Clinical Trials Directory

Trials / Completed

CompletedNCT02667990

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
Phase
N/A
Study type
Interventional
Enrollment
22 (actual)
Sponsor
Copenhagen University Hospital, Hvidovre · Academic / Other
Sex
Female
Age
18 Years – 67 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERorthopaedic stilettoestilettos with orthopaedic in-sole buildt into the shoe
OTHERstandard stilettostandard stiletto without insole
OTHERcomfy trainercomfy trainer

Timeline

Start date
2015-08-01
Primary completion
2015-10-01
Completion
2016-01-01
First posted
2016-01-29
Last updated
2016-01-29

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT02667990. Inclusion in this directory is not an endorsement.