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Clinical Trials/NCT01773369
NCT01773369CompletedNot Applicable

Intensive Motor Training After Perinatal Stroke to Enhance Walking

University of Alberta3 sites in 1 country33 target enrollmentStarted: November 1, 2012Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
33
Locations
3
Primary Endpoint
Change in Gross Motor Function Measure - 66 (GMFM-66) from baseline

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
8 Months to 4 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Change in Gross Motor Function Measure - 66 (GMFM-66) from baseline

Time Frame: Pre baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months and at 4 years of age

This is a 66 item criterion-referenced observational measure to assess change in gross motor function of children with cerebral palsy. Two measures will occur within two weeks prior to beginning training/delay phase (called pre baseline and baseline), monthly measures will occur thereafter for 6 months, then one final assessment when the child turns 4 years old, for a total of 9 measures.

Secondary Outcomes

  • Change in kinematics and forces during treadmill walking from baseline(Pre baseline, 3 months, 6 months)
  • Change in activity monitored at home from baseline(Pre baseline, 3 months, 6 months, at 4 years of age)
  • Gait analysis(At 4 years of age)
  • Change in tendon reflexes from baseline(Pre baseline, 3 months, 6 months and at 4 years of age)
  • Change in transcranial magnetic stimulation from baseline(Pre baseline, 3 months, 6 months, at 4 years of age)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (3)

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