NCT04489342招募中不适用
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
Western Health and Social Care Trust1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in composite IMU sensor based metrology index (IMU-ASMI)
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in composite IMU sensor based metrology index (IMU-ASMI)
时间窗: 4 months
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.
次要结局
- Change in Assessment of Spondyloarthritis International Society Response Criteria (ASAS20)(4 months)
- Change in Bath Ankylosing Spondylitis Functional Index (BASFI)(4 months)
- Change in Bath Ankylosing Spondylitis Metrology Index (BASMI)(4 months)
- Change in modified Stoke Ankylosing Spondylitis Spine Score (mSASSS)(4 months)
- Change in Sit to Stand Test Scores(4 months)
- Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)(4 months)
研究者
Dr Philip Gardiner
Consultant Rheumatologist
Western Health and Social Care Trust
研究点 (1)
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