How Shoes With Rocker Soles Affect Walking

This study has been completed.
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00006438
First received: November 3, 2000
Last updated: June 23, 2005
Last verified: March 2000
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Rocker Sole Kinetics and Kinematics

Resource links provided by NLM:


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
Investigators
Principal Investigator: Jacqueline Wertsch, M.D. Medical College of Wisconsin
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00006438     History of Changes
Other Study ID Numbers: NICHD-0118, R01 HD31989
Study First Received: November 3, 2000
Last Updated: June 23, 2005
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:
Diabetic Foot
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies

ClinicalTrials.gov processed this record on April 14, 2014