Maximal Plantar Pressure and Comfort Evaluation of Orthopedic Stilettos

Overview

22 women Testing "orthopedic" stilettos compared to standard stilettos and a comfy trainer.

Testing involves pedobar pressures and a validated comfort questionnaire.

Full Title of Study: “Maximal Plantar Pressure and Comfort Evaluation During Normal Every Day Use of an “Orthopedic” Stiletto, a Normal Stiletto and a Control Trainer Shoe”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2015

Detailed Description

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.

Interventions

  • Other: orthopaedic stilettoe
    • stilettos with orthopaedic in-sole buildt into the shoe
  • Other: standard stiletto
    • standard stiletto without insole
  • Other: comfy trainer
    • comfy trainer

Arms, Groups and Cohorts

  • Experimental: orthopaedic stilettoe
    • orthopaedic stilettoe will be compared to standard stilettoe and comfy trainer

Clinical Trial Outcome Measures

Primary Measures

  • plantar foot pressure
    • Time Frame: 1 hrs
    • 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.

Secondary Measures

  • comfort rating footwear
    • Time Frame: 1 month
    • 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.)

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 67 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Copenhagen University Hospital, Hvidovre
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jeannette Penny, orthopedic surgeon, PhD. – Copenhagen University Hospital, Hvidovre
  • Overall Official(s)
    • jeannette penny, PhD, Principal Investigator, Copenhagen University Hospital, Hvidovre

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