Status:
TERMINATED
Does Physiotherapy Plus Non-invasive Brain Stimulation Improve Motor Recovery in Children With Acquired Brain Injury?
Lead Sponsor:
Holland Bloorview Kids Rehabilitation Hospital
Conditions:
Acquired Brain Injury
Recovery of Function
Eligibility:
All Genders
5-18 years
Phase:
NA
Brief Summary
The current study will evaluate the feasibility of transcranial direct current stimulation (tDCS) combined with an existing intensive physiotherapy program for children with ABI within the in/day-pati...
Detailed Description
Objectives The purpose of this study is to test the feasibility of using tDCS as a pre-treatment adjunct to intensive physiotherapy (the 'physio+tDCS' protocol) for children with ABI in the inpatient...
Eligibility Criteria
Inclusion
- sustained a cerebral stroke (ischaemic or haemorrhage) or TBI within the last three months;
- admitted to Holland Bloorview for intensive brain injury rehabilitation in the in/day patient programs;
- medically stable, as determined by their primary physician at Holland Bloorview;
- receiving active motor learning-based physiotherapy intervention four to five times per week, as prescribed by their treating PT;
- tolerate approximately 45 minutes of physiotherapy intervention;
- able to sit at the edge of the bed independently for 5s
- capable of participating in standardized physiotherapy assessment, from a cognitive and behavioural perspective, and;
- able to communicate discomfort (verbally or non-verbally).
Exclusion
- primary injury of the cerebellum
- pre-existing seizure disorder (i.e., prior to ABI);
- anti-seizure medication not optimized at the time of study enrollment (i.e., physician is actively adjusting type or dose of anti-seizure medication)
- brain tumour;
- metal implants in the head;
- cranial bone flap removed;
- stitches/staples or open wound on the head;
- experience with tDCS in the last two years (as knowledge of the sensation of active tDCS will affect blinding of treatment groups);
- diagnosed with another neurological disorder(s) affecting gross motor function (e.g., cerebral palsy, spinal cord injury, guillain-barre syndrome, etc…);
- requires more than 15 minutes per physiotherapy treatment session of non-motor learning content (e.g., behavioural redirection, craniosacral therapy, vestibular therapy, passive range of motion)
- lower extremity weight bearing activity restrictions secondary to injuries (e.g., fracture, ligamentous injury)(at the time of study enrollment)
- non-orthopaedic physical activity restrictions secondary to other injuries (e.g., splenic laceration)
- balances on most affected leg for greater than 5s
- enrolment in another treatment-based research study
Key Trial Info
Start Date :
January 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2021
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04422886
Start Date
January 15 2020
End Date
September 30 2021
Last Update
November 30 2022
Active Locations (1)
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1
Holland Bloorview Kids Rehabilitation Hospital
Toronto, Ontario, Canada, M4G 1R8