Maximal Plantar Pressure and Comfort Evaluation of Orthopedic Stilettos

Not Applicable

Completed

• Conditions: Metatarsalgia
• Interventions: Other: orthopaedic stilettoe; Other: standard stiletto; Other: comfy trainer

• Registration Number: NCT02667990
• Lead Sponsor: Copenhagen University Hospital, Hvidovre

Brief Summary

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

Testing involves pedobar pressures and a validated comfort questionnaire.

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.

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-28
• Primary Completion: 2015-10
• Status Verified: 2016-01
• Study Completion: 2016-01
• Study First Submitted QC: 2016-01-28
• Last Update Submitted: 2016-01-28
• Study First Posted: 2016-01-29
• Last Update Posted: 2016-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
orthopaedic stilettoe	orthopaedic stilettoe	orthopaedic stilettoe will be compared to standard stilettoe and comfy trainer
orthopaedic stilettoe	standard stiletto	orthopaedic stilettoe will be compared to standard stilettoe and comfy trainer
orthopaedic stilettoe	comfy trainer	orthopaedic stilettoe will be compared to standard stilettoe and comfy trainer

Primary Outcome Measures

Name	Time	Method
plantar foot pressure	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 Outcome Measures

Name	Time	Method
comfort rating footwear	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.)

Trial Locations

Locations (1)

Hvidovre Hospital; 🇩🇰 Hvidovre, Denmark