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临床试验/NCT04845269
NCT04845269已完成不适用

Post-Stroke Osteopathy: Characterization of Fractures and Changes in the Bone Microstructure After Ischemic Stroke or TIA

VASCage GmbH1 个研究点 分布在 1 个国家目标入组 127 人开始时间: 2021年3月31日最近更新:
适应症

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

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

研究者

发起方
VASCage GmbH
申办方类型
Other
责任方
Sponsor

研究点 (1)

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