Advanced Sensor Based Functional ASsessmenTs in Axial Spo... | NCT04489342

Studies
Advanced Sensor Based Functional ASsessmenTs in Axial Spondyloarthritis

NCT04489342

Sponsor

Western Health and Social Care Trust

Status

Recruiting

Last Update Posted

Jul 25, 2024Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Axial Spondyloarthritis

Interventions

IMU sensor test

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2019Actual

Primary Completion Date

Jan 7, 2026Estimated

Completion Date

Feb 7, 2026Estimated

First Submitted Date

Jul 24, 2020

First Submission Date that Met QC Criteria

Jul 24, 2020

First Posted Date

Jul 28, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 24, 2024

Last Update Posted Date

Jul 25, 2024Actual

Name	Class
University of Ulster	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IMU sensor test	Device	Measurement of maximum range of movement in the spine; Ambulatory observational data while performing standardised functional tests		ViMove (DorsaVi)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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).
Safety contra-indication for MRI assessment.
Previous biologic agent within 2 months.
Pregnant or breast-feeding women.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dawn Small	Contact	02871345171		Dawn.Small@westerntrust.hscni.net
Aaron Peace, MD	Contact	02871345171		aaron.peace@westerntrust.hscni.net

Overall Officials

Name	Affiliation	Role
Philip Gardiner, MD	Western Health and Social Care Trust	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Rheumatology, Altnagelvin Hospital	Recruiting	Londonderry	N.Ireland	BT47 6SB	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Willing to share details of results and analyses with other researchers

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000089183	Axial Spondyloarthritis

Ancestor Terms

ID	Term
D025242	Spondylarthropathies
D025241	Spondylarthritis
D013166	Spondylitis
D013122	Spinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided