Maximal Plantar Pressure and Comfort Evaluation of Orthopedic Stilettos
NCT ID: NCT02667990
Last Updated: 2016-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
22 participants
INTERVENTIONAL
2015-08-31
2016-01-31
Brief Summary
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Testing involves pedobar pressures and a validated comfort questionnaire.
Detailed Description
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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
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Keywords
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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orthopaedic stilettoe
orthopaedic stilettoe will be compared to standard stilettoe and comfy trainer
orthopaedic stilettoe
stilettos with orthopaedic in-sole buildt into the shoe
standard stiletto
standard stiletto without insole
comfy trainer
comfy trainer
Interventions
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orthopaedic stilettoe
stilettos with orthopaedic in-sole buildt into the shoe
standard stiletto
standard stiletto without insole
comfy trainer
comfy trainer
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Sought doctor for foot or balance related issues
18 Years
67 Years
FEMALE
Yes
Sponsors
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Copenhagen University Hospital, Hvidovre
OTHER
Responsible Party
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Jeannette Penny
orthopedic surgeon, PhD.
Principal Investigators
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jeannette penny, PhD
Role: PRINCIPAL_INVESTIGATOR
Copenhagen University Hospital, Hvidovre
Locations
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Hvidovre Hospital
Hvidovre, , Denmark
Countries
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Other Identifiers
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47798
Identifier Type: -
Identifier Source: org_study_id