Clinical trial NCT04493645: Ankle Instability Using Foot Intensive Rehabilitation
Official title: Optimizing Clinical Outcomes for Patients with Chronic Ankle Instability Using Foot Intensive Rehabilitation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Ankle Injuries
Ankle Sprains
Keywords: chronic ankle instability
rehabilitation
injury
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: University of Virginia
name: Naval Health Research Center
name: Marine Corps Base Camp Pendleton
First posted: 2020-07-30
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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).

Eligibility 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).

Primary outcomes:
measure: Number of recurrent ankle sprains
timeFrame: 24 months
measure: Frequency of episodes of the ankle giving way
timeFrame: 24 months
measure: Severity of chronic ankle instability related symptoms
timeFrame: 24 months
Secondary outcomes:
measure: Postural Control
timeFrame: 24 months
measure: Ankle/Toe Strength
timeFrame: 24 months
measure: Intrinsic Foot Muscle Activation
timeFrame: 24 months
measure: Plantar Cutaneous Sensation
timeFrame: 24 months
Other outcomes:
measure: Self-Reported Ankle Function
timeFrame: 24 months
measure: Self-Reported Disability
timeFrame: 24 months
measure: Self-Reported Fear Avoidance Beliefs
timeFrame: 24 months
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Matthew Hoch, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: