- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04390048
Balance Training With tDCS for CAI
August 13, 2023 updated by: Joosung Kim, University of Miami
Balance Training With Transcranial Direct Current Stimulation (tDCS) for Chronic Ankle Instability (CAI)
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Joosung Kim
- Phone Number: 305-284-9221
- Email: jjk147@miami.edu
Study Locations
-
-
Florida
-
Coral Gables, Florida, United States, 33146
- University of Miami
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Anodal tDCS and Balance Training (BT) Group
Participants will undergo 4 weeks of BT under anodal tDCS treatment.
|
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 Comparator: Sham tDCS and BT Group
Participants will undergo 4 weeks of BT under 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Static postural balance as quantified by center of pressure parameters (COP)
Time Frame: 4 weeks
|
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
|
Cortical excitability as evaluated by Active Motor Threshold (AMT)
Time Frame: 4 weeks
|
The soleus active motor threshold will be measured by TMS using a computation program, Parameter Estimation by Sequential Testing (PEST).
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-reported functional scores
Time Frame: 4 weeks
|
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
|
Spinal reflex excitability as evaluated by H-reflex and M-wave ratio (Hmax/Mmax ratio)
Time Frame: 4 weeks
|
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
|
Corticospinal excitability as evaluated by the peak-to-peak amplitude of Motor Evoked Potential (MEP)
Time Frame: 4 weeks
|
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
|
Dynamic postural control as measured by the reach distance
Time Frame: 4 weeks
|
The reach distance (cm) will be measured by Star Excursion Balance Test (SEBT).
|
4 weeks
|
Dynamic postural balance as measured by the time to complete the lateral hop
Time Frame: 4 weeks
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Joosung Kim, University of Miami
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 20, 2021
Primary Completion (Estimated)
September 20, 2024
Study Completion (Estimated)
September 20, 2024
Study Registration Dates
First Submitted
May 12, 2020
First Submitted That Met QC Criteria
May 12, 2020
First Posted (Actual)
May 15, 2020
Study Record Updates
Last Update Posted (Actual)
August 15, 2023
Last Update Submitted That Met QC Criteria
August 13, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20200090
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ankle Injuries and Disorders
-
University of NebraskaWithdrawnAnkle Sprains | Ankle Injuries and Disorders
-
NHS GrampianRecruitingAnkle Fractures | Syndesmotic Injuries | Ankle Injuries and DisordersUnited Kingdom
-
Manipal UniversityCompletedAnkle Injuries and Disorders : Chronic Ankle InstabilityIndia
-
FH ORTHORecruitingAnkle Injuries and DisordersFrance, Switzerland
-
Tianjin University of SportCompletedAnkle Injuries and DisordersChina
-
Fundación Universidad Católica de Valencia San...CompletedAnkle Injuries and DisordersSpain
-
Sehat Medical ComplexCompletedAnkle Disorders InjuriesPakistan
-
Escola Superior de Tecnologia da Saúde do PortoCompletedAnkle Injuries and DisordersPortugal
-
Escoles Universitaries GimbernatUniversidad Rey Juan CarlosNot yet recruitingExercise Therapy | Transcutaneous Electric Nerve Stimulation | Ankle Injuries and Disorders : Chronic Ankle InstabilitySpain
-
Acibadem UniversityCompleted
Clinical Trials on Anodal tDCS
-
Riphah International UniversityCompleted
-
University of WaterlooThe Hong Kong Polytechnic UniversityRecruitingMacular DegenerationHong Kong, Canada
-
University of WaterlooThe Hong Kong Polytechnic UniversityCompleted
-
Hospital Ernesto DornellesUnknown
-
University of LiegeCompletedDisorders of Consciousness | Minimally Conscious State | Vegetative StateBelgium
-
New York UniversityRecruiting
-
University of TromsoHelse NordCompleted
-
University of LiegeCompletedDisorder of Consciousness | Minimally Conscious State | Vegetative StateBelgium
-
University of LiegeCompletedDisorders of Consciousness | Minimally Conscious State | Vegetative StateBelgium
-
Silvie CeresnakovaCompletedAnorexia NervosaCzechia