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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anodal tDCS and Balance Training (BT) Group | Experimental | Participants will undergo 4 weeks of BT under anodal tDCS treatment. |
|
| Sham tDCS and BT Group | Sham Comparator | Participants will undergo 4 weeks of BT under sham tDCS. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anodal tDCS | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Static Postural Balance | Center of Pressure (COP) velocity (cm/s) | Baseline |
| Static Postural Balance | Center of Pressure (COP) velocity (cm/s) | 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) | 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) | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| Self-reported Functional Scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Arwari | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Coral Gables | Florida | 33146 | United States |
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A total of 24 participants signed informed consent and were enrolled in the study; however, 5 participants withdrew due to scheduling conflicts that occurred after participant enrollment, but prior to assignment of participants to an arm or group; therefore, the enrollment number in the protocol section will differ from the results section as 5 participants did not receive the intervention. The unit assignment are whole participants that have been assigned to the arms/groups.
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| ID | Title | Description |
|---|---|---|
| FG000 | Anodal tDCS and Balance Training (BT) Group | Participants will undergo 4 weeks of BT under anodal tDCS treatment. Anodal tDCS: 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. |
| FG001 | Sham tDCS and BT Group | Participants will undergo 4 weeks of BT under sham tDCS. Sham tDCS: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Anodal tDCS and Balance Training (BT) Group | Participants will undergo 4 weeks of BT under anodal tDCS treatment. Anodal tDCS: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Static Postural Balance | Center of Pressure (COP) velocity (cm/s) | Posted | Mean | Standard Deviation | CM/S | Baseline |
|
4 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Anodal tDCS and Balance Training (BT) Group | Participants will undergo 4 weeks of BT under anodal tDCS treatment. Anodal tDCS: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian Arwari | University of Miami | 305-284-5418 | b.arwari@umiami.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 17, 2023 | Dec 3, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016512 | Ankle Injuries |
| D004194 | Disease |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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| Sham tDCS | Device | 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. |
|
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.
| 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. | 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. | 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. | 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. | 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). | Baseline |
| Dynamic Postural Control as Measured by the Reach Distance | The anterior reach distance (cm) was measured by the Star Excursion Balance Test (SEBT). | 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. | 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. | 4 weeks |
| BG001 | Sham tDCS and BT Group | Participants will undergo 4 weeks of BT under sham tDCS. Sham tDCS: 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Standard Deviation | cm |
|
Participants will undergo 4 weeks of BT under sham tDCS.
Sham tDCS: 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.
|
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| Primary | Static Postural Balance | Center of Pressure (COP) velocity (cm/s) | Posted | Mean | Standard Deviation | CM/S | Week 4 |
|
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| Primary | 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) | Posted | Mean | Standard Deviation | Percentage of MSO | Baseline |
|
|
|
| Primary | 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) | Posted | Mean | Standard Deviation | Percentage of MSO | 4 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Percentage of FAAM | Baseline |
|
|
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| Secondary | 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. | Posted | Mean | Standard Deviation | Percentage of FAAM | 4 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Ratio | Baseline |
|
|
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| Secondary | 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. | Posted | Mean | Standard Deviation | Ratio | 4 weeks |
|
|
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| Secondary | 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. | Posted | Mean | Standard Deviation | mV | Baseline |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | mV | 4 weeks |
|
|
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| Secondary | Dynamic Postural Control as Measured by the Reach Distance | The anterior reach distance (cm) was measured by the Star Excursion Balance Test (SEBT). | Posted | Mean | Standard Deviation | cm | Baseline |
|
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| Secondary | Dynamic Postural Control as Measured by the Reach Distance | The anterior reach distance (cm) was measured by the Star Excursion Balance Test (SEBT). | Posted | Mean | Standard Deviation | cm | 4 weeks |
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| Secondary | 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. | Posted | Mean | Standard Deviation | second | Baseline |
|
|
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| Secondary | 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. | Posted | Mean | Standard Deviation | second | 4 weeks |
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| 0 |
| 10 |
| 0 |
| 10 |
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| 10 |
| EG001 | Sham tDCS and BT Group | Participants will undergo 4 weeks of BT under sham tDCS. Sham tDCS: 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. | 0 | 9 | 0 | 9 | 0 | 9 |
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| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |