跳至主要内容
临床试验/NCT05657548
NCT05657548招募中不适用

Study of Sagittal Pelvic Statics in the Sitting Position in Children With Cerebral Palsy

Centre Hospitalier Universitaire de Nīmes1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年10月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Evolution of the sagittal spinal statics in the sitting position

研究概览

简要总结

Cerebral palsy is the leading cause of motor disability in children. Children with little or no walking (GMFCS III, IV and V) represent 43% of children with cerebral palsy, the majority of whom present pelvic and spinal deformities in the frontal and sagittal planes. However, sagittal pelvic spinal statics have been little studied, especially in the sitting position, which is the functional position of these children.

Moreover, there are currently no recommendations on how to perform follow-up radiographs of the spine in children who do not walk much.

A better understanding of pelvic and sagittal spinal statics would help prevent deformities and their complications.

Standardizing the method of performing pelvic-spinal radiographs in the sitting position will make monitoring of spinal statics more reliable.

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
4 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Child or adolescent aged 4 to 17 years
  • Child or adolescent with cerebral palsy GMFCS III, IV or V
  • Child or adolescent whose parents, or the child if possible, have given free, informed and written consent
  • Child or adolescent affiliated or beneficiary of a health insurance plan

排除标准

  • Child or adolescent with history of spinal surgery
  • Child or adolescent with parents unable to give consent
  • Child or adolescent participating in a therapeutic research study (RIPH 1 or drug study)
  • Child or adolescent in an exclusion period determined by another study
  • Child or adolescent under court protection, guardianship or curatorship
  • Pregnant, parturient or breastfeeding patient

结局指标

主要结局

Evolution of the sagittal spinal statics in the sitting position

时间窗: At baseline

Cobb angle (if scoliosis) (curvature greater than 10 degrees : definition of scoliosis; between 10 and 15 degree: benign scoliosis; between 15 and 35 degrees: moderate scoliosis; curvature greater than 35 degrees: significant scoliosis.)

次要结局

未报告次要终点

研究者

发起方
Centre Hospitalier Universitaire de Nīmes
申办方类型
Other
责任方
Sponsor

研究点 (1)

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