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.

Study Overview

• Status: Completed
• Conditions: Wounds and Injuries; Amputation, Traumatic; Traumatic Amputation of Lower Extremity
• Intervention / Treatment: Device: Otto Bock prosthesis; Device: Ossur prosthesis; Device: Freedom Innovations prosthesis

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Boulder, Colorado, United States, 80309
      • University of Colorado Boulder

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Running; Participants will run on an instrumented treadmill at one speed using three different prostheses.	Device: 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.; 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.; 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.
Experimental: Sprinting; Participants will run on an instrumented treadmill at a range of speeds from a jogging speed up to top speed.	Device: 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.; 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomechanics	The investigators will measure stance average vertical ground reaction forces during running and sprinting.	4-10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metabolic Demand	The investigators will measure rates of oxygen consumption and carbon dioxide production during running to determine the optimal prosthesis for each participant.	4 days
Top Speed	The investigators will measure the top sprinting speed to determine the optimal prosthesis for each participant.	4-10 days

Collaborators and Investigators

• Sponsor: VA Eastern Colorado Health Care System
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: Alena M Grabowski, PhD, VA Eastern Colorado Health Care System

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2013
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: December 12, 2014
• First Submitted That Met QC Criteria: December 12, 2014
• First Posted (Estimate): December 17, 2014

Study Record Updates

• Last Update Posted (Actual): July 30, 2019
• Last Update Submitted That Met QC Criteria: July 18, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Amputation, Traumatic
• Other Study ID Numbers: W81XWH-11-2-0222

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No