Effects of Constraint-induced Movement Therapy With Home-based Hand-arm Bimanual Intensive Therapy in Real-world Bimanual Hand Use in Children With Unilateral Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Change from Assisting Hand Assessment (AHA) score at 2-month follow-up test
研究概览
简要总结
This study evaluates the therapeutic effects of constraint-induced movement therapy (CIMT) with home-based hand-arm bimanual intensive therapy (H-HABIT) with unilateral cerebral palsy. Half of the participants will receive CIMT and H-HABIT and others will only receive CIMT.
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
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 4 to 12 years
- •MACS level 1-3
- •Diagnosed with unilateral CP due to central nervous system lesions
排除标准
- •Severe cognitive dysfunction that rendered them unable to perform simple tasks (e.g., reaching, grasping
- •Untreated seizures
- •Visual or auditory problems interfering with treatment
- •Prior history of musculoskeletal disorders.
- •MACS level 4-5
结局指标
主要结局
Change from Assisting Hand Assessment (AHA) score at 2-month follow-up test
时间窗: baseline and 2 months
AHA is a standardized tool for children(18 months-12 years) with unilateral CP. The AHA measures the child's ability to use the affected hand to assist the unaffected hand in a variety of bimanual activities. The 15-20 minute session uses semi-structured play with specific items. A certified AHA assessor views the videorecording to score the child's displayed willingness and ability to use the weaker arm and hand on each of 22 items from 1 (= does not do) to 4 (= effective). The AHA has inter- and intra-rater reliabilities of 0.98 and 0.97 respectively and content validity established during initial development. For data analysis, we generated AHA Logit scores (as recommended in the administration manual) that transform the raw (ordinal) scores into interval level data.
次要结局
- Change from Baseline Melbourne Assessment 2 (MA2) score at 2-month follow-up test(baseline and 2 months)
- Change from Canadian Occupational Performance Measure (COPM) score at 2-month follow-up test(baseline and 2 months)
- Change from baseline Bilateral magnitude(Accelerometer) at 2-month follow-up test(baseline and 2 months)
- Change from Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT) score at 2-month follow-up test(baseline and 2 months)
- Change from baseline Magnitude ratio(Accelerometer) at 2-month follow-up test(baseline and 2 months)
- Change from Baseline Pediatric Motor Activity Log (PMAL) score at 2-month follow-up test(baseline and 2 months)
- Change from baseline Use ratio(Accelerometer) at 2-month follow-up test(baseline and 2 months)
研究者
Jeong Yi Kwon
Professor
Samsung Medical Center