Ankle Instability Using Foot Intensive Rehabilitation
Purpose
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
Eligibility
- Eligible Ages
- Between 18 Years and 44 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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).
Study Design
- Phase
- N/A
- Study Type
- Interventional
- 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.
- Primary Purpose
- Treatment
- 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.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
|
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. |
|
Recruiting Locations
UK Center for Clinical and Translational Science and nearby locations
Lexington, Kentucky 40536-0200
More Details
- NCT ID
- NCT04493645
- Status
- Recruiting
- Sponsor
- Matthew Hoch
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).