What side effects are associated with this type of intervention?

Common treatments for ankle injuries, such as physical therapy, proprioceptive training, and strength exercises, are generally safe and effective in improving foot and ankle strength, stability, and proprioception. However, some patients may experience mild side effects such as temporary muscle soreness, fatigue, or discomfort during or after exercises. In rare cases, overexertion or improper technique can lead to strains or minor injuries. It is important to follow a structured program and consult with a healthcare professional to minimize risks.

What prior FDA approvals exist?

The FDA has approved various treatments for ankle injuries, primarily focusing on physical therapy and rehabilitation programs that enhance foot and ankle strength, stability, and proprioception. These treatments often include structured exercise regimens, balance training, and proprioceptive exercises. While specific drug approvals for ankle injury rehabilitation are limited, the emphasis remains on non-pharmacological interventions to promote recovery and prevent re-injury.

What other types of research exist?

Promising alternatives to the FIRE Program for ankle injury patients include: 1) Eccentric exercise programs, which have shown superior results in improving tendon health and strength. 2) Sensorimotor exercise programs, which enhance proprioception and mobility, as evidenced by their efficacy in diabetic patients with foot burns. 3) Multidisciplinary rehabilitation approaches, incorporating balance training, resistance training, and functional exercises, which have been effective in various musculoskeletal conditions. These alternatives can be discussed with a healthcare provider to tailor the best treatment plan.

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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

Must not have

History of neurological disease, vestibular or visual disturbance or any other pathology that would impair their sensorimotor performance.

Sustained an ankle sprain in the previous four weeks or lower extremity neuromusculoskeletal injury other than to the ankle in the last 12 months.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a foot-focused exercise program for people with chronic ankle instability. It aims to reduce repeated ankle injuries, improve physical function, and lessen feelings of disability by strengthening and improving foot function.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have any neurological, vestibular, or visual conditions affecting my movement or senses.

Select...

I have had an ankle sprain in the last 4 weeks or another leg injury in the past year.

Select...

I am currently in a program for ankle rehab.

Select...

I have had surgery on my leg.

Select...

I have had a broken bone in my leg.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Frequency of episodes of the ankle giving way

Number of recurrent ankle sprains

Severity of chronic ankle instability related symptoms

Secondary study objectives

Ankle/Toe Strength

Intrinsic Foot Muscle Activation

Plantar Cutaneous Sensation

+1 more

Other study objectives

Self-Reported Ankle Function

Self-Reported Disability

Self-Reported Fear Avoidance Beliefs

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 6Eligibility criteria met

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.