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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
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 moreTrial 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
~610
Find a Location
Who is running the clinical trial?
University of MiamiLead Sponsor
912 Previous Clinical Trials
411,413 Total Patients Enrolled
Kyung-Min KimPrincipal InvestigatorUniversity of Miami
Joosung KimPrincipal InvestigatorUniversity of Miami
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've had a recent injury to my leg joints that stopped me from my usual activities.I am unable to give consent for medical procedures.I can stand on one leg for at least 10 seconds.I am under the age of 18.I have had a herniated disc in the past.I have had a broken leg or foot that needed to be realigned.I have a history of balance or inner ear problems.I do not have a neurological disorder or a history of treatments like TMS or deep brain stimulation.I have had an ankle sprain in the past.I do not have a pacemaker, metal implants near my head, or unstable heart disease.I feel like my ankle is unstable.My ankle often gives way.I often have severe headaches that are hard to manage.I have had surgery on the bones or muscles in my legs.
Research Study Groups:
This trial has the following groups:- Group 1: Sham tDCS and BT Group
- Group 2: Anodal tDCS and Balance Training (BT) Group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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