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Intensive Rehab vs Standard Care for Ankle Injury (FIRE Trial)
FIRE Trial Summary
This trial looks at whether a 6-week rehabilitation program can help people with ankle injuries and improve symptoms, function, and self-reported disability.
FIRE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowFIRE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.FIRE Trial Design
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Who is running the clinical trial?
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- I do not have any neurological, vestibular, or visual conditions affecting my movement or senses.My foot and ankle issues are not due to chronic ankle instability but may be due to other conditions like fractures.You need to answer "yes" to at least 5 questions on the Ankle Instability Instrument.I have had an ankle sprain in the last 4 weeks or another leg injury in the past year.I am currently in a program for ankle rehab.I am between 18 and 44 years old.I've sprained my ankle before and it has given way at least twice recently.You have experienced a head injury within the past year that caused a concussion.I have had surgery on my leg.I have had a broken bone in my leg.You have a score of 11 or higher on a test that shows you have weak ankles that are prone to injury.
- Group 1: Foot Intensive Rehabilitation (FIRE)
- Group 2: Standard of Care (SOC)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the maximum occupancy of this research trial?
"Indeed. According to clinicaltrials.gov, this research study is still recruiting patients as of January 3rd 2022 - the date it was last modified after being published on October 28th 2021. A total of 150 individuals are needed for participation at a single site."
What primary goals are researchers attempting to achieve through this experiment?
"The aim of this two-year study is to measure the frequency in which a patient's ankle gives out. Secondary objectives include measuring patients' plantar cutaneous sensation with a 20 piece Semmes Weinstein Monofilament Kit, assessing intrinsic foot muscle activation through diagnostic ultrasound and Image J software, as well as determining strength surrounding the ankle and toes using digital handheld dynamometers."
Is this research endeavor currently accepting new participants?
"As per the information hosted on clinicaltrials.gov, this medical study is still accepting participants. The experiment was first posted on October 28th 2021 and has had a recent revision on January 3rd 2022."
Does this experiment offer enrollment to elderly individuals?
"As stated in the criteria for inclusion, participants must be between 18 and 44 years old to qualify."
What are the eligibility requirements for participation in this research trial?
"The trial is seeking 150 individuals aged 18-44 with ankle sprains who have a score of 11 or more on the Identification of Functional Ankle Instability (IdFAI), at least one previous sprain, two episodes of "giving way" in the last three months, and five affirmative responses to questions from the Ankle Instability Instrument."
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