Neurophysiology of Ankle Instability

NCT06576687 | Enrolling By Invitation

• 1 other identifier: 0549-24-EP
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Conditions

Ankle Injuries

Keywords

neurocognitive; neurophysiology; chronic ankle instability

Outcome Measures

Primary Outcomes (3)

• Side-hop Test

  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.

  Baseline and post-rehabilitation (six weeks total)

• Choice-reaction Hop Test

  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.

  Baseline and post-rehabilitation (six weeks total)

• Inversion-eversion Force Control

  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.

  Baseline and post-rehabilitation (six weeks total)

Secondary Outcomes (3)

• 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 Arms (1)

Balance Training

EXPERIMENTAL

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.

Other: Physical Rehabilitation

Interventions

Physical Rehabilitation OTHER

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.

Also known as: Balance and hop-training

Balance Training

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska-Omaha, Biomechanics Research Building

Omaha, Nebraska, 68182, United States

Location

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Officials

• Adam B Rosen, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 29, 2024
• Study Start: October 30, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)