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临床试验/NCT04761666
NCT04761666撤回不适用

Influence of Verticalization on Bone Mineral Density and Biological Parameters of Bone Remodeling in Children With Severe Cerebral Palsy

Centre Hospitalier Universitaire, Amiens1 个研究点 分布在 1 个国家开始时间: 2021年2月16日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Variation of Densitometric Z score between both groups

研究概览

简要总结

Low bone mineral density affects 77% of children with severe cerebral palsy (GMFCS IV & V) with an increased fracture risk of 4%. One strategy supposed to improve bone mineral density is verticalisation with static devices. Nowadays there is no time recommendation of verticalisation however high intensity verticalisation has been shown to be effective in improving bone mineral density in childrens with cerebral palsy, but difficult to apply in real life due to lack of qualified therapists, device's complexity, and severe impairment in those children. The investigators aim to compare bone mineral density and bone remodelling factors of verticalized and non verticalized childrens with severe cerebral palsy as achieved in everyday life. The investigators conduced a retrospective study comparing bone mineral density and factors who influence bone remolling in severe cerebral palsy's according to whether they are verticalized or not.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
3 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • patients with cerebral palsy GMFCS (gross motor functional classification scale) IV-V
  • age of patients 3-18 years

排除标准

  • patients with neuro muscular disease
  • patient age < 3 years old and > 18 years old
  • patient with constitutionnal bone disease
  • patient with growth hormone treatment
  • patient with surgery < 6 months
  • patient with fracture <3 months
  • Refusal of the legal representative

结局指标

主要结局

Variation of Densitometric Z score between both groups

时间窗: 6 months

A Z-score compares the patient bone density to the average bone density of people your own age and gender.A Z-score is helpful in diagnosing secondary osteoporosis and is always used for children. It is most useful when the score is less than 2 standard deviations below this normal. In this setting, it is helpful to scrutinize for coexisting illnesses or treatments that may contribute to osteoporosis such as glucocorticoid therapy, hyperparathyroidism, or alcoholism.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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