Neurophysiology of Ankle Instability (NCT06576687) | Clinical Trial Compass
By InvitationNot Applicable
Neurophysiology of Ankle Instability
United States42 participantsStarted 2025-10-30
Plain-language summary
Chronic ankle instability (CAI) is a common debilitating orthopedic condition that disrupts physical function and decreases quality of life. Not all CAI is the same. It can be mechanical ligamentous laxity, perceived disability often referred to as functional instability, or a combination of the two. However, clinicians and researchers most often combine all chronic ankle instability patients without considering these sub-groups, which may account for poor recovery and recurrence. The objective of this research is to determine functional and neurophysiological differences between sub-groups of CAI to allow for development of evidence-based rehabilitation which may improve patient outcomes.
To accomplish this, the study will determine the differences among CAI sub-groups on performance of a traditional side-hop test and neurocognitive hop test, determine differences in neurophysiological response and motor control between CAI sub-groups during a lower limb and an ankle specific task, and determine the underlying neurophysiological effects of a 4-week neurocognitively enhanced balance training protocol among CAI subgroups. Time to complete each of the hop tests, cortical activation during the balance and force control tasks, and neurocognitive performance will be assessed to determine differences in performance and neurological function among subgroups of CAI
Who can participate
Age range
19 Years – 45 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:
* All participants must be physically active (participation in at least 90 total minutes of activity/week including running, walking, lifting weights, or playing a sport, etc.)
* Healthy controls:
* no history of lateral ankle sprain
* no complaints of their ankle giving way
* a Cumberland Ankle Instability Tool (CAIT) score greater than 28
* Coper participants (participants coping with ankle problems:
* a history of lateral ankle sprain, but no episodes of giving way in previous 12 months
* CAIT score greater than 28
* Chronic ankle instability (CAI):
* history of ankle sprain
* two or more episodes of ankle giving way in previous 12 months
* CAIT score less than 25
Exclusion Criteria:
* History of lower extremity surgery or fracture
* Current signs or symptoms of a joint sprain in the lower extremity
* Pregnancy
* Diagnosis of a vestibular disorder
* Diagnosis of a nerve or connective tissue disorder
* Significant history of condition that impaired cognitive function such as concussion or learning disability
* Currently taking medications that may affect cognitive function such as narcotics, anti-depressants, anti-anxiety agents, or stimulants
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
1
Side-hop Test
Timeframe: Baseline and post-rehabilitation (six weeks total)
2
Choice-reaction Hop Test
Timeframe: Baseline and post-rehabilitation (six weeks total)
3
Inversion-eversion Force Control
Timeframe: Baseline and post-rehabilitation (six weeks total)