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	Treatment or Intervention
Diabetic Feet	Device: Shoes with Rocker Soles

Further Study Details: 

Expected Total Enrollment:  46

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.

Ages Eligible for Study:  40 Years   -   60 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

• Healthy individuals
• Insensate individuals

Exclusion Criteria:

• History or physical findings of any trunk, back or lower extremity orthopedic or neurologic abnormalities
• Inability to walk
• Inability to follow verbal directions

Wisconsin
      Medical College of Wisconsin Gait Lab, Milwaukee,  Wisconsin,  53226-0099,  United States

Study chairs or principal investigators

Jacqueline Wertsch, M.D.,  Principal Investigator,  Medical College of Wisconsin   

Study ID Numbers:  NICHD-0118; R01 HD31989
Record last reviewed:  March 2000
Last Updated:  October 13, 2004
Record first received:  November 3, 2000
ClinicalTrials.gov Identifier:  NCT00006438
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08