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| Sponsored by: |
National Institute of Child Health and Human Development (NICHD) |
| Information provided by: | National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT00006438 |
Purpose
The purpose of this study is to compare how 3 special types of shoes with rocker-shaped soles help people with foot deformities to walk better. This study will use modern gait lab techniques to measure the forces on the bottom of the feet and to examine whether there is any effect higher on the leg from the rocker soles.
| Condition | Intervention |
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Diabetic Feet |
Device: Shoes with Rocker Soles |
| MedlinePlus related topics: | Diabetic Foot Foot Health |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study |
| Official Title: | Rocker Sole Kinetics and Kinematics |
| Estimated Enrollment: | 46 |
| Study Start Date: | January 1997 |
| Estimated Study Completion Date: | December 1999 |
The rocker sole is the most commonly prescribed external shoe modification. Use of rocker soles has been based on theoretical considerations and empirical observations with minimal scientific study and validation. With the passage of the therapeutic shoe bill (PL-100-203, section 4072) authorizing Medicare coverage of shoes and shoe modifications for diabetics, it is important to have objective data regarding the effect of rocker soles. This cross-over study will randomize 46 subjects (40 sensate and 6 insensate) to a combination of 3 rocker soles. Patients will be evaluated at baseline and after 20 minutes wearing each rocker sole shoe design to determine the effect of the type of rocker sole on plantar pressure and gait.
Eligibility
| Ages Eligible for Study: | 40 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Wisconsin | |||||
| Medical College of Wisconsin Gait Lab | |||||
| Milwaukee, Wisconsin, United States, 53226-0099 | |||||
| Principal Investigator: | Jacqueline Wertsch, M.D. | Medical College of Wisconsin |
More Information
Medical College of Wisconsin website
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Click here for more information about the National Institute of Child Health and Human Development (NICHD).
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| Study ID Numbers: | NICHD-0118, R01 HD31989 |
| First Received: | November 3, 2000 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00006438 |
| Health Authority: | United States: Federal Government |
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