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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.
Previous history of at least 1 ankle sprain and at least 2 episodes of "giving way" in the past 3 months.
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 below
Select...
I am between 18 and 44 years old.
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I've sprained my ankle before and it has given way at least twice recently.

FIRE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

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 more
Other 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.

Find a Location

Who is running the clinical trial?

Matthew HochLead Sponsor
University of VirginiaOTHER
753 Previous Clinical Trials
1,244,890 Total Patients Enrolled
Naval Health Research CenterFED
18 Previous Clinical Trials
178,397 Total Patients Enrolled

Media Library

Foot Intensive Rehabilitation (FIRE) Clinical Trial Eligibility Overview. Trial Name: NCT04493645 — N/A
Ankle Injury Research Study Groups: Foot Intensive Rehabilitation (FIRE), Standard of Care (SOC)
Ankle Injury Clinical Trial 2023: Foot Intensive Rehabilitation (FIRE) Highlights & Side Effects. Trial Name: NCT04493645 — N/A
Foot Intensive Rehabilitation (FIRE) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04493645 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~57 spots leftby Oct 2025