Linking Neuroplasticity With the Outcomes of Walking-based Interventions: A Feasibility Trial Comparing a Motor Learning Versus a Strength-based Program in Children With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change from baseline in advanced motor skills on the Challenge Module
研究概览
简要总结
The purpose of this study is to compare a motor learning (ML)-based gait-related training intervention to a functional lower limb strength training intervention, with a concurrent evaluation of functional, neural and participation outcomes for children and youth with Cerebral Palsy (CP).
This study is a two-group, parallel arm RCT in which twenty-two children with CP in GMFCS Levels I-II will be randomly allocated to a 6-week, 16 session program of: (i) ML based gait training or (ii) lower limb strength training. Outcome assessments occur pre/post/4-months post-intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •7-17 years old
- •diagnosis of hemiplegic or diplegic Cerebral Palsy
- •GMFCS Level I-II
- •able to follow testing and motor imagery instructions
- •able to actively participate in a minimum of 45 minutes (min) of physical activity
- •show evidence of independent dorsiflexion of 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 put BTX-A on hold during trial
- •severe spasticity (may be a contraindication for neuroimaging procedures)
- •seizure disorder (if not fully controlled by medication for 12 months)
- •not prepared or unable to discontinue any formal lower limb therapy intervention or physical activity program during the trial
- •involved in another intervention study
- •standard MRI contraindications (e.g., magnetic implants, inability to lay still, claustrophobia etc.)
研究组 & 干预措施
BeSTRONG
Lower limb strength training program involving progressive muscle resistance exercises.
干预措施: BeSTRONG (Behavioral)
BeFAST
Motor learning-based program involving athletic lower extremity training of gait-related skills.
干预措施: BeFAST (Behavioral)
结局指标
主要结局
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 walk speed on the Six-minute walk test(7 days pre/7days post/4-months post training intervention)
- 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)
- Change from baseline in functional activity in lower-limb related cortical areas, assessed using functional MRI (fMRI)(7 days pre/7 days post training 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 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)
- Change from baseline in resting state activity, assessed using resting state fMRI(7 days pre/7 days post training intervention)
- Change from baseline in walking activity, assessed using an Actigraph accelerometer(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)