How Shoes With Rocker Soles Affect Walking

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-01-31

Study Completion Date

1999-12-31

Brief Summary

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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

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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

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Diabetic Feet

Keywords

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Rocker sole Plantar pressure Diabetic feet Insensate feet gait analysis Pedorthics Gait abnormalities

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Shoes with Rocker Soles

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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Jacqueline Wertsch, M.D.

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Locations

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Medical College of Wisconsin Gait Lab

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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R01HD031989

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NICHD-0118

Identifier Type: -

Identifier Source: org_study_id