Custom Molded Foot Orthoses Effect on Foot Kinematics and Lower Extremity Electromyography During Walking and Running.

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2010-04-30

Brief Summary

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The purpose of this study was to determine the effectiveness of two types of in-shoe custom made orthotics in altering the motion of the foot and muscle activity of select muscles of the lower leg in individuals experiencing lower extremity symptoms of a non traumatic origin. We hypothesized that orthotics would decrease the extent of motion of the during walking and running when compared to a barefoot condition. The investigators further hypothesized that orthotics would decrease the amount of muscle activity seen during walking and running when compared to barefoot walking.

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Detailed Description

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Conditions

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Lower Extremity Pain of a Mechanical Origin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Full Contact Orthosis

Group Type EXPERIMENTAL

Full Contact Orthosis

Intervention Type DEVICE

The Full Contact orthosis is constructed from a 5/32" blue polypropylene with posting material comprised of white polypropylene.

Maximal Arch Subtalar Stabilization

Maximal Arch Subtalar Stabilization Orthoses

Group Type EXPERIMENTAL

Maximal Arch Subtalar Stabilization

Intervention Type DEVICE

Custom made semi-rigid thermoplastic heel cup extending to the base of the metatarsals with a full foot length 3.0mm thick EVA and ultra-suede top cover

Interventions

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Maximal Arch Subtalar Stabilization

Custom made semi-rigid thermoplastic heel cup extending to the base of the metatarsals with a full foot length 3.0mm thick EVA and ultra-suede top cover

Intervention Type DEVICE

Full Contact Orthosis

The Full Contact orthosis is constructed from a 5/32" blue polypropylene with posting material comprised of white polypropylene.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subjects must have complaints of lower extremity or foot pain of a non-traumatic, mechanical origin.
* Subjects must have at least 60 degrees of frontal plane forefoot on rearfoot passive range of motion (as determined by a modified Gib test in the symptomatic lower extremity.
* Subjects must be able to walk independently on a treadmill at a speed of 4.8 kmh.
* Subjects must have been referred by a health care professional for an orthosis fitting.

Exclusion Criteria

* Subjects having less than 60 degrees of forefoot on rearfoot frontal plane passive range of motion.
* Subjects having a history of a fracture of the foot or ankle.
* Subjects having any previous illness, surgery or other characteristic (e.g., cardiovascular, musculoskeletal or neuromuscular problems) that would affect their lower extremity function or ability to walk independently.
* Subjects having knee, lower leg or foot pain of a non-mechanical nature.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes