- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00006438
How Shoes With Rocker Soles Affect Walking
June 23, 2005 updated by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Rocker Sole Kinetics and Kinematics
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.
Study Overview
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 Type
Interventional
Enrollment
46
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Wisconsin
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Milwaukee, Wisconsin, United States, 53226-0099
- Medical College of Wisconsin Gait Lab
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
38 years to 58 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jacqueline Wertsch, M.D., Medical College Of Wisconsin
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 1997
Study Completion
December 1, 1999
Study Registration Dates
First Submitted
November 3, 2000
First Submitted That Met QC Criteria
November 3, 2000
First Posted (Estimate)
November 6, 2000
Study Record Updates
Last Update Posted (Estimate)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
March 1, 2000
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NICHD-0118
- R01HD031989 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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