Maximal Plantar Pressure and Comfort Evaluation of Orthopedic Stilettos

Sponsor
Copenhagen University Hospital, Hvidovre (Other)
Overall Status
Completed
CT.gov ID
NCT02667990
Collaborator
(none)
22
1
1
5
4.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: orthopaedic stilettoe
  • Other: standard stiletto
  • Other: comfy trainer
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
22 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
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 Start Date :
Aug 1, 2015
Actual Primary Completion Date :
Oct 1, 2015
Actual Study Completion Date :
Jan 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: orthopaedic stilettoe

orthopaedic stilettoe will be compared to standard stilettoe and comfy trainer

Other: orthopaedic stilettoe
stilettos with orthopaedic in-sole buildt into the shoe

Other: standard stiletto
standard stiletto without insole

Other: comfy trainer
comfy trainer

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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 Outcome Measures

  1. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 67 Years
Sexes Eligible for Study:
Female
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hvidovre Hospital Hvidovre Denmark 2650

Sponsors and Collaborators

  • Copenhagen University Hospital, Hvidovre

Investigators

  • Principal Investigator: jeannette penny, PhD, Copenhagen University Hospital, Hvidovre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jeannette Penny, orthopedic surgeon, PhD., Copenhagen University Hospital, Hvidovre
ClinicalTrials.gov Identifier:
NCT02667990
Other Study ID Numbers:
  • 47798
First Posted:
Jan 29, 2016
Last Update Posted:
Jan 29, 2016
Last Verified:
Jan 1, 2016
Keywords provided by Jeannette Penny, orthopedic surgeon, PhD., Copenhagen University Hospital, Hvidovre
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 29, 2016