Modeling Spinal Mobility in Ankylosing Spondylitis (AS) : Towards New Telekinetic Biomarkers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Variation in spinal angle measurement between APS patients and healthy volunteers
研究概览
简要总结
Ankylosing spondylitis (AS) is a chronic inflammatory rheumatic disease that mainly affects the spine and pelvis in its axial form. It is responsible for chronic inflammatory pain and sometimes ankylosis with significant functional retention.
Clinicians need markers capable of precisely measuring the restriction of range of motion in these patients, reflections of the activity and/or sequelae of the disease.
The Inverstigators validated movement markers in the AS by a device including inertial sensors (XSENS) and computer modeling. The accuracy and repeatability of the XSENS-Awinda system compared to the reference measurement system have been demonstrated. The XSENS-Awinda device offers new real-time evaluation possibilities for quantitative gait analysis. This opens the way to new diagnostic tools, prognostics and therapeutic perspectives for the clinician.
详细描述
Ankylosing spondylitis (AS) is a chronic inflammatory rheumatic disease that mainly affects the spine and pelvis in its axial form. It is responsible for chronic inflammatory pain and sometimes ankylosis with significant functional retention. Today, these patients benefit from treatments by biotherapy but the functional monitoring of the therapeutic response is based on the clinical examination, questionnaires, and the measurement of CRP (C reactive Protein).
Clinicians need markers capable of precisely measuring the restriction of range of motion in these patients, reflections of the activity and/or sequelae of the disease. The prevention and/or the restoration of these movement limitations, responsible for gait/attitude/balance disorders, are also among the therapeutic objectives of AS.
In the AS, the synergy between the trunk and the lower limbs is altered with a restriction of the movements of the trunk in the three planes of space. The study of the kinematic variability seems to show a loss of complexity. In addition, MRI morphological examinations are insufficient to assess stiffness and functional disability related to AS.
The investigators validated movement markers in the AS by a device including inertial sensors (XSENS) and computer modeling. The accuracy and repeatability of the XSENS-Awinda system compared to the reference measurement system have been demonstrated. The XSENS-Awinda device offers new real-time evaluation possibilities for quantitative gait analysis. This opens the way to new diagnostic tools, prognostics and therapeutic perspectives for the clinician.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-65
- •BMI between 18.5 and 30
- •Written informed consent
- •Same gender and age within +/- 3 years compared to an unmatched AS patient
- •Inclusion criteria specific to the AS group:
- •Age 18-65
- •BMI between 18.5 and 30
- •Written informed consent
- •AS meeting the ASAS (Assessment of Spondylo Arthritis International Society) criteria, i.e. with spinal pain ≥ 3 months old, with an age of diagnosis < 45 years, with:
- •Sacroiliitis on imaging AND ≥ 1 sign of spondylarthritis. OR
- •HLA-B27 (human leukocyte antigen-B27) positive AND ≥ 2 other signs of spondylarthritis
排除标准
- •Traumatic, tumoral or infectious low back pain
- •History of spinal fracture
- •History of lumbar, pelvis, hips, ankles, and/or knees surgery
- •Severe scoliosis defined by a Cobb angle > 50°
- •Severe impairment of uncorrected visual acuity
- •Concomitant pathology responsible for ataxia
- •Lumbar arthrodesis of two or more stages
- •Pregnant or breastfeeding women
- •Patient unable to give consent: patient under guardianship or curators, mentally retarded, dementia, language barrier
- •Patient not affiliated to a social security plan
- •Patient under legal protection
研究组 & 干预措施
AS patients
Evaluation of kinematic parameters by wearing X-Sens sensors in different movements (flexion and extension of the spine, tying shoelaces, picking up an object on the ground, walking, etc.)
干预措施: XSENS-Awinda (Device)
healthy volunteers
Evaluation of kinematic parameters by wearing X-Sens sensors in different movements (flexion and extension of the spine, tying shoelaces, picking up an object on the ground, walking, etc.)
干预措施: XSENS-Awinda (Device)
结局指标
主要结局
Variation in spinal angle measurement between APS patients and healthy volunteers
时间窗: 1 day
Assess the diagnostic performance of angular measurement in the sagittal plane during flexion and extension of the spine in the diagnosis of AS. spinal angle measurement (in degrees) for both APS patients and healthy volunteers will be compared using a Student's test or Wilcoxon Mann Whitney test depending on the distribution. The diagnostic performances of the different kinematic parameters will be estimated in percentage (%) with their 95% confidence interval.
次要结局
- Percentage of functional impact of the AS by BASMI score(1 day)
- percentage of diagnosis concordant between the kinematic parameters of the lower limb joints and the diagnosis of AS(1 day)
- Percentage of functional impact of the AS by BASFI score(1 day)
- percentage of correlation between clinical and kinematic parameters(1 day)
- Percentage of AS activity by BASDAI score(1 day)
- Variation of kinematic parameters of movement between BASFI and sensors(1 day)
- percentage of diagnosis concordant between the kinematic parameters of the spine and the diagnosis of AS(1 day)