RecruitingNot Applicable

Addressing Neuromuscular Deficits for Improved Outcomes in Ankle Rehabilitation

United States150 participantsStarted 2019-11-12

Plain-language summary

The purpose of this project is to compare a novel sensorimotor ankle rehabilitation training (SMART) protocol for Lateral ankle sprains (LASs) against a standard of care (SOC) protocol to determine if it is more successful at producing successful one-year outcomes and lower rates of re-injury and improved health. This will address the identified needs for evidence-support and reintegration strategies to improve understanding of the management of patient rehabilitation strategies throughout the rehabilitation process following neuromusculoskeletal injury. The project will validate an innovative rehabilitation approach while providing metrics of success using a variety of clinical and innovative markers.

Who can participate

Age range

18 Years – 44 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * initiating rehabilitation for a first time acute grade I, II, or III LAS * have sustained within 72 hours of study enrollment * diagnosed by a physician, medic, athletic trainer, physical therapist, or other providing medical coverage in operational environments as having sustained a LAS Exclusion Criteria: * personal or familial history of epilepsy or seizures * history of migraine headaches * ocular foreign body, increased intracranial pressure, open head injury or significant closed head injury * cochlear implants * implanted brain stimulators, aneurysm clips or other metal in the head (except mouth) * implanted medication pumps, pacemakers or intracardiac lines * current medication with 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 currently withdrawing from alcohol abuse * history of heart disease

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Ankle re-injury rate

Timeframe: 12 months

Change in mental quality of life

Timeframe: rehabilitation discharge visit, 6 and 12 months post-discharge

Change in physical quality of life

Timeframe: rehabilitation discharge visit, 6 and 12 months post-discharge

Change in physical activity

Timeframe: rehabilitation discharge visit, 6 and 12 months post-discharge

Change in self-reported Functional Ankle Instability

Timeframe: rehabilitation discharge visit, 6 and 12 months post-discharge

Change in self-reported Ankle Instability

Timeframe: rehabilitation discharge visit, 6 and 12 months post-discharge

Change in self-reported Ankle Disability

Timeframe: rehabilitation discharge visit, 6 and 12 months post-discharge

Trial details

NCT IDNCT03663361

SponsorPhillip Gribble

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07

Contact for this trial

Kyle Kosik, PhD

859-323-9850 kyle.kosik@uky.edu

View on ClinicalTrials.gov More Ankle Sprains trials

Plain-language summary

Who can participate

Age range

18 Years – 44 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Ankle re-injury rate

Timeframe: 12 months

Change in mental quality of life

Timeframe: rehabilitation discharge visit, 6 and 12 months post-discharge

Change in physical quality of life

Timeframe: rehabilitation discharge visit, 6 and 12 months post-discharge

Change in physical activity

Timeframe: rehabilitation discharge visit, 6 and 12 months post-discharge

Change in self-reported Functional Ankle Instability

Timeframe: rehabilitation discharge visit, 6 and 12 months post-discharge

Change in self-reported Ankle Instability

Timeframe: rehabilitation discharge visit, 6 and 12 months post-discharge

Change in self-reported Ankle Disability

Timeframe: rehabilitation discharge visit, 6 and 12 months post-discharge