CompletedNot Applicable

Functional Electrical Stimulation Use in Trans-tibial Amputations

United States20 participantsStarted 2015-09

Plain-language summary

The purpose of this study is to demonstrate the efficacy of functional electrical stimulation (FES) for trans-tibial amputees. The investigators aim to demonstrate that providing three months of FES intervention will increase knee extension strength, increase volume of the residual limb and decrease chronic and phantom pain.

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: * Men and women over 18 years of age. * Participants have a unilateral trans-tibial amputation with a minimum of a 4" residual limb. This length of amputation was chosen to provide for adequate surface area for the electrodes. * Participants must be a minimum of two years postoperative to insure proper healing of the limb has occurred. * Participants have chronic limb pain. * No prior experience in using TENS or FES. Exclusion Criteria: * No cardiac conditions, such as hypertension, congestive heart failure, or a pacemaker. * People with severe diabetes who have insensate skin and or neuropathy.

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 in Knee Extension Isometric Strength (Peak Torque) Using the Biodex Measurement System

Timeframe: baseline and 12 weeks

Change in Residual Limb Volume Using 3-D Scanner

Timeframe: baseline and 12 weeks

Change in Residual Limb Pain Using Likert Scale Pain Questionnaire

Timeframe: baseline and 12 weeks

Trial details

NCT IDNCT02931396

SponsorAlicia Koontz

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-02-03

Results submitted2019-01-30

View on ClinicalTrials.gov More Traumatic Amputation of Lower Extremity trials

Plain-language summary

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.

What they're measuring

Change in Knee Extension Isometric Strength (Peak Torque) Using the Biodex Measurement System

Timeframe: baseline and 12 weeks

Change in Residual Limb Volume Using 3-D Scanner

Timeframe: baseline and 12 weeks

Change in Residual Limb Pain Using Likert Scale Pain Questionnaire

Timeframe: baseline and 12 weeks