Intensive Rehab vs Standard Care for Ankle Injury (FIRE Trial)
Recruiting in Palo Alto (17 mi)
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.
12345What 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.
678910Is 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.
23111213Eligibility 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
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.
I have had an ankle sprain in the last 4 weeks or another leg injury in the past year.
I am currently in a program for ankle rehab.
I have had surgery on my leg.
I have had a broken bone in my leg.
Participant Groups
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.
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 Clinic Near You
Research locations nearbySelect from list below to view details:
University of KentuckyLexington, KY
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Who is running the clinical trial?
Matthew HochLead Sponsor
University of VirginiaCollaborator
Naval Health Research CenterCollaborator
Marine Corps Base Camp PendletonCollaborator
References
High-energy foot and ankle trauma: principles for formulating an individualized care plan. [2022]Care of the patient with high-energy foot and ankle trauma requires an individualized care plan. Staged treatment respecting the traumatized soft tissue envelope is often advisable. Wound care is a priority, and the vacuum-assisted closure dressing serves an integral role. Before definitive reconstruction, the surgeon needs to develop a treatment plan designed to match the unique personality of the patient and injury. Amputation is considered a rational treatment option for the patient with severe injury and poor host biology. Despite the most appropriate management, many severe foot and ankle injuries have a guarded prognosis.
Effects of foot intensive rehabilitation (FIRE) on clinical outcomes for patients with chronic ankle instability: a randomized controlled trial protocol. [2023]Lateral ankle sprains account for a large proportion of musculoskeletal injuries among civilians and military service members, with up to 40% of patients developing chronic ankle instability (CAI). Although foot function is compromised in patients with CAI, these impairments are not routinely addressed by current standard of care (SOC) rehabilitation protocols, potentially limiting their effectiveness. The purpose of this randomized controlled trial is to determine if a Foot Intensive REhabilitation (FIRE) protocol is more effective compared to SOC rehabilitation for patients with CAI.
Rehabilitation of foot and ankle injuries. [2005]Rehabilitation of foot and ankle injuries is essential for full functional recovery and prevention of chronic disease. Rehabilitation includes the usage of physical therapy modalities and rehabilitative exercise whose goals are the reduction of pain and edema and the increase of strength and proprioception. Physical therapy modalities may be classified as thermal, mechanical or electrical agents and include the use of ice, heat, ultrasound, phonophoresis, iontophoresis, intermittent compression, therapeutic massage and a variety of electrical currents. Rehabilitative exercises are primarily designed to increase flexibility, range of motion, strength, proprioception and sport-specific development prior to resumption of full activity. Proper rehabilitation of the lateral ankle (inversion) sprain is critical due to its frequency and potential for chronic pain and recurrence.
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]To investigate the clinical characteristics, treatment and long-term outcome of patients with acute Charcot feet (CF).
Management of acute trauma. [2016]Diagnosis and treatment of acute trauma to the foot and ankle present a continuing challenge to the foot specialist. Through the awareness and implementation of fundamental and rational management principles excellent results can be obtained. This presentation stresses the importance of (1) attaining hemostasis; (2) performing a detailed history and physical examination to elicit the mechanism and extent of the injury; (3) establishing a diagnosis with proper classification of the injury; and (4) instituting effective primary measures to minimize complications, restore normal function, and promote rapid healing.
Short interval or continuous training programs to improve walking distance for intermittent claudication: Pilot study. [2021]Supervised exercise training is part of first-line therapies for intermittent claudication. Short periods of intensive treadmill training have been found efficient; however, the optimal modalities remain to be determined, especially interval training with active recovery (ITAR). In this prospective assessor-blinded single-centre pilot study, we assessed the feasibility of a randomised controlled trial comparing parallel 4-week intensive rehabilitation programs comprising treadmill training performed as ITAR or conventional training with constant slope and speed interspersed with rest periods (CT).
Safety of supervised exercise therapy in patients with intermittent claudication. [2022]Supervised exercise therapy (SET) is recommended as the primary treatment for patients with intermittent claudication (IC). However, there is concern regarding the safety of performing SET because IC patients are at risk for untoward cardiovascular events. The Dutch physical therapy guideline advocates cardiac exercise testing before SET, if indicated. Perceived uncertainties concerning safety may contribute to the underuse of SET in daily practice. The objective of this review was to analyze the safety of supervised exercise training in patients with IC.
Intensive walking exercise for lower extremity peripheral arterial disease: A systematic review and meta-analysis. [2018]Supervised treadmill exercise is the recommended therapy for peripheral arterial disease (PAD) patients with intermittent claudication (IC). However, most PAD patients do not exhibit typical symptoms of IC. The aim of the present study was to explore the efficacy and safety of intensive walking exercise in PAD patients with and without IC.
Successful Implementation of the Exercise First Approach for Intermittent Claudication in the Netherlands is Associated with Few Lower Limb Revascularisations. [2021]A stepped care model, in which patients are primarily treated with supervised exercise therapy (SET), is recommended as the optimal strategy for intermittent claudication (IC). The aim of this study was to determine the primary treatment (SET, endovascular revascularisation [ER], or open surgery) in relation to secondary lower limb revascularisation and survival in patients with IC.
High-intensity interval training for intermittent claudication in a vascular rehabilitation program. [2019]This article reports an observational study investigating the safety and effectiveness of a high-intensity interval exercise program for patients with peripheral arterial disease. Patients were asked to walk on a treadmill to maximal claudication pain six times in each exercise session, with 3-minute rests in between. Once a patient could walk continuously for 6 minutes without reaching maximal pain, speed and/or grade was increased. To account for the changes in speed and grade, patients' walking ability was measured as a rehabilitation score, calculated as the product of the two. A total of 47 patients were included in the study. Results showed overall improvement in the rehabilitation score with participation in the program, and specifically showed that participation in more exercise sessions led to greater improvement. Moreover, no adverse events occurred in the study patients, suggesting patients with peripheral arterial disease can safely tolerate high-intensity exercise programs.
Early Mobilization, Early Ambulation, and Burn Therapy in the Acute Hospital Setting. [2023]Rehabilitation therapies in the burn acute care environment continue to evolve. Immediate access to therapy is considered standard, and therapy is a key component of the transprofessional care team. Early positioning, edema management, and therapy care in the intensive care unit (ICU) environment can limit later complications; mobility in the ICU can be engaged safely using a systems-based approach in the absence of nondirectable agitation. Later in the course of acute care, early ambulation is an appropriate intervention that can improve outcomes.
[Intermittent impulse compression. An alternative in therapy of post-traumatic and postoperative edema]. [2006]In patients with foot and ankle trauma, surgery and postoperative mobilization are often delayed because of swelling. The aim of this study was to assess if intermittent impulse compression of the foot is better than the standard therapy of applying cool packs at intervals. For intermittent impulse compression the AV impulse device was used (Novamedix Inc.). From May to November 1993, 40 patients (20 ankle fractures, 8 ruptured ligaments, 6 calcaneal fractures, 4 distal tibial fractures, 1 talus fracture, 1 subtalar dislocation) were prospectively assigned at random to the two groups and treated. After 24 h of treatment, the patients with intermittent impulse compression of the foot showed an average reduction of swelling of 47% around the ankle, midfoot and forefoot. With cryotherapy it was 17%. After 4 days of treatment in the postoperative course the swelling subsided at a rate of 74% with impulse compression and 45% with cryotherapy. Intermittent impulse compression of the foot proved to be a highly effective method of treating post-traumatic and postoperative edema. It seems preferable to the standard therapy using cold packs.
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]Ankle and foot sprains and fractures are common injuries affecting many individuals, often requiring considerable and costly medical interventions. The objectives of this systematic review are to collect, assess, and critically appraise the published literature on the health economics of ankle and foot injury (sprain and fracture) treatment.