Post-Stroke Osteopathy: Characterization of Fractures and Changes in the Bone Microstructure After Ischemic Stroke or TIA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- VASCage GmbH
- 入组人数
- 127
- 试验地点
- 1
- 主要终点
- Number of patients with and without fractures
研究概览
简要总结
The sudden biomechanical inactivation, direct neuro-humoral effects and sustained systemic stress reaction, which commonly occur after stroke or TIA, all may be of relevance in triggering alterations in bone metabolism and remodelling of bone microstructure.
The objectives of this observational pilot study are to characterize falls and fractures and their circumstances (sex and age specific incidence, time course, risk conditions, localization) in ischemic stroke patients, study changes in the bone microstructure after ischemic stroke supported by high-resolution peripheral quantitative Computer Tomography, unravel a molecular mechanisms underlying the increased fracture risk (focus on Wnt-signaling and ß-adrenergic projection), establish risk factors to estimate the risk of falls based on information from gait analysis as well as construct deep learning algorithms to identify bone microstructure parameters for predicting fractures.
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
- 60 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion in the STROKE-CARD Registry Study
- •Modified Rankin Scale (mRS) < 5
- •Provision of signed and dated informed consent form
- •Willingness to comply with all study procedures and ability to participate in the study over the complete study duration
排除标准
- •Persistent motor deficit before the onset event
- •Not able to walk without walking aid or not able to put the full bodyweight on either leg before the onset event
- •Medical history of stroke
- •Premedication with Corticosteroids for more than 6 Weeks or Pioglitazone or Bisphosphonate within the last 12 months
- •Limb amputation
- •BMI < 18,5 kg/m2 or > 35 kg/m2
- •Present or previous fracture in the distal Radius or Tibia interfering with HR-pQCT
- •Movement disorder interfering with HR-pQCT imaging
- •Women of childbearing potential
结局指标
主要结局
Number of patients with and without fractures
时间窗: 12 months
次要结局
未报告次要终点
