Clinical trial NCT04390048: Balance Training With tDCS for CAI
Official title: Balance Training With Transcranial Direct Current Stimulation (tDCS) for Chronic Ankle Instability (CAI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Injuries and Disorders
Keywords: Chronic Ankle Instability
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2020-05-15
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoner

Primary outcomes:
measure: Static Postural Balance
timeFrame: Baseline
measure: Static Postural Balance
timeFrame: Week 4
measure: Active Motor Threshold (AMT)
timeFrame: Baseline
measure: Active Motor Threshold (AMT)
timeFrame: 4 weeks
Secondary outcomes:
measure: Self-reported Functional Scores
timeFrame: Baseline
measure: Self-reported Functional Scores
timeFrame: 4 weeks
measure: Spinal Reflex Excitability
timeFrame: Baseline
measure: Spinal Reflex Excitability
timeFrame: 4 weeks
measure: Corticospinal Excitability as Evaluated by the Peak-to-peak Amplitude of Motor Evoked Potential (MEP)
timeFrame: Baseline
measure: Corticospinal Excitability as Evaluated by the Peak-to-peak Amplitude of Motor Evoked Potential (MEP)
timeFrame: 4 weeks
measure: Dynamic Postural Control as Measured by the Reach Distance
timeFrame: Baseline
measure: Dynamic Postural Control as Measured by the Reach Distance
timeFrame: 4 weeks
measure: Dynamic Postural Balance as Measured by the Time to Complete the Lateral Hop
timeFrame: Baseline
measure: Dynamic Postural Balance as Measured by the Time to Complete the Lateral Hop
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Brian Arwari
role: PRINCIPAL_INVESTIGATOR
References: