The Analysis and Applications of Dynamic Impression Insole

Early Phase 1

Completed

• Conditions: Metatarsalgia
• Interventions: Procedure: Dynamic impression insole; Procedure: Custom molded insole; Procedure: 9-mm uncompressed Plastazote; Procedure: 7-mm Ethylene Vinyl Acetate (EVA)

• Registration Number: NCT01629173
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-10-19
• Status Verified: 2012-06
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Study First Submitted QC: 2012-06-24
• Last Update Submitted: 2012-06-24
• Study First Posted: 2012-06-27
• Last Update Posted: 2012-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

• People with flexible flat foot
• Any acute inflammation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Dynamic impression insole	Dynamic impression insole	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.
Custom molded insole	Custom molded insole	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.
9-mm uncompressed Plastazote insole	9-mm uncompressed Plastazote	We used 9-mm flat Plastazote as an insole
7-mm Ethylene Vinyl Acetate (EVA)	7-mm Ethylene Vinyl Acetate (EVA)	We used 7-mm flat Ethylene Vinyl Acetate (EVA) as an insole

Primary Outcome Measures

Name	Time	Method
Change from baseline in peak plantar pressure value with different insoles	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.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in pain levels using Visual Analog Scales	4 weeks	We measure pain levels when using different kinds of insoles by Visual Analog Scales after using dynamic impression insole for four weeks.

Trial Locations

Locations (1)

Taipei VGH; 🇨🇳 Taipei City, Taiwan