Intensive Motor Training After Perinatal Stroke to Enhance Walking

University of Alberta

Status: Completed

Conditions: Perinatal Stroke

Treatments: Behavioral: Delayed leg training; Behavioral: Parent leg training; Behavioral: Early leg training

Study type: Interventional

Funder types: Other

Identifiers

NCT01773369

Pro00032297

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 8 months to 4 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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33 participants in 4 patient groups

Early treatment group

Experimental group

Description:

These children will undergo the intervention (i.e., early leg training) shortly after recruitment. Measures will be taken before, during and after the intervention.

Treatment:

Behavioral: Early leg training

Delayed treatment group

Experimental group

Description:

These children will undergo the intervention (delayed leg training) after a delay of ~3 months, during which outcome measures will be taken so that they can serve as a control for the early treatment group. Their intervention is identical to the Immediate treatment group.

Treatment:

Behavioral: Delayed leg training

Control group

No Intervention group

Description:

These children will be recruited close to the age of 4 years old, and will only undergo gait analysis and GMFM-66 scoring.

Parent training group

Experimental group

Description:

These children will undergo the intervention (i.e., parent leg training) shortly after recruitment. Parents will be trained to provide the intervention instead of a physical therapist. Measures will be taken before, during and after the intervention.

Treatment:

Behavioral: Parent leg training