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临床试验/NCT04453787
NCT04453787终止不适用

The Effects of Different Types of Foot Orthosis in Adults With Compensatory Forefoot Varus

National Yang Ming Chiao Tung University2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2020年10月5日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
22
试验地点
2
主要终点
Foot function index

研究概览

简要总结

Forefoot varus is a type of foot deformities. It is asociate with subtalar joint hyperpronation, and cause too much stress over tissues around foot and lower leg during weight bearing activities.

One of the common interventions for forefoot varus is to use foot orthosis with medial forefoot wedge to accommodate the forefoot deformity. Forefoot varus has been considered as an osseus deformity and caused by insufficient talar torsion during development. However, recent studies have reported forefoot varus may not be an osseus deformity. They might be a result of soft tissue adaption. For example, subtalar joint hyperpronation and ankle equinus could lead to forefoot supination/compensatory forefoot varus, which could be mistaken for osseus forefoot varus after a long period of time. If compensatory forefoot varus is caused by soft tissue adaptions, these adaptions may have a chance to reverse.

Nowadays, orthoses which applying medial forefoot wedge to accommodate the deformity for forefoot varus deformity, and the other type orthoses which applying rearfoot medial wedge and arch support are both used in subject with forefoot varus deformity.

However, some colleges claims that using medial forefoot wedge to accommodate the deformity of forefoot varus, the deformity may be fixed after a long-term period. However, there were no studies compare the effect of arch support orthosis that with and without medial forefoot wedge.

详细描述

Forefoot varus is a type of foot deformities. It is asociate with subtalar joint hyperpronation, and cause too much stress over tissues around foot and lower leg during weight bearing activities.

One of the common interventions for forefoot varus is to use foot orthosis with medial forefoot wedge to accommodate the forefoot deformity. Forefoot varus has been considered as an osseus deformity and caused by insufficient talar torsion during development. However, recent studies have reported forefoot varus may not be an osseus deformity. They might be a result of soft tissue adaption. For example, subtalar joint hyperpronation and ankle equinus could lead to forefoot supination/compensatory forefoot varus, which could be mistaken for osseus forefoot varus after a long period of time. If compensatory forefoot varus is caused by soft tissue adaptions, these adaptions may have a chance to reverse.

Nowadays, orthoses which applying medial forefoot wedge to accommodate the deformity for forefoot varus deformity, and the other type orthoses which applying rearfoot medial wedge and arch support are both used in subject with forefoot varus deformity.

However, some colleges claims that using medial forefoot wedge to accommodate the deformity of forefoot varus, the deformity may be fixed after a long-term period. However, there were no studies compare the effect of arch support orthosis that with and without medial forefoot wedge.

In consideration of few studies have been done for investigating the effects of different orthoses in subjects with flat foot combined forefoot varus. Thus, the purpose of this study is to investigate the effect of different foot orthoses designs on improving pain, muscle activity and displacement of center of pressure. We hypothesized that both orthoses will have the better effect on improving pain than placebo orthoses ,and muscle activity and displacement of center of pressure of arch support orthoses group will have change which close to normal foot.

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
None

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Flexible flatfoot
  • Angle of forefoot varus > 6 degree
  • Feel leg or foot pain when walking or exercising, and pain visual analogue scale > 3 points
  • The duration of wearing shoes > 30 he per week

排除标准

  • Rigid flatfoot
  • Leg length discrepancy > 1cm
  • Angle of Hallux valgus > 20 degree
  • With any nerve problem or disease
  • Used to have trauma over lower limbs
  • Had any severe joint deformity or osteoarthritis over lower limbs
  • Had any acute injury (in two weeks and inflammation)
  • Had wearing insole for 6 months
  • Can't follow order

结局指标

主要结局

Foot function index

时间窗: 6-week intervention

This questionnaire includes 23 questions. These questions are about how difficult or pain over foot when subjects doing some functional activities.

Change From Baseline in Global Rating of Change Scale (GROC)

时间窗: change from baseline at 6 weeks later

To measure improvements in a patient's condition. The minimum value is -7 and it means a very great deal worse. The maximum values is +7 and it means a very great deal better.

Pain visual analogue scale (VAS)

时间窗: 6-week intervention

The scale is from 0 to 10 points. Zero means no pain, and ten points means extremely painful over subject's foot or leg.

次要结局

  • Muscle activity of tibialis anterior muscle, peroneal longus and abductor hallucis brevis(Baseline and after 6-week intervention)
  • Displacement of center of force of gait cycle (medial-lateral and anterior-posterior)(Baseline and after 6-week intervention)

研究者

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

Yi-Fen Shih

Professor

National Yang Ming Chiao Tung University

研究点 (2)

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