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Recruiting NCT05637957

Feasibility of tDCS as an Adjunct to Outpatient Physiotherapy in Children With ABI

Conditions: Acquired Brain Injury, Stroke, Traumatic Brain Injury, Hemiparesis

Sex: All
Ages: 5 Years – 18 Years
Phase: NA
Enrollment: 10
Sponsor: Holland Bloorview Kids Rehabilitation Hospital

Location: Canada

Summary

This study will evaluate the feasibility of transcranial direct current stimulation (tDCS) as an adjunct to an outpatient motor skills-based physiotherapy intervention for children and youth with acquired brain injury. Up to 10 children (age 5-18 years) with childhood onset stroke or traumatic brain injury will be randomly allocated to receive active or sham anodal tDCS immediately prior to the physiotherapy session. These sessions will occur twice weekly for a total of 10 sessions. Assessment of gross motor outcome measures will occur immediately before and after the combined tDCS and physiotherapy treatment protocol. The preliminary treatment effect between the two treatment groups will be compared and other feasibility indicators will be evaluated.

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 rehabilitiationFollowed 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; andCan communicate discomfort either verbally or non-verballyFollows directions provided in EnglishParent/legal guardian can read and speak EnglishExclusion Criteria:Admitted to acute care or inpatient rehabilitation hospitalSeizure(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); orEnrolment in another treatment-based research study during the current study

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05637957). StuddyBuddy aggregates publicly available trial information.