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Balance Training With tDCS for CAI

Primary Purpose

Ankle Injuries and Disorders

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Anodal tDCS
Sham tDCS
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Ankle Injuries and Disorders focused on measuring Chronic Ankle Instability

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Miami

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Anodal tDCS and Balance Training (BT) Group

Sham tDCS and BT Group

Arm Description

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

Participants will undergo 4 weeks of BT under sham tDCS.

Outcomes

Primary Outcome Measures

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.
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).

Secondary Outcome Measures

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.
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.
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.
Dynamic postural control as measured by the reach distance
The reach distance (cm) will be measured by Star Excursion Balance Test (SEBT).
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.

Full Information

First Posted
May 12, 2020
Last Updated
August 13, 2023
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT04390048
Brief Title
Balance Training With tDCS for CAI
Official Title
Balance Training With Transcranial Direct Current Stimulation (tDCS) for Chronic Ankle Instability (CAI)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 20, 2021 (Actual)
Primary Completion Date
September 20, 2024 (Anticipated)
Study Completion Date
September 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Injuries and Disorders
Keywords
Chronic Ankle Instability

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Anodal tDCS and Balance Training (BT) Group
Arm Type
Experimental
Arm Description
Participants will undergo 4 weeks of BT under anodal tDCS treatment.
Arm Title
Sham tDCS and BT Group
Arm Type
Sham Comparator
Arm Description
Participants will undergo 4 weeks of BT under sham tDCS.
Intervention Type
Device
Intervention Name(s)
Anodal tDCS
Intervention Description
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
Intervention Name(s)
Sham tDCS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Static postural balance as quantified by center of pressure parameters (COP)
Description
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.
Time Frame
4 weeks
Title
Cortical excitability as evaluated by Active Motor Threshold (AMT)
Description
The soleus active motor threshold will be measured by TMS using a computation program, Parameter Estimation by Sequential Testing (PEST).
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Self-reported functional scores
Description
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.
Time Frame
4 weeks
Title
Spinal reflex excitability as evaluated by H-reflex and M-wave ratio (Hmax/Mmax ratio)
Description
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.
Time Frame
4 weeks
Title
Corticospinal excitability as evaluated by the peak-to-peak amplitude of Motor Evoked Potential (MEP)
Description
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.
Time Frame
4 weeks
Title
Dynamic postural control as measured by the reach distance
Description
The reach distance (cm) will be measured by Star Excursion Balance Test (SEBT).
Time Frame
4 weeks
Title
Dynamic postural balance as measured by the time to complete the lateral hop
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joosung Kim
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Balance Training With tDCS for CAI

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