The Analysis and Applications of Dynamic Impression Insole
The Effect of Dynamic Impression Insoles on Plantar Pressure and Pain in Persons With Metatarsal Pain
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Apr 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 19, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedFirst Posted
Study publicly available on registry
June 27, 2012
CompletedJune 27, 2012
June 1, 2012
1.2 years
October 19, 2011
June 24, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
4 weeks
Secondary Outcomes (1)
Change from baseline in pain levels using Visual Analog Scales
4 weeks
Study Arms (4)
Dynamic impression insole
EXPERIMENTALWe 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
EXPERIMENTALThe 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
EXPERIMENTALWe used 9-mm flat Plastazote as an insole
7-mm Ethylene Vinyl Acetate (EVA)
EXPERIMENTALWe used 7-mm flat Ethylene Vinyl Acetate (EVA) as an insole
Interventions
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.
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.
We used 9-mm flat Plastazote(15 Shore A hardness, Schein orthopadie service KG. Remscheid, Germany) as an insole
We used 7-mm flat Ethylene Vinyl Acetate (EVA) (40 Shore A hardness, Schein orthopadie service KG. Remscheid, Germany) as an insole
Eligibility Criteria
You may qualify if:
- Adults with metatarsal pain
- Active in walking without any walking aids
You may not qualify if:
- People with flexible flat foot
- Any acute inflammation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Taipei VGH
Taipei, Taiwan
Related Publications (1)
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.
PMID: 24119776DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Chang Bao-Chi
Taipei Veterans General Hospital, Taiwan
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2011
First Posted
June 27, 2012
Study Start
April 1, 2011
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
June 27, 2012
Record last verified: 2012-06