Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:08 PM
Ignite Modification Date:
2025-12-24 @ 7:08 PM
NCT ID:
NCT05637957
Eligibility Criteria:
Inclusion Criteria:
* Stroke or moderate to severe traumatic brain injury, diagnosed with imaging (e.g., MRI, CT scan);
* 5-18 years of age inclusive (at time of study enrolment);
* In the outpatient stage of rehabilitiation
* Followed by a physician through ABI medical follow-up clinic at Holland Bloorview OR previously admitted to the inpatient ABI program at Holland Bloorview;
* Medically stable, as determined by their ABI physician;
* Walks a minimum of 10m with or without assistance;
* Stands independently for 10s;
* Balances for less than 20s on most affected leg;
* Hemiplegia, identified by decreased selective motor control at one ankle compared to the other (i.e., decreased ability to isolate ankle plantar flexion and dorsiflexion on the more affected ankle);
* Available to attend twice weekly appointments for five weeks, as well as a two-hour baseline and post-treatment assessment;
* Tolerates 2 hours of physiotherapy assessment (with short breaks as needed);
* Tolerates 45 minutes of physiotherapy treatment;
* Capable of participating in standardized physiotherapy assessment, from a cognitive and behavioural perspective; and
* Can communicate discomfort either verbally or non-verbally
* Follows directions provided in English
* Parent/legal guardian can read and speak English
Exclusion Criteria:
* Admitted to acute care or inpatient rehabilitation hospital
* Seizure(s) in the last 6 months;
* Planned medication changes during study (i.e., any medication that affects their ability to participate in therapy from a physical, cognitive, emotional standpoint);
* Botox injections in the last 3 months;
* Brain tumour;
* Metal implants or fragments in the head;
* Cranial bone flap removed;
* Stitches/staples on the head;
* Wounds or unhealed incisions at electrode placement sites;
* Cochlear implant;
* Implanted neurostimulator (e.g., vagal nerve stimulator, deep brain stimulator);
* Cardiac pacemaker;
* Battery-powered medication infusion device (e.g., baclofen or insulin pump);
* Pregnancy;
* Diagnosed with another neuromotor disorder(s) affecting gross motor function (e.g., cerebral palsy, spinal cord injury, etc.…);
* Onset of ABI before the age of two years;
* Neurodegenerative diagnosis;
* Lower extremity weight bearing activity restrictions secondary to injuries (e.g., fracture, ligamentous injury) as present at time of study enrollment;
* Non-orthopaedic activity restrictions that limit gross motor activity (e.g., splenic laceration with orders not to run or jump); or
* Enrolment in another treatment-based research study during the current study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
18 Years
Study:
NCT05637957
Study Brief:
Protocol Section:
NCT05637957