Viewing Study NCT00006438



Ignite Creation Date: 2024-05-05 @ 10:01 AM
Last Modification Date: 2024-10-26 @ 9:05 AM
Study NCT ID: NCT00006438
Status: COMPLETED
Last Update Posted: 2005-06-24
First Post: 2000-11-03

Brief Title: How Shoes With Rocker Soles Affect Walking
Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization: Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD

Study Overview

Official Title: Rocker Sole Kinetics and Kinematics
Status: COMPLETED
Status Verified Date: 2000-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
R01HD031989 NIH None httpsreporternihgovquickSearchR01HD031989