Clinical Trials Directory

Trials / Completed

CompletedNCT00006438

How Shoes With Rocker Soles Affect Walking

Rocker Sole Kinetics and Kinematics

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
46 (planned)
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · NIH
Sex
All
Age
40 Years – 60 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEShoes with Rocker Soles

Timeline

Start date
1997-01-01
Completion
1999-12-01
First posted
2000-11-06
Last updated
2005-06-24

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00006438. Inclusion in this directory is not an endorsement.