Actively Recruiting
Addressing Neuromuscular Deficits for Improved Outcomes in Ankle Rehabilitation
Led by Phillip Gribble · Updated on 2026-02-20
150
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
P
Phillip Gribble
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are comparing a new sensorimotor ankle rehabilitation training (SMART) protocol with the standard of care (SOC) for people who have recently experienced lateral ankle sprains (LAS). The study aims to see if the SMART approach leads to better one-year outcomes, including fewer re-injuries and improved overall health. This research addresses the need for better rehabilitation strategies and understanding of patient recovery after neuromusculoskeletal injuries like LAS. The study includes two groups: one receiving the standard care focused on restoring ankle range of motion, strength, and balance, and the other receiving the SMART intervention, which builds on standard care by adding sensorimotor training to improve sensory inputs, motor outputs, and their integration. Participants will be randomly assigned to either group and will begin treatment shortly after their injury. Participants will be assessed when cleared to return to full activity and again at 6 and 12 months after return. Evaluations include clinical outcomes like ankle function, quality of life, physical activity, balance, range of motion, and rates of re-injury. The study also measures innovative markers of central nervous system function and ankle joint health. This follow-up helps researchers determine the success of the rehabilitation approaches over one year.
CONDITIONS
Brief Title
Addressing Neuromuscular Deficits for Improved Outcomes in Ankle Rehabilitation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Initiating rehabilitation for a first-time acute grade I, II, or III lateral ankle sprain
- Injury sustained within 72 hours of study enrollment
- Diagnosed by a physician, medic, athletic trainer, physical therapist, or other medical provider in operational settings
You will not qualify if you...
- Personal or family history of epilepsy or seizures
- History of migraine headaches
- Ocular foreign body, increased intracranial pressure, open head injury, or significant closed head injury
- Presence of cochlear implants
- Implanted brain stimulators, aneurysm clips, or other metal in the head (except mouth)
- Implanted medication pumps, pacemakers, or intracardiac lines
- Current use of tricyclic anti-depressants, neuroleptic agents, or other drugs that lower seizure threshold
- History of diagnosed major psychiatric disorder
- History of illicit drug use
- Current alcohol abuse or withdrawal from alcohol abuse
- History of heart disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From initiation of rehabilitation until cleared to return to full duty/activity (variable duration)
Participants undergo ankle rehabilitation using either the SMART protocol, which includes sensorimotor components, or the Standard of Care protocol focused on restoring range of motion, strength, and balance.
Visits scheduled as part of rehabilitation until discharge
Duration - Up to 12 months after treatment completion
Participants are assessed at the time of return to full activity and at 6 and 12 months post-discharge to evaluate clinical outcomes, re-injury rates, and central nervous system function.
3 visits (at discharge, 6 months, and 12 months post-discharge)
Trial Site Locations
Total: 2 locations
1
University of Kentucky
Lexington, Kentucky, United States, 40506
Actively Recruiting
2
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
Research Team
K
Kyle Kosik, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here