NCT04516876招募中不适用
Efficacy Research of Bimanual Intensive Training in Children With Hemiplegic Cerebral Palsy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Score changes of Melbourne Assessment 2
研究概览
简要总结
This research project aims to investigate the feasibility, efficacy, and acceptability of camp-based model of BIT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of cerebral palsy(CP) with one or more affected sides.
- •Considerable nonuse of the affected upper limb (amount-of-use score of the Pediatric Motor Activity Log < 2.5).
- •No excessive muscle tone (Modified Ashworth Scale ≤ 2 at any joints of the upper limb) before beginning treatment.
- •No severe cognitive, visual, or auditory disorders according to medical documents, parental reports, and the examiner 's clinical observation.
- •No injections of botulinum toxin type A or operations on the upper limb within 6 months.
排除标准
- 未提供
结局指标
主要结局
Score changes of Melbourne Assessment 2
时间窗: baseline, after one week, after 2 months, after 6 months
The Melbourne Assessment 2(MA2) was developed to investigate the objective upper-limb movement in children with CP aged 2.5 to 15 years.The four main elements of movement quality include (1) amount of active ROM; (2) accuracy; (3) dexterity of finger movements; and (4) fluency or smoothness of movement. The scoring sheet consists of 3-, 4-, or 5-point scales from 0 to 4 that allocate scores on the 14 items.Higher scores mean a better outcome.
次要结局
- Score changes of Test of Playfulness(from the first day to the sixth day of the intervention)
- Score changes of ABILHAND-kids Questionnaire(baseline, after one week, after 2 months, after 6 months)
- Score changes of Pediatric Engagement Questionnaire(from the first day to the sixth day of the intervention)
- Score changes of Bruininks-Oseretsky Test of Motor Proficiency(baseline, after one week, after 2 months, after 6 months)
- Score changes of Box and Block test(baseline, after one week, after 2 months, after 6 months)
- Score changes of Pediatric Motor Activity Log-Revised(baseline, after one week, after 2 months, after 6 months)
- Score changes of Dimensions of Mastery Questionnaire(baseline, after one week, after 2 months, after 6 months)
- Performance changes of motion analysis(baseline, after one week, after 2 months, after 6 months)
- Score changes of Pediatric Evaluation of Disability Inventory(baseline, after one week, after 2 months, after 6 months)
- Score changes of Client Satisfaction Questionnaire(from the first day to the sixth day of the intervention)
- Score changes of Parenting Stress Index-Short Form(baseline, after one week, after 2 months, after 6 months)
研究者
研究点 (2)
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