Intensive Rehab vs Standard Care for Ankle Injury

(FIRE Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Matthew Hoch, Ph.D.

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Matthew Hoch

No Placebo Group

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.

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 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 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}

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.

Treatment Details

Interventions

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

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+

James E. Ryan

University of Virginia

Chief Executive Officer since 2018

J.D. from Harvard Law School

Nikki Hastings

University of Virginia

Chief Medical Officer since 2018

Ph.D. in Biomedical Engineering from University of Virginia

Naval Health Research Center

Collaborator

Trials

21

Recruited

177,000+

Marine Corps Base Camp Pendleton

Collaborator

Trials

4

Recruited

4,500+

Findings from Research

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]

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]