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Balance Training With tDCS for CAI

Not Applicable
Completed
Conditions
Ankle Injuries and Disorders
Interventions
Device: Anodal tDCS
Device: Sham tDCS
Registration Number
NCT04390048
Lead Sponsor
University of Miami
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
24
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Anodal tDCS and Balance Training (BT) GroupAnodal tDCSParticipants will undergo 4 weeks of BT under anodal tDCS treatment.
Sham tDCS and BT GroupSham tDCSParticipants will undergo 4 weeks of BT under sham tDCS.
Primary Outcome Measures
NameTimeMethod
Static Postural BalanceWeek 4

Center of Pressure (COP) velocity (cm/s)

Active Motor Threshold (AMT)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)

Secondary Outcome Measures
NameTimeMethod
Corticospinal Excitability as Evaluated by the Peak-to-peak Amplitude of Motor Evoked Potential (MEP)4 weeks

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.

Dynamic Postural Balance as Measured by the Time to Complete the Lateral Hop4 weeks

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.

Self-reported Functional Scores4 weeks

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.

Spinal Reflex Excitability4 weeks

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.

Dynamic Postural Control as Measured by the Reach Distance4 weeks

The anterior reach distance (cm) was measured by the Star Excursion Balance Test (SEBT).

Trial Locations

Locations (1)

University of Miami

🇺🇸

Coral Gables, Florida, United States

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