跳至主要内容
临床试验/NCT02644317
NCT02644317Unknown不适用

Chung Shan Medical University Hospital Institutional Review Board

Chung Shan Medical University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年12月最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
2
主要终点
The balance change of Movement ABC-2 scales

研究概览

简要总结

Flatfoot, one of the most common foot problems experienced by preschool-aged children, characterized by the collapse of the foot's medial longitudinal arch. Children with motor developmental delay often have flatfoot, according to clinical observation, and research indicates that preschool age is the main stage of the medial longitudinal arch development period. There flatfoot symptoms due to poor arch shock effect, poor walking endurance, likely to cause gait problems while growing up. The lack of a stable foot structure to support and maintain posture may lead to delayed motor development. Early training intervention and help to balance stability is the main rehabilitation goal for motor developmental delayed children. With understanding of the foot development of motor development delayed children, proper intervention can be provided to improve the movement and stability of the lower limbs. The possible deformation of the foot structure and resultant pain in the future can also be prevented.

详细描述

The investigators designed a prospective cohort study to long-time follow up of preschool aged children with delayed motor development and to establish standard data, including the foot shape, footprint and balance development. The investigators also discuss the influence of the shoe insert with balance and flatfoot correction. Flatfoot leads to poor gross motor balance and the balance improvement after flatfoot correction has never been studied. The investigators findings should provide direct evidence as a reference for clinical workers.

研究设计

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

入排标准

年龄范围
36 Months 至 83 Months(Child)
性别
All
接受健康志愿者

入选标准

  • preschool aged children with delayed motor development

排除标准

  • lower limb injury case in six months.
  • other neurological history such as cerebral palsy, traumatic brain injury, spina bifida to cause of developmental delay.
  • have been or are receiving insoles correction or treatment.
  • can not be completed with the instruction by foot measurement and balance measurement.

结局指标

主要结局

The balance change of Movement ABC-2 scales

时间窗: baseline/immediately/12 weeks/1 year/2 year

balance subscore of Movement ABC-2 scales

次要结局

  • The change of foot print parameters(baseline/12 weeks/1 year/2 year)

研究者

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

GCRC

Director, Clinical Research

Chung Shan Medical University

研究点 (2)

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