Efficacy of Activities-based Locomotor Training in Children With Cerebral Palsy.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Gross Motor Function Measure (GMFM-66)
研究概览
简要总结
This project aims to improve the quality of life and functional outcomes for young non-ambulatory children with Cerebral Palsy (CP) by investigating the efficacy of an Activities-Based Locomotor Training (AB-LT) program compared to usual care. By targeting the body structures, activities, and participation components of the World Health Organization's International Classification of Functioning, Disability, and Health (ICF) framework, this study seeks to enhance our understanding of neuroplasticity and motor learning in this population, offering a novel approach to rehabilitation. Results from this research will lead to more effective, individualized therapies that improve motor function, reduce disability, and ultimately lower the long-term healthcare needs associated with CP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be eligible for this study, the child must be:
- •• Able to hold their head upright for 5 seconds when supported at the trunk in sitting (the minimal amount of head control necessary for safe walking on the partial body weight support system during the AB-LT intervention);
- •Non-ambulatory or not walking as primary means of mobility;
- •Willing to attend the AB-LT intervention at Fortis Therapy Center in Dripping Springs, Texas for 3 hours/ day, 5 days/week, for 3 weeks; and
- •Willing to commit to a total of 7 weeks of the study, and to continue their usual care during the time period in which they are not enrolled in the AB-LT intervention.
排除标准
- •The child must not have:
- •• Surgery or botulinum toxin injections in the previous 6 months;
- •Uncontrolled epilepsy; and
- •Uncontrolled cardiovascular disease
结局指标
主要结局
Gross Motor Function Measure (GMFM-66)
时间窗: 4 testing sessions: Baseline, end of week 3, end of week 4, end of week 7.
The GMFM-66 is the gold standard for measuring gross motor function in children with CP. A child's capabilities are scored across five dimensions (66 items), including Lying and Rolling (Dimension A), Sitting (Dimension B), Crawling and Kneeling (Dimension C), Standing (Dimension D), and Walking, Running, and Jumping (Dimension E).
次要结局
- functional near infrared spectroscopy (fNIRS)(4 testing sessions: Baseline, end of week 3, end of week 4, end of week 7.)
- Child Engagement in Daily Life (CEDL)(4 testing sessions: Baseline, end of week 3, end of week 4, end of week 7.)