N/A
N=19
Balance Training With tDCS for CAI
Ankle Injuries and Disorders
Bottom Line
View on ClinicalTrials.gov: NCT04390048 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Static Postural Balance — 57.0; 55.9 CM/S
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Anodal tDCS (Device); Sham tDCS (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Miami
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Static Postural Balance |
3.4; 3.4 | — |
| PRIMARY Static Postural Balance |
3.4; 3.4 | — |
| PRIMARY Active Motor Threshold (AMT) |
43.9; 39.4 | — |
| PRIMARY Active Motor Threshold (AMT) |
43.9; 39.4 | — |
| SECONDARY Self-reported Functional Scores |
90.3; 98.4 | — |
| SECONDARY Self-reported Functional Scores |
90.3; 98.4 | — |
| SECONDARY Spinal Reflex Excitability |
0.40; 0.40 | — |
| SECONDARY Spinal Reflex Excitability |
0.40; 0.40 | — |
| SECONDARY Corticospinal Excitability as Evaluated by the Peak-to-peak Amplitude of Motor Evoked Potential (MEP) |
0.46; 0.46 | — |
| SECONDARY Corticospinal Excitability as Evaluated by the Peak-to-peak Amplitude of Motor Evoked Potential (MEP) |
0.46; 0.46 | — |
| SECONDARY Dynamic Postural Control as Measured by the Reach Distance |
61.7; 62.2 | — |
| SECONDARY Dynamic Postural Control as Measured by the Reach Distance |
61.7; 62.2 | — |
| SECONDARY Dynamic Postural Balance as Measured by the Time to Complete the Lateral Hop |
5.3; 6.7 | — |
| SECONDARY Dynamic Postural Balance as Measured by the Time to Complete the Lateral Hop |
5.3; 6.7 | — |
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
Data sourced from ClinicalTrials.gov (NCT04390048). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.