Linking Neuroplasticity With the Outcomes of Motor Learning Based Interventions: Multi-modal Evaluation of Walking-based Training in Children and Youth With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Change from baseline in functional activity in lower-limb related cortical areas, assessed using functional MRI (fMRI)
研究概览
简要总结
The purpose of this study is to determine the associations between changes in neural activity and structure, advanced gross motor skills, gait characteristics, and physical activity participation following a gait-related intervention that is based on motor learning principles for ambulatory children and youth with hemiplegic and diplegic cerebral palsy. The investigators' hypothesis is that in conjunction with a program of motor learning based training, functional neuroplastic changes in the involved motor areas will be strongly associated with changes in gait and advanced gross motor skills, moderately associated with physical activity based participation changes, and will have a fair association with structural neuroplastic change.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 7 to17 years inclusive;
- •GMFCS Level I or II;
- •Able to follow testing and motor imagery instructions;
- •Able to actively participate in a minimum of 45 minutes of physical activity;
- •Able to independently dorsiflex both ankles;
- •Able to commit to attendance of sessions two to three times weekly for six weeks.
排除标准
- •Orthopaedic surgery within the last 9 months (muscle) or 12 months (bone);
- •Botulinum toxin-A (BTX-A) injections to lower limb in the last 4 months;
- •Inability to discontinue BTX-A for period of 12 weeks (during trial) due to concerns about ROM or pain;
- •Severe spasticity (may be a contraindication for neuroimaging procedures);
- •Seizure disorder (if not fully controlled by medication for the 12 months);
- •Not prepared or unable to discontinue a regular lower limb therapy intervention during the course of the trial;
- •Involved in another intervention study;
- •Standard MRI contraindications (e.g., metal implants such as cochlear implant, claustrophobia).
结局指标
主要结局
Change from baseline in functional activity in lower-limb related cortical areas, assessed using functional MRI (fMRI)
时间窗: 7 days pre/7 days post training intervention
Change from baseline in advanced motor skills on the Challenge Module
时间窗: 7 days pre/7 days post/4-months post training intervention
The Challenge Module is a new published measure of advanced motor skills.
次要结局
- Change from baseline in resting state activity, assessed using resting state fMRI(7 days pre/7 days post training intervention)
- Mental chronometry: walking(7 days pre/7days post/4-months post intervention)
- Change from baseline in walking activity, assessed using a StepWatch accelerometer(7 days pre/7days post/4-months post training intervention)
- Change from baseline in walk speed on the Six-minute walk test(7 days pre/7days post/4-months post training intervention)
- Change from baseline in targeted goal abilities and satisfaction with performance as measured by the Canadian Occupational Performance Measure(7 days pre/7days post/4-months post training intervention)
- Motor learning as evaluated using retention and transfer tests(Week 2, 4, 6)
- Change from baseline in microstructure of brain, assessed using diffusion tensor imaging (DTI)(7 days pre/7 days post training intervention)
- Change from baseline in Physical Activity self-efficacy(7 days pre/7days post/4-months post training intervention)
- Motor learning content of interventions, as assessed using the Motor Learning Strategy Rating Instrument (MLSRI)(Week 2, 4, 6)
- Change from baseline in lower-limb proprioception(7 days pre/7days post/4-months post intervention)
- Change from baseline in gait kinematics as measured using an electronic walkway(7 days pre/7days post/4-months post training intervention)
- Change from baseline in gait kinetics/kinematics as measured using 3D motion capture system(7 days pre/7days post/4-months post training intervention)
- Change from baseline in physical activity participation, as measured using the Participation and Environment Measure for Children/Youth (PEM-CY)(7 days pre/7days post/4-months post training intervention)
- Change from baseline in targeted goal abilities as measured by Goal Attainment Scaling (GAS)(7 days pre/7days post/4-months post training intervention)