Health TrialsbyHealthPanel

Advanced Sensor Based Functional ASsessmenTs in Axial Spondyloarthritis

ConditionAxial Spondyloarthritis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorWestern Health and Social Care Trust

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • IMU sensor test

    Device

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

Treatment groups

No treatment groups listed

Trial outcomes

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.

Time frame
4 months

Secondary outcomes

1

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.

Time frame
4 months
2

Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

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

Time frame
4 months
3

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)

Time frame
4 months
4

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.

Time frame
4 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Western Health and Social Care Trust

Lead sponsor

University of Ulster

Collaborator

Source ClinicalTrials.gov
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