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How Shoes With Rocker Soles Affect Walking

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00006438
First Posted: November 6, 2000
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  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
Intervention Model: Crossover Assignment
Masking: None (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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
ClinicalTrials.gov Identifier: NCT00006438     History of Changes
Other Study ID Numbers: NICHD-0118
R01HD031989 ( U.S. NIH Grant/Contract )
First Submitted: November 3, 2000
First Posted: November 6, 2000
Last Update Posted: December 9, 2005
Last Verified: March 2000

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