Effectiveness of Unilateral Versus Bilateral Intensive Training in Children With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 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
- •of this study are:
- •aged between 3 and 16 years
- •diagnosed with congenital hemiplegic or children with CP with one more affected side; (3) apparently disuse phenomenon of the more affected hand at spontaneous contexts
- •Participants will be exclude for:
- •excessive muscle tone (Modified Ashworth Scale ≤ 2 at any joints of the upper limb) before beginning treatment (Bohannon & Smith, 1987)
- •severe cognitive, visual, or auditory disorders according to medical documents, parental reports, and the examiner's clinical observation
- •injections of botulinum toxin type A or operations on the UE within 6 months
排除标准
- 未提供
研究组 & 干预措施
unilateral upper limbs intensive training
The unimanual intensive training group focuses on the training of the more affected arm and restraint the less affected arm.
干预措施: unilateral upper limbs intensive training (Other)
bilateral upper limbs intensive training
The bimanual intensive training focuses activities that required the use of both hands.
干预措施: bilateral upper limbs intensive training (Other)
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 Engagement Questionnaire (EQ)
时间窗: weekly test (from week 1 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
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 Box and Block Test (BBT)
时间窗: weekly test (from baseline to week 8)
Changes from String Beads Test (SBT)
时间窗: weekly test (from baseline to week 8)
Changes from Melbourne Assessment 2 (MA-2)
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 Test of Playfulness (ToP)
时间窗: week 1, week 4, week 5, 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 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)