Balance Training With tDCS for CAI

University of Miami

Status: Completed

Conditions: Ankle Injuries and Disorders

Treatments: Device: Sham tDCS; Device: Anodal tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT04390048

20200090

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups

Anodal tDCS and Balance Training (BT) Group

Experimental group

Description:

Participants will undergo 4 weeks of BT under anodal tDCS treatment.

Treatment:

Device: Anodal tDCS

Sham tDCS and BT Group

Sham Comparator group

Description:

Participants will undergo 4 weeks of BT under sham tDCS.

Treatment:

Device: Sham tDCS