Ankle Instability Using Foot Intensive Rehabilitation (FIRE)

Matthew Hoch

Status: Active, not recruiting

Conditions: Ankle Sprains; Ankle Injuries

Treatments: Behavioral: Foot Intensive Rehabilitation (FIRE); Behavioral: Standard of Care Rehabilitation (SOC)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04493645

58500

CDMRP-OR190060 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 44 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

Standard of Care (SOC)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Standard of Care Rehabilitation (SOC)

Foot Intensive Rehabilitation (FIRE)

Experimental group

Description:

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.

Treatment:

Behavioral: Foot Intensive Rehabilitation (FIRE)