Validation of a New Method of Measuring Spinal Flexibility in Axial Spondyloarthritis Using Inertial Motion (IMU) Sensors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Inter-rater reliability for measurement of lumbar spine range of movement
研究概览
简要总结
This is a clinimetric study to validate the use of IMU spinal sensors to measure the range of spinal movement in a group of patients with axial spondyloarthritis.
详细描述
One of the most important goals of therapy in axial spondyloarthritis is to improve and/or preserve spinal mobility. In the early stages of the disease, spinal stiffness is reversible but eventually the spine can fuse causing permanent loss of flexion. Traditional tests for spinal mobility using tape measures are inaccurate and do not capture many aspects of kinematics such as spinal rotation or speed of movement. There is also a need for wearable sensors to give patients feedback and encourage more regular exercise.
The investigators will be using IMU spinal sensors to measure spinal ROM in a group of 40 patients with axial spondyloarthritis. The investigators will be testing aspects of inter-rater and intra-rater reliability, comparing sensor reliability to the accuracy of the traditional tape measure test (BASMI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Device Feasibility
- 盲法
- Single (Outcomes Assessor)
盲法说明
Each physiotherapist rater will have to independently attach the sensors to the participant's spine before testing, and no positioning marks will be left on the patient in between tests or between visits. They will work in different rooms and will not have access to earlier results.
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
- •Confirmed diagnosis of axSpA according to the ASAS criteria
排除标准
- •Severe joint or spinal pain at the time of the study
- •Severely restricted hip movement
- •History of previous vertebral fracture
- •History of previous spinal surgery
- •Major scoliosis deformity
- •Pregnancy
研究组 & 干预措施
Spinal Mobility Measurement: Rater B
All patients will undergo the same ViMove Spinal Sensor measurement protocol with independent raters.
干预措施: ViMove Spinal Sensor (Device)
Spinal Mobility Measurement: Rater A
All patients will undergo the same ViMove Spinal Sensor measurement protocol with independent raters.
干预措施: ViMove Spinal Sensor (Device)
结局指标
主要结局
Inter-rater reliability for measurement of lumbar spine range of movement
时间窗: 2 weeks
ICC for lumbar side flexion and forward flexion expected to be \>0.8
次要结局
- Inter-rater reliability for measurement of lumbar spine rotational range of movement(2 weeks)
- Reliability of IMU metrology index non-inferior to reliability of BASMI(2 weeks)
- Correlation with BASDAI: IMU metrology index non-inferior compared to BASMI(2 weeks)
- Inter-rater reliability for measurement of cervical rotation range of movement(2 weeks)
研究者
Dr Philip Gardiner
Consultant Rheumatologist
Western Health and Social Care Trust