Metatarsalgia Clinical Trial
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
22 women Testing "orthopedic" stilettos compared to standard stilettos and a comfy trainer.
Testing involves pedobar pressures and a validated comfort questionnaire.
Status | Completed |
Enrollment | 22 |
Est. completion date | January 2016 |
Est. primary completion date | October 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 67 Years |
Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Denmark | Hvidovre Hospital | Hvidovre |
Lead Sponsor | Collaborator |
---|---|
Copenhagen University Hospital, Hvidovre |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | X ray angles of the foot | Hallux valgus, Intermetatarsal and O'Meary angles, index minus (Rui Baracco 2011) and signs of arthrosis (Cockhlin 2003 grade 0-4) | 1 hrs | Yes |
Primary | 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. | 1 hrs | No |
Secondary | 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.) | 1 month | No |
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