RecruitingNot Applicable

Prosthetic Performance Enhancement Trial

United States35 participantsStarted 2025-06-26

Plain-language summary

The purpose of this research is to determine the feasibility of an uneven terrain walking program for lower limb prosthesis users. The training is designed to induce step-to-step variability during walking within a safe environment, with the aim of improving walking skill and confidence.

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.

Inclusion Criteria: * lower limb amputation at ankle (Symes) level and above * age 18+ years * fitted with a walking prosthesis and use it regularly for home and/or community ambulation * good socket fit, assessed by a score of 8-10 on the socket fit comfort scale * able to walk for three minutes at a time with or without an assistive device Exclusion Criteria: * leg/foot ulcer or other conditions that cause pain during weight-bearing * poor skin integrity that could cause tissue breakdown by walking * cardiovascular, respiratory or other critical health conditions that preclude moderate physical activity * unilateral or bilateral upper limb absence or loss at the wrist and above that precludes use of handrails bilaterally, or would require asymmetrical adaptation to body posture for use. * pregnancy

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

Session adherence

Timeframe: Through study completion, over 4 weeks

Trial details

NCT IDNCT06419920

SponsorUniversity of Nevada, Las Vegas

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-07

Contact for this trial

Jenny A Kent, PhD, CSci

7028955949 jenny.kent@unlv.edu

View on ClinicalTrials.gov More Amputation trials

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.