CompletedNot Applicable

Evaluation of the Effect of an Ankle Foot Orthoses for Ambulatory Function

United States20 participantsStarted 2007-08

Plain-language summary

The main purpose of this investigation is to evaluate the effect of a lower leg brace on walking efficiency and community walking in people who have weakness in one side of the body caused after a stroke. The evaluation will consist of several tests that will evaluate movement, tightness, balance and sensation in affected leg.

Who can participate

Age range

18 Years – 75 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: * Between the ages of 18 and 75 * Have sustained a stroke at least 6 months prior to study enrollment * Use a prescribed custom brace while walking * Have no history of injury, orthopedic or other medical problem in the normal leg * Be able to walk independently or with close supervision for 25 feet without a brace or cane * Wear shoes sizes 5 1/2 - 11 US womens or size 6-13 US mens Exclusion Criteria: * Orthopedic problems or history that will interfere with walking or limit the range of motion of legs * Neurological illness, history, or conditions that my interfere with walking except for stroke * Psychiatric conditions or history that would interfere with the ability to walk or follow directions * Serious lung or heart condition that could severely limit the ability to walk

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.

Trial details

NCT IDNCT01336517

SponsorKessler Foundation

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2008-12

View on ClinicalTrials.gov More Hemiplegia, Spastic trials