Balance Training With tDCS for CAI

Ankle Injuries and Disorders Clinical Trial

Official title:

Balance Training With Transcranial Direct Current Stimulation (tDCS) for Chronic Ankle Instability (CAI)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04390048
• Other study ID #: 20200090
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 20, 2021
• Est. completion date: September 20, 2024

Study information

• Verified date: August 2023
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: September 20, 2024
• Est. primary completion date: September 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankle Injuries
• Ankle Injuries and Disorders

Intervention

Device:
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Miami	Coral Gables	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Static postural balance as quantified by center of pressure parameters (COP)	Static postural balance will be assessed by the displacement from COP on the anteroposterior and mediolateral axes using a force platform during quite single and double leg standing. The average of three trials for each standing position will be reported.	4 weeks
Primary	Cortical excitability as evaluated by Active Motor Threshold (AMT)	The soleus active motor threshold will be measured by TMS using a computation program, Parameter Estimation by Sequential Testing (PEST).	4 weeks
Secondary	Self-reported functional scores	The percentage score of the Foot and Ankle Ability Measure (FAAM) will be used for the self-reported function. The total percentage score will be ranging from 0-100. The higher score indicates a better ankle function.	4 weeks
Secondary	Spinal reflex excitability as evaluated by H-reflex and M-wave ratio (Hmax/Mmax ratio)	H-reflex is a refractory muscle response which results from electrical stimulation over the peripheral nerve. M-wave is a compound muscle action potentials which results from supra-maximal electrical stimulation. Maximal H-reflex and M-wave ratios will be measured.	4 weeks
Secondary	Corticospinal excitability as evaluated by the peak-to-peak amplitude of Motor Evoked Potential (MEP)	The soleus active muscle response, due to transcranial magnetic stimulation (TMS) pulses over the motor cortex, will be used for quantifying the motor evoked potential.	4 weeks
Secondary	Dynamic postural control as measured by the reach distance	The reach distance (cm) will be measured by Star Excursion Balance Test (SEBT).	4 weeks
Secondary	Dynamic postural balance as measured by the time to complete the lateral hop	The completion time (seconds) for the lateral hop will be measured. Each trial consists of 10 lateral hops. The average completion time of 3 trials will be reported. The completion time will be recorded using a stopwatch in seconds.	4 weeks