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

Completed · Not applicable

Conditions studied: Amputation

In brief

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.

Key facts

Study ID

NCT02864693

Run by

Ability Prosthetics and Orthotics, Inc.

People needed

30

Starts

2016-06-01

Expected to finish

2018-04-01

Last updated by the study team

2018-07-10

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Ability Prosthetics and Orthotics, Inc. - Hagerstown, MD — Hagerstown, Maryland, United States
• Ability Prosthetics and Orthotics, Inc. - Charlotte, NC — Charlotte, North Carolina, United States
• Ability Prosthetics and Orthotics, Inc. - York, PA — York, Pennsylvania, United States

Full record on ClinicalTrials.gov

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