How Shoes With Rocker Soles Affect Walking

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.

Completed

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Key information

Conditions

Diabetic Feet Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Mobility Limitation Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical College of Wisconsin Gait Lab

Milwaukee, Wisconsin, 53226-0099, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Shoes with Rocker Soles

Device

Sponsors and collaborators

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Nih

Registry information

Official study title

Rocker Sole Kinetics and Kinematics

Important dates

Study start: 1997
Study completion: 1999
First posted: Nov 6, 2000
Registry last updated: Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed