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New treatment option for Ankle Sprains
Official title Addressing Neuromuscular Deficits for Improved Outcomes in Ankle Rehabilitation
ClinicalTrials.gov ID: NCT03663361
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 44
You may be able to join if
- 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...
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Lexington, Kentucky, United States
- Chapel Hill, North Carolina, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 44 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lexington, Kentucky, United States; Chapel Hill, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.