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

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.

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.

Inclusion Criteria:

• Unilateral transtibial amputation
• Age 18-99 years old
• Body weight below 275 lbs
• Non-pregnant
• English speaking
• Current user of prosthesis for at least one year
• Wear time 8 hrs/day or more
• MFCL ≥ K-3
• Well-fitting and functioning prosthesis
• No use of ambulatory aide
• Able to tolerate testing protocol
• Able to walk on slopes
• Must, in the opinion of the investigator, be willing and able to complete all aspects of the study, adhere to the study visit schedule and comply with the assessments

Exclusion Criteria:

• Amputation level other than unilateral transtibial
• Age <18 or >99 years old
• Body weight above 275 lbs
• Pregnant
• Non-English speaking
• Not current user of prosthesis
• Less than one year use of prosthesis
• Wear time less than 8 hr/day
• MFCL <K3
• Poor fitting and functioning prosthesis
• Indicating that the socket fit is painful, or unacceptable
• Use of ambulatory aide
• Unable to tolerate testing protocol
• Unable to walk on slopes
• Presence or history of any condition that, in the view of the investigator, places the participant at high risk of poor treatment compliance or of not completing the study
• Any neurologic impairments known to cause gait and/or balance dysfunction