Skip to main content
Clinical Trials/NCT06576687
NCT06576687
Enrolling By Invitation
Not Applicable

Understanding the Neurophysiology of Ankle Instability to Improve Rehabilitation Outcomes

University of Nebraska1 site in 1 country42 target enrollmentOctober 30, 2025

Overview

Phase
Not Applicable
Intervention
Physical Rehabilitation
Conditions
Ankle Injuries
Sponsor
University of Nebraska
Enrollment
42
Locations
1
Primary Endpoint
Side-hop Test
Status
Enrolling By Invitation
Last Updated
2 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 30, 2025
End Date
September 1, 2027
Last Updated
2 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

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

Arms & Interventions

Balance Training

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.

Intervention: Physical Rehabilitation

Outcomes

Primary Outcomes

Side-hop Test

Time Frame: Baseline 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 Test

Time Frame: Baseline 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 Control

Time Frame: Baseline 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 Outcomes

  • Cumberland Ankle Instability Tool(Baseline and post-rehabilitation (six weeks total))
  • Foot and Ankle Ability Measure Activities of Daily Living (FAAM-ADL) Scale(Baseline and post-rehabilitation (six weeks total))
  • Foot and Ankle Ability Measure Sport (FAAM-Sport) Scale(Baseline and post-rehabilitation (six weeks total))

Study Sites (1)

Loading locations...

Similar Trials