← Back to Search

Balance Training + tDCS for Ankle Injury

N/A
Waitlist Available
Led By Kyung-Min Kim
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects should have abilities to maintain a single-leg stance at least for 10 seconds
Current feelings of ankle joint instability
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights

Study Summary

This trial will study whether non-invasive brain stimulation can help people with chronic ankle instability (CAI) improve their balance.

Who is the study for?
This trial is for people who have chronic ankle instability from past sprains, can stand on one leg for at least 10 seconds, and feel their ankle might give way. It's not for those with balance disorders, previous lower limb surgeries, neurological issues, metal implants near the head, or pregnant women.Check my eligibility
What is being tested?
The study tests if non-invasive brain stimulation (Anodal tDCS) combined with balance exercises helps people with unstable ankles after a sprain. Some will get real treatment while others receive a sham (fake) version to compare results.See study design
What are the potential side effects?
Possible side effects of Anodal tDCS include mild tingling or itching under the electrode during application, fatigue, headache, nausea or discomfort. Serious side effects are rare but may include seizures in susceptible individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can stand on one leg for at least 10 seconds.
Select...
I feel like my ankle is unstable.
Select...
My ankle often gives way.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cortical excitability as evaluated by Active Motor Threshold (AMT)
Static postural balance as quantified by center of pressure parameters (COP)
Secondary outcome measures
Corticospinal excitability as evaluated by the peak-to-peak amplitude of Motor Evoked Potential (MEP)
Dynamic postural balance as measured by the time to complete the lateral hop
Dynamic postural control as measured by the reach distance
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Anodal tDCS and Balance Training (BT) GroupExperimental Treatment1 Intervention
Participants will undergo 4 weeks of BT under anodal tDCS treatment.
Group II: Sham tDCS and BT GroupPlacebo Group1 Intervention
Participants will undergo 4 weeks of BT under sham tDCS.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Anodal tDCS
2010
Completed Phase 2
~580

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor
898 Previous Clinical Trials
409,591 Total Patients Enrolled
Kyung-Min KimPrincipal InvestigatorUniversity of Miami
Joosung KimPrincipal InvestigatorUniversity of Miami

Media Library

BT Clinical Trial Eligibility Overview. Trial Name: NCT04390048 — N/A
Ankle Injury/Disorder Research Study Groups: Sham tDCS and BT Group, Anodal tDCS and Balance Training (BT) Group
Ankle Injury/Disorder Clinical Trial 2023: BT Highlights & Side Effects. Trial Name: NCT04390048 — N/A
BT 2023 Treatment Timeline for Medical Study. Trial Name: NCT04390048 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an opportunity to participate in this experiment at the present time?

"Yes, the clinicaltrials.gov website reveals that this medical experiment is open for recruitment. It was initially posted on September 20th 2021 and recently updated August 16th 2022 with a target of 60 participants from one centre."

Answered by AI

What are the projected outcomes of this experiment?

"The primary efficacy outcome evaluated over the course of four weeks is cortical excitability as defined by Active Motor Threshold (AMT). Secondary outcomes include Corticospinal Excitability, measured with peak-to-peak amplitude of Motor Evoked Potential (MEP), cortical activation quantified via electroencephalogram (EEG) and dynamic postural control assessed through the Star Excursion Balance Test's reach distance."

Answered by AI

Is there the possibility of my involvement in this clinical exploration?

"This trial is looking to enrol 60 individuals with ankle sprains aged 18 and 45. To qualify, they must be able to stay in a single-leg stance for at least 10 seconds without difficulty, demonstrate sound neurological function, have had an ankle sprain previously, experienced the sensation of their joint giving way recently, and possess a feeling that instability exists within said joint."

Answered by AI

How many participants are engaged in this research experiment?

"Affirmative. Clinicaltrials.gov lists this trial, which was first put up on September 20th 2021, as currently recruiting. Sixty participants need to be sourced from 1 medical centre for the experiment to proceed."

Answered by AI

Does the criteria for this study include individuals over 65 years of age?

"This clinical trial is looking for individuals within the age range of 18-45 years old."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Balance Training With tDCS for CAI
Joosung Kim 2021. "Balance Training With tDCS for CAI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04390048.
~8 spots leftby Sep 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top