Maximal Plantar Pressure and Comfort Evaluation of Orthopedic Stilettos
Primary Purpose
Metatarsalgia
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
orthopaedic stilettoe
standard stiletto
comfy trainer
Sponsored by
About this trial
This is an interventional basic science trial for Metatarsalgia focused on measuring metatarsalgia, pedobar, foot, stiletto, insoles
Eligibility Criteria
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
Sites / Locations
- Hvidovre Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
orthopaedic stilettoe
Arm Description
orthopaedic stilettoe will be compared to standard stilettoe and comfy trainer
Outcomes
Primary Outcome Measures
plantar foot pressure
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
comfort rating footwear
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.)
Full Information
NCT ID
NCT02667990
First Posted
August 28, 2015
Last Updated
January 28, 2016
Sponsor
Copenhagen University Hospital, Hvidovre
1. Study Identification
Unique Protocol Identification Number
NCT02667990
Brief Title
Maximal Plantar Pressure and Comfort Evaluation of Orthopedic Stilettos
Official Title
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
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Copenhagen University Hospital, Hvidovre
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metatarsalgia
Keywords
metatarsalgia, pedobar, foot, stiletto, insoles
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
orthopaedic stilettoe
Arm Type
Experimental
Arm Description
orthopaedic stilettoe will be compared to standard stilettoe and comfy trainer
Intervention Type
Other
Intervention Name(s)
orthopaedic stilettoe
Intervention Description
stilettos with orthopaedic in-sole buildt into the shoe
Intervention Type
Other
Intervention Name(s)
standard stiletto
Intervention Description
standard stiletto without insole
Intervention Type
Other
Intervention Name(s)
comfy trainer
Intervention Description
comfy trainer
Primary Outcome Measure Information:
Title
plantar foot pressure
Description
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.
Time Frame
1 hrs
Secondary Outcome Measure Information:
Title
comfort rating footwear
Description
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.)
Time Frame
1 month
Other Pre-specified Outcome Measures:
Title
X ray angles of the foot
Description
Hallux valgus, Intermetatarsal and O'Meary angles, index minus (Rui Baracco 2011) and signs of arthrosis (Cockhlin 2003 grade 0-4)
Time Frame
1 hrs
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jeannette penny, PhD
Organizational Affiliation
Copenhagen University Hospital, Hvidovre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hvidovre Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
12. IPD Sharing Statement
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Maximal Plantar Pressure and Comfort Evaluation of Orthopedic Stilettos
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