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Balance Training With tDCS for CAI

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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

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

Trial contacts and locations

1

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Central trial contact

Joosung Kim

Data sourced from clinicaltrials.gov

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