Clinical Trial: Intensive Motor Training After Perinatal Stroke to Enhance Walking

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Intensive Motor Training After Perinatal Stroke to Enhance Walking

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 Summary:

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.

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Change in kinematics and forces during treadmill walking from baseline [ Time Frame: Pre baseline, 3 months, 6 months ]
  The child will be supported to walk on a treadmill while we record the leg motions and the forces under the feet during walking. Two measures will occur within two weeks prior to beginning training/delay phase (called pre baseline and baseline), then after each of the training/delay periods, for a total of 5 measures.
• Change in tendon reflexes from baseline [ Time Frame: Pre baseline, 3 months, 6 months and at 4 years of age ]
  The patellar tendon reflexes will be induced by tapping the left and right tendon using a reflex hammer. The response in leg muscles will be recorded with surface electromyography. Two measures will occur within two weeks prior to beginning training/delay phase (called pre baseline and baseline), after each of the training/delay periods, then a final measure when the child turns 4 yr old for a total of 5 measures.
• Change in transcranial magnetic stimulation from baseline [ Time Frame: Pre baseline, 3 months, 6 months, at 4 years of age ]
  Transcranial magnetic stimulation (TMS) is a non-invasive way to activate brain cells. A single or double pulse is applied over the motor area of the brain (feels like a tap to the head), and the response is measured in leg muscles using electromyography. The safety concern is that people who are prone to seizures or have implants in their head should not have TMS. Two measures will occur within two weeks prior to beginning training/delay phase (called pre baseline and baseline), after each of the training/delay periods, then a final measure when the child turns 4 yr old for a total of 5 measures.
• Change in activity monitored at home from baseline [ Time Frame: Pre baseline, 3 months, 6 months, at 4 years of age ]
  The child will wear a small activity monitor on each ankle for 3 days, so that we can determine how active the child is at home. Two measures will occur within two weeks prior to beginning training/delay phase (called pre baseline and baseline), after each of the training/delay periods, then a final measure when the child turns 4 yr old, for a total of 5 measures.
• Gait analysis [ Time Frame: At 4 years of age ]
  The child's walking over ground will be recorded with video cameras, force plates and surface electromyography to determine their walking pattern at 4 years old. This measure will be taken just once when the child is age 4 yr old

Original Secondary Outcome:

• Change in kinematics and forces during treadmill walking from baseline [ Time Frame: Pre baseline, 3 months, 6 months ]
  The child will be supported to walk on a treadmill while we record the leg motions and the forces under the feet during walking. Two measures will occur within two weeks prior to beginning training/delay phase (called pre baseline and baseline), then after each of the training/delay periods, for a total of 5 measures.
• Change in tendon reflexes from baseline [ Time Frame: Pre baseline, 3 months, 6 months and at 4 years of age ]
  The patellar tendon reflexes will be induced by tapping the left and right tendon using a reflex hammer. The response in leg muscles will be recorded with surface electromyography. Two measures will occur within two weeks prior to beginning training/delay phase (called pre baseline and baseline), after each of the training/delay periods, then a final measure when the child turns 4 yr old for a total of 5 measures.
• Change in transcranial magnetic stimulation from baseline [ Time Frame: Pre baseline, 3 months, 6 months, at 4 years of age ]
  Transcranial magnetic stimulation (TMS) is a non-invasive way to activate brain cells. A single or double pulse is applied over the motor area of the brain (feels like a tap to the head), and the response is measured in leg muscles using electromyography. The safety concern is that people who are prone to seizures or have implants in their head should not have TMS. Two measures will occur within two weeks prior to beginning training/delay phase (called pre baseline and baseline), after each of the training/delay periods, then a final measure when the child turns 4 yr old for a total of 5 measures.
• Change in somatosensory evoked potentials from baseline [ Time Frame: Pre baseline, 3 months, 6 months, at 4 years of age ]
  We will use surface electrical stimulation to stimulate a nerve at the ankle and record the activity generated in the brain using electroencephalography (EEG). Surface EEG electrodes will be placed on the head. Two measures will occur within two weeks prior to beginning training/delay phase (called pre baseline and baseline), after each of the training/delay periods, then a final measure when the child turns 4 yr old, for a total of 5 measures.
• Change in activity monitored at home from baseline [ Time Frame: Pre baseline, 3 months, 6 months, at 4 years of age ]
  The child will wear a small activity monitor on each ankle for 3 days, so that we can determine how active the child is at home. Two measures will occur within two weeks prior to beginning training/delay phase (called pre baseline and baseline), after each of the training/delay periods, then a final measure when the child turns 4 yr old, for a total of 5 measures.
• Gait analysis [ Time Frame: At 4 years of age ]
  The child's walking over ground will be recorded with video cameras, force plates and surface electromyography to determine their walking pattern at 4 years old. This measure will be taken just once when the child is age 4 yr old

Dates:
Date Received: November 30, 2012
Date Started: November 2012
Date Completion: December 2017
Last Updated: December 14, 2016
Last Verified: December 2016