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Clinical Trials/NCT04390048
NCT04390048
Completed
Not Applicable

Balance Training With Transcranial Direct Current Stimulation (tDCS) for Chronic Ankle Instability (CAI)

University of Miami1 site in 1 country24 target enrollmentSeptember 20, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ankle Injuries and Disorders
Sponsor
University of Miami
Enrollment
24
Locations
1
Primary Endpoint
Static Postural Balance
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 20, 2021
End Date
December 20, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Brian Arwari

Associate Professor

University of Miami

Eligibility Criteria

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

Outcomes

Primary Outcomes

Static Postural Balance

Time Frame: Week 4

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

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)

Secondary Outcomes

  • Corticospinal Excitability as Evaluated by the Peak-to-peak Amplitude of Motor Evoked Potential (MEP)(4 weeks)
  • Self-reported Functional Scores(4 weeks)
  • Spinal Reflex Excitability(4 weeks)
  • Dynamic Postural Control as Measured by the Reach Distance(4 weeks)
  • Dynamic Postural Balance as Measured by the Time to Complete the Lateral Hop(4 weeks)

Study Sites (1)

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