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The Analysis and Applications of Dynamic Impression Insole

Primary Purpose

Metatarsalgia

Status
Completed
Phase
Early Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
Dynamic impression insole
Custom molded insole
9-mm uncompressed Plastazote
7-mm Ethylene Vinyl Acetate (EVA)
Sponsored by
Taipei Veterans General Hospital, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Metatarsalgia focused on measuring plantar pressure, metatarsalgia, insole

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • People with flexible flat foot
  • Any acute inflammation

Sites / Locations

  • Taipei VGH

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Dynamic impression insole

Custom molded insole

9-mm uncompressed Plastazote insole

7-mm Ethylene Vinyl Acetate (EVA)

Arm Description

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.

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.

We used 9-mm flat Plastazote as an insole

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

Outcomes

Primary Outcome Measures

Change from baseline in peak plantar pressure value with different insoles
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

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

Full Information

First Posted
October 19, 2011
Last Updated
June 24, 2012
Sponsor
Taipei Veterans General Hospital, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT01629173
Brief Title
The Analysis and Applications of Dynamic Impression Insole
Official Title
The Effect of Dynamic Impression Insoles on Plantar Pressure and Pain in Persons With Metatarsal Pain
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metatarsalgia
Keywords
plantar pressure, metatarsalgia, insole

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dynamic impression insole
Arm Type
Experimental
Arm Description
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.
Arm Title
Custom molded insole
Arm Type
Experimental
Arm Description
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.
Arm Title
9-mm uncompressed Plastazote insole
Arm Type
Experimental
Arm Description
We used 9-mm flat Plastazote as an insole
Arm Title
7-mm Ethylene Vinyl Acetate (EVA)
Arm Type
Experimental
Arm Description
We used 7-mm flat Ethylene Vinyl Acetate (EVA) as an insole
Intervention Type
Procedure
Intervention Name(s)
Dynamic impression insole
Intervention Description
We sequentially padded (1)a 6.5-mm thick P-cell (21 Shore A hardness, Acor orthopedic Inc. Cleveland, Ohio, USA), and (2)a piece of metatarsal pad and arch support made of Ethylene Vinyl Acetate (EVA) (40 Shore A hardness, Schein orthopadie service KG. Remscheid, Germany) to the bottom of the impressed 9-mm thick plastazote (15 Shore A hardness, Schein orthopadie service KG. Remscheid, Germany) with double-sided adhesive tape in the forefoot region and just proximal to the first, second, and third metatarsal head region. We additionally padded a 2-mm thick Multiform (30 Shore A hardness, Schein orthopadie service KG. Remscheid, Germany) on the top of the impressed insole with double-sided adhesive tape.
Intervention Type
Procedure
Intervention Name(s)
Custom molded insole
Intervention Description
The custom molded insole was made by sequentially padded Multiform (30 Shore A hardness, Schein orthopadie service KG. Remscheid, Germany), P-cell (21 Shore A hardness, Acor orthopedic Inc. Cleveland, Ohio, USA), Ethylene Vinyl Acetate (EVA)(40 Shore A hardness, Schein orthopadie service KG. Remscheid, Germany), and cork (50 Shore A hardness, Schein orthopadie service KG. Remscheid, Germany) on the positive plaster cast impressed by an impression box while holding the subtalar joint at a neutral position.
Intervention Type
Procedure
Intervention Name(s)
9-mm uncompressed Plastazote
Intervention Description
We used 9-mm flat Plastazote(15 Shore A hardness, Schein orthopadie service KG. Remscheid, Germany) as an insole
Intervention Type
Procedure
Intervention Name(s)
7-mm Ethylene Vinyl Acetate (EVA)
Intervention Description
We used 7-mm flat Ethylene Vinyl Acetate (EVA) (40 Shore A hardness, Schein orthopadie service KG. Remscheid, Germany) as an insole
Primary Outcome Measure Information:
Title
Change from baseline in peak plantar pressure value with different insoles
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in pain levels using Visual Analog Scales
Description
We measure pain levels when using different kinds of insoles by Visual Analog Scales after using dynamic impression insole for four weeks.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults with metatarsal pain Active in walking without any walking aids Exclusion Criteria: People with flexible flat foot Any acute inflammation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chang Bao-Chi
Organizational Affiliation
Taipei Veterans General Hospital, Taiwan
Official's Role
Study Director
Facility Information:
Facility Name
Taipei VGH
City
Taipei City
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
24119776
Citation
Chang BC, Liu DH, Chang JL, Lee SH, Wang JY. Plantar pressure analysis of accommodative insole in older people with metatarsalgia. Gait Posture. 2014;39(1):449-54. doi: 10.1016/j.gaitpost.2013.08.027. Epub 2013 Aug 31.
Results Reference
derived

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The Analysis and Applications of Dynamic Impression Insole

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