How Shoes With Rocker Soles Affect Walking

Diabetic Feet Clinical Trial

Official title:

Rocker Sole Kinetics and Kinematics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006438
• Other study ID #: NICHD-0118
• Secondary ID: R01HD031989
• Status: Completed
• Phase: N/A
• First received: November 3, 2000
• Last updated: June 23, 2005
• Start date: January 1997
• Est. completion date: December 1999

Study information

• Verified date: March 2000
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: December 1999
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Feet
• Diabetic Foot

Intervention

Device:
• Shoes with Rocker Soles

Locations

Country	Name	City	State
United States	Medical College of Wisconsin Gait Lab	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

External Links

•   Click here for more information about the National Institute of Child Health and Human Development (NICHD).
•   Medical College of Wisconsin website