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Ankle Instability Using Foot Intensive Rehabilitation (FIRE)

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ClinicalTrials.gov Identifier: NCT04493645
Recruitment Status : Recruiting
First Posted : July 30, 2020
Last Update Posted : January 4, 2022
Sponsor:
Collaborators:
University of Virginia
Naval Health Research Center
Marine Corps Base Camp Pendleton
Information provided by (Responsible Party):
Matthew Hoch, University of Kentucky

Brief Summary:
The overall objective of this study is to examine the effects of a 6-week foot-intensive rehabilitation (FIRE) program on lateral ankle sprain (LAS) re-injury rates, CAI symptoms, sensorimotor function, and self-reported disability in CAI patients.

Condition or disease Intervention/treatment Phase
Ankle Injuries Ankle Sprains Behavioral: Standard of Care Rehabilitation (SOC) Behavioral: Foot Intensive Rehabilitation (FIRE) Not Applicable

Detailed Description:
Lateral ankle sprains are one of the most common injuries sustained by the general population with the greatest rates in people who are physically active or service members. Approximately 40% of lateral ankle sprain patients develop chronic ankle instability (CAI) characterized by recurrent lateral ankle sprains, repetitive sensations of ankle "giving way", residual ankle sprain symptoms, and self-reported disability. Factors related to the development and progression of CAI has been thoroughly studied. However, few interventions have been developed which have successfully created long term reductions in re-injury rates, physical function, or health-related quality of life. Recent work by our research team has uncovered several novel motor and sensory deficits in the foot in patients with CAI. Deficits in foot function may contribute to the high re-injury rates, deficits in balance and strength, and diminished health-related quality of life commonly experienced by individuals with CAI. The investigators expect the additive effect of FIRE with components of the standard of care (balance training, strength training, and range of motion) will create the synergy needed to reduce future injuries (Aim 1), enhance physical function (Aim 2), and reduce self-reported disability in CAI patients (Aim 3).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The investigators will compare clinical and innovative outcome measures collected at five time points between cohorts of patients with CAI that receive a standard of care (SOC) rehabilitation program compared to an innovative foot intensive rehabilitation (FIRE) program to determine if FIRE can further reduce the rate of re-injury, improve sensorimotor function, and reduce self-reported disability during the 24 months following the intervention.
Masking: Single (Outcomes Assessor)
Masking Description: The investigators collecting the outcomes will be blinded to group allocation. Separate investigators will be used for intervention delivery and outcomes assessment.
Primary Purpose: Treatment
Official Title: Optimizing Clinical Outcomes for Patients With Chronic Ankle Instability Using Foot Intensive Rehabilitation
Actual Study Start Date : October 28, 2021
Estimated Primary Completion Date : October 1, 2024
Estimated Study Completion Date : October 1, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard of Care (SOC)
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.
Behavioral: Standard of Care Rehabilitation (SOC)
6 weeks of standard of care rehabilitation will be given designed to restore ankle joint range of motion, strength, postural control, and functional movement. Each participant will be expected to complete 2 supervised sessions and 3 unsupervised at home sessions per week.

Experimental: Foot Intensive Rehabilitation (FIRE)
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.
Behavioral: Foot Intensive Rehabilitation (FIRE)
6 weeks of FIRE will be given along with elements of SOC. Each participant will be expected to complete 2 supervised sessions and 3 unsupervised at home sessions per week.




Primary Outcome Measures :
  1. Number of recurrent ankle sprains [ Time Frame: 24 months ]
    The ability of FIRE to attenuate the occurrence of ankle sprains compared to SOC rehabilitation will be determined through self-report. An ankle sprain will be operationally defined as an incident in which the rearfoot was inverted or supinated and resulted in a combination of swelling, pain, and time lost or modification of normal function for at least one day.

  2. Frequency of episodes of the ankle giving way [ Time Frame: 24 months ]
    The ability of FIRE to attenuate the number of episodes of the ankle giving way compared to SOC rehabilitation will be determined through self-reported occurrences per week in the past month. Episodes of giving way will be operationally defined for the subject as an incident in which the rearfoot suddenly rolled, felt weak, or lost stability; however, the individual did not sustain an ankle sprain and was able to continue with normal function.

  3. Severity of chronic ankle instability related symptoms [ Time Frame: 24 months ]
    The ability of FIRE to attenuate the severity of related symptoms compared to SOC rehabilitation will be determined through the Cumberland Ankle Instability Tool. The Cumberland Ankle Instability Tool is a 9-item instrument used to identify self-reported impairments associated with CAI. This instrument is scored on a 0-30 scale, where lower scores represent greater severity of CAI related symptoms.


Secondary Outcome Measures :
  1. Postural Control [ Time Frame: 24 months ]
    The ability of FIRE to improve static and dynamic postural control compared to SOC rehabilitation will be determined. Multiple measurements will be made including: Single-limb stance on each limb with eyes open and eyes closed with use of a force plate for center of pressure measurements, Star Excursion Balance Test, forward jump single limb landing stabilization task. All measurements will be monitored while the participant wears an inertial sensor placed on the lumbar spine.

  2. Ankle/Toe Strength [ Time Frame: 24 months ]
    The ability of FIRE to improve strength compared to SOC rehabilitation will be determined. Strength of the muscles surrounding the ankle and the toes will be assessed through a series of assessments with a digital handheld dynamometer.

  3. Intrinsic Foot Muscle Activation [ Time Frame: 24 months ]
    The ability of FIRE to improve foot muscle activation compared to SOC rehabilitation will be determined. Abductor hallucis, flexor digitorum brevis, quadratus plantae, and flexor hallucis brevis functional activity ratios will be captured using diagnostic ultrasound with a 12-4 MHz linear array transducer probe and measured using Image J software.

  4. Plantar Cutaneous Sensation [ Time Frame: 24 months ]
    The ability of FIRE to improve plantar cutaneous sensation compared to SOC rehabilitation will be determined. Plantar cutaneous sensation will be tested using a 20-piece Semmes-Weinstein Monofilament kit which has monofilaments ranging from to 0.008g of force (1.65 level) to 300g of force (6.65 level). Light touch detection thresholds will be assessed on the plantar surface at the 1st metatarsal head.


Other Outcome Measures:
  1. Self-Reported Ankle Function [ Time Frame: 24 months ]
    The ability of FIRE to improve disability outcomes compared to SOC rehabilitation will be determined. Self-reported disability will be assessed using the Foot and Ankle Ability Measure (FAAM). Sports and activities of daily living subscale scores will be calculated.

  2. Self-Reported Disability [ Time Frame: 24 months ]
    The ability of FIRE to improve disability outcomes compared to SOC rehabilitation will be determined. Self-reported disability will be assessed using the Disablement in the Physically Active Scale (DPA).

  3. Self-Reported Fear Avoidance Beliefs [ Time Frame: 24 months ]
    The ability of FIRE to improve disability outcomes compared to SOC rehabilitation will be determined. Self-reported disability will be assessed using the Fear Avoidance Beliefs Questionnaire.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged 18-44.
  2. Previous history of at least 1 ankle sprain and at least 2 episodes of "giving way" in the past 3 months.
  3. Participants must answer "yes" to at least 5 questions on the Ankle Instability Instrument.
  4. Score of 11 or higher on the Identification of Functional Ankle Instability (IdFAI).
  5. Confirmed clinical presentation of CAI by a PT, AT, or MD.

Exclusion Criteria:

  1. Sustained an ankle sprain in the previous four weeks or lower extremity neuromusculoskeletal injury other than to the ankle in the last 12 months.
  2. History of surgery to the lower extremity.
  3. Sustained a lower extremity fracture.
  4. History of neurological disease, vestibular or visual disturbance or any other pathology that would impair their sensorimotor performance.
  5. Current participation in a formal ankle joint rehabilitation program.
  6. Sustained a concussion in the last 12 months.
  7. Exhibit clinical examination characteristics of foot and ankle function which are consistent with conditions other than CAI (i.e. fracture, deformity).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04493645


Contacts
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Contact: Douglas Long, M.S. 859-323-5438 delong2@uky.edu
Contact: Matthew Hoch, Ph.D. 859-323-9850 matt.hoch@uky.edu

Locations
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United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536-0200
Contact: Douglas Long, M.S.    859-323-5438    delong2@uky.edu   
Contact: Matt Hoch, Ph.D.    859-323-9850    matt.hoch@uky.edu   
Sponsors and Collaborators
Matthew Hoch
University of Virginia
Naval Health Research Center
Marine Corps Base Camp Pendleton
Investigators
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Principal Investigator: Matthew Hoch, Ph.D. University of Kentucky
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Responsible Party: Matthew Hoch, Associate Professor, Principal Investigator, University of Kentucky
ClinicalTrials.gov Identifier: NCT04493645    
Other Study ID Numbers: 58500
CDMRP-OR190060 ( Other Grant/Funding Number: Department of Defense )
First Posted: July 30, 2020    Key Record Dates
Last Update Posted: January 4, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Matthew Hoch, University of Kentucky:
chronic ankle instability
rehabilitation
injury
Additional relevant MeSH terms:
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Ankle Injuries
Leg Injuries
Wounds and Injuries