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临床试验/NCT06191588
NCT06191588已完成不适用

Feasibility and Effectiveness of Home-base Early Intensive Therapy in Unilateral Cerebral Palsy (Ucp-HEIT) Under-2-years-old

University of Seville3 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年12月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
3
主要终点
mini Assisting Hand Assesment

研究概览

简要总结

mCIMT and BIT are therapies applied in children with hemiplegia which have a great evidence, but not in a early age. This research has the objective to know the effects of this therapies in infants diagnosed of infantile hemiplegia from 9 to 18 months applying 50 hours of dose for both interventions during 10 weeks, executing them at home by families.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
9 Months 至 18 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Infantile hemiplegia
  • Age from 9 months to 18 months.
  • No use of the affected upper limb

排除标准

  • Associated pathologies
  • Epilepsy no controlled with drugs
  • No collaborated families

结局指标

主要结局

mini Assisting Hand Assesment

时间窗: 10 weeks

Bimanual functional performance Assessment in children with hemiplegia from 8 to 18 months.

次要结局

  • Satisfaction questionnaire for families(10 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elena Piñero Pinto

Professor

University of Seville

研究点 (3)

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