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OpenTrials
Completed

NCT Number: NCT02318979

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

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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Key information

Conditions

Amputation, Traumatic Traumatic Amputation of Lower Extremity Wounds and Injuries

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Boulder

Boulder, Colorado, 80309, United States

Who can participate

Healthy volunteers accepted: Yes

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

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

Exclusion criteria

  • Cardiovascular, pulmonary, or neurological disease or disorder

Treatment and study plan

Otto Bock prosthesis

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

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

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.

Primary outcomes

  1. Biomechanics

    Time frame: 4-10 days

    The investigators will measure stance average vertical ground reaction forces during running and sprinting.

Secondary outcomes

  1. Metabolic Demand

    Time frame: 4 days

    The investigators will measure rates of oxygen consumption and carbon dioxide production during running to determine the optimal prosthesis for each participant.

  2. Top Speed

    Time frame: 4-10 days

    The investigators will measure the top sprinting speed to determine the optimal prosthesis for each participant.

Sponsors and collaborators

Lead sponsor

VA Eastern Colorado Health Care System

Fed

Collaborators

  • United States Department of Defense

Registry information

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Dec 17, 2014
Registry last updated
Jul 30, 2019

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.

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