Advanced Sensor Based Functional ASsessmenTs in Axial Spondyloarthritis

NCT ID: NCT04489342

Last Updated: 2024-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-01

Study Completion Date

2026-02-07

Brief Summary

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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

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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

Conditions

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Axial Spondyloarthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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IMU sensor test

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

Intervention Type DEVICE

Other Intervention Names

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ViMove (DorsaVi)

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Ulster

OTHER

Sponsor Role collaborator

Western Health and Social Care Trust

OTHER

Sponsor Role lead

Responsible Party

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Dr Philip Gardiner

Consultant Rheumatologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Philip Gardiner, MD

Role: PRINCIPAL_INVESTIGATOR

Western Health and Social Care Trust

Locations

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Department of Rheumatology, Altnagelvin Hospital

Londonderry, N.Ireland, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Dawn Small

Role: CONTACT

02871345171

Aaron Peace, MD

Role: CONTACT

02871345171

Facility Contacts

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Philip V Gardiner, MD FRCP

Role: primary

02871345171 ext. 213618

Other Identifiers

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WesternHSCT

Identifier Type: -

Identifier Source: org_study_id

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