NCT02864693

Comparative Effectiveness of Microprocessor Controlled and Carbon Fiber Prosthetic Feet in Transtibial Amputees

Comparative Effectiveness of Microprocessor Controlled and Carbon Fiber Energy Storing and Returning Prosthetic Feet in Persons With Unilateral Transtibial Amputation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Ability Prosthetics and Orthotics, Inc. · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research is to evaluate benefits of a microprocessor controlled prosthetic ankle-foot device compared to a non-microprocessor controlled or passive carbon fiber prosthetic ankle-foot device.

Detailed description

Recent advancements in microprocessor controlled prosthetic ankle-foot systems have allowed additional functionality for the lower limb amputee, but research into the effectiveness of microprocessor controlled ankle-foot systems has been limited. In this research study, differences in perceived mobility, functional capabilities and gait parameters between energy storing and returning and microprocessor controlled ankle-foot mechanisms will be identified where they exist. Also a comparison of the initial function with a new system compared to the function after a four week accommodation period will provide insight into the time it takes for the prosthesis user to experience a benefit from a microprocessor ankle-foot.

Conditions

• Amputation

Interventions

Type	Name	Description
DEVICE	Kinnex	The Kinnex is a microprocessor controlled hydraulic ankle foot device (Freedom Innovations, Irvine, CA).
DEVICE	Pacifica LP	The Pacifica LP is a carbon-fiber ankle foot device (Freedom Innovations, Irvine, CA)

Timeline

• Start date: 2016-06-01
• Primary completion: 2017-08-01
• Completion: 2018-04-01
• First posted: 2016-08-12
• Last updated: 2018-07-10

Locations

3 sites across 1 country: United States