Ankle InjuriesNCT05655143
Effects of Balance Training on Corticospinal Excitability in People With Chronic Ankle Instability
A study testing Balance training in people with Ankle Injuries, run by Old Dominion University at 1 site in United States.
Trial summary
Ankle sprains are prevalent and debilitating injuries in daily living and sports activities. The emergency room annually cares for over 206,000 patients with lateral ankle sprain in the United States, resulting in over $12,000 of health care cost per injury. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Ankle Injuries
- What is being tested?
- Balance training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2022to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Between 18 to 40 years old
- A previous history of a significant ankle sprain that caused pain and swelling (initial ankle sprain is required to occur at least 12 months prior to study enrollment; the most recent ankle sprain must occur at least 3 months prior to study enrollment)
- At least two recurrent episodes of "giving way," "feeling of instability," or repeated ankle sprains in the six months before the study enrollment
- Scored ≥5 on the Ankle Instability Instrument (AII), >10 on the Identification of Functional Ankle Instability (IdFAI), and <24 on the Cumberland Ankle Instability Tool (CAIT).
Who cannot join
- Participants should not have any kind of neurological, vestibular, respiratory, or heart disorders, previous surgery, smoke or history of illicit drug use, or be pregnant.
- history of heart disease
- history of stroke
- cardiac pacemaker or implanted cardiac defibrillator
- history of migraines or severe headaches
- history of cancer in brain or leg muscles
Show all 36Show fewer
- diagnosed psychiatric disorder
- intracranial metallic clips
- currently pregnant or breastfeeding
- taking pain relieving, neuroinhibitory, or stimulating medication within 7 days prior to testing
- metal implants anywhere in the head, neck, or shoulders (excluding dental work)
- personal or familial history of seizures or epilepsy
- ocular foreign objects or cochlear implants
- implanted brain stimulators
- aneurysm clips
- implanted medication pump
- intra- cardiac lines
- history of or is currently abusing illicit drugs or alcohol or is currently withdrawing from any substance
- history of serious head injury or increased intracranial pressure that would keep participants from participating in this study.
- smokers
- diagnosed with a neurologic disorder (e.g., Parkinson's disease, multiple sclerosis, or stroke)
- cognitive status that does not allow the individual to consistently comprehend and repeat back directions regarding the details of the study
- diabetes
- fibromyalgia
- peripheral neuropathy (i.e., numbness, tingling, or loss of sensation in the hands or feet)
- history of acute head or lower extremity injury within 3 months prior to testing
- any history of lower extremity fracture or surgery
- currently using any of the following types of medications:
- Pain relief medications: common examples include Aspirin, Acetaminophen (Tylenol), Morphine, Tramadol (Ultram), Oxycodone (Percocet), Hydrocodone (Vicodin)
- Neuroinhibitory medications: common examples include Alprazolam (Xanax), Diazepam (Valium), Clonazepam (Klonopin), Baclofen (Lioresal),
- o These medications are commonly used to treat anxiety and seizures.
- Stimulating medications: common examples include Methylphenidate (Ritalin), Amphetamine (Adderall), Caffeine
- o These medications are commonly used to treat ADD and narcolepsy.
- Tricyclic antidepressants: common examples include Amitriptyline, Amoxapine, Desipramine (Norpramin), Doxepin, Imipramine (Tofranil), Nortriptyline (Pamelor), Protriptyline (Vivactil), Trimipramine (Surmontil)
- o These medications are commonly used to treat depression, agoraphobia with panic attacks, obsessive compulsive disorder, chronic pain, and migraine headaches.
- Neuroleptic (antipsychotic) medications: common examples include Chlorpromazine (Thorazine), Loxapine (Loxitane), Clozapine (Clozaril) o These medications are commonly used to treat psychoses and schizophrenia.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Brain Research and Rehabilitation
Norfolk, Virginia, 23508
About this study
Ankle sprains are prevalent and debilitating injuries in daily living and sports activities. The emergency room annually cares for over 206,000 patients with lateral ankle sprain in the United States, resulting in over $12,000 of health care cost per injury. Although many rehabilitation techniques for ankle sprains have been implemented, up to 40% of individuals with ankle sprains experience residual symptoms including recurrent sprain, episodes of ankle joint "giving way," and feelings of instability, which collectively define chronic ankle instability (CAI). Individuals with CAI commonly exhibit neuromuscular dysfunction with reduced motor control due to decreased sensory input to the central nervous system (CNS) after the initial injury. As a result, the CNS sends altered motor signals to lower extremity muscles. These CNS changes contribute to various neuromuscular impairments in CAI patients, the most common of which is reduced balance performance.
Neural stimulation techniques, such as the Hoffman reflex (H-reflex) and transcranial magnetic stimulation (TMS) have been used to directly assess changes in the CNS. One of the most consistently identified CNS changes in individuals with CAI is reduced ability to modulate spinal reflex excitability and corticospinal excitability of the calf muscle when transitioning from simpler to more complex balance conditions. Neural excitability refers to the ability of the central nervous system to elicit skeletal muscle contractions. That is, the spinal reflex excitability and corticospinal excitability can be described as the ability to contract muscle conducted by the spine and brain, respectively. Typically, healthy individuals modulate or quiet down their spinal reflexes and rely more on the corticospinal excitability during more demanding balance tasks. However, evidence indicates that the individuals with CAI are unable to modulate spinal reflexes and shift control to brain, leading to reduced balance performance. Given that the calf muscle plays a crucial role in balance, improving proper supraspinal and spinal reflexive control of the calf muscle is imperative to balance maintenance of individuals with CAI.
To improve balance function for those with CAI, many balance training programs have been implemented to improve static and dynamic stability and proprioception for those with CAI. The majority of findings indicate that balance training can be effective in preventing initial and recurrent ankle sprains. However, it is unclear if common balance training methods can restore the function of the CNS in those with CAI. Therefore, the purpose of this study is to determine the effects of balance training on the calf muscle spinal-reflexive excitability modulation, corticospinal excitability, and balance performance in individuals with CAI. The rationale for this study is that patients with CAI require effective rehabilitation that can restore their neurosignature and improve balance ability.
- Conditions
- Ankle Injuries
- Being tested
- Balance training
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance trainingBehavioural
Participants will undergo a 4-week balance training protocol modified from that described previously.
Participants will undergo supervised exercise three times per week for approximately 30 minutes per session. The exercise consists of single-leg balance training, hop to stabilization, and hop to stabilization plus reaching activities as presented in Figure 1. Particularly, the levels of difficulty will be progressed with visual conditions (eyes open and eyes closed), time (sec), and base of support (floor and foam pad) while hopping distance (inches) for single-leg and hopping activities, respectively. These activities will be progressed in difficulty as participants become proficient at the task.
| Study group | Role | What they receive |
|---|---|---|
| Balance Training | Experimental | Not described Receives: Behavioral: Balance training |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Active Motor Threshold
Transcranial magnetic stimulation will be delivered to the primary motor cortex of each participant using a Magstim Super RAPID2 PLUS1 System. A Double Cone Coil will be positioned over the primary motor cortex's approximated representation of the soleus to deliver single-pulse stimulations. From the output of the soleus MEP, the spot that generates the highest electromyographic (EMG) amplitudes with consistency will be identified as the "hotspot". To acquire the active motor threshold (AMT), the average peak amplitude of the background EMG signal will be collected while participants conduct the single-leg balance without magnetic stimulus. AMT will be defined as the lowest stimulator intensity needed to generate 4/8 stimulations with soleus EMG activity 2 standard deviations above baseline EMG data.
Measured: 1 year
Motor Evoked Potential
After testing active motor threshold (AMT) 8 stimulations at intensities of 100% and 120% of AMT will be delivered using single-pulse stimulations over the soleus "hot spot." The electromyographic activity of the soleus from each stimulation will be recorded as the motor evoked potential (MEP).
Measured: 1 year
Corticosilent Period
From the same stimulations used to test motor evoked potential (MEP), we measure corticosilent period (CSP) as the time from the end of MEP to a return of baseline electromyographic activity of the soleus.
Measured: 1 year
Spinal Reflexive Excitability Modulation
Spinal reflexive excitability modulation will be measured while the participants are in the prone position and a single-leg stance. As a first step, the spinal reflexive excitability during prone and single-leg balance will be determined using a ratio of the Hoffmann-reflex (H-reflex) to the muscle response (M-wave) (H:M). H-reflex and M-wave will be elicited by BIOPAC stimulator module with a 2mm shield disk stimulating electrode attached to the popliteal fossa to stimulate the tibial nerve. The stimulation will be progressively increased with 0.2V until the maximal H-reflex and M-wave are obtained. Five the maximal H-reflex and M-wave will be recorded to calculate the H:M ratio. The following formula will be employed to calculate the modulation of H-reflex:
(Prone-Single leg standing H:M Ratio)/(Prone H:M ratio)×100
Measured: 1 year
Balance function
Balance performance will be measured via a force platform (AccuSway Plus, AMTI, Watertown, MA, USA) by doing a single-leg standing. The force platform will be connected to the Balance Clinic software (AMTI, Watertown, MA, USA) to acquire the center of pressure (COP) data. Balance function testing will include two visual conditions (Eyes open vs Eyes closed) while participants maintain single-leg balance on the involved limb. Each condition will be conducted three 20-second trials. Averaged COP path length, area, and maximum velocity in anterior-posterior and medial-lateral directions will be utilized for the final data analysis. Rest intervals of 1 minute will be provided between each condition. Furthermore, subjects will be protected by the primary investigator to prevent falling from the base of supports.
3)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start6 Dec 2022
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ankle InjuriesStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Old Dominion University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryan McCann, Old Dominion University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05655143
- Sponsor's protocol ID
- 1957702-4
- Status last verified
- May 2024
- First submitted
- 6 Dec 2022
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chung S, Freeman J, Gray J, McCann RS. The Effects Of 6-week Balance Training on Corticospinal Excitability, Spinal Reflexive Excitability Modulation, and Balance Performance in Individuals with Chronic Ankle Instability: Randomized Controlled Trial. J Electromyogr Kinesiol. 2026 Aug;89:103160. doi: 10.1016/j.jelekin.2026.103160. Epub 2026 May 2.
PubMed 42090740
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Balance Training on Corticospinal Excitability in People With Chronic Ankle Instability
- ClinicalTrials.gov ID
- NCT05655143
- Acronym / sponsor ID
- 1957702-4
- Conditions
- Ankle Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Old Dominion UniversityUniversity, hospital or other
- Study start
- 6 Dec 2022 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 19 Dec 2022 (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.
Ankle sprains are prevalent and debilitating injuries in daily living and sports activities. The emergency room annually cares for over 206,000 patients with lateral ankle sprain in the United States, resulting in over $12,000 of health care cost per injury. Although many rehabilitation techniques for ankle sprains have been implemented, up to 40% of individuals with ankle sprains experience residual symptoms including recurrent sprain, episodes of ankle joint "giving way," and feelings of instability, which collectively define chronic ankle instability (CAI). Individuals with CAI commonly exhibit neuromuscular dysfunction with reduced motor control due to decreased sensory input to the central nervous system (CNS) after the initial injury. As a result, the CNS sends altered motor signals to lower extremity muscles. These CNS changes contribute to various neuromuscular impairments in CAI patients, the most common of which is reduced balance performance.
Neural stimulation techniques, such as the Hoffman reflex (H-reflex) and transcranial magnetic stimulation (TMS) have been used to directly assess changes in the CNS. One of the most consistently identified CNS changes in individuals with CAI is reduced ability to modulate spinal reflex excitability and corticospinal excitability of the calf muscle when transitioning from simpler to more complex balance conditions. Neural excitability refers to the ability of the central nervous system to elicit skeletal muscle contractions. That is, the spinal reflex excitability and corticospinal excitability can be described as the ability to contract muscle conducted by the spine and brain, respectively. Typically, healthy individuals modulate or quiet down their spinal reflexes and rely more on the corticospinal excitability during more demanding balance tasks. However, evidence indicates that the individuals with CAI are unable to modulate spinal reflexes and shift control to brain, leading to reduced balance performance. Given that the calf muscle plays a crucial role in balance, improving proper supraspinal and spinal reflexive control of the calf muscle is imperative to balance maintenance of individuals with CAI.
To improve balance function for those with CAI, many balance training programs have been implemented to improve static and dynamic stability and proprioception for those with CAI. The majority of findings indicate that balance training can be effective in preventing initial and recurrent ankle sprains. However, it is unclear if common balance training methods can restore the function of the CNS in those with CAI. Therefore, the purpose of this study is to determine the effects of balance training on the calf muscle spinal-reflexive excitability modulation, corticospinal excitability, and balance performance in individuals with CAI. The rationale for this study is that patients with CAI require effective rehabilitation that can restore their neurosignature and improve balance ability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balance Training | Experimental | Behavioral: Balance training |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Between 18 to 40 years old
- A previous history of a significant ankle sprain that caused pain and swelling (initial ankle sprain is required to occur at least 12 months prior to study enrollment; the most recent ankle sprain must occur at least 3 months prior to study enrollment)
- At least two recurrent episodes of "giving way," "feeling of instability," or repeated ankle sprains in the six months before the study enrollment
- Scored ≥5 on the Ankle Instability Instrument (AII), >10 on the Identification of Functional Ankle Instability (IdFAI), and <24 on the Cumberland Ankle Instability Tool (CAIT).
Key exclusion criteria (36 listed)
- Participants should not have any kind of neurological, vestibular, respiratory, or heart disorders, previous surgery, smoke or history of illicit drug use, or be pregnant.
- history of heart disease
- history of stroke
- cardiac pacemaker or implanted cardiac defibrillator
- history of migraines or severe headaches
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 |
|---|---|---|
| Balance trainingParticipants will undergo a 4-week balance training protocol modified from that described previously. Participants will undergo supervised exercise three times per week for approximately 30 minutes per session. The exercise consists of single-leg balance training, hop to stabilization, and hop to stabilization plus reaching activities as presented in Figure 1. Particularly, the levels of difficulty will be progressed with visual conditions (eyes open and eyes closed), time (sec), and base of support (floor and foam pad) while hopping distance (inches) for single-leg and hopping activities, respectively. These activities will be progressed in difficulty as participants become proficient at the task. | Behavioural | Balance Training |
Primary outcome
Active Motor Threshold
Time frame: 1 year
Transcranial magnetic stimulation will be delivered to the primary motor cortex of each participant using a Magstim Super RAPID2 PLUS1 System. A Double Cone Coil will be positioned over the primary motor cortex's approximated representation of the soleus to deliver single-pulse stimulations. From the output of the soleus MEP, the spot that generates the highest electromyographic (EMG) amplitudes with consistency will be identified as the "hotspot". To acquire the active motor threshold (AMT), the average peak amplitude of the background EMG signal will be collected while participants conduct the single-leg balance without magnetic stimulus. AMT will be defined as the lowest stimulator intensity needed to generate 4/8 stimulations with soleus EMG activity 2 standard deviations above baseline EMG data.
Motor Evoked Potential
Time frame: 1 year
After testing active motor threshold (AMT) 8 stimulations at intensities of 100% and 120% of AMT will be delivered using single-pulse stimulations over the soleus "hot spot." The electromyographic activity of the soleus from each stimulation will be recorded as the motor evoked potential (MEP).
Corticosilent Period
Time frame: 1 year
From the same stimulations used to test motor evoked potential (MEP), we measure corticosilent period (CSP) as the time from the end of MEP to a return of baseline electromyographic activity of the soleus.
Spinal Reflexive Excitability Modulation
Time frame: 1 year
Spinal reflexive excitability modulation will be measured while the participants are in the prone position and a single-leg stance. As a first step, the spinal reflexive excitability during prone and single-leg balance will be determined using a ratio of the Hoffmann-reflex (H-reflex) to the muscle response (M-wave) (H:M). H-reflex and M-wave will be elicited by BIOPAC stimulator module with a 2mm shield disk stimulating electrode attached to the popliteal fossa to stimulate the tibial nerve. The stimulation will be progressively increased with 0.2V until the maximal H-reflex and M-wave are obtained. Five the maximal H-reflex and M-wave will be recorded to calculate the H:M ratio. The following formula will be employed to calculate the modulation of H-reflex: (Prone-Single leg standing H:M Ratio)/(Prone H:M ratio)×100
Balance function
Time frame: 1 year
Balance performance will be measured via a force platform (AccuSway Plus, AMTI, Watertown, MA, USA) by doing a single-leg standing. The force platform will be connected to the Balance Clinic software (AMTI, Watertown, MA, USA) to acquire the center of pressure (COP) data. Balance function testing will include two visual conditions (Eyes open vs Eyes closed) while participants maintain single-leg balance on the involved limb. Each condition will be conducted three 20-second trials. Averaged COP path length, area, and maximum velocity in anterior-posterior and medial-lateral directions will be utilized for the final data analysis. Rest intervals of 1 minute will be provided between each condition. Furthermore, subjects will be protected by the primary investigator to prevent falling from the base of supports. 3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Derived from this study: PubMed 42090740Chung S, Freeman J, Gray J, McCann RS. The Effects Of 6-week Balance Training on Corticospinal Excitability, Spinal Reflexive Excitability Modulation, and Balance Performance in Individuals with Chronic Ankle Instability: Randomized Controlled Trial. J Electromyogr Kinesiol. 2026 Aug;89:103160. doi: 10.1016/j.jelekin.2026.103160. Epub 2026 May 2.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance training in people with Ankle Injuries, run by Old Dominion University 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 4 inclusion and 36 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: finished, as of the sponsor's last update on 7 May 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Active Motor Threshold (time frame: 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05655143, which also lists 1 linked publication.
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 7 May 2024.