Intensive Motor Training After Perinatal Stroke to Enhance Walking
1 other identifier
interventional
33
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2012
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 30, 2012
CompletedFirst Posted
Study publicly available on registry
January 23, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 25, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 2, 2020
CompletedNovember 5, 2020
November 1, 2020
6.6 years
November 30, 2012
November 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Change in kinematics and forces during treadmill walking from baseline
Pre baseline, 3 months, 6 months
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
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
Study Arms (4)
Early treatment group
EXPERIMENTALThese children will undergo the intervention (i.e., early leg training) shortly after recruitment. Measures will be taken before, during and after the intervention.
Delayed treatment group
EXPERIMENTALThese 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.
Control group
NO INTERVENTIONThese 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
EXPERIMENTALThese 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.
Interventions
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.
The training activity will be exactly the same as the Early leg training group, except that it will occur \~3 months after recruitment.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Albertalead
- Alberta Innovates Health Solutionscollaborator
Study Sites (2)
Alberta Children's Hospital
Calgary, Alberta, Canada
University of Alberta
Edmonton, Alberta, T6G 2G4, Canada
Related Publications (1)
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.
PMID: 35427191DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jaynie Yang, PhD
University of Alberta
- PRINCIPAL INVESTIGATOR
Monica Gorassini, PhD
University of Alberta
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2012
First Posted
January 23, 2013
Study Start
November 1, 2012
Primary Completion
June 25, 2019
Study Completion
November 2, 2020
Last Updated
November 5, 2020
Record last verified: 2020-11