Ankle Instability Using Foot Intensive Rehabilitation

NCT04493645 | Active Not Recruiting

• 2 other identifiers: 58500CDMRP-OR190060
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankle Injuries; Ankle Sprains

Keywords

chronic ankle instability; rehabilitation; injury

Outcome Measures

Primary Outcomes (3)

• Number of recurrent ankle sprains

  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.

  24 months

• Frequency of episodes of the ankle giving way

  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.

  24 months

• Severity of chronic ankle instability related symptoms

  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.

  24 months

Secondary Outcomes (4)

• Postural Control

  24 months

• Ankle/Toe Strength

  24 months

• Intrinsic Foot Muscle Activation

  24 months

• Plantar Cutaneous Sensation

  24 months

Other Outcomes (3)

• Self-Reported Ankle Function

  24 months

• Self-Reported Disability

  24 months

• Self-Reported Fear Avoidance Beliefs

  24 months

Study Arms (2)

Standard of Care (SOC)

ACTIVE COMPARATOR

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)

Foot Intensive Rehabilitation (FIRE)

EXPERIMENTAL

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)

Interventions

Standard of Care Rehabilitation (SOC) BEHAVIORAL

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.

Standard of Care (SOC)

Foot Intensive Rehabilitation (FIRE) BEHAVIORAL

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.

Foot Intensive Rehabilitation (FIRE)

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Matthew Hoch: lead
• University of Virginia: collaborator
• Naval Health Research Center: collaborator
• Marine Corps Base Camp Pendleton: collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536-0200, United States

Location

Related Publications (1)

• Hoch MC, Hertel J, Gribble PA, Heebner NR, Hoch JM, Kosik KB, Long D, Sessoms PH, Silder A, Torp DM, Thompson KL, Fraser JJ. Effects of foot intensive rehabilitation (FIRE) on clinical outcomes for patients with chronic ankle instability: a randomized controlled trial protocol. BMC Sports Sci Med Rehabil. 2023 Apr 9;15(1):54. doi: 10.1186/s13102-023-00667-7.

  PMID: 37032355 DERIVED

MeSH Terms

Conditions

Ankle Injuries; Wounds and Injuries

Condition Hierarchy (Ancestors)

Leg Injuries

Study Officials

• Matthew Hoch, Ph.D.

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The investigators collecting the outcomes will be blinded to group allocation. Separate investigators will be used for intervention delivery and outcomes assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 20, 2020
• First Posted: July 30, 2020
• Study Start: October 28, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)