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Ankle Instability Using Foot Intensive Rehabilitation

NCT ID: NCT04493645

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-28

Study Completion Date

2026-12-01

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Ankle Injuries Ankle Sprains

Keywords

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chronic ankle instability rehabilitation injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The investigators collecting the outcomes will be blinded to group allocation. Separate investigators will be used for intervention delivery and outcomes assessment.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Standard of Care Rehabilitation (SOC)

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Foot Intensive Rehabilitation (FIRE)

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

44 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Virginia

OTHER

Sponsor Role collaborator

Naval Health Research Center

FED

Sponsor Role collaborator

Marine Corps Base Camp Pendleton

OTHER

Sponsor Role collaborator

Matthew Hoch

OTHER

Sponsor Role lead

Responsible Party

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Matthew Hoch

Associate Professor, Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Matthew Hoch, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

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University of Kentucky

Lexington, Kentucky, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 37032355 (View on PubMed)

Other Identifiers

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CDMRP-OR190060

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

58500

Identifier Type: -

Identifier Source: org_study_id