Not Yet RecruitingNot Applicable

Effect of a Microprocessor-controlled Prosthetic Knee Joint on K2 Level Ambulators

United States20 participantsStarted 2026-07-01

Plain-language summary

Microprocessor-controlled knees (MPKs) automatically adjust resistance or damping in the joint to improve swing- and/or stance-phase control as appropriate for the prosthesis user during gait. The purpose of this proposed investigation is to determine if there are substantial physical and psychological benefits to fitting lower functioning Veteran ambulators having transfemoral amputations with an MPK compared with a nonmicroprocessor-controlled knee (NMPK). Using a repeated-measures, cross-sectional experimental design, approximately 20 Veterans with unilateral, transfemoral amputations will be evaluated on two separate occasions at the Jesse Brown VA Medical Center or the Edward Hines, Jr. VA Hospital, first with their conventional NMPK and then again after a 2-month accommodation period with the College Park Icon MPK.

Who can participate

Age range

45 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Unilateral, transfemoral amputation (any etiology). * Age from 45-85 years. * Residual limb length classified as standard (i.e., medium) to long. * Prosthesis user for at least 1 year prior to enrolling in the study. * K2-level classification while using their NMPK. * Good sensation on their residual limb. * Good skin integrity upon visual inspection. * Presents with good socket fit based upon a standard assessment by the study prosthetist. Exclusion Criteria: * Bilateral leg amputations. * Individuals with a knee disarticulation.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Walking speed

Timeframe: To be measured before and immediately following the 2-month accommodation period of wearing the MPK.

Falls during walking

Timeframe: To be determined before and during the 2-month accommodation period of wearing the MPK

PLUS-M

Timeframe: To be measured before and immediately following the 2-month accommodation period of wearing the MPK.

Prosthetic Knee Preference

Timeframe: To be asked immediately following the 2-month accommodation period of wearing the MPK.

Trial details

NCT IDNCT07103798

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2028-05-01

Contact for this trial

Rebecca Stine, MS

(312) 503-5726 rebecca.stine@va.gov

View on ClinicalTrials.gov More Transfemoral Amputation trials

Plain-language summary

Who can participate

Age range

45 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Walking speed

Timeframe: To be measured before and immediately following the 2-month accommodation period of wearing the MPK.

Falls during walking

Timeframe: To be determined before and during the 2-month accommodation period of wearing the MPK

PLUS-M

Timeframe: To be measured before and immediately following the 2-month accommodation period of wearing the MPK.

Prosthetic Knee Preference

Timeframe: To be asked immediately following the 2-month accommodation period of wearing the MPK.