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Intensive Rehab vs Standard Care for Ankle Injury (FIRE Trial)
N/A
Recruiting
Led By Matthew Hoch, Ph.D.
Research Sponsored by Matthew Hoch
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aged 18-44.
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
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.
Who is the study for?
This trial is for people aged 18-44 who have had at least one ankle sprain and two instances of their ankle 'giving way' in the past three months. They must score positively on specific questionnaires assessing ankle instability, confirmed by a healthcare professional. Exclusions include recent concussions, lower extremity injuries or surgeries, current rehab participation, or other conditions affecting sensorimotor performance.Check my eligibility
What is being tested?
The study compares a 6-week Foot Intensive Rehabilitation (FIRE) program with Standard of Care Rehabilitation (SOC) to see which is better at preventing re-injury and reducing symptoms and disability from Chronic Ankle Instability (CAI). It also looks at how these treatments affect sensorimotor function in patients.See study design
What are the potential side effects?
While not explicitly stated, potential side effects may include increased pain or discomfort during exercises, temporary swelling or stiffness post-rehabilitation sessions, muscle fatigue, and risk of overuse if exercises are not performed correctly.
FIRE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 44 years old.
FIRE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Frequency of episodes of the ankle giving way
Number of recurrent ankle sprains
Severity of chronic ankle instability related symptoms
Secondary outcome measures
Ankle/Toe Strength
Intrinsic Foot Muscle Activation
Plantar Cutaneous Sensation
+1 moreOther outcome measures
Self-Reported Ankle Function
Self-Reported Disability
Self-Reported Fear Avoidance Beliefs
FIRE Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Foot Intensive Rehabilitation (FIRE)Experimental Treatment1 Intervention
Participants will be randomized to receive foot intensive rehabilitation (FIRE) for a period of 6 weeks.The investigators will prospectively follow participants assigned to the FIRE group for 24 months following completion of their assigned SOC intervention.
Group II: Standard of Care (SOC)Active Control1 Intervention
Participants will be randomized to receive standard of care rehabilitation (SOC) for a period of 6 weeks.The investigators will prospectively follow participants assigned to the SOC group for 24 months following completion of their assigned SOC intervention.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for ankle injuries, such as the Foot-Intensive Rehabilitation (FIRE) Program, work by enhancing foot and ankle strength, stability, and proprioception. These treatments involve targeted exercises that strengthen the muscles around the ankle, improve joint stability, and enhance proprioceptive feedback.
This is crucial for ankle injury patients as it helps prevent re-injury, reduces symptoms of chronic ankle instability (CAI), and improves overall functional performance, thereby promoting a quicker and more effective recovery.
Find a Location
Who is running the clinical trial?
Matthew HochLead Sponsor
University of VirginiaOTHER
759 Previous Clinical Trials
1,245,436 Total Patients Enrolled
Naval Health Research CenterFED
18 Previous Clinical Trials
175,176 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Foot Intensive Rehabilitation (FIRE)
- Group 2: Standard of Care (SOC)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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