Clinical Trial: Maximal Plantar Pressure and Comfort Evaluation of Orthopedic Stilettos
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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
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 Summary:
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.
Sponsor: Copenhagen University Hospital, Hvidovre
Current Primary Outcome: plantar foot pressure [ Time Frame: 1 hrs ]
Original Primary Outcome: Same as current
Current Secondary Outcome: comfort rating footwear [ Time Frame: 1 month ]
Original Secondary Outcome: Same as current
Information By: Copenhagen University Hospital, Hvidovre
Dates:
Date Received: August 28, 2015
Date Started: August 2015
Date Completion:
Last Updated: January 28, 2016
Last Verified: January 2016