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临床试验/NCT03858335
NCT03858335已完成不适用

Therapeutic Effects of Constraint-Induced Movement Therapy on Young Children With Cerebral Palsy

Samsung Medical Center2 个研究点 分布在 2 个国家目标入组 32 人开始时间: 2015年9月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
2
主要终点
Change From Baseline Accelerometers_Vector Magnitude Average Counts(VMA) at Post Test

研究概览

简要总结

This study evaluates the therapeutic effects of constraint-induced movement therapy on infants and children with hemiplegic cerebral palsy. Half of the participants will receive CIMT (constraint-induced movement therapy) and others will not.

详细描述

This study evaluates the therapeutic effects of constraint-induced movement therapy on infants and children with hemiplegic cerebral palsy. Half of the participants will receive CIMT (constraint-induced movement therapy) and others will not.

Participants will be randomly assigned to either CIMT group or control group. Children of the CIMT group will wear forearm splint 24 hours for 3 weeks to inhibit use of the unaffected arm.

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
7 Months 至 36 Months(Child)
性别
All
接受健康志愿者

入选标准

  • spastic hemiplegic cerebral palsy patients
  • 7~36 months old

排除标准

  • cognitive impairment severe enough to make participation impossible
  • uncontrolled epilepsy
  • visual or hearing impairment
  • musculoskeletal disorders

结局指标

主要结局

Change From Baseline Accelerometers_Vector Magnitude Average Counts(VMA) at Post Test

时间窗: baseline and 4 weeks

To evaluate the upper limb use in the real-world, participants wore two accelerometers (one on each wrist). Three variables were measured using accelerometers: vector magnitude average counts (VMA), percent of time in moderate to vigorous physical activity (% MVPA), and use ratio (UR). VMA refers to the magnitude of the resulting vector that forms when combining the sampled acceleration from all three axes.

Change From Baseline Pediatric Motor Activity Log (PMAL) Score at Post Test

时间窗: baseline and 4 weeks

The PMAL was derived from the Motor Activity Log, which is used as an assessment tool in adults who participated CIMT, to measure changes in upper extremity use in real life. This parental assessment tool rates the use of the children's affected upper extremities in daily activities. Twenty-two arm-hand functional tasks that are typical for children aged 7 months to 8 years (e.g., taking off socks or shoes, holding a cup) were assessed and collected as a systemic data. The test has two components: (1) how often (PMAL HO) and (2) how well (PMAL HW). Parents rate PMAL HO on a 6-point scale from 0 (not at all) to 5 (all the time) and PMAL HW from 0 (does not use) to 5 (same as the unaffected arm). This tool has a high test-retest reliability (r=0.94; P\<0.01) and a high internal consistency (Cronbach's α=0.88 to 0.95).

次要结局

  • Change From Baseline Peabody Developmental Motor Scales-2 (PDMS-2) at Post Test(baseline and 4 weeks)
  • Change From Baseline Accelerometers_% Moderate to Vigorous Physical Activity(MVPA) at Post Test(baseline and 4 weeks)
  • Change From Baseline Accelerometers_Use Ratio at Post Test(baseline and 4 weeks)
  • Change From Baseline Gross Motor Function Measure (GMFM) at Post Test(baseline and 4 weeks)
  • Change From Baseline Pediatric Evaluation of Disability Inventory (PEDI) at Post Test(baseline and 4 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeong Yi Kwon

Professor

Samsung Medical Center

研究点 (2)

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