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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
24
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.
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.
University of Miami
Coral Gables, Florida, United States
Static Postural Balance
Center of Pressure (COP) velocity (cm/s)
Time frame: Baseline
Static Postural Balance
Center of Pressure (COP) velocity (cm/s)
Time frame: 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)
Time frame: 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)
Time frame: 4 weeks
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
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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Baseline
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
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
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