Effet de la réadaptation Sur Les déficiences, Limitations d'activité et Restriction de la Participation Des Enfants présentant Des lésions Neurologiques Non-évolutives. Part IIb
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in activity measure (questionnaires)
研究概览
简要总结
Studying in a RCT the changes in everyday llife activities of children with CP during HABIT-ILE or control period, changes being scored by parents and by experts.
详细描述
Studying in a RCT the changes in everyday llife activities of children with CP (unilateral and bilateral) during HABIT-ILE or control period, changes being scored by parents and by experts on ABILHAND-Kids, the PEDI, the ACTIVLM-CP and the COPM. Investigate neuroplastic changes and correlation with everyday life changes.
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 (Care Provider, 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
- •cerebral palsy
- •ability to make a few steps with a walking device
- •ability to pick a light object from a table with the more affected hand
- •ability to understand simple games
排除标准
- •no active seizure
- •no botulinum toxin in the 6 months previous to the intervention or during intervention time
- •major visual deficit
研究组 & 干预措施
HABIT-ILE
HABIT-ILE (Hand and arm bimanual intensive therapy including lower extremities) will be applied over 2 weeks.
干预措施: HABIT-ILE (Other)
Control
A two weeks period of usual customary care.
干预措施: Control (Other)
结局指标
主要结局
Change in activity measure (questionnaires)
时间窗: 2 weeks of intervention and 4 months (follow-up)
change in a measure of daily activities through ABILHAND-Kids, ACTIVLIM-CP and the COPM
次要结局
- neuroplastic changes in the cortex (MRI, fMRI, DTI, TMS)(baseline and 2 weeks of intervention)
研究者
Yannick Bleyenheuft
Professor
Université Catholique de Louvain