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

Wounds and Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02318979
• Other study ID #: W81XWH-11-2-0222
• Status: Completed
• Phase: N/A
• Start date: October 2013
• Est. completion date: January 2018

Study information

• Verified date: May 2019
• Source: VA Eastern Colorado Health Care System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Amputation, Traumatic
• Leg Injuries
• Traumatic Amputation of Lower Extremity
• Wounds and Injuries

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Colorado Boulder	Boulder	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
VA Eastern Colorado Health Care System	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomechanics	The investigators will measure stance average vertical ground reaction forces during running and sprinting.	4-10 days
Secondary	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
Secondary	Top Speed	The investigators will measure the top sprinting speed to determine the optimal prosthesis for each participant.	4-10 days