How Shoes With Rocker Soles Affect Walking

This study has been completed.

First Received: November 3, 2000 Last Updated: June 23, 2005 History of Changes

Sponsor:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:	NCT00006438

Purpose

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	Intervention
Diabetic Feet	Device: Shoes with Rocker Soles

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
Official Title:	Rocker Sole Kinetics and Kinematics

Resource links provided by NLM:

MedlinePlus related topics: Diabetic Foot Foot Health

U.S. FDA Resources

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Estimated Enrollment:	46
Study Start Date:	January 1997
Estimated Study Completion Date:	December 1999

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.

Eligibility

Ages Eligible for Study:	40 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006438

Locations

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

Sponsors and Collaborators

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

Investigators

Principal Investigator:

Jacqueline Wertsch, M.D.

Medical College of Wisconsin

More Information

Additional Information:

Medical College of Wisconsin website This link exits the ClinicalTrials.gov site

Click here for more information about the National Institute of Child Health and Human Development (NICHD). This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	NICHD-0118, R01 HD31989
Study First Received:	November 3, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00006438 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Rocker sole
Plantar pressure
Diabetic feet
Insensate feet

gait analysis
Pedorthics
Gait abnormalities

Additional relevant MeSH terms:

Foot Ulcer
Diabetic Neuropathies
Skin Diseases
Diabetes Mellitus
Vascular Diseases
Endocrine System Diseases

Cardiovascular Diseases
Skin Ulcer
Diabetes Complications
Leg Ulcer
Diabetic Angiopathies
Diabetic Foot

ClinicalTrials.gov processed this record on November 05, 2009