Ankle InjuriesNCT06576687
Neurophysiology of Ankle Instability
A study testing Physical Rehabilitation in people with Ankle Injuries, run by University of Nebraska at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Ankle Injuries
- What is being tested?
- Physical Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2025to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Nebraska-Omaha, Biomechanics Research Building
Omaha, Nebraska, 68182
About this study
Official title: Understanding the Neurophysiology of Ankle Instability to Improve Rehabilitation Outcomes
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
Read the 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.
- Conditions
- Ankle Injuries
- Being tested
- Physical Rehabilitation
- Keywords
- neurocognitive, neurophysiology, chronic ankle instability
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical RehabilitationOther
Also called Balance and hop-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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Physical Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline and post-rehabilitation (six weeks total)
Secondary outcomes (3)
Cumberland Ankle Instability Tool
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.
Measured: Baseline and post-rehabilitation (six weeks total)
Foot and Ankle Ability Measure Activities of Daily Living (FAAM-ADL) Scale
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.
Measured: Baseline and post-rehabilitation (six weeks total)
Foot and Ankle Ability Measure Sport (FAAM-Sport) Scale
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.
Measured: Baseline and post-rehabilitation (six weeks total)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start30 Oct 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle InjuriesStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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).
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adam B Rosen, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06576687
- Sponsor's protocol ID
- 0549-24-EP
- Status last verified
- Feb 2026
- First submitted
- 26 Aug 2024
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Neurophysiology of Ankle Instability to Improve Rehabilitation Outcomes
- ClinicalTrials.gov ID
- NCT06576687
- Acronym / sponsor ID
- 0549-24-EP
- Conditions
- Ankle Injuries
- Keywords
- neurocognitive, neurophysiology, chronic ankle instability
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 30 Oct 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 29 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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).
| Arm | Type | Receives |
|---|---|---|
| Balance Training | Experimental | Other: Physical RehabilitationExercises 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. |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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:
- Coper participants (participants coping with ankle problems:
- Chronic ankle instability (CAI):
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical RehabilitationAlso: Balance and hop-trainingExercises 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 | Balance Training |
Primary outcome
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.
3 secondary outcomes
Cumberland Ankle Instability Tool
Time frame: Baseline and post-rehabilitation (six weeks total)
Foot and Ankle Ability Measure Activities of Daily Living (FAAM-ADL) Scale
Time frame: Baseline and post-rehabilitation (six weeks total)
Foot and Ankle Ability Measure Sport (FAAM-Sport) Scale
Time frame: Baseline and post-rehabilitation (six weeks total)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adam B Rosen, PhD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Rehabilitation in people with Ankle Injuries, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Side-hop Test (time frame: Baseline and post-rehabilitation (six weeks total)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.