultant Rheumatologist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spondylitis</mesh_term>
    <mesh_term>Spondylarthritis</mesh_term>
    <mesh_term>Axial Spondyloarthritis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Willing to share details of results and analyses with other researchers</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04489342
org study id: WesternHSCT
nct id: NCT04489342
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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
observational model: Cohort
time perspective: Prospective
measure: Change in composite IMU sensor based metrology index (IMU-ASMI)
time frame: 4 months
description: 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.
measure: Change in Bath Ankylosing Spondylitis Metrology Index (BASMI)
time frame: 4 months
description: Change in traditional metrology index of spinal mobility. Scale 0-10, with 10 being severe loss of spinal mobility.
measure: Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
time frame: 4 months
description: Change in axSpA disease activity. BASDAI scale 0-10, 10 representing high disease activity
measure: Change in Assessment of Spondyloarthritis International Society Response Criteria (ASAS20)
time frame: 4 months
description: 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)
measure: Change in modified Stoke Ankylosing Spondylitis Spine Score (mSASSS)
time frame: 4 months
description: 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.
measure: Change in Bath Ankylosing Spondylitis Functional Index (BASFI)
time frame: 4 months
description: Change in traditional questionnaire function assessment 0-10 scale, 10 representing a high degree of functional impairment
measure: Change in Sit to Stand Test Scores
time frame: 4 months
description: Change in standardised function score. Time taken to complete 5 sit to stand actions from a seated position on a chair at standard height.
intervention type: Device
intervention name: IMU sensor test
description: Measurement of maximum range of movement in the spine; Ambulatory observational data while performing standardised functional tests
other name: ViMove (DorsaVi)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
last name: Philip Gardiner, MD
role: Principal Investigator
affiliation: Western Health and Social Care Trust
last name: Dawn Small
phone: 02871345171
email: Dawn.Small@westerntrust.hscni.net
last name: Aaron Peace, MD
phone: 02871345171
email: aaron.peace@westerntrust.hscni.net
facility: 
status: Recruiting
contact: 
investigator: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Western Health and Social Care Trust
investigator full name: Dr Philip Gardiner
investigator title: Consultant Rheumatologist
mesh term: Spondylitis
mesh term: Spondylarthritis
mesh term: Axial Spondyloarthritis
sharing ipd: Undecided
ipd description: Willing to share details of results and analyses with other researchers