What is the Optimal Stiffness and Height of a Running-specific Prosthesis?

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2018-01-31

Brief Summary

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The proposed study aims to characterize the effects of running-specific leg prosthetic stiffness and height during on performance during running and sprinting to optimize running-specific prosthesis prescription. The investigators will collect biomechanical and metabolic data from participants with unilateral and bilateral below the knee amputations while they run at different speeds on a treadmill. This data will be used to understand the effects of running prostheses. Then, these parameters will be used to develop prosthetic prescription techniques for people with below the knee amputations.

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Detailed Description

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Conditions

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Amputation, Traumatic Traumatic Amputation of Lower Extremity Wounds and Injuries

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

10 athletes with a unilateral and 5 athletes with bilateral transtibial amputations used 15 different running-specific prosthetic configurations while they ran at one speed and we measured metabolic rates and biomechanics. 10 athletes with a unilateral and 5 athletes with bilateral transtibial amputations used 15 different running-specific prosthetic configurations while they ran at multiple speeds and we measured top speeds and biomechanics.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Running

Participants will run on an instrumented treadmill at one speed using three different prostheses.

Group Type EXPERIMENTAL

Otto Bock prosthesis

Intervention Type DEVICE

Participants will run using the Otto Bock prosthesis at a recommended stiffness and height, one category stiffer than recommended at the recommended height, one category softter than recommended at the recommended height, at the optimal stiffness and 2 cm taller, and at the optimal stiffness and 2 cm shorter.

Ossur prosthesis

Intervention Type DEVICE

Participants will run using the Ossur prosthesis at a recommended stiffness and height, one category stiffer than recommended at the recommended height, one category softter than recommended at the recommended height, at the optimal stiffness and 2 cm taller, and at the optimal stiffness and 2 cm shorter.

Freedom Innovations prosthesis

Intervention Type DEVICE

Participants will run using the Freedom Innovations prosthesis at a recommended stiffness and height, one category stiffer than recommended at the recommended height, one category softter than recommended at the recommended height, at the optimal stiffness and 2 cm taller, and at the optimal stiffness and 2 cm shorter.

Sprinting

Participants will run on an instrumented treadmill at a range of speeds from a jogging speed up to top speed.

Group Type EXPERIMENTAL

Otto Bock prosthesis

Intervention Type DEVICE

Participants will run using the Otto Bock prosthesis at a recommended stiffness and height, one category stiffer than recommended at the recommended height, one category softter than recommended at the recommended height, at the optimal stiffness and 2 cm taller, and at the optimal stiffness and 2 cm shorter.

Ossur prosthesis

Intervention Type DEVICE

Participants will run using the Ossur prosthesis at a recommended stiffness and height, one category stiffer than recommended at the recommended height, one category softter than recommended at the recommended height, at the optimal stiffness and 2 cm taller, and at the optimal stiffness and 2 cm shorter.

Freedom Innovations prosthesis

Intervention Type DEVICE

Participants will run using the Freedom Innovations prosthesis at a recommended stiffness and height, one category stiffer than recommended at the recommended height, one category softter than recommended at the recommended height, at the optimal stiffness and 2 cm taller, and at the optimal stiffness and 2 cm shorter.

Interventions

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Otto Bock prosthesis

Participants will run using the Otto Bock prosthesis at a recommended stiffness and height, one category stiffer than recommended at the recommended height, one category softter than recommended at the recommended height, at the optimal stiffness and 2 cm taller, and at the optimal stiffness and 2 cm shorter.

Intervention Type DEVICE

Ossur prosthesis

Participants will run using the Ossur prosthesis at a recommended stiffness and height, one category stiffer than recommended at the recommended height, one category softter than recommended at the recommended height, at the optimal stiffness and 2 cm taller, and at the optimal stiffness and 2 cm shorter.

Intervention Type DEVICE

Freedom Innovations prosthesis

Participants will run using the Freedom Innovations prosthesis at a recommended stiffness and height, one category stiffer than recommended at the recommended height, one category softter than recommended at the recommended height, at the optimal stiffness and 2 cm taller, and at the optimal stiffness and 2 cm shorter.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* bilateral or unilateral transtibial amputation
* at least one year of running experience using running-specific prostheses
* 18-55 years old
* no current problems with their prosthesis or residual limb
* at a K4 Medicare Functional Classification Level