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临床试验/NCT02633566
NCT02633566已完成不适用

Randomized Clinical Trial of the Effect of Functional Orthoses on the Joint Position of the Hindfoot in Children With Flat Feet After a Year of Follow-up

Fresno, Raquel Lopez, M.D.0 个研究点目标入组 61 人开始时间: 2013年1月1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
入组人数
61
主要终点
X-ray measurements of the angles: talus-calcaneus, talus-navicular and talus-first metatarsal angle.

研究概览

简要总结

The purpose of this study is to investigate the efficay of functional plantar orthoses on flatfoot in children.

详细描述

There's a considerable controversy regarding the effectiveness of plantar orthoses in the treatment of flexible flat foot, despite being the most widely used treatment. Several studies tried to investigate the correction of the deformity using plantar orthoses, but there are few studies with a control group of people, not enough to compare the effectiveness of the treatment.

A randomized, double-blind, parallel design clinical trial was conducted with two study groups. The sample consisted of 61 children, aged 3 and 4 years old, who were randomly assigned to each study group. One group (intervention group) received treatment with functional plantar orthotics, and the other group (control group) received treatment with placebo-type plantar orthotics, to use as a reference or comparison. Both groups were followed for a one-year period. Before delivering the treatment, all subjects underwent dorsoplantar radiography, repeated at the end of the treatment (after one year). Differences in the talus-calcaneus, tibionavicular and talus-first metatarsal angles were compared, pre and post-treatment of both study groups. Test analysis of covariance (ANCOVA) was performed as a statistical test.

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
3 Years 至 4 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Flexible flatfoot

排除标准

  • Congenital Vertical talus
  • Tarsal coalition
  • Neuromuscular disease
  • Ligamentous laxity
  • Previous history of surgery on lower limb
  • Previous orthotic treatment

结局指标

主要结局

X-ray measurements of the angles: talus-calcaneus, talus-navicular and talus-first metatarsal angle.

时间窗: One year

Before delivering the treatment, all subjects underwent dorsoplantar radiography, repeated at the end of the treatment (after one year). Differences in the talus-calcaneus, tibionavicular and talus-first metatarsal angles were compared, pre and post-treatment of both study groups. Test analysis of covariance (ANCOVA) was performed as a sataistical test.

次要结局

未报告次要终点

研究者

发起方
Fresno, Raquel Lopez, M.D.
申办方类型
Indiv
责任方
Principal Investigator
主要研究者

Raquel Lopez Fresno

PhD Student (Podiatrist)

Fresno, Raquel Lopez, M.D.

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