Ankle Injuries and Disorders
Conditions
Keywords
Chronic Ankle Instability
Brief 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.
Interventions
DEVICEAnodal 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.
DEVICESham 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.
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Static Postural Balance | Baseline | Center of Pressure (COP) velocity (cm/s) |
| Active Motor Threshold (AMT) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Corticospinal Excitability as Evaluated by the Peak-to-peak Amplitude of Motor Evoked Potential (MEP) | Baseline | 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. |
| Self-reported Functional Scores | Baseline | 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. |
| Dynamic Postural Balance as Measured by the Time to Complete the Lateral Hop | Baseline | 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. |
| Dynamic Postural Control as Measured by the Reach Distance | Baseline | The anterior reach distance (cm) was measured by the Star Excursion Balance Test (SEBT). |
| Spinal Reflex Excitability | Baseline | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 9 |
| 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. | 6 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 3 |
Baseline characteristics
| Characteristic | Anodal tDCS and Balance Training (BT) Group | Sham tDCS and BT Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 2 Participants | 0 Participants | 2 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 6 Participants | 13 Participants |
| Age, Continuous | 23.1 years STANDARD_DEVIATION 8.2 | 22.3 years STANDARD_DEVIATION 6.7 | 22.8 years STANDARD_DEVIATION 7.4 |
| Height | 173.6 cm STANDARD_DEVIATION 9.8 | 170.6 cm STANDARD_DEVIATION 9.7 | 172.4 cm STANDARD_DEVIATION 9.5 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 9 participants | 6 participants | 15 participants |
| Sex: Female, Male Female | 5 Participants | 4 Participants | 9 Participants |
| Sex: Female, Male Male | 4 Participants | 2 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 9 |
| other Total, other adverse events | 0 / 10 | 0 / 9 |
| serious Total, serious adverse events | 0 / 10 | 0 / 9 |
Outcome results
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)
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anodal tDCS and Balance Training (BT) Group | Active Motor Threshold (AMT) | 43.6 Percentage of MSO | Standard Deviation 9 |
| Sham tDCS and BT Group | Active Motor Threshold (AMT) | 39.4 Percentage of MSO | Standard Deviation 13.1 |
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)
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anodal tDCS and Balance Training (BT) Group | Active Motor Threshold (AMT) | 43.9 Percentage of MSO | Standard Deviation 12.1 |
| Sham tDCS and BT Group | Active Motor Threshold (AMT) | 39.4 Percentage of MSO | Standard Deviation 13 |
Primary
Static Postural Balance
Center of Pressure (COP) velocity (cm/s)
Time frame: Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anodal tDCS and Balance Training (BT) Group | Static Postural Balance | 3.4 CM/S | Standard Deviation 0.7 |
| Sham tDCS and BT Group | Static Postural Balance | 3.4 CM/S | Standard Deviation 0.7 |
Primary
Static Postural Balance
Center of Pressure (COP) velocity (cm/s)
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anodal tDCS and Balance Training (BT) Group | Static Postural Balance | 57.0 CM/S | Standard Deviation 3.6 |
| Sham tDCS and BT Group | Static Postural Balance | 55.9 CM/S | Standard Deviation 3.7 |
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anodal tDCS and Balance Training (BT) Group | Corticospinal Excitability as Evaluated by the Peak-to-peak Amplitude of Motor Evoked Potential (MEP) | 0.68 mV | Standard Deviation 0.33 |
| Sham tDCS and BT Group | Corticospinal Excitability as Evaluated by the Peak-to-peak Amplitude of Motor Evoked Potential (MEP) | 0.63 mV | Standard Deviation 0.25 |
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.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anodal tDCS and Balance Training (BT) Group | Corticospinal Excitability as Evaluated by the Peak-to-peak Amplitude of Motor Evoked Potential (MEP) | 0.46 mV | Standard Deviation 0.16 |
| Sham tDCS and BT Group | Corticospinal Excitability as Evaluated by the Peak-to-peak Amplitude of Motor Evoked Potential (MEP) | 0.46 mV | Standard Deviation 17 |
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.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anodal tDCS and Balance Training (BT) Group | Dynamic Postural Balance as Measured by the Time to Complete the Lateral Hop | 5.3 second | Standard Deviation 1.3 |
| Sham tDCS and BT Group | Dynamic Postural Balance as Measured by the Time to Complete the Lateral Hop | 6.7 second | Standard Deviation 3.8 |
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anodal tDCS and Balance Training (BT) Group | Dynamic Postural Balance as Measured by the Time to Complete the Lateral Hop | 7.4 second | Standard Deviation 2.9 |
| Sham tDCS and BT Group | Dynamic Postural Balance as Measured by the Time to Complete the Lateral Hop | 7.2 second | Standard Deviation 2.7 |
Secondary
Dynamic Postural Control as Measured by the Reach Distance
The anterior reach distance (cm) was measured by the Star Excursion Balance Test (SEBT).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anodal tDCS and Balance Training (BT) Group | Dynamic Postural Control as Measured by the Reach Distance | 57.0 cm | Standard Deviation 3.6 |
| Sham tDCS and BT Group | Dynamic Postural Control as Measured by the Reach Distance | 55.9 cm | Standard Deviation 3.7 |
Secondary
Dynamic Postural Control as Measured by the Reach Distance
The anterior reach distance (cm) was measured by the Star Excursion Balance Test (SEBT).
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anodal tDCS and Balance Training (BT) Group | Dynamic Postural Control as Measured by the Reach Distance | 61.7 cm | Standard Deviation 4.5 |
| Sham tDCS and BT Group | Dynamic Postural Control as Measured by the Reach Distance | 62.2 cm | Standard Deviation 9.1 |
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.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anodal tDCS and Balance Training (BT) Group | Self-reported Functional Scores | 90.3 Percentage of FAAM | Standard Deviation 15.4 |
| Sham tDCS and BT Group | Self-reported Functional Scores | 98.4 Percentage of FAAM | Standard Deviation 1.2 |
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anodal tDCS and Balance Training (BT) Group | Self-reported Functional Scores | 82.8 Percentage of FAAM | Standard Deviation 15.2 |
| Sham tDCS and BT Group | Self-reported Functional Scores | 89.5 Percentage of FAAM | Standard Deviation 13.8 |
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anodal tDCS and Balance Training (BT) Group | Spinal Reflex Excitability | 0.40 Ratio | Standard Deviation 0.21 |
| Sham tDCS and BT Group | Spinal Reflex Excitability | 0.39 Ratio | Standard Deviation 0.1 |
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.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anodal tDCS and Balance Training (BT) Group | Spinal Reflex Excitability | 0.40 Ratio | Standard Deviation 0.16 |
| Sham tDCS and BT Group | Spinal Reflex Excitability | 0.40 Ratio | Standard Deviation 0.18 |