Skip to content

Neurophysiology of Ankle Instability

Understanding the Neurophysiology of Ankle Instability to Improve Rehabilitation Outcomes

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06576687
Enrollment
42
Registered
2024-08-29
Start date
2025-10-30
Completion date
2027-09-01
Last updated
2026-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankle Injuries

Keywords

neurocognitive, neurophysiology, chronic ankle instability

Brief 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

Detailed description

Chronic ankle instability (CAI) is a common debilitating orthopedic condition that disrupts physical function and decreases quality of life. CAI is heterogenous and can manifest as 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 the poor recovery and recurrent nature of this pathology. Neurocognitive and neurophysiologic discrepancies may explain the different sub-groups; however, technological limitations have previously limited this assessment. 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. This study hypothesizes functional performance will be similar between sub-groups during a traditional side-hop test, but those with functional instability without mechanical laxity will perform worse during a choice-reaction hop test compared to those with mechanical ankle instability. It also hypothesizes individuals with functional ankle instability will demonstrate greater cortical activation during the research tasks and after a 4-week balance training protocol compared to individuals with mechanical ankle instability. 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.

Interventions

Exercises include (1) single-limb hops to stabilization, (2) hop to stabilization and reach, (3) unanticipated hop to stabilization, (4) single-limb stance activities, and (5) continuous choice-reaction hopping.

Sponsors

University of Nebraska
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Participants will be enrolled into one of three groups based on ankle instability: mechanical instability, functional ankle instability and Coper (sprained ankle, but no residual symptoms as a comparison). Participants will complete a 4-week balance training protocol. Prior to and following the training protocol the following tasks will be completed to evaluate the training: patient-reported functioning in daily life and sports, neurocognitive hop-testing, force-control, and functional near-infrared spectroscopy (fNIRS).

Eligibility

Sex/Gender
ALL
Age
19 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Side-hop TestBaseline and post-rehabilitation (six weeks total)Amount of time it takes participants to hop medially and laterally across a 30-cm gap ten times will be measured. Greater times equals worse performance.
Choice-reaction Hop TestBaseline and post-rehabilitation (six weeks total)Amount of time it takes participants hop on a mat medially and laterally across a 30-cm gap ten times, using visual cues to direct movement to one of two squares on each side. Greater times equals worse performance.
Inversion-eversion Force ControlBaseline and post-rehabilitation (six weeks total)The force control accuracy at 50% maximal contraction for eversion and inversion will be determined. This is analyzed by a non-linear analysis Lyapunov exponent (LyE) which measures the quality or the natural, inherent fluctuations in movement. Greater values indicate reduced neuromuscular control.

Secondary

MeasureTime frameDescription
Cumberland Ankle Instability ToolBaseline and post-rehabilitation (six weeks total)Cumberland Ankle Instability Tool (CAIT), a 9-item scale, will be used to measure the severity of functional ankle instability. It is scored from 0 to 30. Higher scores indicate a better outcome.
Foot and Ankle Ability Measure Activities of Daily Living (FAAM-ADL) ScaleBaseline and post-rehabilitation (six weeks total)The Foot and Ankle Ability Measure Activities of Daily Living Scale will be used to assess physical function in activities of daily living (ADL) for individuals with foot and ankle impairments. It is a patient-reported outcome instrument that is scored as a percentage from 0% to 100%. Higher scores indicate a better outcome.
Foot and Ankle Ability Measure Sport (FAAM-Sport) ScaleBaseline and post-rehabilitation (six weeks total)The Foot and Ankle Ability Measure Activities of Daily Living Scale will be used to assess physical function in sports activities for individuals with foot and ankle impairments. It is a patient-reported outcome instrument that is scored as a percentage from 0% to 100%. Higher scores indicate a better outcome.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAdam B Rosen, PhD

University of Nebraska

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026