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

VA Eastern Colorado Health Care System

Status: Completed

Conditions: Amputation, Traumatic; Wounds and Injuries; Traumatic Amputation of Lower Extremity

Treatments: Device: Ossur prosthesis; Device: Freedom Innovations prosthesis; Device: Otto Bock prosthesis

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02318979

W81XWH-11-2-0222

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Running

Experimental group

Description:

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

Treatment:

Device: Otto Bock prosthesis

Device: Ossur prosthesis

Device: Freedom Innovations prosthesis

Sprinting

Experimental group

Description:

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

Treatment:

Device: Otto Bock prosthesis

Device: Ossur prosthesis

Device: Freedom Innovations prosthesis