Effet de la réadaptation Sur Les déficiences, Limitations d'activité et Restriction de la Participation Des Enfants présentant Des lésions Neurologiques Non-évolutives (Infirmes Moteurs cérébraux).
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Impairment, disability, participation
研究概览
简要总结
A randomized control trial of "HABIT-ILE" therapy compared with regular / conventional intervention (same amount of hours). The protocols have been developed on the basis of bimanual therapy (HABIT) developed at Columbia University.
详细描述
A randomized control trial of "HABIT-ILE" therapy at intensive frequency contrasted with regular frequency intervention. The protocols have been developed on the basis of bimanual therapy (HABIT) developed at Columbia University. The intervention takes place either in a 2 weeks day and night camp, either in regular/conventional intervention (1 to 5 hours a week). Children of all groups will benefit from 90h of intensive treatment (children in regular frequency will be crossed over afterwards to benefit from HABIT-ILE. Both in the camp and the regular interventions, there is at least one therapist for each child.
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
- 是
入选标准
- •willingness to enter the research program and the testing procedures
排除标准
- •uncontrolled epilepsy
- •upper limb injections in the upper limb during the last six months / or intend to receive during the training period
结局指标
主要结局
Impairment, disability, participation
时间窗: 4 years
The 3 WHO main domains will be investigated. Impairments will be investigated through force, sensory and manipulation testing (including manipulation with mechanical device). Analysis of lower limb is also included in the protocol. Disabilities will be tested through video-taped assessments and questionnaires. Participation will be assessed through questionnaires.
次要结局
未报告次要终点
研究者
Yannick Bleyenheuft
Scientific collaborator, Institute of Neuroscience UCL
University Hospital of Mont-Godinne