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tDCS + Physiotherapy for Acquired Brain Injury
Study Summary
This trial will investigate if using a mild electrical current can help children with brain injuries learn motor skills better in physiotherapy. Up to 10 kids (5-18yo) will get either active or sham treatment. Results will be compared.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I can handle 2 hours of physical therapy with short breaks.I have weakness or paralysis on one side of my body, affecting my ankle movement.I can handle 45 minutes of physical therapy.I have not had Botox injections in the last 3 months.I can attend twice weekly appointments for five weeks and a two-hour assessment before and after treatment.You have been treated by a doctor at the ABI medical follow-up clinic at Holland Bloorview or have been admitted to the inpatient ABI program at Holland Bloorview.I have stitches or staples on my head.I am not planning any medication changes that would affect my participation in the study.I have a brain tumor.I have had a part of my skull removed.You have a cochlear implant.I have open wounds or unhealed cuts where the device would be placed.I have had a stroke or serious brain injury confirmed by a scan.I can't balance on my most affected leg for more than 20 seconds.I can stand on my own for at least 10 seconds.I am currently in a hospital or rehab center.I am currently in outpatient rehab.I can walk at least 10 meters, with or without help.You have a cardiac pacemaker.I have a condition like cerebral palsy affecting my movement.My ABI started before I turned two years old.I am between 5 and 18 years old.You are using a battery-powered medication infusion device, like a baclofen or insulin pump.I can follow instructions and participate in physical therapy assessments.You have a medical device implanted in your body to stimulate your nerves or brain.I have metal implants or fragments in my head.I have had a seizure in the past 6 months.I have been diagnosed with a neurodegenerative condition.I currently have an injury that limits my ability to put weight on my legs.I have been advised not to engage in activities like running or jumping due to a medical condition.
- Group 1: Physiotherapy + Sham tDCS
- Group 2: Physiotherapy + Active tDCS
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Does the study consider applicants within a certain age bracket?
"The participant requirements for this study necessitate that individuals are aged between 5 and 18 years old."
Are individuals still being recruited for this trial?
"As per information on clinicaltrials.gov, the trial is still recruiting participants. This research endeavour was made available to the public starting June 1st of 2022 and has been revised as recently as November 25th of 2022."
Who qualifies to be a participant in this clinical research?
"This clinical trial is recruiting up to 10 minors who have suffered from either a stroke or traumatic brain injury, as confirmed through imaging such MRI and CT scans. Eligible patients must be medically stable per their attending physician's evaluation, ambulatory with the ability to walk at least 10 meters independently or aided, able to stand for 10 seconds without assistance, demonstrate impaired balance on the more affected leg (i.e., decreased selective motor control of the ankle compared to other), available twice weekly over 5 weeks in addition to baseline and post-treatment assessment sessions; all candidates need fall between ages five and eighteen years old."
What is the current capacity for enrollees of this experiment?
"Indeed, the information on clinicaltrials.gov affirms that this medical trial is actively recruiting from one site and in need of 10 participants. It was initially posted June 1st 2022 with its most recent update being November 25th 2022."
What is the objective of this experimentation?
"During the 2-year period of this study, its primary objective is to gauge patient eligibility. Secondary goals include administering a 10 metre fast walk test, an Acquired Brain injury Challenge Assessment with scoring on a 5 point scale and Goal Attainment Scaling where baseline ability is classified as '-2' and each goal's expected level is set at '0'."
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