Intensive Motor Training After Perinatal Stroke to Enhance Walking
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Perinatal Stroke
- 发起方
- University of Alberta
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Change in Gross Motor Function Measure - 66 (GMFM-66) from baseline
- 状态
- 已完成
- 最后更新
- 5年前
概览
简要总结
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.
详细描述
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.
研究者
入排标准
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in Gross Motor Function Measure - 66 (GMFM-66) from baseline
时间窗: 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.
次要结局
- 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)