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临床试验/NCT02667990
NCT02667990已完成不适用

Maximal Plantar Pressure and Comfort Evaluation During Normal Every Day Use of an "Orthopedic" Stiletto, a Normal Stiletto and a Control Trainer Shoe

Copenhagen University Hospital, Hvidovre1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2015年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
22
试验地点
1
主要终点
plantar foot pressure

研究概览

简要总结

22 women Testing "orthopedic" stilettos compared to standard stilettos and a comfy trainer.

Testing involves pedobar pressures and a validated comfort questionnaire.

详细描述

22 women Testing "orthopedic" stilettos compared to standard stilettos and a comfy trainer testing involved pedobar pressures and a validated comfort questionnaire.

x rays with arthrosis 1. metatarsophalangeal joint (MTPJ), hallux valgus and Intermetatarsal (IM) angles will be recorded.

Clinically, weight, height, foot length, heel valgus, 1. MTPJ range of motion, pain, callus, hammertoes will be recorded.

Sole pressure in heel, arch and forefoot grids measured by in-sole pressure pedar-x (Novel) and possible Emed system (Novel).

3 working days in each type of shoe with Steps measured by pedometer Comfort assed as VAS according to: Mundermann,A., Nigg,B.M., Stefanyshyn,D.J., and Humble,R.N.: Development of a reliable method to asses footwear comfort during running. Gait Posture, 16:38-45, 2002.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 67 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Foot healthy females used to wearing stilettos.

排除标准

  • •Shoe sized outside European 37-
  • •Sought doctor for foot or balance related issues

研究组 & 干预措施

orthopaedic stilettoe

Experimental

orthopaedic stilettoe will be compared to standard stilettoe and comfy trainer

干预措施: orthopaedic stilettoe (Other)

orthopaedic stilettoe

Experimental

orthopaedic stilettoe will be compared to standard stilettoe and comfy trainer

干预措施: standard stiletto (Other)

orthopaedic stilettoe

Experimental

orthopaedic stilettoe will be compared to standard stilettoe and comfy trainer

干预措施: comfy trainer (Other)

结局指标

主要结局

plantar foot pressure

时间窗: 1 hrs

Mean and peak pressure and pressure/time in the heel, arch and fore foot ( fore foot subdivided into 1. metatarsal head, 2+3 rd head, 4+5th head and the big toe). Pressure measured as Newton/sq. cm.

次要结局

  • comfort rating footwear(1 month)

研究者

发起方
Copenhagen University Hospital, Hvidovre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeannette Penny

orthopedic surgeon, PhD.

Copenhagen University Hospital, Hvidovre

研究点 (1)

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