Ankle Injuries and DisordersNCT04390048
Balance Training With tDCS for CAI
A study testing Anodal tDCS in people with Ankle Injuries and Disorders, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this research study is to examine the efficacy of non-invasive brain stimulation in addition to balance exercise for chronic ankle instability (CAI), a condition that develops following an initial ankle sprain, usually because of loose or unstable ankle joints. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Ankle Injuries and Disorders
- What is being tested?
- Anodal tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2021to 20 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects should be neurologically sound
- Subjects should have abilities to maintain a single-leg stance at least for 10 seconds.
- A history of ankle sprain
- A history of ankle joint giving ways
- Current feelings of ankle joint instability
Who cannot join
- Individuals with a clinically defined neurological disorder, with an increased risk of seizure for any reason, with a history of treatment with Transcranial Magnetic Stimulation (TMS), deep brain stimulation for any disorder will be excluded.
- Patients with cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed will be excluded.
- A history of balance or vestibular disorder
- A history of previous surgeries to the musculoskeletal structures in either limb of the lower extremity
- A history of a fracture in either limb of the lower extremity requiring realignment
- A history of acute injuries to the lower extremity joints in the previous 3 months, which impacted joint integrity and function (i.e., sprains, fractures) resulting in at least 1 interrupted day of desired physical activity
Show all 13Show fewer
- A history of herniated disc
- Poorly controlled headache
- Hypersensitivity to electrical or magnetic stimulation
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoner
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Balance Training With Transcranial Direct Current Stimulation (tDCS) for Chronic Ankle Instability (CAI)
The purpose of this research study is to examine the efficacy of non-invasive brain stimulation in addition to balance exercise for chronic ankle instability (CAI), a condition that develops following an initial ankle sprain, usually because of loose or unstable ankle joints.
- Conditions
- Ankle Injuries and Disorders
- Being tested
- Anodal tDCS, Sham tDCS
- Keywords
- Chronic Ankle Instability
- Medical subject headings
- Ankle Injuries, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anodal tDCSDevice
An anodal surface electrode will be attached to the contralateral motor cortex (M1) of the CAI-involved side and the reference electrode will be placed on the ipsilateral side of the supraorbital ridge. Anodal tDCS will deliver a low electrical current stimulation at 2 milliamps (mA). Participants will undergo 3 sessions per week for a total of 12 sessions and each session will last approximately 20 minutes.
Sham tDCSDevice
An anodal surface electrode will be attached to the contralateral motor cortex (M1) of the CAI-involved side and the reference electrode will be placed on the ipsilateral side of the supraorbital ridge. Sham tDCS will deliver a low electrical current stimulation at 2 mA and will be turned off 30 seconds following the application. Participants will undergo 3 sessions per week for a total of 12 sessions and each session will last approximately 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Anodal tDCS and Balance Training (BT) Group | Experimental | Participants will undergo 4 weeks of BT under anodal tDCS treatment. Receives: Device: Anodal tDCS |
| Sham tDCS and BT Group | Sham comparator | Participants will undergo 4 weeks of BT under sham tDCS. Receives: Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static Postural Balance
Center of Pressure (COP) velocity (cm/s)
Measured: Baseline
Static Postural Balance
Center of Pressure (COP) velocity (cm/s)
Measured: Week 4
Active Motor Threshold (AMT)
The active motor threshold (AMT) was measured by transcranial magnetic stimulation (TMS) using a computation program, Parameter Estimation by Sequential Testing (PEST). AMT was defined as the minimum TMS intensity required to elicit an adequate motor-evoked potential (MEP) in the soleus muscle. A lower AMT reflects greater corticospinal excitability. The unit of measure is Percentage of Maximum Stimulus Output (MSO)
Measured: Baseline
Active Motor Threshold (AMT)
The active motor threshold (AMT) was measured by transcranial magnetic stimulation (TMS) using a computation program, Parameter Estimation by Sequential Testing (PEST). AMT was defined as the minimum TMS intensity required to elicit an adequate motor-evoked potential (MEP) in the soleus muscle. A lower AMT reflects greater corticospinal excitability. The unit of measure is Percentage of Maximum Stimulus Output (MSO)
Measured: 4 weeks
Secondary outcomes (10)
Self-reported Functional Scores
The percentage score of the Foot and Ankle Ability Measure (FAAM). The total percentage score ranges from 0-100. The higher score indicates a better ankle function.
Measured: Baseline
Self-reported Functional Scores
The percentage score of the Foot and Ankle Ability Measure (FAAM). The total percentage score ranges from 0-100. The higher score indicates a better ankle function.
Measured: 4 weeks
Spinal Reflex Excitability
The maximal peak-to-peak amplitude ratios of the Hoffman reflex (H-reflex) and the motor response (M-wave) of the soleus muscle were calculated by normalizing the maximal H-reflex amplitude to the maximal M-wave amplitude (Hmax/Mmax ratio). A higher Hmax/Mmax indicates a greater spinal reflex excitability.
Measured: Baseline
Spinal Reflex Excitability
The maximal peak-to-peak amplitude ratios of the Hoffman reflex (H-reflex) and the motor response (M-wave) of the soleus muscle were calculated by normalizing the maximal H-reflex amplitude to the maximal M-wave amplitude (Hmax/Mmax ratio). A higher Hmax/Mmax indicates a greater spinal reflex excitability.
Measured: 4 weeks
Corticospinal Excitability as Evaluated by the Peak-to-peak Amplitude of Motor Evoked Potential (MEP)
The soleus active muscle response, due to transcranial magnetic stimulation (TMS) pulses over the motor cortex, will be used for quantifying the motor evoked potential.
Measured: Baseline
Corticospinal Excitability as Evaluated by the Peak-to-peak Amplitude of Motor Evoked Potential (MEP)
The soleus active muscle response, due to transcranial magnetic stimulation (TMS) pulses over the motor cortex, will be used for quantifying the motor evoked potential.
Measured: 4 weeks
Dynamic Postural Control as Measured by the Reach Distance
The anterior reach distance (cm) was measured by the Star Excursion Balance Test (SEBT).
Measured: Baseline
Dynamic Postural Control as Measured by the Reach Distance
The anterior reach distance (cm) was measured by the Star Excursion Balance Test (SEBT).
Measured: 4 weeks
Dynamic Postural Balance as Measured by the Time to Complete the Lateral Hop
The completion time (seconds) for the lateral hop will be measured. Each trial consists of 10 lateral hops. The average completion time of 3 trials will be reported. The completion time will be recorded using a stopwatch in seconds.
Measured: Baseline
Dynamic Postural Balance as Measured by the Time to Complete the Lateral Hop
The completion time (seconds) for the lateral hop will be measured. Each trial consists of 10 lateral hops. The average completion time of 3 trials will be reported. The completion time will be recorded using a stopwatch in seconds.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start20 Sep 2021
- Primary completion20 Dec 2023
- Study completion20 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ankle Injuries and DisordersStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Arwari, University of Miami
- Investigators
- Brian Arwari, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04390048
- Sponsor's protocol ID
- 20200090
- Status last verified
- Feb 2025
- First submitted
- 12 May 2020
- Last updated
- 6 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balance Training With Transcranial Direct Current Stimulation (tDCS) for Chronic Ankle Instability (CAI)
- ClinicalTrials.gov ID
- NCT04390048
- Acronym / sponsor ID
- 20200090
- Conditions
- Ankle Injuries and Disorders
- Keywords
- Chronic Ankle Instability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 15 May 2020 (actual)
- Results
- Posted 11 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to examine the efficacy of non-invasive brain stimulation in addition to balance exercise for chronic ankle instability (CAI), a condition that develops following an initial ankle sprain, usually because of loose or unstable ankle joints.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anodal tDCS and Balance Training (BT) Group | Experimental | Device: Anodal tDCSParticipants will undergo 4 weeks of BT under anodal tDCS treatment. |
| Sham tDCS and BT Group | Sham comparator | Device: Sham tDCSParticipants will undergo 4 weeks of BT under sham tDCS. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subjects should be neurologically sound
- Subjects should have abilities to maintain a single-leg stance at least for 10 seconds.
- A history of ankle sprain
- A history of ankle joint giving ways
- Current feelings of ankle joint instability
Key exclusion criteria (13 listed)
- Individuals with a clinically defined neurological disorder, with an increased risk of seizure for any reason, with a history of treatment with Transcranial Magnetic Stimulation (TMS), deep brain stimulation for any disorder will be excluded.
- Patients with cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed will be excluded.
- A history of balance or vestibular disorder
- A history of previous surgeries to the musculoskeletal structures in either limb of the lower extremity
- A history of a fracture in either limb of the lower extremity requiring realignment
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 |
|---|---|---|
| Anodal tDCSAn anodal surface electrode will be attached to the contralateral motor cortex (M1) of the CAI-involved side and the reference electrode will be placed on the ipsilateral side of the supraorbital ridge. Anodal tDCS will deliver a low electrical current stimulation at 2 milliamps (mA). Participants will undergo 3 sessions per week for a total of 12 sessions and each session will last approximately 20 minutes. | Device | Anodal tDCS and Balance Training (BT) Group |
| Sham tDCSAn anodal surface electrode will be attached to the contralateral motor cortex (M1) of the CAI-involved side and the reference electrode will be placed on the ipsilateral side of the supraorbital ridge. Sham tDCS will deliver a low electrical current stimulation at 2 mA and will be turned off 30 seconds following the application. Participants will undergo 3 sessions per week for a total of 12 sessions and each session will last approximately 20 minutes. | Device | Sham tDCS and BT Group |
Primary outcome
Static Postural Balance
Time frame: Baseline
Center of Pressure (COP) velocity (cm/s)
Static Postural Balance
Time frame: Week 4
Center of Pressure (COP) velocity (cm/s)
Active Motor Threshold (AMT)
Time frame: Baseline
The active motor threshold (AMT) was measured by transcranial magnetic stimulation (TMS) using a computation program, Parameter Estimation by Sequential Testing (PEST). AMT was defined as the minimum TMS intensity required to elicit an adequate motor-evoked potential (MEP) in the soleus muscle. A lower AMT reflects greater corticospinal excitability. The unit of measure is Percentage of Maximum Stimulus Output (MSO)
Active Motor Threshold (AMT)
Time frame: 4 weeks
The active motor threshold (AMT) was measured by transcranial magnetic stimulation (TMS) using a computation program, Parameter Estimation by Sequential Testing (PEST). AMT was defined as the minimum TMS intensity required to elicit an adequate motor-evoked potential (MEP) in the soleus muscle. A lower AMT reflects greater corticospinal excitability. The unit of measure is Percentage of Maximum Stimulus Output (MSO)
10 secondary outcomes
Self-reported Functional Scores
Time frame: Baseline
Self-reported Functional Scores
Time frame: 4 weeks
Spinal Reflex Excitability
Time frame: Baseline
Spinal Reflex Excitability
Time frame: 4 weeks
Corticospinal Excitability as Evaluated by the Peak-to-peak Amplitude of Motor Evoked Potential (MEP)
Time frame: Baseline
Corticospinal Excitability as Evaluated by the Peak-to-peak Amplitude of Motor Evoked Potential (MEP)
Time frame: 4 weeks
Dynamic Postural Control as Measured by the Reach Distance
Time frame: Baseline
Dynamic Postural Control as Measured by the Reach Distance
Time frame: 4 weeks
Dynamic Postural Balance as Measured by the Time to Complete the Lateral Hop
Time frame: Baseline
Dynamic Postural Balance as Measured by the Time to Complete the Lateral Hop
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Brian Arwari principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anodal tDCS in people with Ankle Injuries and Disorders, run by University of Miami 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 5 inclusion and 13 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 6 Mar 2025. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 11 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Static Postural Balance (time frame: Baseline). The study lists 4 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 6 Mar 2025.