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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD031989 | U.S. NIH Grant/Contract | View source |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shoes with Rocker Soles | Device |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacqueline Wertsch, M.D. | Medical College of Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical College of Wisconsin Gait Lab | Milwaukee | Wisconsin | 53226-0099 | United States |
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| Label | URL |
|---|---|
| Medical College of Wisconsin website | View source |
| Click here for more information about the National Institute of Child Health and Human Development (NICHD). | View source |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| D051346 | Mobility Limitation |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |