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How Shoes with Rocker Soles Affect Walking



How Shoes with Rocker Soles Affect Walking

For Condition: Diabetic Feet
Status: Completed
Sponsor(s): National Institute of Child Health and Human Development (NICHD) ,
Synopsis: 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.
Details: 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:
Study Type:
  Interventional, Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
Minimum Age/Maximum Age: 40 Years/60 Years
Genders: Both
Protocol Entry 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
Total Enrollment: 46

Location and Contact Information:

Overall Study Official:
JacquelineWertsch,  Principal Investigator,  Medical College of Wisconsin

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


Additional Information:
Study ID Numbers:
  NICHD-0118;  R01 HD31989
Study Start Date: January 1997
Record last reviewed: March 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006438

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