Intensive Rehab vs Standard Care for Ankle Injury

(FIRE Trial)

Overseen By Matthew Hoch, Ph.D.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Matthew Hoch

Disqualifiers: Recent sprain, Surgery, Fracture, Neurological, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates whether a specialized 6-week rehab program called FIRE (Foot Intensive Rehabilitation) benefits individuals with chronic ankle instability (CAI) more than standard rehab care. It aims to reduce re-injury rates, improve balance and movement, and lessen feelings of disability. Participants will receive either the FIRE treatment or regular rehab to determine which is more effective over time. This trial suits individuals who have experienced an ankle sprain and often feel their ankle "gives way." As an unphased trial, it provides a unique opportunity to explore new rehabilitation methods that could enhance the recovery experience.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Foot Intensive Rehabilitation (FIRE) is generally easy for patients to handle. Similar studies have demonstrated good results without major side effects. Participants in these studies reported improved ankle stability and function, with no serious safety issues. This suggests that the treatment is safe, as no major side effects have been found so far. For those considering joining a trial with FIRE, current information indicates it is a safe choice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Foot Intensive Rehabilitation (FIRE) is unique because it offers a specialized and intensive approach to recovering from an ankle injury. Unlike standard rehabilitation methods, which typically involve more generalized exercises, FIRE focuses specifically on strengthening and restoring function to the foot and ankle through targeted, intensive exercises. Researchers are excited about FIRE because it might lead to faster and more complete recovery, potentially improving long-term outcomes by significantly reducing the risk of re-injury. This innovative approach has the potential to enhance rehabilitation by providing a more personalized and concentrated treatment plan.

What evidence suggests that this trial's treatments could be effective for ankle injury?

Research has shown that the Foot Intensive Rehabilitation (FIRE) program, which participants in this trial may receive, works well for people with chronic ankle instability (CAI). Studies have found that FIRE can stabilize ankles and reduce the likelihood of them "giving way." Participants in earlier studies experienced fewer ankle sprains after completing the FIRE program. This program uses focused foot exercises to strengthen the ankle and improve balance. Overall, promising evidence suggests that FIRE can lead to significant improvements for those with ankle problems. ^{1 2 4 5 6}

Who Is on the Research Team?

Matthew Hoch, Ph.D.

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Confirmed clinical presentation of CAI by a PT, AT, or MD.

You need to answer "yes" to at least 5 questions on the Ankle Instability Instrument.

I've sprained my ankle before and it has given way at least twice recently.

Exclusion 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.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either foot intensive rehabilitation (FIRE) or standard of care (SOC) rehabilitation for a period of 6 weeks

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with a focus on chronic ankle instability symptoms, postural control, plantar cutaneous sensation, and other outcomes

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Foot Intensive Rehabilitation (FIRE)
• Standard of Care Rehabilitation (SOC)

Trial Overview 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.

How Is the Trial Designed?

Group I: Foot Intensive Rehabilitation (FIRE) Experimental Treatment 1 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 Control 1 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.

Who Is Running the Clinical Trial?

Matthew Hoch

Lead Sponsor

Trials

1

Recruited

150+

University of Virginia

Collaborator

Trials

802

Recruited

1,342,000+

Naval Health Research Center

Collaborator

Trials

21

Recruited

177,000+

Marine Corps Base Camp Pendleton

Collaborator

Trials

4

Recruited

4,500+

Published Research Related to This Trial

Intensive walking exercise significantly improves walking ability in patients with peripheral arterial disease (PAD), enhancing metrics like maximal walking distance and pain-free walking distance compared to usual care, based on a systematic review of 18 trials involving 1200 patients.

The presence of diabetes may reduce the effectiveness of intensive walking exercise in improving walking performance for PAD patients, but overall, the exercise showed no significant increase in adverse events compared to usual care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensive walking exercise for lower extremity peripheral arterial disease: A systematic review and meta-analysis. Lyu, X., Li, S., Peng, S., et al.[2018]

Supervised exercise therapy (SET) for patients with intermittent claudication (IC) is very safe, with only eight adverse events reported over 82,725 hours of training, resulting in a complication rate of just one event per 10,340 patient-hours.

The study suggests that routine cardiac screening before starting SET is unnecessary, which may encourage more healthcare providers to recommend this effective treatment for IC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of supervised exercise therapy in patients with intermittent claudication. Gommans, LN., Fokkenrood, HJ., van Dalen, HC., et al.[2022]

In a study of 54,504 patients with intermittent claudication, those treated primarily with supervised exercise therapy (SET) had significantly better outcomes, including fewer secondary lower limb revascularisations and improved five-year survival rates compared to those who underwent endovascular revascularisation (ER) or open surgery.

The use of SET as the primary treatment increased from 63% in 2013 to 87% in 2017, indicating a positive trend towards guideline adherence in managing intermittent claudication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful Implementation of the Exercise First Approach for Intermittent Claudication in the Netherlands is Associated with Few Lower Limb Revascularisations. Jansen, SCP., van Nistelrooij, LPJ., Scheltinga, MRM., et al.[2021]

A 4-week intensive rehabilitation program using either interval training with active recovery (ITAR) or conventional training (CT) for patients with intermittent claudication showed high adherence and excellent tolerance, with no adverse events reported.

Both training methods significantly improved maximum walking distance on a graded treadmill, achieving similar results, which suggests that shorter, intensive training programs can be as effective as longer conventional ones.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short interval or continuous training programs to improve walking distance for intermittent claudication: Pilot study. Villemur, B., Thoreau, V., Guinot, M., et al.[2021]

In a study of 40 patients with various foot and ankle injuries, intermittent impulse compression significantly reduced swelling by 47% after 24 hours, compared to only 17% reduction with standard cool pack therapy.

After 4 days of treatment, swelling reduction was 74% with impulse compression versus 45% with cryotherapy, indicating that intermittent impulse compression is a more effective method for managing post-traumatic and postoperative edema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Intermittent impulse compression. An alternative in therapy of post-traumatic and postoperative edema]. Stöckle, U., Hoffmann, R., Raschke, M., et al.[2006]

Individualized care plans are crucial for patients with high-energy foot and ankle trauma, emphasizing the importance of tailored treatment strategies that consider both the patient's needs and the specifics of their injury.

Vacuum-assisted closure dressings play a vital role in wound care, and in cases of severe injury with poor healing potential, amputation may be a reasonable option, although the overall prognosis for severe injuries remains uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-energy foot and ankle trauma: principles for formulating an individualized care plan. Tarkin, IS., Sop, A., Pape, HC.[2022]

The study analyzed 164 patients with acute Charcot feet, revealing that those with type 2 diabetes were typically older, heavier, and had a longer duration of diabetes compared to type 1 diabetes patients, who were younger and had a normal BMI.

Major complications from Charcot feet, such as rocker bottom deformities and foot ulcerations, were common, with diabetic nephropathy identified as a potential risk factor for these complications, highlighting the need for increased awareness and management strategies for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetic nephropathy but not HbA1c is predictive for frequent complications of Charcot feet - long-term follow-up of 164 consecutive patients with 195 acute Charcot feet. Sämann, A., Pofahl, S., Lehmann, T., et al.[2022]

Effective management of acute foot and ankle trauma relies on achieving hemostasis and conducting a thorough history and physical examination to understand the injury's mechanism and extent.

Proper classification of the injury is crucial for establishing an accurate diagnosis, which helps in implementing primary measures that minimize complications and promote faster healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of acute trauma. Tepelidis, NT., Karstetter, K.[2016]

In a study of 47 patients with peripheral arterial disease, a high-intensity interval exercise program led to significant improvements in walking ability, as measured by a rehabilitation score.

The program was safe, with no adverse events reported, indicating that patients with peripheral arterial disease can tolerate high-intensity exercise without risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-intensity interval training for intermittent claudication in a vascular rehabilitation program. Adams, J., Ogola, G., Stafford, P., et al.[2019]

This randomized controlled trial will assess the effectiveness of a new Foot Intensive REhabilitation (FIRE) protocol compared to standard of care (SOC) rehabilitation in 150 patients with chronic ankle instability (CAI) over a 6-week intervention and follow-ups for up to 24 months.

The FIRE protocol includes additional exercises targeting intrinsic foot muscle activation and dynamic foot stability, which are hypothesized to lead to better functional outcomes, reduced recurrence of ankle sprains, and improved sensorimotor function compared to the traditional SOC approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of foot intensive rehabilitation (FIRE) on clinical outcomes for patients with chronic ankle instability: a randomized controlled trial protocol. Hoch, MC., Hertel, J., Gribble, PA., et al.[2023]

Effective rehabilitation of foot and ankle injuries is crucial for full recovery and preventing chronic issues, involving both physical therapy modalities and rehabilitative exercises.

Rehabilitation strategies, including the use of thermal, mechanical, and electrical agents, aim to reduce pain and swelling while enhancing strength and proprioception, particularly for common injuries like lateral ankle sprains.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rehabilitation of foot and ankle injuries. Losito, JM., O'Neil, J.[2005]

Immediate access to rehabilitation therapy in the burn acute care environment is essential, as it helps prevent complications through early positioning and edema management.

Engaging in mobility and early ambulation in the ICU can significantly improve patient outcomes, demonstrating the importance of a systems-based approach to therapy during recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Mobilization, Early Ambulation, and Burn Therapy in the Acute Hospital Setting. O'Neil, A., Hines, D., Wirdzek, E., et al.[2023]

This systematic review analyzed 32 studies on the health economics of treating ankle and foot sprains and fractures, highlighting that many studies lack comprehensive economic data and transparency in methodology.

The review emphasizes the need for future research to improve reporting standards in economic evaluations to enhance the quality of information available for healthcare decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The health economics of ankle and foot sprains and fractures: A systematic review of English-language published papers. Part 1: Overview and critical appraisal. Bielska, IA., Wang, X., Lee, R., et al.[2020]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37032355/

Effects of foot intensive rehabilitation (FIRE) on clinical ... We hypothesize the FIRE program will reduce the occurrence of future ankle sprains and ankle giving way episodes while creating clinically ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04493645

Ankle Instability Using Foot Intensive Rehabilitation Effects of foot intensive rehabilitation (FIRE) on clinical outcomes for patients with chronic ankle instability: a randomized controlled trial protocol.

3. scholars.uky.edu scholars.uky.edu/en/publications/effects-of-foot-intensive-rehabilitation-fire-on-clinical-outcome/

Effects of foot intensive rehabilitation (FIRE) on clinical ... We hypothesize the FIRE program will reduce the occurrence of future ankle sprains and ankle giving way episodes while creating clinically relevant improvements ...

4. researchgate.net researchgate.net/publication/377585282_Effectiveness_of_Foot_Intensive_Exercise_Training_for_Subjects_with_Chronic_Ankle_Sprain_Experimental_Study

(PDF) Effectiveness of Foot Intensive Exercise Training for ... Foot Intensive Exercise is effective and increases functional ankle stability and decreases episodes of giving away in subjects with chronic ankle sprain.

5. trialx.com trialx.com/clinical-trials/listings/242502/effects-of-smart-vs-fire-training-in-chronic-ankle-instability/

Effects of SMART VS FIRE Training in Chronic Ankle ... Seventy-four percent of patients with an acute ankle sprain suffered from residual symptoms lasting 29 months after the initial ankle sprain, ...

6. researchgate.net researchgate.net/publication/369910929_Effects_of_foot_intensive_rehabilitation_FIRE_on_clinical_outcomes_for_patients_with_chronic_ankle_instability_a_randomized_controlled_trial_protocol

Effects of foot intensive rehabilitation (FIRE) on clinical ... We hypothesize the FIRE program will reduce the occurrence of future ankle sprains and ankle giving way episodes while creating clinically ...