Abstract
Background: 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. Methods: This study will use a three-site, single-blind, randomized controlled trial design with data collected over four data collection points (baseline and post-intervention with 6-, 12-, and 24-month follow-ups) to assess variables related to recurrent injury, sensorimotor function, and self-reported function. A total of 150 CAI patients (50 per site) will be randomly assigned to one of two rehabilitation groups (FIRE or SOC). Rehabilitation will consist of a 6-week intervention composed of supervised and home exercises. Patients assigned to SOC will complete exercises focused on ankle strengthening, balance training, and range of motion, while patients assigned to FIRE will complete a modified SOC program along with additional exercises focused on intrinsic foot muscle activation, dynamic foot stability, and plantar cutaneous stimulation. Discussion: The overall goal of this trial is to compare the effectiveness of a FIRE program versus a SOC program on near- and long-term functional outcomes in patients with CAI. We hypothesize the FIRE program will reduce the occurrence of future ankle sprains and ankle giving way episodes while creating clinically relevant improvements in sensorimotor function and self-reported disability beyond the SOC program alone. This study will also provide longitudinal outcome findings for both FIRE and SOC for up to two years. Enhancing the current SOC for CAI will improve the ability of rehabilitation to reduce subsequent ankle injuries, diminish CAI-related impairments, and improve patient-oriented measures of health, which are critical for the immediate and long-term health of civilians and service members with this condition. Trial Registration Clinicaltrials.gov Registry: NCT #NCT04493645 (7/29/20).
| Original language | English |
|---|---|
| Article number | 54 |
| Journal | BMC Sports Science, Medicine and Rehabilitation |
| Volume | 15 |
| Issue number | 1 |
| DOIs | |
| State | Published - Dec 2023 |
Bibliographical note
Funding Information:We thank the Department of Defense Congressionally Directed Medical Research Programs for funding our research. We also are greatly appreciative to the countless support and regulatory staff at the University of Kentucky, University of Virginia, and the US Naval Health Research Center for their assistance facilitating this work. We also thank Ke’La Porter for assistance with the development of the rehabilitation plan supplement.
Funding Information:
This clinical trial will employ a multisite, single-blinded parallel group randomized controlled trial design where patients will enroll at one of three sites: the University of Kentucky, the University of Virginia, or Naval Hospital Camp Pendleton (in partnership with the study teams at Naval Health Research Center). The framework of this design is to assess the superiority of the FIRE intervention in conjunction with SOC over SOC alone. This clinical trial was registered in the United States National Library of Medicine through ClinicalTrials.gov (NCT04493645). Table details the key information pertaining to the registered trial. Ethical approval was granted by the University of Kentucky Institutional Review Board (#58,500), with reliance agreements and ethical approvals granted from the University of Virginia and the Naval Health Research Center in compliance with the single IRB protocol. This protocol has also been reviewed and approved by the Human Research Protection Offices of the U.S. Army Medical Research and Development Command Office of Research Protections and the US Marine Corps. Informed consent will be obtained in writing from all patients prior to enrollment. This work was supported by the Congressionally Directed Medical Research Programs (820 Chandler St; Fort Detrick MD 21,702–5014; help@eBRAP.org; 301-682-5507), grant W81XWH-20-2-0035. Outside of the human research protection review, the funding sponsor does not have direct role in directing study design; collection, management, analysis, and interpretation of data; writing of the report; or the decision to submit the report for publication. The CONSORT Statement for Randomized Trials of Nonpharmacologic Treatments [], the template for intervention description and replication (TIDieR) [], and Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 [] were used to guide reporting.
Funding Information:
This work was supported by the Office of the Assistant Secretary of Defense for Health Affairs and the Defense Health Agency J9, Research and Development Directorate, or the U.S. Army Medical Research Acquisition Activity at the U.S. Army Medical Research and Development Command, in the amount of $2,498,983 through the Peer Reviewed Orthopaedic Research Program under Award No. W81XWH-20-2-0035. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the Department of Defense.
Funding Information:
We thank the Department of Defense Congressionally Directed Medical Research Programs for funding our research. We also are greatly appreciative to the countless support and regulatory staff at the University of Kentucky, University of Virginia, and the US Naval Health Research Center for their assistance facilitating this work. We also thank Ke’La Porter for assistance with the development of the rehabilitation plan supplement.
Publisher Copyright:
© 2023, The Author(s).
Keywords
- Ankle injury
- Muscle
- Plantar sensation
- Secondary prevention
- Therapeutics
ASJC Scopus subject areas
- Orthopedics and Sports Medicine
- Physical Therapy, Sports Therapy and Rehabilitation
- Rehabilitation