Maximal Plantar Pressure and Comfort Evaluation of Orthopedic Stilettos

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02667990

Enrollment

Registered

2016-01-29

Start date

2015-08-31

Completion date

2016-01-31

Last updated

2016-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metatarsalgia

Keywords

metatarsalgia, pedobar, foot, stiletto, insoles

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.

Interventions

OTHERorthopaedic stilettoe

stilettos with orthopaedic in-sole buildt into the shoe

OTHERstandard stiletto

standard stiletto without insole

OTHERcomfy trainer

comfy trainer

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 67 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.)

Other

Measure	Time frame	Description
X ray angles of the foot	1 hrs	Hallux valgus, Intermetatarsal and O'Meary angles, index minus (Rui Baracco 2011) and signs of arthrosis (Cockhlin 2003 grade 0-4)

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026