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

150 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the idea that Intensive Rehab vs Standard Care for Ankle Injury is an effective treatment?

The available research shows that Intensive Rehab, specifically the Foot Intensive Rehabilitation (FIRE) protocol, may be more effective than Standard Care for patients with chronic ankle instability. This is because Standard Care often doesn't address all the foot function issues that can arise with this condition, potentially limiting its effectiveness. The research suggests that by focusing more on these specific impairments, Intensive Rehab could lead to better outcomes for those suffering from chronic ankle instability. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Foot Intensive Rehabilitation (FIRE) for ankle injuries?

Research suggests that the Foot Intensive Rehabilitation (FIRE) protocol may be more effective than standard care for patients with chronic ankle instability, as it addresses foot function impairments that are often overlooked in standard rehabilitation. ^{1 2 3 4 5}

What safety data exists for intensive rehab vs standard care for ankle injury?

The provided research primarily focuses on supervised exercise therapy and high-intensity interval training for intermittent claudication and peripheral arterial disease, not specifically on ankle injuries. However, it suggests that supervised exercise programs, including high-intensity interval training, are generally safe, as no adverse events were reported in the studies. This implies that similar rehabilitation programs for ankle injuries might also be safe, but specific safety data for ankle injury rehabilitation is not directly addressed in the provided research. ^{6 7 8 9 10}

Is intensive rehabilitation safe for humans?

Research on intensive rehabilitation programs, particularly for conditions like peripheral arterial disease, suggests that they are generally safe for humans. Studies have shown that patients can safely tolerate high-intensity exercise programs without adverse events. ^{6 7 8 9 10}

Is the treatment Foot Intensive Rehabilitation (FIRE) a promising treatment for ankle injuries?

Yes, the Foot Intensive Rehabilitation (FIRE) treatment is promising for ankle injuries because it focuses on improving foot function, which is often not addressed in standard care. This approach could be more effective for people with chronic ankle instability. ^{2 3 11 12 13}

How is the FIRE treatment different from standard care for ankle injuries?

The FIRE treatment is unique because it specifically targets foot function impairments in patients with chronic ankle instability, which are often overlooked in standard care. This approach may enhance rehabilitation effectiveness by addressing these specific impairments. ^{2 3 11 12 13}

Research Team

Matthew Hoch, Ph.D.

Principal Investigator

University of Kentucky

Eligibility Criteria

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 am between 18 and 44 years old.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

High-energy foot and ankle trauma: principles for formulating an individualized care plan. [2022]

2. England 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. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Rehabilitation of foot and ankle injuries. [2005]

4. Germany 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. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Management of acute trauma. [2016]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Short interval or continuous training programs to improve walking distance for intermittent claudication: Pilot study. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Safety of supervised exercise therapy in patients with intermittent claudication. [2022]

8. Australia pubmed.ncbi.nlm.nih.gov

Intensive walking exercise for lower extremity peripheral arterial disease: A systematic review and meta-analysis. [2018]

9. England 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. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

High-intensity interval training for intermittent claudication in a vascular rehabilitation program. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Early Mobilization, Early Ambulation, and Burn Therapy in the Acute Hospital Setting. [2023]

12. Germany pubmed.ncbi.nlm.nih.gov

[Intermittent impulse compression. An alternative in therapy of post-traumatic and postoperative edema]. [2006]

13. Scotland 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. [2020]