Advanced Sensor Based Functional ASsessmenTs in Axial Spondyloarthritis

Axial Spondyloarthritis Clinical Trial

— ASFASTAS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04489342
• Other study ID #: WesternHSCT
• Status: Recruiting
• Start date: July 1, 2019
• Est. completion date: February 7, 2025

Study information

• Verified date: April 2023
• Source: Western Health and Social Care Trust
• Contact: Dawn Small
• Phone: 02871345171
• Email: Dawn.Small[@]westerntrust.hscni.net
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 7, 2025
• Est. primary completion date: January 7, 2025
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Axial Spondyloarthritis
• Spondylarthritis
• Spondylitis

Intervention

Device:
• IMU sensor test
Measurement of maximum range of movement in the spine; Ambulatory observational data while performing standardised functional tests

Locations

Country	Name	City	State
United Kingdom	Department of Rheumatology, Altnagelvin Hospital	Londonderry	N.Ireland

Sponsors (2)

Lead Sponsor	Collaborator
Western Health and Social Care Trust	University of Ulster

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 months
Secondary	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.	4 months
Secondary	Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)	Change in axSpA disease activity. BASDAI scale 0-10, 10 representing high disease activity	4 months
Secondary	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)	4 months
Secondary	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.	4 months
Secondary	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	4 months
Secondary	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.	4 months