Implementation of a New Interactive Interface Applying Motor Skill Learning Principles to Generate Motor, Functional and Neuroplastic Changes During High and Low Dosage Interventions in Children With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Change from baseline 6 Minutes Walking Test score at 1 week post-camp
研究概览
简要总结
Study of the efficiency of a new interactive interface to apply all the therapeutic principles of motor skill learning used in high dosage intensive interventions. Investigation of its effects on motor, functional and neuroplastic changes in children after high and low dosage intensive interventions using or not the interface.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of unilateral cerebral palsy
- •MACS level I, II or III
- •GMFCS level I, II, III
排除标准
- •unstable seizure
- •cognitive deficit that prevent understanding of simple games
- •botulinic toxin injection, surgery, or another unusual intervention in the 6 months preceding the study and for the duration of the study
结局指标
主要结局
Change from baseline 6 Minutes Walking Test score at 1 week post-camp
时间窗: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Measurement developped to assess the exercise tolerance and walking abilities by asking the patient to walk as much as possible during 6 minutes in a 30 meters long corridor
Change from baseline Assisting Hand Assessments score at 1 week post-camp
时间窗: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
The Assisting Hand Assessment has been developped to measure and describe the efficacy of use of the affected hand of children with unilateral cerebral palsy bimanual activity performance. This is a standardized criterion-referenced test. It is conducted as a recorded semi-structured play session using specific objects usually used in a bimanual manner. With twenty-two test items, the child's performance is measured and obtain a sum score measure and a scaled score (percent scale).
次要结局
- Change from baseline ACTIVLIM-CP questionnaire score at 1 week post-camp(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
- Change from baseline Jebsen-Taylor Test of Hand Function score at 1 week post-camp(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
- Change from baseline Modified Cooper test at 1 week post-camp(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
- Change from baseline MHAVIE-child questionnaire score at 1 week post-camp(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
- Change from baseline Box and Blocks test score at 1 week post-camp(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
- Change from baseline ABILHAND-Kids questionnaire score at 1 week post-camp(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
- Change from baseline ABILOCO-Kids questionnaire at 1 week post-camp(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
- Change from baseline Pediatric Evaluation of Disability Inventory score at 1 week post-camp(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
- Change from baseline Canadian Occupational Performance Measure scores at 1 week post-camp(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
研究者
Yannick Bleyenheuft
Professor
Université Catholique de Louvain