Effectiveness of Unilateral Versus Bilateral Intensive Training in Children With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Changes from Satisfactory Questionnaire (SQ)
研究概览
简要总结
This 3-year research project aims to investigate and compare the immediate and long-term treatment effectiveness as well as motor improving curve and potential predictors of the unimanual intensive training and bimanual intensive training protocols with an equivalent intervention period in children with hemiplegic CP and children with CP with apparently one side affected. In addition, based on the ICF-CY model, comprehensive outcome measures including motor functions as well as psychological functions will be included.
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
- 3 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Changes from Satisfactory Questionnaire (SQ)
时间窗: baseline, week 4, week 8, week 24
Changes from Building Tower Test (BTT)
时间窗: weekly test (from baseline to week 8)
Changes from Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2)
时间窗: baseline, week 4, week 8, week 24
Changes from Test of Playfulness (ToP)
时间窗: week 1, week 4, week 5, week 8
Changes from Box and Block Test (BBT)
时间窗: weekly test (from baseline to week 8)
Changes from Pediatric Motor Activity Log-Revised (PMAL-R)
时间窗: baseline, week 4, week 8, week 24
Changes from ABILHAND-Kids
时间窗: baseline, week 4, week 8, week 24
Changes from Melbourne Assessment 2 (MA-2)
时间窗: baseline, week 4, week 8, week 24
Performance changes assessed by Kinematics Analysis
时间窗: baseline, week 8, week 24
Kinematic Analysis including parameters of endpoint control, inter-joints coordination, and trunk involvement, we will analyse children's performance changes from performing reaching tasks
Changes from Engagement Questionnaire (EQ)
时间窗: weekly test (from week 1 to week 8)
Changes from String Beads Test (SBT)
时间窗: weekly test (from baseline to week 8)
Changes from muscle strength
时间窗: baseline, week 8, week 24
Measured by Electromyography (EMG)
次要结局
- Changes from Pediatric Evaluation of Disability Inventory (PEDI)(baseline, week 4, week 8, week 24)
- Changes from Parenting Stress Index-Short Form (PSI-short)(baseline, week 4, week 8, week 24)
- Changes from Cerebral Palsy Quality of Life Questionnaire for Children (CPQOL)(baseline, week 4, week 8, week 24)