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临床试验/NCT01629173
NCT01629173已完成1 期

The Effect of Dynamic Impression Insoles on Plantar Pressure and Pain in Persons With Metatarsal Pain

Taipei Veterans General Hospital, Taiwan1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2011年4月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
50
试验地点
1
主要终点
Change from baseline in peak plantar pressure value with different insoles

研究概览

简要总结

The aim of the study was to investigate the effectiveness of dynamic impression insoles on plantar pressure and pain reduction. A dynamic impression insole was made by sequential padding with Plastazote and P-cell under daily walking compression. The pain levels and plantar pressure with the use of dynamic impression insole were assessed and compared with 7-mm Ethylene Vinyl Acetate (EVA) control, 9-mm uncompressed Plastazote and custom molded insoles. Plantar pressure was measured by a Pedar-X mobile system, and pain level was assessed using a Visual Analog Scales.

详细描述

Toe deformities may cause prominence of the metatarsal heads (MTH) and distal displacement of fat-pad cushion beneath the MTH, resulting in the metatarsal pain. Foot pain frequently leads to limitation of activities of daily life and deterioration of life quality. Foot orthoses have been commonly used in clinical practice to reduce plantar pressure and subsequent pain. However, the therapeutic efficacies of custom molded insoles with a metatarsal support vary widely with their designs and materials. We designed a simple and effective method that a dynamic impression insole was made by sequential padding of foams with different compressibility under successive dynamic impression in daily walking. A piece of metatarsal pad and arch support made of EVA was attached to the bottom of impressed insole just proximal to the first, second, and third MTH according to the foot impression. Fifty participants with metatarsal pain were recruited from the podiatry outpatient clinic of Taipei Veteran General Hospital. The plantar pressure measurements were carried out under a comfortable and stable walking speed preferred by the participants one month after the dynamic impression and custom molded insoles were well fabricated. All pressure data were processed with the Novel-Win Multimask analysis software. The purposes of this study were to investigate the biomechanics of dynamic impression insole in plantar pressure and pain reduction.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Factorial
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adults with metatarsal pain
  • •Active in walking without any walking aids

排除标准

  • •People with flexible flat foot
  • •Any acute inflammation

研究组 & 干预措施

Dynamic impression insole

Experimental

We sequentially padded P-cell, Ethylene Vinyl Acetate, and Multiform on the 9-mm thick plastazote under daily walking compression to make dynamic impression insole.

干预措施: Dynamic impression insole (Procedure)

Custom molded insole

Experimental

The custom molded insole was made by sequentially padded Multiform, P-cell, EVA, and cork on the positive plaster cast impressed by an impression box while holding the subtalar joint at a neutral position.

干预措施: Custom molded insole (Procedure)

9-mm uncompressed Plastazote insole

Experimental

We used 9-mm flat Plastazote as an insole

干预措施: 9-mm uncompressed Plastazote (Procedure)

7-mm Ethylene Vinyl Acetate (EVA)

Experimental

We used 7-mm flat Ethylene Vinyl Acetate (EVA) as an insole

干预措施: 7-mm Ethylene Vinyl Acetate (EVA) (Procedure)

结局指标

主要结局

Change from baseline in peak plantar pressure value with different insoles

时间窗: 4 weeks

We measure peak pressure (in unit of kPa) under forefoot, midfoot, and rearfoot when using different kinds of insoles by Pedar-X mobile in-shoe system (Novel gmbh, Munich, Germany), and data were processed with the Novel-Win Multimask analysis software (Novel gmbh, Munich, Germany) after using dynamic impression insole for four weeks.

次要结局

  • Change from baseline in pain levels using Visual Analog Scales(4 weeks)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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