Ankle Instability Using Foot Intensive Rehabilitation
United States150 participantsStarted 2021-10-28
Plain-language summary
The overall objective of this study is to examine the effects of a 6-week foot-intensive rehabilitation (FIRE) program on lateral ankle sprain (LAS) re-injury rates, CAI symptoms, sensorimotor function, and self-reported disability in CAI patients.
Who can participate
Age range
18 Years – 44 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
. Aged 18-44.
. Previous history of at least 1 ankle sprain and at least 2 episodes of "giving way" in the past 3 months.
. Participants must answer "yes" to at least 5 questions on the Ankle Instability Instrument.
. Score of 11 or higher on the Identification of Functional Ankle Instability (IdFAI).
. Confirmed clinical presentation of CAI by a PT, AT, or MD.
Exclusion criteria
. Sustained an ankle sprain in the previous four weeks or lower extremity neuromusculoskeletal injury other than to the ankle in the last 12 months.
. History of surgery to the lower extremity.
. Sustained a lower extremity fracture.
. History of neurological disease, vestibular or visual disturbance or any other pathology that would impair their sensorimotor performance.
. Current participation in a formal ankle joint rehabilitation program.
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
1
Number of recurrent ankle sprains
Timeframe: 24 months
2
Frequency of episodes of the ankle giving way
Timeframe: 24 months
3
Severity of chronic ankle instability related symptoms
. Exhibit clinical examination characteristics of foot and ankle function which are consistent with conditions other than CAI (i.e. fracture, deformity).