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

Not Applicable

Completed

• Conditions: Wounds and Injuries; Amputation, Traumatic; Traumatic Amputation of Lower Extremity
• Interventions: Device: Otto Bock prosthesis; Device: Ossur prosthesis; Device: Freedom Innovations prosthesis

• Registration Number: NCT02318979
• Lead Sponsor: VA Eastern Colorado Health Care System

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-12-12
• Study First Submitted QC: 2014-12-12
• Study First Posted: 2014-12-17
• Primary Completion: 2018-01
• Study Completion: 2018-01
• Status Verified: 2019-05
• Results First Submitted: 2019-05-20
• Results First Submitted QC: 2019-06-25
• Results First Posted: 2019-07-16
• Last Update Submitted: 2019-07-18
• Last Update Posted: 2019-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sprinting	Freedom Innovations prosthesis	Participants will run on an instrumented treadmill at a range of speeds from a jogging speed up to top speed.
Running	Otto Bock prosthesis	Participants will run on an instrumented treadmill at one speed using three different prostheses.
Running	Ossur prosthesis	Participants will run on an instrumented treadmill at one speed using three different prostheses.
Running	Freedom Innovations prosthesis	Participants will run on an instrumented treadmill at one speed using three different prostheses.
Sprinting	Otto Bock prosthesis	Participants will run on an instrumented treadmill at a range of speeds from a jogging speed up to top speed.
Sprinting	Ossur prosthesis	Participants will run on an instrumented treadmill at a range of speeds from a jogging speed up to top speed.

Primary Outcome Measures

Name	Time	Method
Biomechanics	4-10 days	The investigators will measure stance average vertical ground reaction forces during running and sprinting.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Colorado Boulder; 🇺🇸 Boulder, Colorado, United States