Maximal Plantar Pressure and Comfort Evaluation of Orthopedic Stilettos

Study Overview
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Brief Summary
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22 women Testing orthopedic stilettos compared to standard stilettos and a comfy trainer. Testing involves pedobar pressures and a validated comfort questionnaire.

Detailed Description
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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. Primary outcome is the foot sole pressures. Both VAS comfort and foot pressures will be regressed to see if age, BMI, shoe size, steps, shoe type, callus, index minus, hallux valgus etc has an effect. 16 needed for the pressure and 21 for the comfort score. 22 will be included to make sure the investigators have enough power.

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

Conditions
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Metatarsalgia

Intervention / Treatment
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* Other: orthopaedic stilettoe
* Other: standard stiletto
* Other: comfy trainer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Foot healthy females used to wearing stilettos. Exclusion Criteria: Shoe sized outside European 37-42. Sought doctor for foot or balance related issues

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 67 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: orthopaedic stilettoe<br>orthopaedic stilettoe will be compared to standard stilettoe and comfy trainer | Other: orthopaedic stilettoe<br>* stilettos with orthopaedic in-sole buildt into the shoe<br>Other: standard stiletto<br>* standard stiletto without insole<br>Other: comfy trainer<br>* comfy trainer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plantar foot pressure | 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. | 1 hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comfort rating footwear | VAS scale indication comfort around the shoe. The scale is continuous from 0 to 15, with 15 being the most comfortable condition imaginable. It measures: Overall comfort, Heel cushioning, Forefoot cushioning, Arch height, Heel cup fit, Heel cup width, Shoe forefoot width, Shoe length. The investigators will register all but the overall comfort and the cushioning measures are assumed the most interesting measures in this study. (Mundermann,A., Nigg,B.M., Stefanyshyn,D.J., and Humble,R.N.: Development of a reliable method to assess footwear comfort during running. Gait Posture, 16:38-45, 2002.) | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metatarsalgia, pedobar, foot, stiletto, insoles