How Shoes With Rocker Soles Affect Walking - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

November 3, 2000

Last Updated Date

June 23, 2005

Start Date ^†

January 1997

Current Primary Outcome Measures ^†

Original Primary Outcome Measures ^†

Change History

Complete list of historical versions of study NCT00006438 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

How Shoes With Rocker Soles Affect Walking

Official Title ^†

Rocker Sole Kinetics and Kinematics

Brief 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.

Detailed 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.

Study Phase

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study

Condition ^†

Diabetic Feet

Intervention ^†

Device: Shoes with Rocker Soles

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

December 1999

Primary Completion Date

Eligibility 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

Gender

Both

Ages

40 Years to 60 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00006438

Responsible Party

Secondary IDs ^††

R01 HD31989

Study Sponsor ^†

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

Collaborators ^††

Investigators ^†

Principal Investigator:

Jacqueline Wertsch, M.D.

Medical College of Wisconsin

Information Provided By

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

Verification Date

March 2000

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.