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

Ability Prosthetics and Orthotics

Status: Completed

Conditions: Amputation

Treatments: Device: Kinnex; Device: Pacifica LP

Study type: Interventional

Funder types: Industry

Identifiers

NCT02864693

FI-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Configuration A (Kinnex)

Active Comparator group

Treatment:

Device: Kinnex

Configuration B (Pacifica LP)

Active Comparator group

Treatment:

Device: Pacifica LP