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临床试验/NCT04179591
NCT04179591已完成不适用

Comparison of the Effects of Foot Exercise Program and Arch Support Insoles on Foot Posture, Plantar Force Distribution, and Balance in Individuals With Flexible Pes Planus

Dokuz Eylul University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年11月30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
40
试验地点
2
主要终点
Foot posture

研究概览

简要总结

The aim is to compare the effects of intrinsic foot muscles and tibialis posterior strengthening exercise, and customized arch support insoles on foot posture, plantar force distribution, and balance in individuals with flexible pes planus.

详细描述

The aim is to compare the effects of intrinsic foot muscles and tibialis posterior strengthening exercise, and customized arch support insoles on foot posture, plantar force distribution, and balance in individuals with flexible pes planus. Forty-two individuals with flexible pes planus will be recruited into the study according to the inclusion criteria. Participants will be randomly divided into three groups: (1) Exercise, (2) Insole, (3) Exercise plus Insole. Exercises will be performed three times per week for six weeks, also custom-made insoles will be worn for six weeks. Foot posture will be assessed using the Navicular drop, Valgus index and Foot posture index-6. Plantar force variables will be recorded by the pressure-sensitive mat (HR Mat, Tekscan, USA) mounted in the middle of the 6-meter walkway in three sessions: (1) Upright standing, (2) Walking at different speeds: self-selected slow, normal and fast speeds, (3) Walking just after the heel-rise test for endurance. Balance performance will be assessed by the Balance Master System (NeuroCom® International Inc., USA). The assessments will be made pre/post intervention and at 6-weeks follow-up.

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
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • being between 18 and 40 years of age,
  • having Navicular drop test greater than 10 mm,
  • having Foot posture index-6 greater than or equal to 6,
  • having bilateral flexible pes planus.

排除标准

  • a lack of anatomical integrity of the foot,
  • a history of surgery or trauma in the foot region,
  • other musculoskeletal or neurological problems which may affect balance and gait performance.
  • having received any treatment for lower extremity disorders including pes planus within the last 1 year
  • having a body mass index equal to or greater than 30.

结局指标

主要结局

Foot posture

时间窗: Change in foot posture measures from baseline to six weeks and to twelve weeks

Foot posture will be assessed using the Navicular drop, Valgus index and Foot posture index-6.

Balance

时间窗: Change in balance scores from baseline to six weeks and to twelve weeks

Balance performance will be assessed by the Balance Master System (NeuroCom® International Inc., USA).

Plantar force variables

时间窗: Change in plantar pressure variables from baseline to six weeks and to twelve weeks

Plantar force variables will be recorded by the pressure-sensitive mat (HR Mat, Tekscan, USA) mounted in the middle of the 6-meter walkway in three sessions: (1) Upright standing, (2) Walking at different speeds: self-selected slow, normal, and fast speeds, (3) Walking just after the heel-rise test for endurance.

次要结局

未报告次要终点

研究者

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

Müge KIRMIZI

Research Assistant

Dokuz Eylul University

研究点 (2)

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