Intensive Motor Training After Perinatal Stroke to Enhance Walking

Perinatal Stroke Clinical Trial

Official title:

Intensive Motor Training After Perinatal Stroke to Enhance Walking

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01773369
• Other study ID #: Pro00032297
• Status: Completed
• Phase: N/A
• Start date: November 1, 2012
• Est. completion date: November 2, 2020

Study information

• Verified date: November 2020
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: November 2, 2020
• Est. primary completion date: June 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Months to 4 Years

Eligibility

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

Related Conditions & MeSH terms

• Perinatal Stroke
• Stroke

Intervention

Behavioral:
• Early leg training
Children will engage in ~1 hour/day, 4 days/week treatment for 3 months. The treadmill will consist of supported walking on a treadmill, over ground, stair climbing, standing, kicking, splashing ... etc. leg activity. Activities will be directed by a physical therapist in the clinical setting.
• Delayed leg training
The training activity will be exactly the same as the Early leg training group, except that it will occur ~3 months after recruitment.
• Parent leg training
Children will engage in ~1 hour/day, 4 days/week treatment for 3 months. The treadmill will consist of supported walking on a treadmill, over ground, stair climbing, standing, kicking, splashing ... etc. leg activity. Activities will be directed by parents in their home or community environment.

Locations

Country	Name	City	State
Canada	Alberta Children's Hospital	Calgary	Alberta
Canada	University of Alberta	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	Alberta Innovates Health Solutions

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Gross Motor Function Measure - 66 (GMFM-66) from baseline	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.	Pre baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months and at 4 years of age
Secondary	Change in kinematics and forces during treadmill walking from baseline	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.	Pre baseline, 3 months, 6 months
Secondary	Change in tendon reflexes from baseline	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.	Pre baseline, 3 months, 6 months and at 4 years of age
Secondary	Change in transcranial magnetic stimulation from baseline	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.	Pre baseline, 3 months, 6 months, at 4 years of age
Secondary	Change in activity monitored at home from baseline	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.	Pre baseline, 3 months, 6 months, at 4 years of age
Secondary	Gait analysis	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	At 4 years of age