CompletedNot Applicable

No Power Bionic Lower Extremity Prosthesis

United States6 participantsStarted 2020-09-01

Plain-language summary

Typically people need separate prosthetic feet for running and walking. To bridge the gap, this study will test the Compliant Adaptive Energy Storage and Return (CAESAR) foot. This foot can change from a walk mode to a run mode with the push of a button. The investigators will test and improve this foot design mechanically, and then test this design on individuals with lower limb amputation in a lab setting. The goal of this project is to develop a passive prosthetic foot that can serve two purposes in someone's daily life: walking and running, to allow them to be more active.

Who can participate

Age range

18 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.

Patient Population: Inclusion Criteria: * At least 18 years old * Transtibial amputation of one or both legs * Classified as K3 or K4 on the Medicare Functional Classification Level * Use of a well-fitting prosthetic socket and prosthetic foot for at least 6 months * Able to walk and run without assistance Exclusion Criteria: * Significant injury to intact limb * History of balance impairments or neurologic disorders * Significant cardiovascular or respiratory disease

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

Peak Propulsive Ground Reaction Force on the Prosthetic Side During Walking

Timeframe: All conditions were complete during 3 lab visits, approximately four hours long

Participants Perceived Comfort When Using Different Prosthetic Feet During Walking

Timeframe: All conditions were complete during 3 lab visits, approximately four hours long

Peak Propulsive Ground Reaction Force on the Prosthetic Side During Running

Timeframe: All conditions were complete during 3 lab visits, approximately four hours long

Participants Perceived Comfort When Using Different Prosthetic Feet During Running

Timeframe: All conditions were complete during 3 lab visits, approximately four hours long

Trial details

NCT IDNCT04070105

SponsorUniversity of Michigan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-31

Results submitted2024-01-05

View on ClinicalTrials.gov More Amputation trials