Effect of Rehabilitation in Deficiencies, Activities Limitations and Restrictions of the Participation of the Children Presenting Neurological Lesions. Impact of Contextual Factors on the Functioning of These Patients. Part II
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- change in "Ogden Figure" test
研究概览
简要总结
This study aims to investigate the changes induced by HABIT-ILE in impairments, activity and participation of children with unilateral CP, as well as neuroplastic changes induced by the treatment. Visuospatial deficits will be investigated and the effect of prismatic adaptation will be measured.
详细描述
This study aims to investigate the changes induced by HABIT-ILE at the 3 levels of the international classification of functioning and health (ICF) in children with unilateral CP, as well as neuroplastic changes induced by the treatment. Visuospatial deficits will be investigated and the effect of prismatic adaptation will be measured.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •unilateral CP
- •minimal ability to pick an light object from a table
排除标准
- •no active seizure
- •no botox or orthopedic intervention in the 6 months preceding the study or during the study
结局指标
主要结局
change in "Ogden Figure" test
时间窗: at baseline and after 90 hours/two weeks of intensive bimanual intervention
number of elements omitted when reproducing a drawing
visuo-spatial pointing
时间窗: at baseline and after 90 hours/two weeks of intensive bimanual intervention
pointing in a blind box in the direction of a visual cue, measuring the deviation from midline
changes in star cancellation
时间窗: at baseline and after 90 hours/two weeks of intensive bimanual intervention
number of little stars omitted in a frame including many stars of different size
changes in line bissection
时间窗: at baseline and after 90 hours/two weeks of intensive bimanual intervention
deviation from midline during line section
proprioceptive pointing
时间窗: at baseline and after 90 hours/two weeks of intensive bimanual intervention
pointing without any visual feedback in the direction of body midline and measuring deviation
次要结局
- Jebsen-Taylor test of hand function(at baseline and after 90 hours/two weeks of intensive bimanual intervention)
- functional magnetic resonance imaging (fMRI)(at baseline and after 90 hours/two weeks of intensive bimanual intervention)
- Assisting Hand Assessment(at baseline and after 90 hours/two weeks of intensive bimanual intervention)
- "ABILHAND-Kids" questionnaire(at baseline and after 90 hours/two weeks of intensive bimanual intervention)
- diffusion tensor imaging (DDTI)(at baseline and after 90 hours/two weeks of intensive bimanual intervention)
- Box and blocks(at baseline and after 90 hours/two weeks of intensive bimanual intervention)
- "ACTIVLIM-CP" questionnaire(at baseline and after 90 hours/two weeks of intensive bimanual intervention)
- Canadian Occupationnal Performance Measure(at baseline and after 90 hours/two weeks of intensive bimanual intervention)
研究者
Yannick Bleyenheuft
Professor
Université Catholique de Louvain