Not Yet RecruitingNot Applicable

Determining the Effects of Ischemic Conditioning and Neuromuscular Electrical Stimulation on Overall Function After Lower Limb Amputation

United States24 participantsStarted 2026-07-01

Plain-language summary

The goal of this clinical trial is to learn if ischemic conditioning and neuromuscular electrical stimulation improves muscle strength and walking behavior in those with limb loss. The main questions this trial aims to answer are: Does neuromuscular electrical stimulation improve muscle strength and gait behavior in people who have a leg amputation? Does neuromuscular electrical stimulation boost the effects of ischemic conditioning on muscle strength and gait behavior in people who have a leg amputation? Researchers will compare the effects of neuromuscular electrical stimulation to ischemic conditioning to see if there are any significant differences between the impacts of each intervention. Also, researchers will use both interventions together to see if the interventions can boost each other's positive impacts on walking and function in people with leg amputation. Participants will: * Do ischemic conditioning OR neuromuscular electrical stimulation OR both interventions at home every other day for 2 weeks * Visit the laboratory before and after completing interventions for the tests * Visit the laboratory one week after the post intervention visit for follow-up tests

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: * Older than 18 years old * History of unilateral transfemoral or transtibial amputation * Able to ambulate independently without the use of aids (i.e., walking cane) * Able to walk at least 6 minutes continuously without stopping. * Has a safe residuum with no open wounds on either the residual or intact limb * Has a prosthetic limb with materials that are sound and safe to withstand the mobility requirements of the study Exclusion Criteria: * Younger than 18 years old * Inability to give informed consent * Neurological disorder such as multiple sclerosis that affects gait * Currently pregnant (or intend to become pregnant while participating in study) * Blood clots in the leg, or any condition in which compression of the thigh or transient ischemia is contraindicated (e.g. open wounds in the leg) * History of uncontrolled hypertension * History of heart failure * Implanted electrical device such as a pacemaker or defibrillator * Head injury within the previous 6 months * Seizure disorder * History of thrombosis * History of sickle cell trait * History of genetic disease that impacts gait (e.g. cerebral palsy, muscular dystrophy).

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

Change from baseline in the self-selected gait speed (m/s) at week 3 and 4

Timeframe: From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation

Change from baseline in the hip's isometric muscle strength (N.m/kg) using a handheld dynamometer at the 3rd and 4th weeks.

Timeframe: From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation

Changes from baseline in gait kinematics (angle) through gait motion analysis at 3rd and 4th weeks

Timeframe: From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation

Changes from baseline in gait kinetics (N.m) through gait motion analysis at 3rd and 4th weeks

Timeframe: From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation

Trial details

NCT IDNCT07664995

SponsorUniversity of Illinois at Chicago

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-08-30

Contact for this trial

Nikou Nikoumanesh

857-919-4211 nniko@uic.edu

View on ClinicalTrials.gov More Lower Limb Amputation Above Knee trials