How Shoes With Rocker Soles Affect Walking
Primary Purpose
Diabetic Feet
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Shoes with Rocker Soles
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Feet focused on measuring Rocker sole, Plantar pressure, Diabetic feet, Insensate feet, gait analysis, Pedorthics, Gait abnormalities
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
Sites / Locations
- Medical College of Wisconsin Gait Lab
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00006438
First Posted
November 3, 2000
Last Updated
June 23, 2005
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT00006438
Brief Title
How Shoes With Rocker Soles Affect Walking
Official Title
Rocker Sole Kinetics and Kinematics
Study Type
Interventional
2. Study Status
Record Verification Date
March 2000
Overall Recruitment Status
Completed
Study Start Date
January 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 1999 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Feet
Keywords
Rocker sole, Plantar pressure, Diabetic feet, Insensate feet, gait analysis, Pedorthics, Gait abnormalities
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Shoes with Rocker Soles
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacqueline Wertsch, M.D.
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical College of Wisconsin Gait Lab
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226-0099
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mcw.edu
Description
Medical College of Wisconsin website
URL
http://www.nichd.nih.gov/
Description
Click here for more information about the National Institute of Child Health and Human Development (NICHD).
Learn more about this trial
How Shoes With Rocker Soles Affect Walking
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