Clinical trial NCT01773369: Intensive Motor Training After Perinatal Stroke to Enhance Walking
Official title: Intensive Motor Training After Perinatal Stroke to Enhance Walking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perinatal Stroke
Keywords: cerebral palsy
physical therapy
rehabilitation
hemiplegia
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Alberta Innovates Health Solutions
First posted: 2013-01-23
Enrollment: 33
Sex: ALL
Minimum age (years): 8
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Early childhood injuries such as perinatal (around birth) stroke are devastating because the child lives with the problem for life, typically close to a normal lifespan. One 'opportunity' presented by a brain injury early in life compared to later in adulthood is that the young brain is much more plastic (malleable) and receptive to interventions. This is particularly true for neural circuits that are still under development. We will test the hypothesis that early (\<2 yr old), intensive leg training will improve walking more than no training or training at \>2 yr old. We will further determine the changes induced by training in motor and sensory pathways.

Detailed description: Children 8 mo to 3 yr old with unilateral perinatal stroke will be randomized into either: 1) Immediate Training, or 2) Delayed Training groups. The Immediate Group will train for 3 mo shortly after recruitment. The Delayed Group will go through the same measurements from the time of recruitment and at 3 mo later (with no training in between) to obtain a 3 mo change score which will serve as a control measure for the Immediate Group. The Delayed Group will also train after the 3 mo delay, when all control measures have been taken. Comparison of the improvements made by children who started training \<2 yr old with those \>2 yr old will answer the question if training at \<2 yr old is better than \>2 yr old. Finally, to determine if there are long term effects of this training, we will compare outcomes of these trained children with another group of children with the same injuries but no intensive training (i.e., too old for the training study), when all children turn 4 yr old. Clinical, kinematic and electrophysiological measures will be taken to help us understand not only the efficacy of the treatment, but also the neural mechanisms that might underlie improvements in outcome.

We are measuring outcomes at multiple times because change scores are of most interest. All children change as they age, so it is critical that we compare the change score with and without intervention.

Eligibility criteria: Inclusion Criteria:

* hemiplegia with confirmation of perinatal stroke through magnetic resonance imaging
* born near term (\> or equal to 36 weeks gestation)
* current age between 8 months to 3.0 years old; or currently 4 years old (control)
* no other neurological disorders
* informed consent from parent or guardian

Exclusion Criteria:

* central nervous system injury besides the one-sided stroke
* musculoskeletal problems that limit leg activity
* cognitive, behavioral or developmental impairments that preclude participation in the protocol
* unstable epileptic seizures within the last 6 months
* any contraindications to transcranial magnetic stimulation
* Botox injection in the legs over the last 6 months

Primary outcomes:
measure: Change in Gross Motor Function Measure - 66 (GMFM-66) from baseline
timeFrame: Pre baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months and at 4 years of age
Secondary outcomes:
measure: Change in kinematics and forces during treadmill walking from baseline
timeFrame: Pre baseline, 3 months, 6 months
measure: Change in tendon reflexes from baseline
timeFrame: Pre baseline, 3 months, 6 months and at 4 years of age
measure: Change in transcranial magnetic stimulation from baseline
timeFrame: Pre baseline, 3 months, 6 months, at 4 years of age
measure: Change in activity monitored at home from baseline
timeFrame: Pre baseline, 3 months, 6 months, at 4 years of age
measure: Gait analysis
timeFrame: At 4 years of age
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Jaynie Yang, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alberta
name: Monica Gorassini, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hurd C, Livingstone D, Brunton K, Smith A, Gorassini M, Watt MJ, Andersen J, Kirton A, Yang JF. Early, Intensive, Lower Extremity Rehabilitation Shows Preliminary Efficacy After Perinatal Stroke: Results of a Pilot Randomized Controlled Trial. Neurorehabil Neural Repair. 2022 Jun;36(6):360-370. doi: 10.1177/15459683221090931. Epub 2022 Apr 15.