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Corticosteroid
Balance Training for Ankle Injury
N/A
Recruiting
Research Sponsored by Old Dominion University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is about finding better ways to treat ankle sprains that can cause chronic ankle instability, leading to reduced balance and neuromuscular dysfunction. Balance training programs are being tested to see if they can restore the central nervous system and improve balance.
Who is the study for?
This trial is for people aged 18-40 who've had a significant ankle sprain at least a year ago, with recent instability or sprains. They must score specific values on the Ankle Instability Instrument, Identification of Functional Ankle Instability, and Cumberland Ankle Instability Tool.Check my eligibility
What is being tested?
The study tests if balance training can improve spinal reflexes and brain control over calf muscles to enhance balance in those with chronic ankle instability (CAI). It aims to see whether this training can correct central nervous system functions affected by CAI.See study design
What are the potential side effects?
Balance training is generally safe but may include muscle soreness, fatigue, or increased risk of falls during exercises. Participants should report any discomfort experienced during the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Active Motor Threshold
Balance function
Corticosilent Period
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Balance TrainingExperimental Treatment1 Intervention
Group II: ControlActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Balance training
2014
Completed Phase 1
~790
Find a Location
Who is running the clinical trial?
Old Dominion UniversityLead Sponsor
20 Previous Clinical Trials
15,014 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have experienced multiple instances of your ankle giving way, feeling unstable, or having repeated sprains in the six months before joining the study.You should not have any problems with your brain, balance, breathing, or heart. You should not have had any surgeries, smoke, use illegal drugs, or be pregnant.You have a history of using illegal drugs or alcohol, or you are currently going through withdrawal from any substances.You have experienced a severe ankle sprain with pain and swelling in the past year, and your most recent ankle sprain occurred at least 3 months ago.You have had cancer in your brain or leg muscles before.You have been diagnosed with a mental health condition.You have taken any pain relievers, medications that affect the nerves, or medications that stimulate the body within the past week.You have been diagnosed with a brain or nerve disorder like Parkinson's disease, multiple sclerosis, or stroke.You have a history of migraines or very bad headaches.You have a device implanted in your brain that stimulates brain activity.You have metal clips in your brain.You or someone in your family has a history of seizures or epilepsy.You have a device implanted in your body that delivers medication.You have a high score on tests that measure ankle instability and low score on a tool that measures ankle stability.You have had a previous stroke.You have something stuck in your eye or have a cochlear implant.You have metal clips in your brain to treat aneurysms.You have fibromyalgia, a condition that causes widespread pain and tenderness in the body.You have had a recent injury to your head or legs within the past 3 months.You are a smoker.You have a history of heart problems.You have numbness, tingling, or loss of sensation in your hands or feet.You have had a fracture or surgery in your legs in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Balance Training
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any octogenarians being accepted into the trial?
"The age criteria for this trial requires participants to be of adult age yet younger than 40 years."
Answered by AI
On what basis can individuals be admitted to this experiment?
"Eligibility for this clinical trial involves having an ankle sprain and being within the ages of 18 to 40. Around 30 participants are planned for recruitment."
Answered by AI
Are any enrollment opportunities for participants still available in this research project?
"According to the clinicaltrials.gov website, this investigation is presently enrolling patients; it was initially publicized on December 6th 2022 and most recently edited on December 14th of that same year."
Answered by AI
How many individuals have been enrolled into this research endeavor?
"Affirmative, the information found on clinicaltrials.gov shows that this medical experiment is presently recruiting participants. It was initially posted on December 6th 2022 and it has been modified as recently as December 14th 2022. 30 patients are sought to join at a single site."
Answered by AI
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