Balance Training With tDCS for CAI

NCT ID: NCT04390048

Last Updated: 2025-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-20
• Study Completion Date: 2023-12-20

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.

Conditions

Ankle Injuries and Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Anodal tDCS and Balance Training (BT) Group

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

Group Type: EXPERIMENTAL

Anodal tDCS

Intervention Type: DEVICE

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.

Sham tDCS and BT Group

Participants will undergo 4 weeks of BT under sham tDCS.

Group Type: SHAM_COMPARATOR

Sham tDCS

Intervention Type: DEVICE

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.

Interventions

Anodal tDCS

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.

Intervention Type: DEVICE

Sham tDCS

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Brian Arwari

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brian Arwari

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Coral Gables, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

20200090

Identifier Type: -

Identifier Source: org_study_id