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How Shoes With Rocker Soles Affect Walking

United States Department of Health and Human Services (HHS) logo

United States Department of Health and Human Services (HHS)

Status

Completed

Conditions

Diabetic Feet

Treatments

Device: Shoes with Rocker Soles

Study type

Interventional

Funder types

NIH

Identifiers

NCT00006438
NICHD-0118
R01HD031989 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

40 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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